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an ASD Healthcare publication

spring

In side Out

3101 Gaylord Parkway Frisco, Texas 75034 www.asdhealthcare.com

inform + connect + improve

Hi Bernadette Rospigliosi, We hope you find the new issue of InsideOut and this reminder helpful in your healthcare community. — Compliments of your ASD Healthcare Sales Team. Yes, it’s time to plan this year’s flu programs, and ASD Healthcare can help. We offer advantages that reduce your purchasing risks. Now you can protect your community while protecting your facility’s bottom line with:

2011 / 2012

Price protection.  Best return policy.  Most favorable delivery schedules.

For more information, see Page 25 in this issue of InsideOut magazine.

Call ASD Healthcare at 866.281.4FLU (4358) to prebook your vaccines today!

Expert Flu Advice page 12

Social Media

Does it work for pharma?

page 17

Warning:

Bad Bites Ahead!

In side Out inform + connect + improve

page

FLU ALERT: Prebooked is Prepared!

48

Look w hat ’ s

NEW in InsideOut! Bad Bites Ahead gives you the knowledge you need to stay safe this snake bite season.

This quarter, InsideOut magazine takes you into the great outdoors to enjoy nature – safely. Plus, you’ll get these stories to help you stay informed and connected to your healthcare communities.

Which B Strain? Find out what the experts advise for the 2011/2012 flu season.

Save One Life brings hope to hemophilia patients in developing countries.

Accountable Care Organizations? Discover opportunities and challenges for you.

Inhibitor Insights:

When to suspect an inhibitor Also in this issue, see what’s In the Works, In the News and what’s happening in healthcare that affects your world – inside and out.

page 18

Accountable Care Organizations

Opportunities and Challenges

page 36


DILUENT

Available Now in 3000 IU.

XYNTHA

Additional dosing options in 2011. Visit PfizerHemophilia.com to learn more.

New for your hemophilia A patients

For illustration of size only. Please see full Prescribing Information for reconstitution instructions.

Indication for XYNTHA

Xyntha® Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia) and for surgical prophylaxis in patients with hemophilia A. XYNTHA does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand’s disease.

Important Safety Information for XYNTHA

• Anaphylaxis and severe hypersensitivity reactions are possible. Should such reactions occur, treatment with the product should be discontinued, and appropriate treatment should be administered.

• Patients using coagulation factor VIII products should be monitored for inhibitors, which have been detected in patients receiving factor VIII-containing products, including XYNTHA. • The most common adverse reaction in study 1 (safety and efficacy study) is headache (24% of subjects) and in study 2 (surgery study) is fever (41% of subjects). The most common adverse reactions (≥5% of subjects) in clinical studies were headache, fever, nausea, diarrhea, vomiting, and weakness. • Patients may develop hypersensitivity to hamster protein, which is present in trace amounts in XYNTHA.

The only one that’s all-in-one Next-generation purification now in an innovative reconstitution-ready device.1,2 Zero transfer step. More convenience. For the first time ever, factor VIII and diluent come preloaded in a single device for your patients.3

References: 1. Xyntha™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Prescribing Information, Wyeth Pharmaceuticals Inc. April 2008 2. Kelley B, Jankowski M, Booth J. An improved manufacturing process for Xyntha/ReFacto AF. Haemophilia. 2009. doi:10.1111/j.1365-2516.2009.02160.x. 3. Xyntha™ Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Prescribing Information, Wyeth Pharmaceuticals Inc. August 2010.

• XYNTHA is an injectable medicine administered by intravenous (IV) infusion.

Manufactured by Wyeth Pharmaceuticals Inc.

Please see brief summary of Prescribing Information.

271246-01 Copyright © 2010 Pfizer Inc. All rights reserved.

Marketed by Pfizer Inc. December 2010


spring

in the news

In side Out inform + connect + improve

Brief Summary

Surgical Prophylaxis in Patients with Hemophilia A XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for surgical prophylaxis in patients with hemophilia A.

Immunogenicity In Study 1, the incidence of FVIII inhibitors to XYNTHA was the primary safety endpoint. Two subjects with inhibitors were observed in 89 subjects (2.2%) who completed ≥ 50 exposure days. These results were consistent with the pre-specified endpoint that no more than 2 inhibitors may be observed in at least 81 subjects.

CONTRAINDICATIONS—None.

In a Bayesian statistical analysis, results from this study were used to update PTP results from a prior supporting study using XYNTHA manufactured at the initial facility, where one de novo and two recurrent inhibitors were observed in 110 subjects, and the experience with predecessor product (1 inhibitor in 113 subjects). This Bayesian analysis indicates that the population (true) inhibitor rate for XYNTHA, the estimate of the 95% upper limit of the true inhibitor rate, was 4.17%.

WARNINGS AND PRECAUTIONS

DRUG INTERACTIONS—None known.

DOSAGE FORMS AND STRENGTHS XYNTHA is supplied as a white to off-white freeze-dried powder in the following dosages: 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU.

Anaphylaxis and Severe Hypersensitivity Reactions—Allergic type hypersensitivity reactions are possible. Patients should be informed of the early signs or symptoms of hypersensitivity reactions [including hives (rash with itching), generalized urticaria, tightness of the chest, wheezing, and hypotension] and anaphylaxis. Patients should be advised to discontinue use of the product and contact their physicians if these symptoms occur. Neutralizing Antibodies—The occurrence of neutralizing antibodies (inhibitors) is well known in the treatment of patients with hemophilia A. Inhibitors have been detected in patients receiving factor VIII-containing products. Inhibitors are common in previously untreated patients and have been observed in previously treated patients on factor VIII products. Patients using coagulation factor VIII products, including XYNTHA, should be monitored for the development of factor VIII inhibitors. If expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present. If detected, inhibitors should be titered in Bethesda Units (BU). Formation of Antibodies to Hamster Protein—XYNTHA contains trace amounts of hamster proteins. Patients treated with this product could develop hypersensitivity to these non-human mammalian proteins. Monitoring: Laboratory Tests—Monitor plasma factor VIII activity levels by the one-stage clotting assay to confirm that adequate factor VIII levels have been achieved and are maintained, when clinically indicated [see Dosage and Administration in full Prescribing Information]. It is recommended that individual factor VIII values for recovery and, if clinically indicated, other pharmacokinetic characteristics be used to guide dosing and administration. Monitor for development of factor VIII inhibitors. Perform assay to determine if factor VIII inhibitor is present when expected factor VIII activity plasma levels are not attained, or when bleeding is not controlled with the expected dose of XYNTHA. Use Bethesda Units (BU) to titer inhibitors. ADVERSE REACTIONS Clinical Trials Experience—Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Study 1 is a pivotal phase 3 (safety and efficacy) study in which previously treated patients (PTPs) with hemophilia A received XYNTHA for routine prophylaxis and on-demand treatment, 94 subjects received at least one dose of XYNTHA, resulting in a total of 6,775 infusions [see Clinical Studies in full Prescribing Information]. In Study 1, the most frequently reported treatment-emergent adverse reaction was headache (24% of subjects). Other adverse reactions reported in ≥ 5% of subjects were: nausea (6%), diarrhea (5%), asthenia (5%) and pyrexia (5%). No subject developed anti-CHO or anti-TN8.2 antibodies.

page

52 WARNING!

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C - Animal reproduction studies have not been conducted with XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free. It is also not known whether XYNTHA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. XYNTHA should be given to a pregnant woman only if clinically indicated.

Geriatric Use—Clinical studies of XYNTHA did not include subjects aged 65 and over. In general, dose selection for an elderly patient should be individualized.

20

Drug trial delivers positive results for hemophilia patients in poor countries

STORAGE AND HANDLING Product as Packaged for Sale - Store XYNTHA under refrigeration at a temperature of 2° to 8°C (36° to 46°F) for up to 36 months from the date of manufacture until the expiration date stated on the label. XYNTHA may also be stored at room temperature not to exceed 25°C (77°F) for up to 3 months. The starting date at room temperature storage should be clearly recorded in the space provided on the outer carton. At the end of the 3-month period, the product must not be put back into the refrigerator, but must be used immediately or discarded. Do not use XYNTHA after the expiration date stated on the label or after 3 months when stored at room temperature, whichever is earlier. Do not freeze, to prevent damage to the XYNTHA prefilled syringe. During storage, avoid prolonged exposure of XYNTHA to light. Product After Reconstitution - Administer XYNTHA within 3 hours after reconstitution or after removal of the grey rubber tip cap from the XYNTHA prefilled syringe. The reconstituted solution may be stored at room temperature prior to administration. This brief summary is based on the Xyntha [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free] Prescribing Information W10528C004, revised 04/08, and W10547C002, revised 08/10. ®

28

Payer Trends: Specialty Infusible Management Editorial Staff

Article and Advertising Submissions

Marketing manager

Article submissions and suggestions, as well as advertising inquiries may be sent to:

Teri Burgess Copywriter

Christina McFarland Contributing Writers

Dale Dirks Gavin Lindberg Advertising sales

Bernadette Rospigliosi Juli Phillips

Manufactured by Wyeth Pharmaceuticals Inc.

4

insideout

Marketed by Pfizer Inc. All rights reserved.

September 2010

22

Considering Long-Term Health in Your 20s

se a son!

Nursing Mothers—It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, caution should be exercised if XYNTHA is administered to nursing mothers. XYNTHA should be given to nursing mothers only if clinically indicated. Pediatric Use—Pharmacokinetics of XYNTHA was studied in 7 previously treated patients 12-16 years of age. Pharmacokinetic parameters in these patients were similar to those obtained for adults after a dose of 50 IU/kg. For these 7 patients, the mean (± SD) Cmax and AUC∞ were 1.09 ± 0.21 IU/mL and 11.5 ± 5.2 IU·h/mL, respectively. The mean clearance and plasma half-life values were 5.23 ± 2.36 mL/h/ kg and 8.03 ± 2.44 hours (range 3.52 – 10.6 hours), respectively. The mean K-value and in vivo recoveries were 2.18 ± 0.41 IU/dL per IU/kg and 112 ± 23%, respectively.

18

Inhibitor Insights: When to Suspect an Inhibitor

Snake bite

Labor and Delivery—There is no information available on the effect of factor VIII replacement therapy on labor and delivery. XYNTHA should be used only if clinically indicated.

Advertising Coordinator

270327-01 Copyright © 2010 Pfizer Inc.

Radiologist reviews iPad imaging apps

Graphic Designer

ASD Healthcare attn: InsideOut Marketing 3101 Gaylord Parkway Frisco, Texas 75034 or by email: Sarah.Millecker@asdhealthcare.com

12

35

44

81 in the works

XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is indicated for the control and prevention of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia). XYNTHA does not contain von Willebrand factor, and therefore is not indicated in patients with von Willebrand’s disease.

“Keep Current Flu Strains in Vaccine”

17

in the community

Control and Prevention of Bleeding Episodes in Hemophilia A

12

in the spotlight

INDICATIONS AND USAGE

Study 2 (surgery) is an open-label, single-arm study of at least 25 evaluable PTPs with severe or moderately severe hemophilia A (factor VIII activity in plasma [FVIII:C] ≤ 2%) who required elective major surgery and were planned to receive XYNTHA replacement therapy for at least 6 days post-surgery. Twenty-two subjects received at least one dose of XYNTHA, resulting in 766 infusions [see Clinical Studies in full Prescribing Information]. In Study 2, the most frequently reported treatmentemergent adverse reaction was pyrexia (41% of subjects). Other adverse reactions reported in ≥ 5% of subjects were: headache (9%), nausea (9%), diarrhea (5%), vomiting (5%) and asthenia (5%). The adverse reactions reported in either study were considered mild or moderate in severity.

in the news

See package insert for full Prescribing Information. For further product information and current package insert, please visit XYNTHA.com or call Wyeth Pharmaceuticals toll-free at 1-800-934-5556.

ASD Healthcare is committed to providing our customers with timely, relevant information. In the coming months, InsideOut will include articles and sections that are important to you and your business. As we move forward, we are reaching out to you, our valued customers, for ideas and input on topics you would like to see covered. Please send your thoughts, ideas and suggestions for making this a dynamic and interesting publication to ASD Healthcare’s Marketing Coordinator — Sarah Millecker (Sarah.Millecker@asdhealthcare.com).

Wes Geiger Information presented in this publication is not intended as a substitute for the personalized advice given by a healthcare provider. Although ASD Healthcare strives to present only current and accurate information, readers should not consider it as professional advice or endorsement of any position. Although great care has been taken in compiling and checking the information given in this publication to ensure accuracy, the authors, ASD Healthcare, and its employees or agents shall not be responsible or in any way liable for the continued currency of the information or for any errors, omissions, or inaccuracies in this catalog, whether arising from negligence or otherwise or for any consequence arising therefrom.

Spring 2011

5


With Alphanate® you have a choice! Packaged with Mix2Vial® Filter Transfer Set Say “hello” to the great outdoors. With summer on its way and the kids out of school, it’s the perfect time to step outside, go on an adventure and enjoy nature. It’s also a time to remember that the season does come with a mixture of the good (outdoor adventures), the bad (this year, it’s certain to be gas prices) and in some cases the deadly – specifically snake bites. To help you “be prepared,” this issue of InsideOut gives you information you need to know in Bad Bites Ahead: Staying Safe this Snake Bite Season (Page 52). Most of us don’t spend our time thinking about snake bites, but when we venture out into areas where they live, it does happen. In fact, there are about 8,000 snake bites in the U.S. each year, some resulting in death. And those most vulnerable to lethal bites are children. That number could rise this year due to the wide spread flooding in the North Central United States and along the Mississippi River through the South. Flood waters have flushed snakes and other animals out of their natural habitats and into areas where we don’t expect to encounter them. Bad Bites Ahead will show you how to play it safe and what to do in an emergency. Plus, you’ll find updates on anti-venom vaccines that save lives. ASD Healthcare is proud to support Save One Life in this issue by featuring it and its upcoming fundraiser, Climb for a Cause. This August, I will have the privilege of joining Save One Life in a true outdoor adventure. I’ll be joining a group, including Save One Life Founder Laurie Kelley, and scaling the highest mountain in Africa –  19,340 foot Mt. Kilimanjaro. It’s an adventure with a purpose – to raise funds and put a spotlight on hemophilia care in Africa.

VWF:RCo and FVIII potency on vial labels and folding cartons

Potency

Diluent Size

250 IU FVIII Range

5 mL

500 IU FVIII Range

5 mL

1000 IU FVIII Range

10 mL

1500 IU FVIII Range

10 mL

For further information call: Grifols USA, LLC Professional Service: 888 GRIFOLS (888 474 3657) Customer Service: 888 325 8579 Fax: 323 441 7968 www.grifols.com

6

Grifols Biologicals Inc. 5555 Valley Boulevard, Los Angeles, California 90032, USA insideout

A8L10-23-US-10

Available in the following potencies and color coded assay ranges

I’d like to encourage readers and professionals who serve the hemophilia community to reach the top with us by supporting your favorite climber in this event. (Did I mention that I will be one of the climbers?) The article on page 44 will give you more details and how you can support a climber in this life-saving mission. May 13 proved to be a lucky day for the three winners of our MP3-Player drawing (see You’re a Winner on Page 49). Their names were drawn from the hundreds of content survey cards sent in by readers like you. It was my pleasure to call the winners, tell them the good news and thank them for their comments. I’d also like to say, “thank you” to all of you for sending in your survey cards and sharing your thoughts. Your input is vital in helping us make InsideOut a magazine that works for your profession and your life. As ASD Healthcare looks for new ways to customize its content for you, we welcome your ongoing ideas, suggestions and insights about the news you want to read. This vision for InsideOut is an extension of our True Blue philosophy at ASD Healthcare. It reflects our commitment to building superior customer relationships and delivering the superior support you turn to in business and in your communities. We hope you’ll share this InsideOut with your patients, family and friends for a season of outdoor adventures that are both safe and rewarding. Sincerely,

Neil Herson, President on behalf of ASD Healthcare

inside out: (adv) to a thorough degree <knows the subject inside out>

Spring 2011

7


Introducing

Flebogamma 10%DIF ®

For your convenience

Enhancing our commitment to you

• Liquid • Room temperature storage 2-25° C (36-77° F) for the entire 2-year shelf life • Three presentations: 5, 10 and 20 gram vials

• Every vial is laser etched with its own unique identifier number*, which helps to deter tampering and counterfeiting • PediGri® On Line, unique to Grifols, offers full traceability from donation to the final product at www.pedigri.grifols.com

Immune Globulin Intravenous (Human)

* Laser etched identifier number may at times be covered by the label.

Highly purified IGIV • Trace amounts of IgA: <0.006 mg/mL (specification value: <0.1 mg/mL) • Very low sodium content • Sorbitol stabilized

Broad pathogen safety margin

• Seven validated pathogen elimination steps including: - 20 nm nanofiltration - Dual specific inactivation: pasteurization and solvent detergent • Highly effective process: Demonstrated benefits in replacement - 15.0 log reduction of PPV (PVB19 model) therapy - ≥ 13.3 log reduction of EMCV (HAV model) • In the pre-approval clinical trial: 2 - ≥ 6.2 log reduction through 4% PEG precipitation - 0.025 serious bacterial infections/patient/year and ≥ 5.5 log reduction through 20 nm nanofiltration - Well tolerated: Does not put patients at increased risk of an experimental agent considered a model for the for any adverse events other than those that could be vCJD and CJD agents 3 reasonably expected in primary immune deficiency patients who are receiving an infusion of intravenous immune globulin 1

Important Safety Information Flebogamma® 10% DIF is a human immune globulin intravenous (IGIV) that is indicated for the treatment of primary immune deficiency (PI), including the humoral immune defect in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott - Aldrich syndrome.

WARNING: ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE • Use of immune globulin intravenous (IGIV) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death (1). Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or those receiving known nephrotoxic drugs (see Warnings and Precautions [5.2]). Flebogamma® 10% DIF does not contain sucrose. • For patients at risk of renal dysfunction or failure, administer Flebogamma® 10% DIF at the minimum infusion rate practicable (see Dosage and Administration [2.3], Warnings and Precautions [5.2]). Flebogamma® 10% DIF is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to the administration of human immune globulin and in IgA deficient patients with antibodies to IgA and a history of hypersensitivity. In case of hypersensitivity, discontinue Flebogamma® 10% DIF infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions. In patients at risk for developing acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine, and urine output. Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving Flebogamma® 10% DIF therapy. Thrombotic events may occur during or following treatment with Flebogamma® 10% DIF. Monitor patients at risk for thrombotic events, including those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and known or suspected hyperviscosity. Aseptic meningitis syndrome (AMS) may occur infrequently with Flebogamma® 10% DIF treatment. AMS may occur more frequently following high doses and/or rapid infusion of IGIV.

Please see reverse for Important Safety Information and Black Box Warning. (1) Data on file, Instituto Grifols, S. A. (2) Berger M. et al. Efficacy, Pharmacokinetics, Safety and Tolerability of Flebogamma® 10% DIF, a high purity human intravenous immunoglobulin in primary immunodeficiency. J Clin Immunol 2010; 30 (2): 321-9. (3) Diez JM, et al. Capacity of the manufacturing process of Flebogamma® DIF, a new human high purity intravenous immunoglobulin, to remove a TSE model-agent. Biologicals (2010), doi:10.1016/j.biologicals.2010.08.003.

Flebogamma® 10% DIF may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis. Non-cardiogenic pulmonary edema [Transfusion-Related Acute Lung Injury (TRALI)] may occur in patients following Flebogamma® 10% DIF

treatment. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient serum. All patients, but especially individuals receiving Flebogamma® 10% DIF for the first time or being restarted on the product after a treatment hiatus of more than 8 weeks, may be at a higher risk for the development of fever, chills, nausea, and vomiting. Careful monitoring of recipients and adherence to recommendations regarding dosage and administration may reduce the risk of these types of events. Because Flebogamma® 10% DIF is made from human plasma, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for Flebogamma® 10% DIF. The most common adverse reactions (reported in ≥ 5% of clinical trial subjects) occurring during or within 72 hours of the end of an infusion were headache, chills, fever, shaking, fatigue, malaise, anxiety, back pain, muscle cramps, abdominal cramps, blood pressure changes, chest tightness, palpitations, tachycardia, nausea, vomiting, cutaneous reactions, wheezing, rash, arthralgia, and edema. The most serious adverse reactions observed with Flebogamma® 10% DIF were back pain, chest discomfort, and headache (2 patients); and chest pain, maculopathy, rigors, tachycardia, bacterial pneumonia, and vasovagal syncope (1 patient). Please refer to enclosed Flebogamma® 10% DIF full prescribing information for full prescribing details, including comprehensive adverse event profile and black box warning.

See the difference today

FDA04-1-US-10

Shaping the future


Hemolysis Flebogamma® 10% DIF may contain blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin reaction and hemolysis (5-6). Delayed hemolytic anemia may develop subsequent to Flebogamma® 10% DIF therapy due to enhanced RBC sequestration (7), and acute hemolysis, consistent with intravascular hemolysis, has been reported.

Immune Globulin Intravenous (Human)

Flebogamma® 10% DIF For intravenous use only RX only

BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE Flebogamma® 10% DIF is a human immune globulin intravenous (IGIV) that is indicated for the treatment of primary immune deficiency (PI), including the humoral immune defect in common variable immunodeficiency, x-linked agammaglobulinemia, severe combined immunodeficiency, and Wiskott - Aldrich syndrome. DOSAGE AND ADMINISTRATION The recommended dose of Flebogamma® 10% DIF for patients with PI is 300 to 600 mg/kg body weight (3.0 to 6.0 mL/kg), administered every 3 to 4 weeks. The infusion of Flebogamma® 10% DIF should be initiated at a rate of 0.01 mL/kg body weight/minute (1.0 mg/kg/minute). If there are no adverse drug reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate of 0.08 mL/kg/minute (8 mg/kg/minute). Ensure that patients with pre-existing renal insufficiency are not volume depleted. For patients judged to be at risk for renal dysfunction or thrombotic events, administer Flebogamma® 10% DIF at the minimum infusion rate practicable, and consider discontinuation of administration if renal function deteriorates. CONTRAINDICATIONS Flebogamma® 10% DIF is contraindicated in patients who have had a history of anaphylactic or severe systemic reactions to the administration of human immune globulin and in IgA deficient patients with antibodies to IgA and a history of hypersensitivity. WARNINGS AND PRECAUTIONS

WARNING: ACUTE RENAL DYSFUNCTION AND ACUTE RENAL FAILURE • Use of immune globulin intravenous (IGIV) products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death (1). Patients at risk of acute renal failure include those with any degree of pre-existing renal insufficiency, diabetes mellitus, advanced age (above 65 years of age), volume depletion, sepsis, paraproteinemia, or those receiving known nephrotoxic drugs (see Warnings and Precautions [5.2]). Flebogamma® 10% DIF does not contain sucrose. • For patients at risk of renal dysfunction or failure, administer Flebogamma 10% DIF at the tminimum infusion rate practicable (see Dosage and Administration [2.3], Warnings and Precautions [5.2]). ®

• Weigh the potential risks and benefits of Flebogamma® 10% DIF against those of alternative therapies in all patients for whom Flebogamma® 10% DIF is being considered. • Before prescribing Flebogamma® 10% DIF, the physician should discuss risks and benefits of its use with patients. Hypersensitivity Severe hypersensitivity reactions may occur. In case of hypersensitivity, discontinue Flebogamma® 10% DIF infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions. Renal Dysfunction/Failure Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of Flebogamma® 10% DIF and at appropriate intervals thereafter. If renal function deteriorates, consider discontinue use of Flebogamma® 10% DIF. In patients who are at risk of developing renal dysfunction because of pre-existing renal insufficiency or predisposition to acute renal failure, administer Flebogamma® 10% DIF at the minimum rate of infusion practicable. Hyperproteinemia Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving Flebogamma® 10% DIF therapy. It is clinically critical to distinguish true hyponatremia from a pseudo-hyponatremia that is temporally or causally related to hyperproteinemia with concomitant decreased calculated serum osmolarity or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a higher risk of thrombotic events.

Monitor patients for clinical signs and symptoms of hemolysis. If signs and/or symptoms of hemolysis are present after Flebogamma® 10% DIF infusion, perform appropriate confirmatory laboratory testing (see Patient Counseling Information [17]). Transfusion-Related Acute Lung Injury (TRALI) Non-cardiogenic pulmonary edema may occur in patients following Flebogamma® 10% DIF treatment (11). TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours following treatment. Monitor patients for pulmonary adverse reactions (see Patient Counseling Information [17]). If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support. Infusion Reactions All patients, but especially individuals receiving Flebogamma® 10% DIF for the first time or being restarted on the product after a treatment hiatus of more than 8 weeks, may be at a higher risk for the development of fever, chills, nausea, and vomiting. Careful monitoring of recipients and adherence to recommendations regarding dosage and administration may reduce the risk of these types of events (see Dosage and Administration [2.3]). Transmissible Infectious Agents Because Flebogamma® 10% DIF is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for Flebogamma 10% DIF. All infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Biologicals at 1-888-474-3657. Before prescribing or administering Flebogamma® 10% DIF, the physician should discuss the risks and benefits of its use with the patient (see Patient Counseling Information [17]). Monitoring: Laboratory Tests • Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of Flebogamma® 10% DIF and at appropriate intervals thereafter. • Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis. • If signs and/or symptoms of hemolysis are present after an infusion of Flebogamma® 10% DIF, perform appropriate laboratory testing for confirmation. • If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies and anti-HLA antibodies in both the product and patient’s serum. Interference with Laboratory Tests After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test. Adverse Reactions The most common adverse reactions (reported in ≥ 5% of clinical trial subjects) occurring during or within 72 hours of the end of an infusion were headache, chills, fever, shaking, fatigue, malaise, anxiety, back pain, muscle cramps, abdominal cramps, blood pressure changes, chest tightness, palpitations, tachycardia, nausea, vomiting, cutaneous reactions, wheezing, rash, arthralgia, and edema. The most serious adverse reactions observed with Flebogamma® 10% DIF were back pain, chest discomfort, and headache (2 patients); and chest pain, maculopathy, rigors, tachycardia, bacterial pneumonia, and vasovagal syncope (1 patient). Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In a multicenter, open-label, non-randomized, historically controlled clinical study, 46 individuals with primary humoral immunodeficiency received infusion doses of Flebogamma 10% DIF at 300 to 600 mg/kg body weight every 3 weeks (mean dose 469 mg/kg) or 4 weeks (mean dose 457 mg/kg) for up to 12 months (see Clinical Studies [14.1]). Routine pre-medication was not allowed. Of the 601 infusions administered, 130 infusions (22%) in 21 (47%) subjects were given pre-medications (antipyretic, antihistamine, or antiemetic agent) because of experience with consecutive infusion-related adverse reactions.

Thrombotic events may occur during or following treatment with Flebogamma® 10% DIF. Monitor patients at risk for thrombotic events, including those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and known or suspected hyperviscosity.

One subject experienced four serious adverse events (AEs, bacterial pneumonia, subcutaneous abscess and two episodes of cellulitis) and withdrew from the study. Two other subjects who participated in the study discontinued prematurely due to AEs (back pain/chest pain/headache; and chills/tachycardia). Three subjects experienced four serious non-related AEs (drug abuse/depression; hernia; and sinusitis).

Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients judged to be at risk of developing thrombotic events, administer Flebogamma® 10% DIF at the minimum rate of infusion practicable (see Dosage and Administration [2.3]).

Forty-five (98%) subjects experienced at least 1 AE irrespective of the relationship with the product, and these subjects reported a total of 723 AEs. Thirty-eight subjects (83%) had an adverse reaction at some time during the study that was considered product-related. Of the 21 subjects receiving pre-medications, 12 (57%) subjects reported adverse reactions during or within 72 hours after the infusion in 48 of the 130 pre-medicated infusions (37%).

Aseptic Meningitis Syndrome (AMS) AMS may occur infrequently with Flebogamma® 10% DIF treatment. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae (3-4). AMS is characterized by the following signs and symptoms: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting (see Patient Counseling Information [17]). Cerebrospinal fluid (CSF) studies frequently reveal pleocytosis up to several thousand cells per cubic millimeter, predominantly from the granulocytic series and elevated protein levels up to several hundred mg/dL, but negative culture results. Conduct a thorough neurological examination to patients exhibiting such signs and symptoms, including CSF studies, to rule out other causes of meningitis. AMS may occur more frequently following high doses (2 g/kg) and/or rapid infusion of IGIV.

Table 2. Treatment-related Adverse Events Occurring in ≥ 5% of Subjects with PI during a Flebogamma® 10% DIF Infusion or within 72 Hours after the End of an infusion Adverse Event

Adverse Event

Subjects (%) [N=46]

Infusions (%) [N=601]

Back pain

8 (17%)

27 (5%)

Myalgia

8 (17%)

17 (3%)

Body temperature increased

4 (9%)

6 (1%)

Nausea

4 (9%)

6 (1%)

Pain

4 (9%)

8 (1%)

Chest discomfort

3 (7%)

4 (1%)

Chest pain

3 (7%)

5 (1%)

Infusion site reaction

3 (7%)

4 (1%)

Pain in extremity

3 (7%)

3 (0.5%)

The total number of adverse events occurring during or within 72 hours after the end of an infusion, irrespective of causality, was 359, excluding non-serious infections. Table 3 lists the AEs that occurred in greater than 5% of subjects during a Flebogamma® 10% DIF infusion or within 72 hours after the end of an infusion, irrespective of causality. Table 3. Adverse Events Occurring in ≥ 5% of Subjects with PI during a Flebogamma® 10% DIF Infusion or within 72 Hours after the End of an infusion, Irrespective of Causality Adverse Event

Subjects (%) [N=46]

Infusions (%) [N=601]

Headache

28 (61%)

71 (12%)

Pyrexia

17 (37%)

27 (5%)

Rigors

17 (37%)

37 (6%)

Back pain

13 (28%)

29 (5%)

Cough or Productive cough

12 (26%)

5 (1%)

Nausea

12 (26%)

8 (1%)

Hypotension

10 (22%)

13 (2%)

Tachycardia

10 (22%)

19 (3%)

Myalgia

9 (20%)

17 (3%) 2 (0.3%)

Diarrhea

8 (17%)

Infusion site reaction

8 (17%)

8 (1%)

Pharyngolaryngeal pain

7 (15%)

3 (1%)

Nasal congestion

7 (15%)

2 (0.3%)

Postnasal drip

7 (15%)

4 (1%)

Arthralgia

6 (13%)

2 (0.3%)

Conjunctivitis

6 (13%)

2 (0.3%)

Pain

6 (13%)

10 (2%)

Vomiting

6 (13%)

0 (0%)

Dizziness

5 (11%)

3 (1%) 1 (0.2%)

Fatigue

5 (11%)

Urinary tract infection

5 (11%)

4 (1%)

Chest pain

5 (11%)

4 (1%)

Ear pain

5 (11%)

1 (0.2%)

Pain in extremity

5 (11%)

2 (0.3%)

Dyspnea

5 (11%)

0 (0%)

Rhinorrhea

4 (9%)

1 (0.2%)

Wheezing

4 (9%)

4 (1%)

In this study, the upper bound of the 1-sided 95% confidence interval for the proportion of Flebogamma® 10% DIF infusions associated with one or more AEs was 37.8% (total infusions: 208; actual proportions: 34.6%). The average percent of infusions with AEs during or within 72 hours after the end of an infusion for each individual subject was 36.7% and the upper bound of the 1-sided 95% confidence interval was 43.9%. AE reporting was based upon a clinical protocol precluding pre-medication against AEs. Pre-medication could be utilized only after the first 2 infusions only in those patients that exhibited adverse events. Forty-three of the 46 subjects enrolled in this study had a negative Coombs test at baseline. Of these 43 subjects, 10 (23.3%) developed a positive Coombs test at some time during the study. However, no subjects showed evidence of hemolytic anemia. Post-marketing Experience Because adverse reactions are reported voluntarily post-approval from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. The following adverse reactions have been identified during post approval use of intravenous immune globulins, including Flebogamma 5% (see References [15]). Infusion reactions

Renal Respiratory

Cardiovascular Neurological Integumentary Hematologic Musculoskeletal Gastrointestinal General/Body as a Whole

Hypersensitivity (e.g., anaphylaxis), headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, urticaria or other skin reactions, wheezing or other chest discomfort, nausea, vomiting, rigors, back pain, myalgia, arthralgia, and changes in blood pressure Acute renal dysfunction/failure, osmotic nephropathy Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion-Related Acute Lung Injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm Cardiac arrest, thromboembolism, vascular collapse, hypotension Coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome Stevens-Johnson Syndrome, epidermolysis, erythema multiformae, dermatitis (e.g., bullous dermatitis) Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs) test Back pain Hepatic dysfunction, abdominal pain Pyrexia, rigors

DRUG INTERACTIONS Passive transfer of antibodies may transiently impair the immune response to live attenuated virus vaccines such as measles, mumps, and rubella. Inform the immunizing physician of recent therapy with Flebogama® 10% DIF so that appropriate measures may be taken (see Patient Counseling Information [17]). USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Animal reproduction studies have not been performed with Flebogamma® 10% DIF. It is also not known whether Flebogamma® 10% DIF can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Flebogamma® 10% DIF should be given to a pregnant woman only if clearly needed. Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. Nursing Mothers Use of Flebogamma® 10% DIF has not been evaluated in nursing mothers. Pediatric Use Three (3) pediatric patients with primary humoral immunodeficiency (two between the ages of 6 and 10, and one 16 year old) were included in the clinical evaluation of Flebogamma® 10% DIF. This number of subjects is too small to establish safety and efficacy in the pediatric population (see Clinical Studies [14]). Geriatric Use Use caution when administering Flebogamma® 10% DIF to patients over 65 years of age who are judged to be at increased risk for developing certain adverse reactions such as thromboembolic events and acute renal failure (see Boxed Warning, Warnings and Precautions [5.2]). Do not exceed the recommended dose, and infuse Flebogamma® 10% DIF at the minimum infusion rate practicable. One (1) patient with primary humoral immunodeficiency at or over the age of 65 was included within the clinical evaluation of Flebogamma® 10% DIF. This number of geriatric patients was too small for separate evaluation from the younger patients for safety or efficacy (see Clinical Studies [14]). HOW SUPPLIED/STORAGE AND HANDLING Flebogamma® 10% DIF is supplied in single-use, individually laser etched vials containing the labeled amount of functionally active IgG. The following presentations of Flebogamma® 10% DIF are available:

NDC Number

Fill Size

Grams Protein

Body temperature increased

4 (9%)

6 (1%)

61953-0005-1

50 mL

5g

Neck pain

4 (9%)

2 (0.3%)

61953-0005-2

100 mL

10g

Sinus pain

4 (9%)

1 (0.2%)

61953-0005-3

200 mL

20g

Chest discomfort

4 (9%)

4 (1%)

Each vial has an integral suspension band and a label with two peel-off strips showing the product name and lot number. DO NOT FREEZE. When stored at room temperature (up to 25 ºC [77 ºF]), Flebogamma® 10% DIF is stable for up to 24 months, as indicated by the expiration date printed on the outer carton and container label.

Crackles lung

4 (9%)

2 (0.3%)

Abdominal pain

3 (7%)

2 (0.3%)

Dyspepsia

3 (7%)

1 (0.2%)

Toothache

3 (7%)

0 (0%)

Gastroesophageal reflux disease

3 (7%)

0 (0%)

Subjects (%) [N=46]

Infusions (%) [N=601]

Headache

24 (52%)

67 (11%)

Lymphadenopathy

3 (7%)

3 (1%)

Rigors

17 (37%)

37 (6%)

Respiratory tract congestion

3 (7%)

0 (0%)

Pyrexia

15 (33%)

27 (5%)

Fall

3 (7%)

1 (0.2%)

Tachycardia

10 (22%)

18 (3%)

Hypertension

3 (7%)

4 (1%)

Hypotension

9 (20%)

11 (2%)

Keep Flebogamma® 10% DIF in its original carton to protect it from light.

Manufactured by INSTITUTO GRIFOLS, S.A. Barcelona - Spain U.S. License No. 1181 Distributed by GRIFOLS BIOLOGICALS Inc. Los Angeles - CA 90032 Phone: 888-GRIFOLS (888-474-3657)


in the news Advisers Say:

“Keep Current Flu Strains in Vaccine”

D

uring the meeting of the Federal Drug Administration’s Vaccines and Related Biological Products Advisory Committee, held in Bethesda, Md., the 16 advisers voted unanimously to retain the current influenza type A H3N2 and influenza B strains in next season’s (2011-2012) vaccine formulation. The specific recommendations are for an A/California/7/2009-like H1N1 virus, an A/Perth/16/2009-like H3N2 virus, and a /Brisbane/60/2008-like virus. This is the same Northern Hemisphere recommendation made days earlier by the World Health Organization. Influenza Activity At the time of the late February meeting, 44 states had widespread influenza activity, and 35 pediatric deaths from influenza had been reported to the Centers for Disease Control and Prevention (CDC). Nancy Cox, director of CDC’s Influenza Division, said the pandemic-causing H1N1 influenza strain that emerged in 2009 has essentially supplanted the seasonal H1N1 viruses that caused illness before the pandemic. From Aug. 29, 2010, through Jan. 29, 2011, Cox said, global surveillance laboratories identified a total of six specimens of former seasonal H1N1 viruses. Cox said these viruses came from five countries, including the United States, and “were resistant to oseltamivir but sensitive to zanamivir.”

“As is often the case, making a decision about which influenza B strain to recommend for the upcoming flu season caused problems.”

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Which B Strain? As is often the case, making a decision about which influenza B strain to recommend for the upcoming flu season caused problems for the expert panel. “We are always struggling with this B issue,” said Pamela McInnes of the National Institutes of Health. Two distinct types of influenza B strains, known as Victoria-lineage and Yamagata-lineage viruses, typically circulate each year. FDA’s advisers must predict, on the basis of recent surveillance data, which lineage is likely to circulate in the United States in the upcoming flu season and recommend a corresponding vaccine strain.

In most of the world, Victoria-lineage strains similar to those in this season’s U.S. vaccines have been the main strains circulating. But in China, strains of the Yamagata-lineage have been responsible for most influenza B infections. A big unknown factor is whether Yamagata-lineage viruses will overtake Victoria-lineage viruses in the Southern Hemisphere this summer and then surge into the Northern Hemisphere in the fall. By midsummer, U.S. vaccine production is well underway, and introducing a new strain into the vaccine would be problematic for manufacturers. “It’s very difficult to predict what’s going to happen with the influenza B virus,” Cox said. “We simply have to make the best judgment we can based on the information that we have at the time.” Questions about effectiveness Worldwide surveillance data from the Department of Defense (DOD) suggest that this season’s vaccine is not performing robustly, said Navy Captain Kevin Russell, director of DOD’s Global Emerging Infectious Surveillance and Response System. “We’re seeing a dramatic increase in H1N1 among our service members, particularly among our recruits,” Russell said. He said live attenuated influenza virus (LAIV) appears to be less effective among the military than trivalent inactivated vaccine formulations. Russell said one study of new recruits, all of whom were vaccinated with LAIV, indicated that it was 81% effective overall but just 41% effective against H1N1. A small study of active-duty personnel that excluded recruits suggested a 59% overall effectiveness for trivalent inactivated influenza vaccines, compared with 30% for LAIV. Russell said the studies used different methods but all suggest the same thing: “There appears to be poor protection against H1N1, particularly with LAIV.” 

Source: “Advisers Say Keep Current Flu Strains in Vaccine,” American Journal of Health-System Pharmacy, 1 Apr. 2011, http://www.ajhp.org

Bayer HealthCare

Gadavist injection gets FDA approval

Corifact Licensed for Factor XIII Deficiency In February the FDA announced the licensing of Corifact for the prevention of bleeding in people with congenital factor XIII deficiency. The CSL Behring product is made from purified plasma from healthy donors, according to the FDA. New U.S. labeling for Corifact is not yet available. According to FDA, congenital factor XIII deficiency is a rare disease that may cause soft-tissue bruising, mucosal bleeding and fatal intracranial bleeding. About 1

NORD Presents

CSL Behring with 2011 Corporate Award CSL Behring, a global biotherapeutics company specializing in plasma-derived and recombinant therapies and a subsidiary of CSL Limited (ASX:CSL), is a recipient of the National Organization for Rare Disorders (NORD) 2011 Corporate Award. The award was presented at the NORD Partners in Progress Celebration 2011 for “new treatments brought to market for patients with rare diseases.” CSL Behring’s new treatment, factor XIII concentrate (human), is approved for the routine prophylactic treatment of congenital factor XIII deficiency, an extremely rare and potentially lifethreatening bleeding disorder. Factor

of every 3–5 million people are estimated to have the congenital deficiency. Corifact was approved under FDA’s accelerated approval process. According to the agency, the approval was granted on the basis of a study involving 14 adults and children with congenital factor XIII deficiency. According to the FDA, the most common adverse events associated with Corifact use in clinical studies were hypersensitivity reactions, chills, fever, arthralgia, headache, elevated thrombin–antithrombin levels and elevated liver enzymes. 

XIII concentrate (human) is the first and only dual sub-unit FXIII concentrate. It contains both A and B sub-units to treat FXIII patients regardless of sub-unit deficiency. Congenital factor XIII deficiency is estimated to affect one person in two million, with an incidence in the U.S. of approximately 150 people. “CSL Behring is honored to receive this NORD Corporate Award,” said Paul Perreault, CSL Behring Executive Vice President for Worldwide Commercial Operations and incoming president. “People with rare diseases often face a host of challenges in being accurately diagnosed and in gaining ongoing access to appropriate medical care. CSL Behring focuses on these areas and partners with groups such as NORD to improve patients’ lives. We commend NORD for their outstanding achievements

Bayer HealthCare Pharmaceuticals has received U.S. Food and Drug Administration’s approval for its Gadavist (gadobutrol) injection for the detection and visualization of areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in diagnostic magnetic resonance imaging in adults and children (2 years of age and older). According to Bayer HealthCare, Gadavist demonstrated improvement of visualization endpoints in paired Gadavist images compared to pre-contrast images resulted in improved assessment of normal and abnormal CNS anatomy in two Phase III trials. John Rotondo, Bayer HealthCare Commercial Operations, said the approval of Gadavist enriches their portfolio of MRI contrast media and provides a new option for U.S. healthcare providers in contrastenhanced imaging of the CNS.  Source: © 1994-2011 by Medscape. All Rights Reserved. (http://www.medscape.com/public/copyright)

and dedication to supporting people with rare diseases.” This award is the most recent in a series of recognitions for CSL Behring’s innovative therapies used to treat rare and serious diseases. NORD previously honored CSL Behring for developing fibrinogen concentrate (human) for treating acute bleeding episodes in patients in the U.S. with congenital fibrinogen deficiency (CFD). NORD is a leading patient advocacy organization whose mission is to advance the causes of people with rare diseases. They provide support for orphan product research – products used to treat serious conditions that affect fewer than 200,000 people – and they develop and advocate on public policy issues before Congress and health agencies.  Source: www.cslbehring.com

Spring 2011

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Important Safety Information Privigen is indicated for the treatment of patients with primary immunodeficiency (PI) associated with defects in humoral immunity, including but not limited to common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. WARNING: Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with the administration of Immune Globulin Intravenous (Human) (IVIg) products in predisposed patients. Administer IVIg products at the minimum infusion rate possible. Renal dysfunction and acute renal failure occur more commonly in patients receiving IVIg products containing sucrose. Privigen does not contain sucrose. See full Prescribing Information for complete Boxed Warning. Privigen is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Privigen is manufactured by CSL Behring AG and distributed by CSL Behring LLC. Privigen is a registered trademark of CSL Behring AG. ©2010 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring-us.com www.Privigen.com 09-PVG-051 4/2010

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In patients at risk for developing renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine. Thrombotic events have been reported with Privigen and other IVIg treatments. Monitor patients with risk factors for thrombotic events, including a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. Aseptic meningitis syndrome (AMS) may occur infrequently with Privigen and other IVIg treatments; AMS may occur more frequently with high doses and/or rapid infusion of IVIg. Hemolysis, hemolytic anemia, and pulmonary adverse events have also been reported. There have been reports of noncardiogenic pulmonary edema in patients administered IVIg. If transfusion-related acute lung injury is suspected, test product and patient for antineutrophil antibodies. Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. In clinical studies, the most common adverse reactions with Privigen were headache, pain, nausea, pyrexia/hyperthermia, fatigue, and chills. Please see brief summary of full Prescribing Information on following pages.

Spring 2011

15


in the news Life Science Companies Not Rushing to Social Networking

T

he FDA hasn’t yet weighed in on how pharma should be using social media without running afoul of the agency’s rules on drug marketing. And that, says a report from Deloitte, is one of the chief reasons more life sciences companies haven’t embraced social networking more aggressively. The results are based on interviews with life sciences company executives and an online survey of 208 life sciences marketing and risk management professionals.

41%

Company currently uses online social networks to seek or disseminate information

21% Plans to

38%

No plans to do so

Even after the FDA issues guidance, 53% of respondents expect there to be confusion about how life sciences companies can use things like Facebook and Twitter. Some 28% say their companies are waiting to see from others’ experiences what the return on investment in social media efforts will be. Of those respondents who are already engaged in social media, more than half say they’re using them to disseminate information, 42% to proactively seek information and 23% to react or respond to information posted on an online social network. There are “significant” risks for companies using social media. Deloitte says data collection is least risky since most social network users have already agreed to swap personal data for the free use of the network. It’s the information dissemination that has the big risks, because of the FDA’s marketing rules. The agency “worries that conversation could result in off-label promotion, unfair or unbalanced portrayals of therapy risks and benefits, and failure to report adverse events,” the report says.  Source: HealthBlog at blogs.wsj.com/health

Radiologist reviews iPad® imaging apps

Expect “a lot of the Apple® iPad® in our departments –  and, more importantly, outside the radiology suite,” says Sam Friedman, CTO and Director for Nuclear Medicine at Pitts Radiology in South Carolina. Friedman also is a radiology blogger at Doctor Dalai’s. He doesn’t expect that radiologists will replace their PC-based picture archiving and communications systems overnight, but rather at the pace of software and hardware developments. He reviews current radiology viewing apps for the iPhone in advance. They include offerings from Merge Healthcare, OsiriX, iCRco Inc, MIM Software and Calgary Scientific.

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The current offerings are “bare-bones programs,” he writes, with much code devoted to file management. Most function as extensions of their desktop viewer counterparts. He does find that the current crop functions well in magnified mode. The viewers have disclaimers against their use for diagnosis – something that Friedman says he won’t dispute. And he notes that computed radiography exams “don’t look as good on the iPad as the cross-sectional modalities.” But the iPad screen should be adequate for diagnosis, he reasons. “How many of us use standard Dell consumer-grade monitors here and there instead of ‘proper’ medicalgrade equipment?”  Source: “Radiologist reviews iPad imaging apps,” by George Miller, www.fiercebiotechit.com

Spring 2011

17


in the news

Inhibitor Insights:

Unresolved bleeds You may suspect an inhibitor the hard way: when factor no longer works well to stop bleeds. If you’re new to hemophilia, this may be difficult to judge – how long should it take for a bleed to stop after an infusion? It may not immediately dawn on you that the infused factor isn’t working properly, especially if your child is already well into a muscle or joint bleed. It’s common for parents to think that they simply need to give their child more frequent infusions, or give a higher dose per infusion. If you think your child’s bleed is not resolving normally, or wonder whether you should dose higher or more frequently, please call your hemophilia treatment center (HTC).

even with adequate factor, should be immediately tested for an inhibitor. Ideally, all children with hemophilia should be tested for an inhibitor before any surgery. If you see any kind of bleeding following surgery, call your HTC immediately. Reaction following infusion An allergic reaction is a response by the immune system to environmental contam-

Following a major bleed or emergency Whenever your child receives large amounts of factor – in response to a major bleed or during and after surgery – he may be at higher risk of developing an inhibitor. Experts aren’t sure if large amounts of factor stimulate inhibitor development, or if the body is more susceptible to inhibitor development during a medical crisis because the immune

Increased bruising Bruising in young children with severe hemophilia is common. But if your child is on prophylaxis and you notice increased bruising, this may be a sign of an inhibitor.

Let’s face it: an inhibitor is a major complication of hemophilia. It develops when the body’s immune system does not recognize infused factor as a normal part of blood. Instead, the body thinks that factor is a foreign invader, like a virus or germ, and it develops antibodies to attack the factor and make it harmless – and useless. So despite an infusion of factor, your child continues to bleed. Prolonged bleeding, even after a factor infusion, is the most common sign that your child may have an inhibitor. But other symptoms may also tip you off.

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Routine clinic visit A blood test at your child’s HTC comprehensive clinic visit can identify an inhibitor. Low-level inhibitors are often diagnosed in this way. It’s wise to have a child with hemophilia tested for inhibitors routinely. Learning that he has an inhibitor prior to surgery or a major bleed allows parents to have a plan in place and the correct treatment on hand. Breakthrough bleeds while on prophylaxis Prophylaxis is the scheduled infusion of factor to help prevent bleeding. Many children with hemophilia on prophylaxis receive factor two to three times a week, enough to allow circulating factor to prevent most spontaneous bleeds and abnormal bruising. When a child on prophylaxis starts bruising or bleeding more often than usual, an inhibitor may be inactivating some of the factor, lowering his factor level and increasing his risk of bleeding. Bleeding after surgery Any kind of surgery on a child with hemophilia requires careful planning and monitoring of factor levels, and any child who continues to bleed following surgery,

inants such as pollen, animal dander, or food. It can also happen after an infusion of factor. Symptoms may include sneezing; itching; hives; rapid swelling of the skin, neck or face; wheezing; faintness; fast heart rate; low blood pressure. Allergic reactions are especially worrisome with hemophilia B. An allergic reaction after a factor IX infusion is sometimes the first sign that an inhibitor to factor IX has developed. A whopping 45% of people with hemophilia B and inhibitors also develop allergic reactions at about the same time that they develop inhibitors. Don’t downplay allergic reactions. They may start out mild but then increase in severity after repeated exposure to products containing factor IX, often to a serious, life-threatening allergic reaction called anaphylaxis. If your child has severe hemophilia B, his first 20 infusions of factor IX concentrate should be done in a hospital or clinic with expertise in treating severe allergic reactions.

system is on high alert. But whatever the reasons, be aware that the risk of developing an inhibitor is slightly higher during an illness or surgery. Later in life If a person with hemophilia develops an inhibitor, it’s usually while he’s a child, almost always before exposure day 100. And he probably has severe hemophilia. But in rare cases, an inhibitor develops in a teen or an adult – usually in people with mild or moderate hemophilia, and usually after intensive exposure to factor during and after surgery or traumatic injury. Inhibitors are scary to contemplate. Even when your child passes exposure day 100, don’t be lulled into thinking that he may never develop one. You can always request an inhibitor test from your HTC. Never try to diagnose on your own, or change your child’s dosing regimen on your own.  Source: “Inhibitor Insights: When to Suspect an Inhibitor,” The Parent Empowerment Newsletter, February 2011. www.kelleycom.com © LA Kelley Communications, Inc. 2011

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in the news

Out of India Drug trial delivers

THE HEMOPHILIA SOCIETY, NASHIK (INDIA) CHAPTER, AFFILIATED WITH THE HEMOPHILIA

positive results for

FEDERATION IS LOCATED ABOUT 150 MILES NORTHEAST OF MUMBAI (BOMBAY). WE

hemophilia patients

SUPPORT 150 PATIENTS WITH HEMOPHILIA AND THEIR FAMILIES. IN THIS PART OF INDIA,

in poor countries.

BECAUSE OF POOR PUBLIC AWARENESS AND LACK OF MEDICAL TRAINING, WE HAVE FEW HEALTH PROFESSIONALS WITH EVERYDAY EXPERIENCE TREATING HEMOPHILIA.

The Pain of Poverty I’ve treated patients with hemophilia for ten years, and I’m frustrated that I can infuse factor only during an active bleed, due to the exorbitant cost. We can do nothing between bleeding episodes except counseling or physical therapy for patients. Most patients do not receive factor because they are too poor to travel to the hemophilia treatment center (HTC). We have few HTCs, so most patients must travel long distances. When patients can’t come to the HTC, due to either ignorance or poverty, they may consult a local health professional who is unaware of their special needs. The result is usually incorrect or inadequate treatment, which may cause permanent damage – sometimes death. As a result, we often see patients with severely damaged joints when they arrive at our HTC for the first time. This is the situation at almost all HTCs in India. Hemophilia patients here lead lives filled with pain. If patients can’t afford a single visit to the HTC, how can we expect them to take regular physical therapy? Replacement Factor The best treatment is factor, but this is impossible to prescribe for most patients here. Yet, India is home to many alternative therapies: Ayurveda, Unani, Siddha, different forms of traditional complementary and alternative medicine, and homeopathy. One government sector (AYUSH) even encourages research into these branches of medicine. Watching my patients suffer, I seriously considered alternative medicines for hemophilia. Following one of my presentations to create awareness about hemophilia at Homeopathy Medical College in Nashik, Dr. Kundu, head of homeopathy medicine,

offered immediately to start a drug trial with me for hemophilia patients. It would be a double-blind placebo control trial with some patients receiving homeopathic medicine and others a placebo. In December 2007, we began the trial. Our main concern was relieving severe pain after joint and muscle bleeds. We applied these remedies: ❉ Lachesis

30 for pain and bleeding 30 (silica) for patients requiring repeated factor ❉  Bryonia 30 + calcaria carb 30 (calcium carbonate) for excruciating pain ❉  Hamamelis virginiana (witch hazel) for local application and gum bleeds ❉  Silicea

The selection and combination of each drug depended on each patient’s history and personality type. We have found that generalized use for any person with hemophilia is not effective. The evaluation and follow-up of patients was based on the Wong-Baker FACES Pain Rating Scale, the Child Adaptive-Maladaptive Behavior Scale and the Joint Mobility Assessment SF-32 scale. Results with Unexpected Benefits We observed significant pain relief in the majority of cases, along with other benefits. In the past ten years, I have often observed aggression and depression in children with hemophilia. But following our homeopathic drug trial, the changes were amazing. Alleviation of pain was accomplished and accompanied by: ❉  Reduced duration of bleeding ❉  Reduced frequency of bleeds ❉  Reduced school or work absenteeism ❉  Improved range of motion in the affected joints

The most significant change: children were more friendly and cheerful, less irritable and depressed during painful bleeding episodes. Families reported a positive improvement in attitude toward living with hemophilia. Sharing Success Encouraged by these promising results, we have extended this trial to three more chapters in western India. I’d like to expand the database and include more patients and chapters. If similar results are obtained in more patients, we can continue the trial throughout India and perhaps in other developing countries where factor is unaffordable. As an allopathic doctor, I believe strongly in holistic health. I believe the majority of patients will benefit from appropriate homeopathic medicine prescribed by homeopathic physicians. My faith is based on the results of my personal follow-up of patients for the past two years. Though this is a short period, I believe that the results of our trial invite a larger, multi-centric trial on a bigger scale. A Vision of Hope Support in any form for this unique project will help to open some unexpected and promising new doors in hemophilia treatment, especially in developing countries. We someday want to see, Hemophilia without disability; children free of pain; the vision of the Hemophilia Federation (India).  Dr. Ranjana Kulkarni is a pathologist and President of Hemophilia Society Nashik, India. Source: “As I See It,” Dr. Ranjana Kulkarni, The Parent Empowerment Newsletter, February 2011, www.kelleycom.com

“I’ve treated patients with hemophilia for ten years, and I’m frustrated that I can infuse factor only during an active bleed, due to the exorbitant cost. We can do nothing between bleeding episodes except counseling or physical therapy for patients.” 20

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in the news

Transitions: Considering Long-Term

Health in Your 20s

By the time teens with hemophilia transition into their 20s, ideally they’ve built a firm foundation on which to manage their disorder. Among the many skills needed, young adults should be able to self-infuse and negotiate health insurance. But when you’re healthy and your hemophilia is under control, it’s easy to overlook general health maintenance beyond hemophilia. It’s uncommon for 20-somethings to consider the long-term impact of their lifestyle choices. But young adulthood is the time to develop the habits that will help maintain a healthy body in the decades ahead. Independent at Last! Perhaps more than any other time in our lives, the 20s are a decade of major transformation. Many young adults move out of their parents’ homes. Others graduate from college. Even those who’ve diligently managed their hemophilia may be thrown for a loop by all the changes in their lives. Your hemophilia treatment center (HTC) may no longer be in the same town or even the same time zone. And finding an HTC is just one of the myriad 22

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issues you’ll need to address. You’ll also have to ask yourself some of the basics. “Where will I buy groceries? How long will my commute be? When will I find time to renew my driver’s license?”

Weighty Issues Entering the 9-to-5 world for the first time is a big deal that can have a major impact on your health—and not just for those in Deadliest-Catch-type occupations. For many, this is their first experience sitting behind a desk for several hours a day. A

tangible and common consequence is weight gain. Not only is extra weight bad for your joints, but obesity is a contributing factor to several leading causes of death, including heart disease, stroke and certain types of cancer. The effects of “a few extra pounds” may not be immediately apparent, but that’s the point. In your 20s, you need to establish good habits to protect your body for the long run. This means adjusting what you’re eating while maintaining some form of routine exercise. Ian Muir, a 25-year-old with hemophilia, took a new job recently and is slowly figuring out how to get all the pieces of his life to mesh. In college, Ian competed in triathlons, training 25 hours a week. “In school, you had the motivation of working out with your teammates,” says Ian. “And you had a relatively flexible

schedule.” Now he’s struggling to find the hours to train for just a fraction of that time. And like many of his peers, Ian has let his diet suffer: “I know I need to get back to eating food that’s good for me, and not just what’s convenient.” Living healthy in your 20s doesn’t necessarily require big time commitments. In some cases, you just have to make better choices. When you can, take the stairs instead of the elevator. Cut back on the amount of alcohol and caffeine you consume. And if you’re among the 1 in 5 Americans who smoke, quit now.

Get a Health Net While you lived at home with your family, you probably had a stable network of medical resources. But once you’re on your own, you may need to rebuild that network by establishing a relationship

with your new HTC, plus maintaining all facets of your health. Dental health is one of the most neglected aspects of overall well-being. By the time you’re in your 20s, Mom or Dad probably don’t schedule your dental appointments, which means that nobody does… until a minor toothache becomes something worse. As Ian assembles the medical resources he needs near his new home, he sees the value in finding the right Primary Care Physician. “You want someone you can talk to about health concerns that aren’t hemophilia related,” he says. “Someone who knows you and your medical history and if necessary, who can point you to the right specialists.”  Source: “Transitions: Considering Long-Term Health in Your 20s,” The Parent Empowerment Newsletter, February 2011, www.kelleycom.com

Shaping Your Future Throughout your 20s, medical concerns may surface that have nothing to do with hemophilia, and everything to do with the natural aging process. You’ll begin to shed the cloak of invincibility you donned as a teen, and realize that you need to act with an eye to your future. So manage your total health as attentively as you manage your hemophilia:

 Eat a healthy, balanced diet.  Maintain your optimal body weight.  Make exercise a priority.  If you drink or smoke, reduce your alcohol consumption – and quit smoking!

 Schedule all the exams you’ve neglected for so long.

 If you don’t have a local dentist, eye doctor, or physician, contact your HTC or insurance company. They can help you find one.

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if you spot it, you can stop it Name: Joseph Miller

Age: 62 years

Symptoms1,2: • Arrives at the ER with spontaneous, severe gastrointestinal bleeding • No prior history of bleeding

Labs1,3: • Prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests and additional testing ordered by the attending physician

Treatments1: • Did not respond to treatments, including platelets and fresh frozen plasma

Diagnosis:

Model is used for illustrative purposes only.

Joe has acquired hemophilia (acquired inhibitors), which can be very difficult to diagnose and is fatal in more than 20% of all cases.4 You can help patients like Joe by being aware of the red flags of acquired hemophilia and bringing them up to the physician.

When you see an unusual order of factor VIII (FVIII), ask some simple questions:

Protect yourself this flu season. Reduce your risks with the ASD Healthcare advantage: Price protection

Most favorable delivery schedules

Best return policy

• What is the reason for your recent unusual order of FVIII? • Do you have a patient with congenital hemophilia? • Is bleeding under control? • What diagnostic tests, such as an aPTT or a mixing study, have been performed? • Was the aPTT prolonged? • Have you consulted a hematologist? • Have you considered acquired hemophilia?

Let’s face it. Flu season is risky – especially for pharmacy professionals, like you. That’s why ASD Healthcare is helping you protect your community while protecting your facility’s bottom line. Order from the largest range of vaccine options, plus get the

ASD Healthcare advantage on price, returns and deliveries. It’s going the extra mile to keep your vaccine programs on-time and on-budget, so everyone gets the protection they need – including you. That’s an example of our True Blue customer support.

Protection’s just a call away. Start reducing your flu season risks by calling ASD Healthcare at 866.281.4FLU (4358) today and visit www.asdhealthcare.com.

Find out more about acquired hemophilia and treatment at CoagsUncomplicated.com/Joe. References: 1. Huth-Kühne A, Baudo F, Collins P, et al. International recommendations on the diagnosis and treatment of patients with acquired hemophilia A. Haematologica. 2009;94(4):566-575. 2. Collins PW, Hirsch S, Baglin TP, et al; for UK Haemophilia Centre Doctors’ Organisation. Acquired hemophilia A in the United Kingdom: a 2-year national surveillance study by the United Kingdom Haemophilia Centre Doctors’ Organisation. Blood. 2007;109(5):1870-1877. 3. Collins PW, Percy CL. Advances in the understanding of acquired haemophilia A: implications for clinical practice. Br J Haematol. 2010;148(2):183-194. 4. Bitting RL, Bent S, Li Y, Kohlwes J. The prognosis and treatment of acquired hemophilia: a systematic review and meta-analysis. Blood Coagul Fibrinolysis. 2009;20(7):517-523.

Novo Nordisk Inc., 100 College Road West, Princeton, New Jersey 08540 U.S.A. © 2011 Novo Nordisk

Printed in the U.S.A.

0211-00001711-1

March 2011

Fun and Free! It’s just the combination to help take the sting out of getting the flu vaccine. Order some of these colorful, complimentary “Stop the Flu” stickers for your next vaccine program. Just call ASD Healthcare at 866.281.4FLU or order online at www.asdhealthcare.com and ask for Item #10953 (30 stickers per sheet).


in the news Washington Representatives for ASD Healthcare

Overview

Washington updates provided by Dale Dirks & Gavin Lindberg

HEALTH REFORM

PRESIDENT OBAMA’S FY12 BUDGET PROPOSAL

Although Congress has yet to finalize the FY11 appropriations process, President Obama sent his FY12 budget request to Capitol Hill on Feb. 14. The proposal calls for $3.7 trillion in federal spending. The White House projects that the plan would reduce the federal deficit by $1.1 trillion over 10 years. $400 billion of that savings would result from a five-year freeze in “non-defense discretionary” spending. The Administration did not call for any major reforms to entitlement programs such as Medicare and Social Security. The President’s budget is non-binding and serves primarily as a blueprint for Congress to consider as it crafts its own budget. Congressional Republicans, and several prominent Democrats, have deemed the President’s proposal insufficient to combat the nation’s budget challenges. Despite the inherent political risks, a growing number of lawmakers on both sides of the aisle want to address the disproportionate burden that entitlement spending has on the ballooning national debt. Sixty-four senators from both parties sent a letter to President Obama in March urging him to support a comprehensive solution to the budget crisis through a combination of entitlement reforms, discretionary spending reductions, and tax policy changes.

Regulatory Update Medicare Physician Payment In it’s annual report to Congress, the Medicare Payment Advisory Commission (MedPAC) recommended that lawmakers increase reimbursement to Medicare physicians by 1% in FY12. Under the “Sustainable Growth Rate” formula used to calculate the annual physician fee schedule, payments to Medicare providers are slated for a 25% reduction unless Congress acts to avert the cuts. FDA Workshop on IVIG On May 17 and 18, the Food and Drug Administration will sponsor a public workshop in Rockville, Md. on risk mitigation strategies for pro-coagulant activity 26

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IMPLEMENTATION

The 112th Congress convened in early January with Republicans holding a historic 49 seat majority in the House of Representatives. Speaker of the House John Boehner (R-OH) and his GOP colleagues wasted little time following through on their campaign pledge to repeal the health care reform bill and cut federal spending. On Jan. 19, the House voted 245-189 to repeal the Affordable Care Act (ACA). On Feb. 19, the House passed an appropriations package for the remainder of fiscal year 2011 that cuts $60 billion in discretionary spending. Both bills were quickly rejected by the Senate as the Democratic majority in that chamber banded together in opposition to the Tea Party inspired proposals.

that may be present in some intravenous immune globulin (IVIG) products. The purposes of the public workshop are: 1) Identify the most likely causes of IVIG-associated thrombotic events, 2) determine which pro-coagulant proteins may be involved, and; 3) identify tests to assess the activity of the proteins in IVIG products. The workshop will feature presentations by national and international experts from government, academia and industry.

Erythropoiesis Stimulating Agents (ESAs) After a nine month review, the Centers for Medicare and Medicaid Services announced in March their decision to forgo a National Coverage Determination for ESAs used to treat anemia in chronic kidney disease patients. The agency said that published studies on the use of ESAs are insufficient to identify the risk/benefit of the therapy for the Medicare population. The FDA is expected to announce a label change for the use of ESAs in dialysis and pre-dialysis patients this spring which may trigger another review of Medicare reimbursement policy. Until then, local Medicare coverage policies for ESAs remain in effect.

March 23 marked the one-year anniversary of the enactment of the Affordable Care Act. Notwithstanding the repeal vote in the House and pending action in the federal courts to overturn the law, Health and Human Services is moving forward with full implementation of the statute. The following provisions went into effect at the beginning of this year:

Medicare Part B

“PROMPT-PAY” LEGISLATION INTRODUCED Congressmen Ed Whitfield (R-KY) and Gene Green (D-TX) introduced legislation in March to address a chronic shortfall in the Medicare drug reimbursement system for physicians. The bill (H.R. 905) would exclude customary prompt-pay discounts extended to wholesalers from the manufacturer’s Average Sales Price. Similar legislation was introduced in the last Congress and attracted 74 bipartisan co-sponsors in the House. ASP is the price Medicare uses to set reimbursement rates for Part B drugs administered in the physician’s office. Inclusion of prompt-pay discounts in the ASP methodology effectively reduces Part B drug reimbursement to a level that hinders the ability of many providers to meet the therapeutic needs of their patients. Inclusion of the discounts also threatens the secure and highly efficient U.S. pharmaceutical distribution model resulting in increased costs and inefficiencies. It is estimated that distributors save consumers $34 billion a year by distributing products to local doctors and clinics.

A 10% Medicare bonus payment for primary care services. A 10% Medicare bonus payment to general surgeons practicing in health professions shortage areas. A requirement that health insurers provide rebates to consumers if the share of premium dollars spent on clinical and quality services is less than 85% for plans in the large group market, and 80% for plans in the individual and small group markets. A requirement that pharmaceutical companies provide a 50% discount on brand-name prescriptions filled in the Medicare Part D coverage gap. An elimination of beneficiary cost sharing for Medicare-covered preventive screenings and services. Authorization of $50 million in demonstration grants for states to develop and implement alternatives to medical malpractice litigation. An increase in the number of Graduate Medical Education training positions through a redistribution of currently unused slots.

Supreme court hears 340B drug discount case On Jan. 19, the Supreme Court heard oral arguments in Astra USA, Inc. v. Santa Clara County, a case involving whether safety net hospitals and clinics have a private right to sue drug manufacturers to enforce requirements of the federal 340B drug discount program. Under the 340B program, pharmaceutical companies are required to provide outpatient drugs at a discounted price to more than 15,000 “covered entities.” The U.S. Department of Health and Human Services enters into agreements with manufacturers to establish maximum prices for drugs sold to 340B providers. Santa Clara County, California brought suit on behalf of several 340B covered entities that it operates. Counsel for the drug companies and the U.S. Solicitor General (representing the federal government) argued that 340B entities do not have a private right to sue for breach of 340B agreements. A ruling will be handed down by the Supreme Court soon.

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in the news

now you Strategic Imperatives Xcenda, a member of the AmerisourceBergen Consulting Services family of companies, is the premier provider of services that develop, communicate and deliver the value of healthcare technologies and pharmaceuticals. Xcenda recommends the following strategic imperatives for Specialty Pharmacy Market Access Success: >> >>

Payer Trends:

>>

Analyze payer trends in specialty pharmacy management Contracting - develop integrated strategy models Assess specialty pharmacy network segmentation

Specialty Infusible Management

KNOW A new monthly publication that delivers actionable insights from the stakeholders who mean the most to your business.

• Timely payer and provider market research data • Strategic recommendations • Resources to help your team take action Are you responsible for the design and/or implementation of a value-based commercial plan? Want to be the first to know how a group of payers who collectively represent nearly 200 million covered lives responds to industry changes and trends? Join other senior decision makers at pharmaceutical, biotech, and device firms who already receive “Now You Know,” a complimentary publication from our managed markets agency.

I

n today’s healthcare environment, payers have a greater interest in determining the total cost of care for various disease states and in establishing guidelines to ensure the appropriate use of specialty infusible product. To accomplish this, payers use cost and utilization management strategies that focus on the use of benefit design to alter prescribing patterns, ensure affordability, utilize the most appropriate drug and prevent waste. Payers expect prescribers to follow evidence-based clinical guidelines to ensure appropriate use of specialty drugs and minimize the risk to patient safety. The list of high-cost infusible medications based on disease states that payers recognize includes: >> >> >> >> >> >> >> >> >> >>

Oncology Human Growth Hormone Multiple Sclerosis Hemophilia Rheumatoid Arthritis Hepatitis HIV/AIDS Kidney Disease Ophthalmology Other selected major conditions targeted by specialty pharmacies

As payers are faced with significant challenges related to coverage, cost, clinical management, and reimbursement, a variety of strategies has been utilized to address these challenges. These strategies will continue to evolve as payers analyze key areas. Currently, payers and employers are engaging more intense management techniques in specialty drug areas, like:

>> >> >> >> >> >> >> >>

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>>

>> >>

>>

>>

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Specialty pharmacies are sensing the pressures from payers through narrowing of the specialty pharmacy networks and other restrictive utilization techniques, such as:

Specialty pharmacy contracts and agreements Cost and reimbursement issues Medical policy coverage challenges/limitations Clinical outcomes Compliance and adherence – Medication Possession Ratio (MPR) Site of care of administration Office Based Injection programs (OBI) Benefit design Provider/employer partnerships Technologic enhancements to claims visibility for infusible medications

>>

>> >> >>

>> >>

Correlations between payer policy and specialty pharmacy – building commonalities across plan designs Preferred Specialty Pharmacy Networks PHS centers taking share from specialty pharmacies Payer waste management – dose optimization programs and proactive refill compliance assessments Payer adherence programs Payer precertification, predetermination, revaluation policies Medication Therapy Management or Pharmacy Therapy Management programs that focus on dosing, duration, therapy interval, diagnosis and drug Movement to ASP reimbursement methodology Preferred product selection

Read and subscribe to “Now You Know” at www.xcenda.com.

Areas of expertise: Managed Markets Market Research Outcomes Research Reimbursement Strategy & Field Support Established Brands & Pre-commercialization Phase Products

Xcenda_now You Know_5.5x8.5Ad.indd 1

Manufacturers need to consider how to navigate the complexities and degree of their relationships with specialty pharmacies and payers as they are recognizing ways to manage these areas by gathering data on specialty costs. Look for more tiers, preferred product tiers within specialty tiers, and even other specialty disease-related programs. 

2/24/11 9:22 AM

About the author: Mike Baldzicki is a Senior Director at Xcenda within the Customer Relations team. With more than 14 years of experience in the pharmaceutical and biotech industry, Mr. Baldzicki offers manufacturers strategic insight into payer marketing, contracting, reimbursement, and the application of health outcomes and economic evidence to prove product value.

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Influenza can kill almost as many people a year as AIDS or breast cancer.1,2

Important Safety Information Serious allergic reactions, including anaphylactic shock, have been observed in people receiving FLUVIRIN Influenza Virus Vaccine. FLUVIRIN vaccine should not be administered to individuals with a history of systemic hypersensitivity reaction to eggs or egg proteins or other components of FLUVIRIN vaccine, including thimerosal, or to anyone who has had a lifethreatening reaction to previous influenza vaccination. Pre-filled syringes of 2010/2011 FLUVIRIN influenza vaccine are tipped with caps which may contain natural rubber latex in trace amounts. Do not administer pre-filled syringe doses of FLUVIRIN vaccine to any patients with a demonstrated history of hypersensitivity to latex. Multidose vial presentations of FLUVIRIN are latex-free. In clinical trials, the most common adverse events in adults were headache, fatigue, injection site reactions (pain, mass, redness, and induration), and malaise. These adverse events were generally mild/moderate and transient. Vaccination with FLUVIRIN vaccine may not protect all individuals who are susceptible to influenza.

Order FLUVIRIN® now and help protect your patients for the 2011-2012 flu season. In 2010, more than 17,000 people are expected to die from AIDS1 and nearly 40,000 women from breast cancer.2 Though influenza may not seem like a serious disease, in any given flu season it may cause 3,000 to 49,000 flu-associated deaths.3 The ACIP recommendation for annual influenza vaccination now includes all persons aged 6 months and older.4 FLUVIRIN is indicated for persons 4 years of age and older. Novartis Vaccines is committed to providing seasonal flu vaccine doses on time. In fact, in 2010 Novartis Vaccines completed the shipping of ~40 million seasonal flu vaccine doses ahead of schedule, allowing for early and convenient administration.

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a reduced immune response to FLUVIRIN vaccine. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to use FLUVIRIN vaccine should be based on careful consideration of the potential benefits and risks. All people, including those who are pregnant, nursing, and/or taking other medications, should consult their healthcare providers before receiving FLUVIRIN vaccine. Please see a Brief Summary of the FLUVIRIN Prescribing Information on the following pages. References: 1. Avert. United States HIV & AIDS Statistics Summary. Avert Web site. http://www.avert.org/usa-statistics. htm. Accessed October 27, 2010. 2. American Cancer Society. Breast Cancer Overview: How Many Women Get Breast Cancer? American Cancer Society Web site. http://www.cancer.org/Cancer/BreastCancer/OverviewGuide/breast-canceroverview-key-statistics. Accessed November 1, 2010. 3. Centers for Disease Control and Prevention. Questions & Answers: Seasonal Influenza. CDC Web site. http://www.cdc.gov/flu/about/qa/disease.htm. Accessed October 26, 2010. 4. Centers for Disease Control and Prevention (MMWR). Prevention and Control of Influenza with Vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. CDC Web site. http://www.cdc.gov/mmwr/preview/mmwrhtml/ rr59e0729a1.htm. Accessed November 17, 2010.

Make sure you have your supply of vaccine ready for the next flu season. Contact your ASD Healthcare representative today at 866.281.4FLU or visit www.asdhealthcare.com Indication FLUVIRIN is an inactivated influenza virus vaccine indicated for active immunization of persons 4 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUVIRIN vaccine is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group. Please see reverse for Important Safety Information.

Novartis Vaccines and Diagnostics, Inc. Cambridge, MA 02139

Influenza Virus Vaccine Fluvirin®

FVN6566-B_JournalAd_FFF_DR3_ASD-Rework.indd 1 30 i n s i d e o u t

© 2011 Novartis Vaccines

6/7/11 4:02 PM

Printed in USA

February 2011

NVDFLU286-1

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FLUVIRIN®

(Influenza Virus Vaccine) Suspension for Intramuscular Injection 2010-2011 Formula Initial U.S. Approval: 1988

FLUVIRIN® should only be used for the immunization of persons aged 4 years and over.

2000-2001*§

Local Adverse Events Pain 16 (24%) 4 (9%) 16 (21%) Mass 7 (11%) 1 (2%) 4 (5%) Inflammation 5 (8%) 2 (5%) 6 (8%) Ecchymosis 4 (6%) 1 (2%) 3 (4%) Edema 2 (3%) 1 (2%) 1 (1%) Reaction 2 (3%) 2 (3%) Hemorrhage 1 (1%)

1 (3%) 2 (6%) -

9 (12%) 8 (11%) 7 (9%) 4 (5%) 3 (4%) 4 (5%) -

1 (3%) 1 (3%) 1 (3%) 1 (3%) -

Systemic Adverse Events Headache Fatigue Malaise Myalgia Fever Arthralgia Sweating

3 (9%) 1 (3%) 1 (3%) 1 (3%) -

4 (5%) 3 (4%) 1 (1%) 1 (1%)

1 (3%)

7 (11%) 3 (5%) 2 (3%) 1 (2%) 1 (2%) -

1 (2%) 17 (22%) 2 (5%) 4 (5%) 1 (2%) 2 (3%) 2 (3%) 1 (1%) 1 (2%) 3 (4%)

2001-2002*^

2002-2003*^

6.3 Postmarketing Experience The following additional adverse reactions have been reported during postapproval use of FLUVIRIN®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events described here are included because: a) they represent reactions which are known to occur following immunizations generally or influenza immunizations specifically; b) they are potentially serious; or c) the frequency of reporting.

2004-2005*^

18-64 yrs ≥65 yrs 18-64 yrs ≥65 yrs 18-64 yrs ≥65 yrs N=75 N=35 N=107 N=88 N=74 N=61 Local Adverse Events Pain 12 (16%) 1 (3%) 14 (13%) Mass 4 (5%) 1 (3%) Ecchymosis 2 (3%) 3 (3%) Edema 2 (3%) 1 (3%) 6 (6%) Erythema 5 (7%) 11 (10%) Swelling Reaction 2 (2%) Induration 14 (13%) Pruritus 1 (1%)

7 (8%) 3 (3%) 2 (2%) 5 (6%) 3 (3%) -

15 (20%) 2 (3%) 16 (22%) 11 (15%) 11 (15%) -

9 (15%) 1 (2%) 5 (8%) 4 (7%) 1 (2%) -

Systemic Adverse Events Headache Fatigue Malaise Myalgia Fever Arthralgia Sweating Shivering

9 (10%) 4 (5%) 3 (3%) 1 (1%) 2 (2%) 1 (1%)

14 (19%) 5 (7%) 1 (1%) 8 (11%) 1 (1%) -

3 (5%) 2 (3%) 1 (2%) 1 (2%) -

8 (11%) 1 (3%) 12 (11%) 1 (1%) 1 (3%) 3 (4%) 3 (3%) 3 (4%) 5 (5%) 2 (2%) 3 (4%) 1 (3%) -

Results reported to the nearest whole percent; Fever defined as >38°C - not reported * Solicited adverse events in the first 72 hours after administration of FLUVIRIN® § Solicited adverse events reported by COSTART preferred term ^ Solicited adverse events reported by MedDRA preferred term

T:10.5”

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1999-2000*§

B:10.75”

32

1998-1999*§

18-64 yrs ≥65 yrs 18-64 yrs ≥65 yrs 18-64 yrs ≥65 yrs N=66 N=44 N=76 N=34 N=75 N=35

S:9.125”

BRIEF SUMMARY: Please see package insert for full prescribing information. 1 INDICATIONS AND USAGE FLUVIRIN® is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza virus disease caused by influenza virus subtypes A and type B contained in the vaccine [see DOSAGE FORMS AND STRENGTHS (3) in the full prescribing information]. FLUVIRIN® is not indicated for children less than 4 years of age because there is evidence of diminished immune response in this age group. 4 CONTRAINDICATIONS 4.1 Hypersensitivity FLUVIRIN® should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of FLUVIRIN®, or who has had a life-threatening reaction to previous influenza vaccinations. 5 WARNINGS AND PRECAUTIONS 5.1 Guillain-Barré Syndrome If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUVIRIN® should be based on careful consideration of the potential benefits and risks. 5.2 Altered Immunocompetence If FLUVIRIN® is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. 5.3 Preventing and Managing Allergic Reactions Prior to administration of any dose of FLUVIRIN®, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with FLUVIRIN® and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. The tip caps of the FLUVIRIN® prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. 5.4 Limitations of Vaccine Effectiveness Vaccination with FLUVIRIN® may not protect all individuals. 6 ADVERSE REACTIONS 6.1 Overall Adverse Reaction Profile Serious allergic reactions, including anaphylactic shock, have been observed in individuals receiving FLUVIRIN® during postmarketing surveillance. 6.2 Clinical Trial Experience Adverse event information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating the rates of these events. However, because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect rates observed in clinical practice. Adult and Geriatric Subjects Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age and older) who have received FLUVIRIN® in 29 clinical studies since 1982. In 9 clinical studies since 1997, among 1261 recipients of FLUVIRIN®, 745 (59%) were women; 1211 (96%) were White, 23 (2%) Asian, 15 (1%) Black and 12 (1%) other; 370 (29%) of subjects were elderly (≥65 years of age). All studies have been conducted in the UK, apart from a study run in the US in 2005-2006 where FLUVIRIN® was used as a comparator for an unlicensed vaccine. After vaccination, the subjects were observed for 30 minutes for hypersensitivity or other immediate reactions. Subjects were instructed to complete a diary card for three days following immunization (i.e. Day 1 to 4) to collect local and systemic reactions (see Tables 1 and 2). All local and systemic adverse events were considered to be at least possibly related to the vaccine. Local and systemic reactions mostly began between day 1 and day 2. The overall adverse events reported in clinical trials since 1998 in at least 5% of the subjects are summarized in Table 3.

Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6-47 months). Of these, 285 healthy subjects plus 41 ‘at risk’ subjects received FLUVIRIN®. No serious adverse events were reported.

TABLE 1 Solicited Adverse Events in the First 72-96 Hours After Administration of FLUVIRIN® in Adult (18-64 years of age) and Geriatric (≥65 years of age) Subjects

• Body as a whole: Local injection site reactions (including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration), hot flashes/flushes; chills; fever; malaise; shivering; fatigue; asthenia; facial edema. • Immune system disorders: Hypersensitivity reactions (including throat and/or mouth edema). In rare cases, hypersensitivity reactions have lead to anaphylactic shock and death. • Cardiovascular disorders: Vasculitis (in rare cases with transient renal involvement), syncope shortly after vaccination. • Digestive disorders: Diarrhea; nausea; vomiting; abdominal pain. • Blood and lymphatic disorders: Local lymphadenopathy; transient thrombocytopenia. • Metabolic and nutritional disorders: Loss of appetite. • Musculoskeletal: Arthralgia; myalgia; myasthenia. • Nervous system disorders: Headache; dizziness; neuralgia; paraesthesia; confusion; febrile convulsions; Guillain-Barré Syndrome; myelitis (including encephalomyelitis and transverse myelitis); neuropathy (including neuritis); paralysis (including Bell’s Palsy). • Respiratory disorders: Dyspnea; chest pain; cough; pharyngitis; rhinitis. • Skin and appendages: Stevens-Johnson syndrome; sweating; pruritus; urticaria; rash (including non-specific, maculopapular, and vesiculobullous). 6.4 Other Adverse Reactions Associated with Influenza Vaccination Anaphylaxis has been reported after administration of FLUVIRIN®. Although FLUVIRIN® contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis [see CONTRAINDICATIONS (4)]. The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated. Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported. Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.

7 DRUG INTERACTIONS 7.1 Concomitant Administration with Other Vaccines There are no data to assess the concomitant administration of FLUVIRIN® with other vaccines. If FLUVIRIN® is to be given at the same time as another injectable vaccine(s), the vaccines should always be administered at different injection sites. FLUVIRIN® should not be mixed with any other vaccine in the same syringe or vial. 7.2 Concurrent Use with Immunosuppressive Therapies Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to FLUVIRIN®. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with FLUVIRIN®. It is also not known whether FLUVIRIN® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLUVIRIN® should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers It is not known whether FLUVIRIN® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUVIRIN® is administered to a nursing woman. 8.4 Pediatric Use The safety and immunogenicity of FLUVIRIN® have not been established in children under 4 years of age. The safety and immunogenicity of FLUVIRIN® have been established in the age group 4 years to 16 years. The use of FLUVIRIN® in these age groups is supported by evidence from adequate and well controlled studies of FLUVIRIN® in adults that demonstrate the immunogenicity of FLUVIRIN® [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14) in the full prescribing information]. 8.5 Geriatric Use Since 1997, of the total number of geriatric subjects (n=397) in clinical studies of FLUVIRIN®, 29% were 65 years and over, while 2.1% were 75 years and over. Antibody responses were lower in the geriatric population than in younger subjects. Adverse events occurred less frequently in geriatric subjects (≥65 years) than in younger adults. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. [See ADVERSE REACTIONS (6) and CLINICAL STUDIES (14) in the full prescribing information.] FLUVIRIN® is a registered trademark of Novartis Vaccines and Diagnostics Limited. Manufactured by: Novartis Vaccines and Diagnostics Limited, Speke, Liverpool, UK An affiliate of: Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139 USA 1-800-244-7668

TABLE 2 Solicited Adverse Events in the First 72 Hours After Administration of FLUVIRIN® in Adult Subjects (18-49 years of age) 2005-2006 US Trial FLUVIRIN® N=304 Local Adverse Events Pain Erythema Ecchymosis Induration Swelling

168 (55%) 48 (16%) 22 (7%) 19 (6%) 16 (5%) (continued)

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Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6-47 months). Of these, 285 healthy subjects plus 41 ‘at risk’ subjects received FLUVIRIN®. No serious adverse events were reported. FLUVIRIN® should only be used for the immunization of persons aged 4 years and over. 6.3 Postmarketing Experience The following additional adverse reactions have been reported during postapproval use of FLUVIRIN®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events described here are included because: a) they represent reactions which are known to occur following immunizations generally or influenza immunizations specifically; b) they are potentially serious; or c) the frequency of reporting.

Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported. Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination.

Announcing the winners of the InsideOut contest survey

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with FLUVIRIN®. It is also not known whether FLUVIRIN® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. FLUVIRIN® should be given to a pregnant woman only if clearly needed.

In the premier issue of InsideOut magazine, we made a winning proposition: “Tell us what articles you’d like to see in the magazine, and we’ll give MP3 Players to three lucky winners.” Well the results are in! And even though only three names were drawn – everyone is a winner.

8.3 Nursing Mothers It is not known whether FLUVIRIN® is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when FLUVIRIN® is administered to a nursing woman.

The information each of you shared in the survey will help us create a magazine that’s an even better resource for you. That’s a win/win for everyone. The editorial staff at InsideOut thanks you for your comments and welcomes your ongoing ideas, suggestions and insights about the news that matters to you. Your input will help ASD Healthcare create a magazine that’s truly in touch with your professional and lifestyle interests.

8.4 Pediatric Use The safety and immunogenicity of FLUVIRIN® have not been established in children under 4 years of age. The safety and immunogenicity of FLUVIRIN® have been established in the age group 4 years to 16 years. The use of FLUVIRIN® in these age groups is supported by evidence from adequate and well controlled studies of FLUVIRIN® in adults that demonstrate the immunogenicity of FLUVIRIN® [see ADVERSE REACTIONS (6) and CLINICAL STUDIES (14) in the full prescribing information]. 8.5 Geriatric Use Since 1997, of the total number of geriatric subjects (n=397) in clinical studies of FLUVIRIN®, 29% were 65 years and over, while 2.1% were 75 years and over.

T:10.5”

The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than 1 additional case/1 million persons vaccinated.

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7.2 Concurrent Use with Immunosuppressive Therapies Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to FLUVIRIN®.

Each quarter InsideOut will continue to include news-worthy articles that make a difference to your practice and to the patients you serve. Our goal is to help you serve them better by keeping you informed and connected to your world – inside and out.

B:10.75”

6.4 Other Adverse Reactions Associated with Influenza Vaccination Anaphylaxis has been reported after administration of FLUVIRIN®. Although FLUVIRIN® contains only a limited quantity of egg protein, this protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, allergic asthma, and systemic anaphylaxis [see CONTRAINDICATIONS (4)].

FLUVIRIN® should not be mixed with any other vaccine in the same syringe or vial.

S:9.125”

• Body as a whole: Local injection site reactions (including pain, pain limiting limb movement, redness, swelling, warmth, ecchymosis, induration), hot flashes/flushes; chills; fever; malaise; shivering; fatigue; asthenia; facial edema. • Immune system disorders: Hypersensitivity reactions (including throat and/or mouth edema). In rare cases, hypersensitivity reactions have lead to anaphylactic shock and death. • Cardiovascular disorders: Vasculitis (in rare cases with transient renal involvement), syncope shortly after vaccination. • Digestive disorders: Diarrhea; nausea; vomiting; abdominal pain. • Blood and lymphatic disorders: Local lymphadenopathy; transient thrombocytopenia. • Metabolic and nutritional disorders: Loss of appetite. • Musculoskeletal: Arthralgia; myalgia; myasthenia. • Nervous system disorders: Headache; dizziness; neuralgia; paraesthesia; confusion; febrile convulsions; Guillain-Barré Syndrome; myelitis (including encephalomyelitis and transverse myelitis); neuropathy (including neuritis); paralysis (including Bell’s Palsy). • Respiratory disorders: Dyspnea; chest pain; cough; pharyngitis; rhinitis. • Skin and appendages: Stevens-Johnson syndrome; sweating; pruritus; urticaria; rash (including non-specific, maculopapular, and vesiculobullous).

in the spotlight

7 DRUG INTERACTIONS 7.1 Concomitant Administration with Other Vaccines There are no data to assess the concomitant administration of FLUVIRIN® with other vaccines. If FLUVIRIN® is to be given at the same time as another injectable vaccine(s), the vaccines should always be administered at different injection sites.

Antibody responses were lower in the geriatric population than in younger subjects. Adverse events occurred less frequently in geriatric subjects (≥65 years) than in younger adults. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. [See ADVERSE REACTIONS (6) and CLINICAL STUDIES (14) in the full prescribing information.] FLUVIRIN® is a registered trademark of Novartis Vaccines and Diagnostics Limited.

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Manufactured by: Novartis Vaccines and Diagnostics Limited, Speke, Liverpool, UK An affiliate of: Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139 USA 1-800-244-7668

Chief Operating Officer, Chris Myers, at ASD Healthcare, selected the winners of the MP3 Players by drawing three names from the survey cards sent in by InsideOut readers.

Making the Personal Connection: Sharing the good news with the winners of the MP3 Players, Neil Herson, President of ASD Healthcare, called to personally thank them for their comments and their business.

And the winners are …

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Penny Stephan

Richard West

Stacey Harsy

Mercy Hospital Grayling, Michigan

Northside Home Infusion Zanesville, Ohio

Manteno Dialysis Center Manteno, Illinois

Top Topics: Articles on social media and nutrition top Penny’s InsideOut editorial list.

Richard’s Picks: He’d like to see disease specific articles and articles on nutrition in upcoming issues.

Most Helpful Source: Stacy finds ASD Healthcare’s customer service the most helpful to her.

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in the news

Accountable Care Organizations:

GROUP GROUP PRACTICE PRACTICE

Seizing the Opportunity Healthcare reform’s needle-in-thehaystack has quickly become its elephant-in-the-room. In the entire 1,000-page reform bill, one of the most thoroughly discussed and highly debated provisions spans only seven pages. Welcome to Accountable Care Organizations (ACOs). The loosely written guidelines serve as a vehicle for the Medicare Shared Savings Program and yield both headaches and valuable opportunities for stakeholders across each sector of healthcare. For providers, ACOs may require business model overhaul and delivery of care realignment, but they also may generate significant cost savings. For pharmaceutical and device manufacturers, the next steps are entirely contingent upon provider reaction toward ACOs.

What is an ACO? An ACO is a network of providers who are responsible for the quality, cost, and overall care of its assigned Medicare beneficiaries. Structurally, ACOs may consist of physicians, group practices, networks of practices, hospitals, and/or joint ventures between hospitals and physicians. Each ACO must encompass at least 5,000 Medicare beneficiaries and possess the formal legal structure to distribute shared savings. ACOs will be measured by predetermined quality-of-care benchmarks and will receive a percentage of the ACO’s shared savings for performing below the benchmark (ie, reducing unnecessary spending by aligning delivery of care and coordinating with network providers).1 Valuable opportunities and key challenges are prominent throughout the great ACO debate. ACO implementation in 2012 will generate both direct and underlying ripple effects for which providers and manufacturers must be prepared.

Opportunities for Providers Organizational flexibility ✻ The health care reform bill purposely sets forth vague ACO language as to not stifle innovation for pilot programs. Therefore, providers have the freedom to outfit their organization with the best fit business model. Currently, providers who establish the ACO are responsible for setting key performance metrics and alignment incentives. Additionally, providers can choose from a variety of payment structures

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PHYSICIAN PHYSICIAN

MEDICARE MEDICARE BENEFICIARIES BENEFICIARIES

??

HOSPITAL HOSPITAL

that offer flexibility in the amount of risk the ACO chooses to assume.2 Ongoing patient relationship ✻  Specialists are likely to experience an ongoing relationship with patients once ACOs are implemented due to their alignment and network of care. Each ACO will need to determine prospectively whether these specialists are members and whether they will participate in its shared savings. Specialists may even prefer participating in bundled payment arrangements over participating in shared savings arrangements.3 Elevated physician engagement ✻  Within ACOs, clinical care delivery requires not only strong physician relationships but also physician leadership presence in decisions affecting strategy. In large part, success in obtaining strategic input arises from internal inclusivity.4

Challenges for Providers The payer market ✻ There are hundreds of different health insurers and healthcare payment programs in the United States, each with its own reimbursement policies, payment methodologies, and rates. There is no assurance that any particular payer will adopt the same method as any other payer for paying or incentivizing an ACO.5 Patient attribution ✻ No provision assigns patients to a unique ACO. Patients who choose their provider must be attrib-

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LOWER LOWER COSTS COSTS

uted to a provider organization via their healthcare claims. A provider can be held accountable for the cost and outcomes of a patient who receives the majority of his or her care from other providers that may or may not belong to the same ACO.6 Shared savings allocation ✻ ACOs may require a transition step from the fee-forservice payment systems toward full riskbased payments. This transition may be necessary because ACOs provide the potential for upside reward (eg, shared cost savings and pay-for-performance bonuses) without the downside risk of exceeding a preset cost or utilization budget.5

Opportunities for Manufacturers 

7

Electronic health records (EHR) ✻ As a prerequisite for ACOs, EHR will make the real-world impact of drugs on provider quality of care more readily available. Manufacturers that offer products with the ability to demonstrate improvements in clinical outcomes will find a much more receptive institutional audience. Formulary influence ✻ Manufacturers armed with compelling data will be able

to influence the inclusion of their products on formularies and in treatment guidelines, especially for value-priced preventive medicines, vaccines, and companion diagnostics. Collaborative opportunities ✻ If ACOs feel a product will assist their quality of care and cost-savings goals, manufacturer representatives may be able to enlist. Representatives may be encouraged to help educate physicians and other healthcare providers about the appropriate use of their product within treatment guidelines.

Challenges for Manufacturers 7 Access to primary care physicians ✻  Sales representatives will more than likely experience reduced access to primary care physicians as they join larger, busier practices. If representatives can demonstrate value by favorably impacting quality of care or cost reductions, physician access will prove less challenging. Governance structure ✻ Selective product recommendations and administrative policies developed by the ACO

are likely to govern manufacturer access to physicians. Healthcare provider teams with therapeutic and cost-benefit expertise will determine formulary and policy guidelines, which may create a communication barrier for representatives who are not armed with matching expertise. Financial vested interest ✻ Due to the ACO’s shared savings arrangement, providers will have a financial vested interest in prescribing cost-effective treatments, complying with formularies, and following recommended treatment guidelines established by the ACO. This vested interest will increase the difficulty for manufacturers to directly influence the prescribing of products not supported by ACOs. As providers and manufacturers embark upon the journey of ACO implementation, additional opportunities and challenges will arise. With a proactive approach, careful due diligence, and emphasis on improving patient quality of care, each stakeholder across the healthcare spectrum will find opportunities to succeed.  About the author: Harrison Burns is an analyst in Reimbursement Strategy and Trends at Xcenda.

References: Accountable Care Organizations: Seizing the ACO Opportunity 1. Medicare Accountable Care Organizations Preliminary Questions and Answers. CMS website. https://www.cms.gov/OfficeofLegislation/Downloads/AccountableCareOrganization.pdf. Accessed March 10, 2011. 2. Accountable Care Organizations: A New Model for Sustainable Innovation. Deloitte website. http://www.deloitte.com/assets/Dcom-UnitedStates/Local%20Assets/Documents/US_CHS_AccountableCareOrganizations_041910.pdf. Accessed March 9, 2011. 3. ACO Learning Network Toolkit. Brookings website. https://xteam.brookings.edu/bdacoln/Documents/ACO%20Toolkit%20January%202011.pdf. Accessed March 7, 2011. 4. Contemplating the ACO Opportunity—An HFM Compendium. HFMA website. http://www.hfma.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=24081. Accessed March 8, 2011. 5. Transforming Health Care Through Accountable Care Organizations. Foley & Lardner website. http://www.foley.com/files/tbl_s84Highlights/FileUpload562/381/ACO_White_Paper.pdf. Accessed March 10, 2011. 6. McCracken J. The Fatal Flaw of ACOs. UT Dallas website. http://amme.utdallas.edu/2011/02/the-fatal-flaw-of-acos/. Accessed March 9, 2011. 7. Wokasch M. How Accountable Care Organizations (ACOs) Will Affect Pharmaceutical Sales Representatives. Pharma Reform website. .

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Important Safety Information

When treating patients with PIDD…

Make the leap to Hizentra The first and only FDA-approved 20% SCIg therapy

High concentration

20%

concentration delivers more Ig in less volume

Up to

Convenient storage

77°F (25°C) room temperature storage for up to 24 months

Hizentra and Vivaglobin are indicated as replacement therapy for patients with primary humoral immunodeficiency (PI). This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. Hizentra and Vivaglobin are contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or their components. Because it contains the stabilizer L-proline, Hizentra is also contraindicated in patients with hyperprolinemia. Both treatments are contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity. Hizentra and Vivaglobin should be administered subcutaneously only. Do not administer intravenously. All IgA-deficient patients with anti-IgA antibodies are at greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. If hypersensitivity occurs or anaphylactic reactions are suspected, discontinue administration of these treatments immediately and treat as medically appropriate.

The most common drug-related adverse reactions with Hizentra (observed in 5% or more of subjects in the clinical trial) were local reactions (ie, swelling, redness, heat, pain, and itching at the injection site), headache, vomiting, pain, and fatigue. The most common drug-related adverse reactions with Vivaglobin (observed in 5% or more of subjects in the clinical trial) were local injection-site reactions (eg, swelling, redness, and itching), headache, nausea, rash, asthenia, and gastrointestinal disorders. Aseptic meningitis syndrome (AMS) has been reported to occur infrequently with IVIg treatment and treatment with Vivaglobin, and might also occur with Hizentra. AMS is usually evidenced within 2 days of administration. Also monitor patients for other reactions reported to occur with IVIg treatment that might also occur with Vivaglobin or Hizentra, including renal dysfunction/failure, thrombotic events, hemolysis, and transfusion-related acute lung injury (TRALI). Ig administration can transiently impair the efficacy of live attenuated virus vaccines, such as measles, mumps and rubella. It can also lead to misinterpretation of serologic testing. Please see brief summary of full Prescribing Information for Hizentra and Vivaglobin on following pages.

Hizentra and Vivaglobin are derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Up to

Similar patient freedom to Vivaglobin®, Immune Globulin Subcutaneous (Human), with the added convenience of room temperature storage

Fast infusion rate

25 mL/hr/site* and a volume of 25 mL/site, as tolerated

25

mL / hr

Get helpful materials for you and your patients at www.HizentraResources.com *Initial infusion rate not to exceed 15 mL/hr/site. Total infusion rate must not exceed 50 mL/hr for all sites combined (maximum of 4 sites).

Important Safety Information

25

mL / hr

25 mL / hr

Hizentra and Vivaglobin are indicated as replacement therapy for patients with primary humoral immunodeficiency (PI). This includes but is not limited to the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

L-proline, Hizentra is also contraindicated in patients with hyperprolinemia. Both treatments are contraindicated in patients with immunoglobulin A deficiency who have antibodies against IgA and a history of hypersensitivity.

Hizentra and Vivaglobin are contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin preparations or their components. Because it contains the stabilizer

Please see Important Safety Information on reverse and brief summary of full Prescribing Information for Hizentra and Vivaglobin on following pages.

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Hizentra and Vivaglobin should be administered subcutaneously only. Do not administer intravenously.

Hizentra is manufactured by CSL Behring AG and distributed by CSL Behring LLC. Hizentra is a registered trademark of CSL Behring AG. Vivaglobin is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. Vivaglobin is a registered trademark of CSL Behring GmbH. ©2010 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring-us.com www.Hizentra.com 11-HIZ-132 10/2010

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CSL Behring BRIEF SUMMARY OF PRESCRIBING INFORMATION

Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid Before prescribing, please consult full prescribing information, a brief summary of which follows. Some text and references refer to full prescribing information. 1 INDICATIONS AND USAGE Hizentra is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Liquid indicated as replacement therapy for primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. 4 CONTRAINDICATIONS Hizentra is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin or to components of Hizentra, such as polysorbate 80. Hizentra is contraindicated in patients with hyperprolinemia because it contains the stabilizer L-proline (see Description [11] ). Hizentra is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity (see Description [11] ). 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Severe hypersensitivity reactions may occur to human immune globulin or components of Hizentra, such as polysorbate 80. In case of hypersensitivity, discontinue the Hizentra infusion immediately and institute appropriate treatment. Individuals with IgA deficiency can develop anti-IgA antibodies and anaphylactic reactions (including anaphylaxis and shock) after administration of blood components containing IgA. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions with administration of Hizentra. Hizentra contains b50 mcg/mL IgA (see Description [11] ). 5.2 Reactions Reported to Occur With IGIV Treatment The following reactions have been reported to occur with IGIV treatment and may occur with IGSC treatment. Renal Dysfunction/Failure Renal dysfunction/failure, osmotic nephropathy, and death may occur with use of human immune globulin products. Ensure that patients are not volume depleted and assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of Hizentra and at appropriate intervals thereafter. Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk of developing acute renal failure.1 If renal function deteriorates, consider discontinuing Hizentra. For patients judged to be at risk of developing renal dysfunction because of pre-existing renal insufficiency or predisposition to acute renal failure (such as those with diabetes mellitus or hypovolemia, those who are overweight or use concomitant nephrotoxic medicinal products, or those who are over 65 years of age), administer Hizentra at the minimum rate practicable. Thrombotic Events Thrombotic events may occur with use of human immune globulin products2-4. Patients at increased risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. Because of the potentially increased risk of thrombosis, consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients judged to be at risk of developing thrombotic events, administer Hizentra at the minimum rate practicable. Aseptic Meningitis Syndrome (AMS) AMS may occur with use of human immune globulin products.5 The syndrome usually begins within several hours to 2 days following IGIV treatment. AMS is characterized by signs and symptoms including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting. Cerebrospinal fluid (CSF) studies frequently show pleocytosis up to several thousand cells per cubic millimeter, predominantly from the granulocytic series, with elevated protein levels up to several hundred mg/dL. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Conduct a thorough neurological examination, including CSF studies, to rule out other causes of meningitis in patients exhibiting signs and symptoms of AMS. Discontinuation 40

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of IGIV treatment has resulted in remission of AMS within several days without sequelae. Hemolysis Hizentra can contain blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin (Coombs’) test result and hemolysis.6-8 Delayed hemolytic anemia can develop subsequent to immune globulin therapy due to enhanced RBC sequestration, and acute hemolysis, consistent with intravascular hemolysis, has been reported.9 Monitor recipients of Hizentra for clinical signs and symptoms of hemolysis. If these are present after a Hizentra infusion, perform appropriate confirmatory laboratory testing. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving Hizentra, perform adequate cross-matching to avoid exacerbating on-going hemolysis. Transfusion-Related Acute Lung Injury (TRALI) Noncardiogenic pulmonary edema may occur in patients administered human immune globulin products.10 TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Typically, it occurs within 1 to 6 hours following transfusion. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support. Monitor Hizentra recipients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient’s serum. 5.3 Transmissible Infectious Agents Because Hizentra is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease [CJD] agent). The risk of infectious agent transmission has been reduced by screening plasma donors for prior exposure to certain viruses, testing for the presence of certain current virus infections, and including virus inactivation/removal steps in the manufacturing process for Hizentra. Report all infections thought to be possibly transmitted by Hizentra to CSL Behring Pharmacovigilance at 1-866-915-6958. 5.4 Laboratory Tests Various passively transferred antibodies in immunoglobulin preparations may lead to misinterpretation of the results of serological testing. 6 ADVERSE REACTIONS The most common adverse reactions (ARs), observed in r5% of study subjects receiving Hizentra, were local reactions (i.e., swelling, redness, heat, pain, and itching at the injection site), headache, vomiting, pain, and fatigue. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, AR rates observed in clinical studies of a product cannot be directly compared to rates in the clinical studies of another product and may not reflect the rates observed in clinical practice. The safety of Hizentra was evaluated in a clinical study for 15 months in subjects with PI who had been treated previously with IGIV every 3 or 4 weeks. The safety analyses included 49 subjects in the intention-to-treat (ITT) population. The ITT population consisted of all subjects who received at least one dose of Hizentra (see Clinical Studies [14] ). Subjects were treated with Hizentra at weekly doses ranging from 66 to 331 mg/kg body weight during the wash-in/wash-out period and from 72 to 379 mg/kg during the efficacy period. The 49 subjects received a total of 2264 weekly infusions of Hizentra. No deaths or serious ARs occurred during the study. Two subjects withdrew from the study due to ARs. One subject experienced a severe injection-site reaction one day after the third weekly infusion, and the other subject experienced moderate myositis. Both reactions were judged to be “at least possibly related” to the administration of Hizentra. Table 2 summarizes the most frequent adverse events (AEs) (experienced by at least 4 subjects), irrespective of causality. Included are all AEs and those considered temporally associated with the Hizentra infusion, i.e., occurring during or within 72 hours after the end of an infusion. Local reactions were the most frequent AEs observed, with injection-site reactions (i.e., swelling, redness, heat, pain, and itching at the site of injection) comprising 98% of local reactions. Table 2: Incidence of Subjects With Adverse Events (AEs)* (Experienced by 4 or More Subjects) and Rate per Infusion, Irrespective of Causality (ITT Population) All AEs*

AE (r4 Subjects)

Local reactions‡

Number (%) of Subjects (n=49)

Number (Rate†) of AEs (n=2264 Infusions)

49 (100)

1340 (0.592)

AEs* Occurring During or Within 72 Hours of Infusion Number Number (Rate†) (%) of AEs of Subjects (n=2264 (n=49) Infusions) 49 (100)

1322 (0.584)

Table 2: (Continued) All AEs*

AE (r4 Subjects) Other AEs: Headache Cough Diarrhea Fatigue Back pain Nausea Abdominal pain, upper Rash Pain in extremity Migraine Pain Epistaxis Pharyngolaryngeal pain Arthralgia

Number (%) of Subjects (n=49)

Number (Rate†) of AEs (n=2264 Infusions)

13 (26.5) 8 (16.3) 7 (14.3) 6 (12.2) 5 (10.2) 5 (10.2) 5 (10.2) 5 (10.2) 4 (8.2) 4 (8.2) 4 (8.2) 4 (8.2) 4 (8.2) 4 (8.2)

40 (0.018) 9 (0.004) 8 (0.004) 6 (0.003) 11 (0.005) 5 (0.002) 5 (0.002) 7 (0.003) 7 (0.003) 5 (0.002) 5 (0.002) 6 (0.003) 6 (0.003) 5 (0.002)

AEs* Occurring During or Within 72 Hours of Infusion Number Number (Rate†) (%) of AEs of Subjects (n=2264 (n=49) Infusions) 12 (24.5) 5 (10.2) 5 (10.2) 4 (8.2) 4 (8.2) 4 (8.2) 3 (6.1) 2 (4.1) 4 (8.2) 3 (6.1) 3 (6.1) 2 (4.1) 2 (4.1) 2 (4.1)

32 (0.014) 6 (0.003) 6 (0.003) 4 (0.002) 5 (0.002) 4 (0.002) 3 (0.001) 3 (0.001) 6 (0.003) 4 (0.002) 4 (0.002) 3 (0.001) 2 (<0.001) 3 (0.001)

* Excluding infections. † Rate of AEs per infusion. ‡ Includes injection-site reactions as well as bruising, scabbing, pain, irritation, cysts, eczema, and nodules at the injection site.

The ratio of infusions with temporally associated AEs, including local reactions, to all infusions was 1338 to 2264 (59.1%; upper 95% confidence limit of 62.4%). Excluding local reactions, the corresponding ratio was 173 to 2264 (7.6%; upper 95% confidence limit of 8.9%). Table 3 summarizes the most frequent ARs (i.e., those AEs considered by the investigators to be “at least possibly related” to Hizentra administration) experienced by at least 2 subjects. Table 3: Incidence of Subjects With Adverse Reactions (Experienced by 2 or More Subjects) to Hizentra and Rate per Infusion (ITT Population) Adverse Reaction (r2 Subjects) Local reactions† Other ARs: Headache Vomiting Pain Fatigue Contusion Back pain Migraine Diarrhea Abdominal pain, upper Nausea Rash Arthralgia

Number (%) of Subjects (n=49) 49 (100)

Number (Rate*) of Adverse Reactions (n=2264 Infusions) 1338 (0.591)

12 (24.5) 3 (6.1) 3 (6.1) 3 (6.1) 2 (4.1) 2 (4.1) 2 (4.1) 2 (4.1) 2 (4.1) 2 (4.1) 2 (4.1) 2 (4.1)

36 (0.016) 3 (0.001) 4 (0.002) 3 (0.001) 3 (0.001) 3 (0.001) 3 (0.001) 2 (<0.001) 2 (<0.001) 2 (<0.001) 2 (<0.001) 2 (<0.001)

* Rate of ARs per infusion. † Includes injection-site reactions as well as bruising, scabbing, pain, irritation, cysts, eczema, and nodules at the injection site.

Table 4 summarizes injection-site reactions based on investigator assessments 15 to 45 minutes after the end of the 683 infusions administered during regularly scheduled visits (every 4 weeks). Table 4: Investigator Assessments* of Injection-Site Reactions by Infusion Injection-Site Reaction Edema/induration Erythema Local heat Local pain Itching

Number† (Rate‡) of Reactions (n=683 Infusions§) 467 (0.68) 346 (0.50) 108 (0.16) 88 (0.13) 64 (0.09)

* 15 to 45 minutes after the end of infusions administered at regularly scheduled visits (every 4 weeks). † For multiple injection sites, every site was judged, but only the site with the strongest reaction was recorded. ‡ Rate of injection-site reactions per infusion. § Number of infusions administered during regularly scheduled visits.

Most local reactions were either mild (93.4%) or moderate (6.3%) in intensity. 6.2 Postmarketing Experience Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

The following adverse reactions have been identified and reported during the postmarketing use of IGIV products11: s Infusion reactions: Hypersensitivity (e.g., anaphylaxis), headache, diarrhea, tachycardia, fever, fatigue, dizziness, malaise, chills, flushing, urticaria or other skin reactions, wheezing or other chest discomfort, nausea, vomiting, rigors, back pain, myalgia, arthralgia, and changes in blood pressure s Renal: Acute renal dysfunction/failure, osmotic nephropathy s Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm s Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension s Neurological: Coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome s Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis) s Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs’) test s Gastrointestinal: Hepatic dysfunction, abdominal pain s General/Body as a Whole: Pyrexia, rigors To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 7 DRUG INTERACTIONS 7.1 Live Virus Vaccines The passive transfer of antibodies with immunoglobulin administration may interfere with the response to live virus vaccines such as measles, mumps, rubella, and varicella (see Patient Counseling Information [17] ). 7.2 Serological Testing Various passively transferred antibodies in immunoglobulin preparations may lead to misinterpretation of the results of serological testing. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Hizentra. It is not known whether Hizentra can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hizentra should be given to pregnant women only if clearly needed. 8.3 Nursing Mothers Hizentra has not been evaluated in nursing mothers. 8.4 Pediatric Use Hizentra was evaluated in 10 pediatric subjects (3 children and 7 adolescents) with PI. No pediatric-specific dose requirements were necessary to achieve the desired serum IgG levels. Hizentra was not evaluated in neonates or infants. 8.5 Geriatric Use Of the 49 subjects evaluated in the clinical study of Hizentra, 6 subjects were 65 years of age or older. No overall differences in safety or efficacy were observed between these subjects and younger subjects. 15 REFERENCES 1. Cayco AV, Perazella MA, Hayslett JP. Renal insufficiency after intravenous immune globulin therapy: a report of two cases and an analysis of the literature. J Am Soc Nephrol 1997;8:1788-1793. 2. Dalakas MC. High-dose intravenous immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. Neurology 1994;44:223-226. 3. Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986;2:217-218. 4. Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000;65:30-34. 5. Gabor EP, Meningitis and skin reaction after intravenous immune globulin therapy. Ann Intern Med 1997;127:1130. 6. Copelan EA, Strohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986;26:410-412. 7. Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, Newsom-Davis J. Hemolysis after high-dose intravenous Ig. Blood 1993;15:3789. 8. Wilson JR, Bhoopalam N, Fisher M. Hemolytic anemia associated with intravenous immunoglobulin. Muscle Nerve 1997;20:1142-1145. 9. Kessary-Shoham H, Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin (IVIg) can lead to enhanced erythrocyte sequestration. J Autoimmun 1999;13:129-135. 10. Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001;41:264-268. 11. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev 2003;17:241-251. Manufactured by: Distributed by: CSL Behring AG CSL Behring LLC Bern, Switzerland Kankakee, IL 60901 USA US License No. 1766 Based on March 2010 version

Spring 2011

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CSL Behring BRIEF SUMMARY OF PRESCRIBING INFORMATION

Vivaglobin® Immune Globulin Subcutaneous (Human) 16% Liquid Before prescribing, please consult prescribing information, a brief summary of which follows. Some text and references refer to full prescribing information. 1 INDICATIONS AND USAGE Vivaglobin is an Immune Globulin Subcutaneous (Human) (IGSC), 16% Liquid indicated as replacement therapy for primary humoral immunodeficiency (PI). This includes, but is not limited to, the primary immunodeficiency in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. 4 CONTRAINDICATIONS Vivaglobin is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of Immune Globulin (Human). Vivaglobin is contraindicated in IgA-deficient patients with antibodies against IgA or a history of hypersensitivity (see Description [11]). 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Severe hypersensitivity reactions may occur (see Patient Counseling Information [17.2]). In case of hypersensitivity, discontinue the Vivaglobin infusion immediately and institute appropriate treatment. Epinephrine should be immediately available to treat any acute severe hypersensitivity reactions. Individuals with IgA deficiency can develop anti-IgA antibodies and anaphylactic reactions (including anaphylaxis and shock) after administration of blood components containing IgA. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Vivaglobin contains b1.7 mg/mL IgA (see Description [11]). The minimum concentration of IgA that will provoke a hypersensitivity reaction is not known; therefore all IgG preparations carry the risk of inducing an anaphylactic reaction to IgA. 5.2 Aseptic Meningitis Syndrome (AMS) AMS has been reported to occur infrequently with IGIV treatment5 and with Vivaglobin treatment. The syndrome usually begins within several hours to 2 days following IGIV treatment. AMS is characterized by signs and symptoms including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting. Cerebrospinal fluid (CSF) studies frequently show pleocytosis up to several thousand cells per cubic millimeter, predominantly from the granulocytic series, and with elevated protein levels up to several hundred mg/dL. AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV. Patients exhibiting such signs and symptoms should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis. Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae. 5.3 Reactions Reported with IGIV Treatment The following reactions have been reported to occur with IGIV treatment and may occur with IGSC treatment. Renal Dysfunction/Failure Renal dysfunction/failure, osmotic nephropathy, and death may occur with use of human immune globulin products. Ensure that patients are not volume depleted and assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of Vivaglobin and at appropriate intervals thereafter. Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk of developing acute renal failure.1 If renal function deteriorates, consider discontinuing Vivaglobin. For patients judged to be at risk of developing renal dysfunction because of pre-existing renal insufficiency or predisposition to acute renal failure (such as those with diabetes mellitus or hypovolemia, those who are overweight or use concomitant nephrotoxic medicinal products, or those who are over 65 years of age), administer Vivaglobin at the minimum rate practicable. Thrombotic Events Thrombotic events may occur with use of human immune globulin products.2-4 Patients at risk may include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. Because of the potentially increased risk of thrombosis, consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/ markedly high triacylglycerols (triglycerides), or monoclonal gammopathies. For patients judged to be at risk of developing thrombotic events, administer Vivaglobin at the minimum rate practicable.

Hemolysis Vivaglobin may contain blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin (Coombs’) test result and hemolysis.6-8 Delayed hemolytic anemia can develop subsequent to immune globulin therapy due to enhanced RBC sequestration, and acute hemolysis, consistent with intravascular hemoylysis, has been reported.9 Monitor recipients of Vivaglobin for clinical signs and symptoms of hemolysis. If these are present after Vivaglobin infusion, perform appropriate confirmatory laboratory testing. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving Vivaglobin, perform adequate cross-matching to avoid exacerbating on-going hemolysis. Transfusion-Related Acute Lung Injury (TRALI) Noncardiogenic pulmonary edema may occur in patients administered human immune globulin products.10 TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Typically, it occurs within 1 to 6 hours following transfusion. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support. Monitor recipients of Vivaglobin for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient’s serum. 5.4 Transmissible Infectious Agents Because Vivaglobin is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses and, theoretically, the Creutzfeldt-Jakob (CJD) agent. No cases of transmission of viral diseases or CJD have been associated with the use of Vivaglobin. Report all infections thought possibly to have been transmitted by Vivaglobin to the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The physician should discuss the risks and benefits of this product with the patient before prescribing or administering it to the patient (see Patient Counseling Information [17.2]). 5.5 Laboratory Tests After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test. 6 ADVERSE REACTIONS The most common adverse reactions (those AEs considered by the investigator to be at least possibly related to Vivaglobin administration) observed in r5% of study subjects receiving Vivaglobin were local injection-site reactions (swelling, redness, and itching), headache, nausea, rash, asthenia, and gastrointestinal disorder. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. US-Canada Study The safety of Vivaglobin was evaluated in a clinical study in the US and Canada for 12 months in 65 subjects with PI who had been previously treated with IGIV every 3 or 4 weeks (see Clinical Studies [14.1]). After 3 months, subjects were switched from IGIV to weekly subcutaneous administration of Vivaglobin for 12 months. Subjects were treated weekly with Vivaglobin at a mean dose of 158 mg/kg body weight (range: 34 to 352 mg/ kg). The 65 subjects received a total of 3,656 infusions of Vivaglobin. Table 2 shows the number of subjects who withdrew from the US-Canada study due to adverse events (AEs) and the AEs leading to discontinuation. Table 2: Subjects with Adverse Events (AEs) Leading to Discontinuation, USCanada Study AEs Subjects with at least 1 AE leading to discontinuation Injection-site reaction Intestinal obstruction Hyperventilation Tachycardia

Subjects with Subjects with AEs Total Number AEs At Least Irrespective of (%) of Subjects Possibly Related Causality 4

1

5 (8%)

3 – 1* 1*

– 1 – –

3 (5%) 1 (2%) 1 (2%) 1 (2%)

* One subject experienced hyperventilation and tachycardia.

Table 3 summarizes the most frequent AEs (experienced by more than 5% of subjects), irrespective of causality. It includes all AEs and those considered temporally associated with the Vivaglobin infusion, i.e., occurring during the infusion or within 72 hours after the end of the infusion.

Table 3: Incidence of Subjects With Adverse Events (AEs)* (Experienced by >5% of Subjects) and Rate† per Infusion, Irrespective of Causality, in the US-Canada Study AEs Occurring During or Within 72 Hours of Infusion Number Number Number Number (Rate†) of (Rate†) of (%) of (%) of AEs per AEs Per Subjects Subjects Infusion Infusion (n=65) (n=65) (n=3656) (n=3656) 1767 60 (92%) 1789 (0.49) 60 (92%) (0.4848) All AEs

AEs* (>5% of Subjects)

AEs at the injection site‡ Other AEs Headache Gastrointestinal disorder Fever Nausea Rash Sore throat Allergic reaction Pain Diarrhea Cough increased Gastrointestinal pain Migraine Skin disorder Asthma Arthralgia Asthenia Malaise

31 (48%) 24 (37%) 16 (25%) 12 (18%) 11 (17%) 10 (15%) 7 (11%) 6 (9%) 6 (9%) 6 (9%) 5 (8%) 5 (8%) 5 (8%) 5 (8%) 4 (6%) 4 (6%) 4 (6%)

159 (0.04) 35 (0.01) 28 (0.008) 18 (0.005) 22 (0.006) 17 (0.005) 8 (0.002) 8 (0.002) 6 (0.002) 6 (0.002) 6 (0.002) 5 (0.001) 7 (0.002) 8 (0.002) 4 (0.001) 4 (0.001) 5 (0.001)

30 (46%) 18 (28%) 12 (8%) 11 (17%) 10 (15%) 8 (12%) 5 (8%) 4 (6%) 5 (8%) 5 (8%) 4 (6%) 2 (3%) 3 (5%) 3 (5%) 3 (5%) 2 (3%) 2 (3%)

* Excluding infections. † Rate, number of AEs per infusion. ‡ Includes injection-site inflammation.

The total number of AEs, irrespective of causality, including injection-site reactions, that began during or within 72 hours after the end of an infusion was 2262 (a rate of 0.62 AEs per infusion); excluding injection-site reactions, the rate of AEs per infusion was 0.14. Table 4 summarizes the severity of local AEs by infusion, irrespective of causality. Table 4: Severity of Local Adverse Events (AEs) by Infusion, Irrespective of Causality, in the US-Canada Study AEs (Number of infusions: 3656) AEs at the injection site Mild† Moderate‡ Severe§ Unknown severity Discontinuations due to AEs at the injection site

Number (Rate*) of AEs Occurring During or Within 72 Hours of Infusion 1767 (0.48) 1100 (0.30) 593 (0.16) 64 (0.02) 10 (<0.01)

Number (Rate*) of AEs 1789 (0.49) 1112 (0.30) 601 (0.16) 65 (0.02) 11 (<0.01)

3 subjects

* Rate, number of AEs per infusion. † Defined as those reactions that did not interfere with routine activities. ‡ Defined as those reactions that interfered with routine activities. § Defined as those reactions that made it impossible to perform routine activities.

Of the three subjects who discontinued the study due to injection-site reactions, one withdrew on Day 1 (Infusion 1) of the wash-in/wash-out period after a moderate injectionsite reaction and a mild headache; one withdrew on Day 22 (Infusion 4) of the wash-in/ wash-out period following severe injection-site reactions for two weeks; and one withdrew on Day 78 following a mild injection-site reaction. Local reactions decreased substantially after repeated use. Table 5 summarizes the most frequent adverse reactions (experienced by at least 3% of subjects) and considered by the investigator to be at least possibly related to Vivaglobin administration. Table 5: Incidence of Subjects With Adverse Reactions (Experienced in r3% of Subjects) and Rate* Per Infusion in the US-Canada Study Related Adverse Reactions (r3% Subjects) Adverse reactions at the injection site† Other Adverse reactions Headache Nausea Rash Asthenia Gastrointestinal disorder Fever Skin disorder Tachycardia Urine abnormality

60 (92%)

Number (Rate*) of Adverse Reactions per Infusion (n=3656) 1787 (0.49)

21 (32%) 7 (11%) 4 (6%) 3 (5%) 3 (5%) 2 (3%) 2 (3%) 2 (3%) 2 (3%)

59 (0.016) 9 (0.002) 9 (0.002) 3 (0.001) 3 (0.001) 2 (0.001) 3 (0.001) 2 (0.001) 3 (0.001)

Number (%) of Subjects (n=65)

* Rate, number of adverse reactions per infusion. † Includes injection-site inflammation.

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104 (0.033) 24 (0.007) 20 (0.005) 15 (0.004) 16 (0.004) 11 (0.003) 5 (0.001) 4 (0.001) 5 (0.001) 5 (0.001) 5 (0.001) 2 (0.001) 5 (0.001) 4 (0.001) 3 (0.001) 2 (0.001) 2 (0.001)

Europe-Brazil Study In a clinical study conducted in Europe and Brazil, the efficacy and safety of Vivaglobin were evaluated for 10 months in 60 subjects with PI. Subjects were treated weekly with Vivaglobin at a mean dose of 89 mg/kg body weight (range: 51 to 147 mg/kg), which was 101% of their previous weekly IGIV or IGSC dose (see Clinical Studies [14.2]). Study subjects received a total of 2,297 infusions of Vivaglobin. The AEs and their rates reported in this study were similar to those reported in the USCanada study, with two exceptions: no episodes of headache were reported; and 18 (a rate of 0.008 per infusion) episodes of fever were judged to be related to the administration of Vivaglobin. One subject discontinued due to repeated local reactions of moderate severity. 6.2 Postmarketing Experience Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure. Vivaglobin Adverse reactions identified during worldwide postmarketing use of Vivaglobin for treatment of PI are allergic-anaphylactic reactions (including dyspnea, pruritus, urticaria, rash, edema and other cutaneous reactions, wheezing, syncope, hypotension, and throat swelling), generalized reactions (including flu-like symptoms, myalgia, chills, fever, tachycardia, arthralgia, nausea and vomiting, diarrhea, gastrointestinal cramping, stomach pain, back pain, headache, headache possibly caused by increased blood pressure, and chest tightness), migraine, and injection-site reactions. General The following adverse reactions have been identified and reported during the postmarketing use of IGIV products11: v Renal: Acute renal dysfunction/failure, osmotic nephropathy v Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), TRALI, cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm v Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension v Neurological: Coma, loss of consciousness, seizures, tremor, aseptic meningitis syndrome v Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis v Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs’) test v General/Body as a Whole: Pyrexia, rigors v Musculoskeletal: Back pain v Gastrointestinal: Hepatic dysfunction, abdominal pain 7 DRUG INTERACTIONS 7.1 Live Virus Vaccines The passive transfer of antibodies with immunoglobulin administration may interfere with the response to live virus vaccines such as measles/mumps/rubella and varicella (see Patient Counseling Information [17.2]). 7.2 Serological Testing Various passively transferred antibodies in immunoglobulin preparations may lead to misinterpretation of the results of serological testing. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Vivaglobin. It is also not known whether Vivaglobin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vivaglobin should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers Vivaglobin has not been evaluated in nursing mothers. 8.4 Pediatric Use v In the US-Canada study, Vivaglobin was evaluated in 6 children (ages 5 through 11) and 4 adolescents (ages 13 through 16). In the Europe-Brazil study, Vivaglobin was evaluated in 16 children (ages 3 through 11) and 6 adolescents (ages 13 through 16). v The safety and efficacy of Vivaglobin were not studied in pediatric subjects under 2 years of age. v There were no differences in the safety and efficacy profiles as compared with adult subjects. v No pediatric-specific dosing requirements were necessary to achieve the desired serum IgG levels. v For recommendations on the number of simultaneous injection sites for pediatric patients who weigh less than 45 kg (99 pounds), see Administration (2.4). 8.5 Geriatric Use The clinical studies of Vivaglobin did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. For recommendations on the number of simultaneous injection sites for geriatric patients, see Administration (2.4). Manufactured by: CSL Behring GmbH Marburg, Germany US License No. 1765

Distributed by: CSL Behring LLC Kankakee, IL 60901 USA Based on April 2010 Revision.

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in the community “I believed that families with hemophilia in wealthier countries, with vast resources and adequate healthcare, would be willing to help once they understood the suffering of people with hemophilia in developing countries.”

Save One Life Imagine, for a moment, living with hemophilia. Consider the uncertainties – how an ordinary day can turn into a life-or-death emergency. Imagine the resources needed to improve the quality of your life or to save it. And imagine the cost – the price of life-saving factor, refrigeration, electricity, clean water – all things we take for granted. Now, imagine living that life in a poor country. No money for medications. No refrigeration to keep it viable. No clean water. And no local treatment center. Those are the life-and-death challenges patients with hemophilia face every

day in countries like Zimbabwe, India and Honduras. They’re the life-and-death challenges Laurie Kelley saw during her many trips to educate patients about hemophilia in developing countries. As the mother of a child with hemophilia, she knew first-hand the daily struggles. But in poor countries, where most hemophilia patients live in households earning about $1 a day, those challenges become staggering. Kelley explains, “Hemophilia is a devastating inherited blood disorder that cause severe pain, crippling and even death when left untreated. In developing countries there are usually no government budgets to purchase the blood-clotting medicine needed to sustain life. Government and social agencies must use scarce resources on other pressing problems – infectious diseases, clean water, natural disasters, high unemploy-

– Laurie Kelley Founder and President of Save One Life

ment – not on a rare chronic disorder.” To address this need, Kelley founded Save One Life in 2000, a registered international nonprofit organization. Her vision was to build a humanitarian bridge by raising awareness and encouraging people in developed countries to give back to the rest of the world in a personal way. “I believed that families with hemophilia in wealthier countries, with vast resources and adequate healthcare, would be willing to help once they understood the suffering of people with hemophilia in developing countries,” Kelley said. Save One Life provides sponsorships for individual hemophilia patients. People in developed countries can choose a child or young adult from a poor country to support for only $20 a month, less than a dollar a day. These funds provide vitamins to anemic children with hemophilia, pain medication, school fees, clothing and other daily living needs. But most of all, these funds provide transportation to the clinic when a child has a bleed. Since these families live in urban slums or distant, rural villages far from medical

A Bridge of Hope for Hemophilia Patients in Developing Countries 44

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care, this is crucial. “We’ve found that most of the sponsorship money, regardless of the country, goes to school fees to help the child get a good education and lift the family out of poverty, and transportation to a hospital when the child has a bleed,” Kelley notes. Along with its dedication to the bleeding disorders community, Save One Life knows the importance of using its funds carefully and diligently. To achieve this, the foundation builds strong personal relationships with the non-governmental organizations (NGOs) that manage its programs in developing countries. This helps define Save One Life as, not just a charity, but a development tool that helps promote long-term care and capacity-building with NGOs through training, progress monitoring and strict accountability. Today the organization provides sponsorships to more than 758 individuals with bleeding disorders in 11 developing nations (see sidebar). Sponsors receive an attractive photo and biography of their sponsored child and are encouraged to write them.

ASD Healthcare is proud to support Save One Life and its mission. Neil Herson, president of ASD Healthcare said, “The contributions Save One Life makes to the hemophilia community are invaluable in raising awareness of the challenges patients face around the world and in saving lives.” Individuals, groups and companies interested in supporting Save One Life are encouraged to participate by visiting www.saveonelife.net. Save One Life offers a variety of ways to support their mission, including the Mount Kilimanjaro Climb for a Cause in August (see below). 

www.saveonelife.net

Join the Adventure Mount Kilimanjaro Climb for a Cause This August, eleven Save One Life supporters, including founder Laurie Kelley and ASD Healthcare president Neil Herson, will be climbing for a cause as they scale the highest mountain in Africa – 19,340 foot Mt. Kilimanjaro. The climbers will pay their own expenses for the trip so that all funds raised will go directly to Save One Life programs in Africa. In addition to the financial goals, this climb also will put a spotlight on hemophilia care in Africa. It’s an event that will inspire people everywhere that they can make a difference in the lives of those affected by hemophilia. To support your favorite climber, go to http://saveonelife.net/mt-kilimanjaro-climb.php Read about the event, learn about the climbers and join in by supporting your favorite climber.

About Save One Life Save One Life was founded in 2000 by Laurie Kelley as a registered international nonprofit organization. The foundation offers individuals, families, companies and organizations the opportunity to sponsor a child or adult with a bleeding disorder in developing country. Today, more than 758 hemophilia patients are being sponsored in 11 countries – Romania, Philippines, India, Nepal, Pakistan, Dominican Republic, Belize, Honduras, Egypt, Zimbabwe and Kenya. The organization also works in partnership with the hemophilia foundations in each country where their members volunteer their care, time and resources to improve the lives of impoverished people with bleeding disorders. As a result, 100% of sponsorship donations go directly to the sponsored child and their local hemophilia chapter.

Our goals: • •

Identify people with bleeding disorders who need aid in the developing world Match them with sponsors who offer long-term friendship and financial support Partner with and mentor local hemophilia organizations through program funding Raise public awareness about people with hemophilia in the developing world

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“For me, delivering exceptional customer support is personal. As Vice President of Business Operations, I know how my teams make a difference in the lives of patients. Relationships become personal when you know people depend on your actions. That’s why our operating systems – whether it’s customer service, project management, administration, internal

Devetta Coulter shares a moment with her fiancé Dwayne James and her thoughts on True Blue service with you.

or external – are built to offer proactive solutions, to think ahead, to plan ahead and to utilize the most effective technologies in supporting our customers and the patients who depend on them. That’s True Blue.”

Our True Blue culture encompasses all aspects of our business. From technology offerings, to customer support, to patient advocacy, to community involvement – ASD Healthcare is here for you. Trust us to provide the products and support you need in an ever-changing landscape of medicine, policy and patient demographics. Call us. Challenge us. Experience True Blue. Learn more about True Blue by going to www.asdtrueblue.com.

Call us at 800.746.6273

46

insideout

Spring 2011

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Staying Safe this Snake Bite Season It’s the time of year when people like to be outdoors. Whether we are camping, picnicking, hiking or just gazing upon some beautiful scenery, a snake bite can bring our enjoyment of Mother Nature to an abrupt end! Snakes bite about 8,000 people each year in the United States. Only 12 people each year die from snake bite. Children are at greater risk of dying or having serious complications from a snake bite because of their smaller size. Most snakes will avoid

The Deadliest Bite

people and bite only when threatened or surprised. A bite from a poisonous snake is considered a medical emergency. There are two types of venomous (or poisonous) snakes found in the United States: pit vipers – rattlesnakes, copperheads and cottonmouths – and elapids – coral snakes. Pit vipers are responsible for 98% of all poisonous snake bites each year. However, more and more exotic and foreign snakes are brought into the country illegally. For that reason, all snake bites are considered serious. Knowing what to do in case of a snake bite is important. Symptoms depend upon the type of snake causing the bite. Each individual may experience different symptoms. Pit viper bites are generally painful when they occur, symptoms usually begin right away and fang marks are seen. Pit viper venom contains peptides and proteins that damage the red blood cells. A bite from a coral snake may be painless at first and symptoms may not develop right away. Coral snake venom is primarily a neurotoxin.

Life-Saving Antivenins

Silent danger Water moccasins (commonly referred to as cottonmouths) are less common and less aggressive than rattlesnakes. They are dangerous and don’t give any type of warning like that of a rattlesnake. Victims are often caught off guard.

The goals of pharmacotherapy are to neutralize the toxin of snake bites, to reduce morbidity and to prevent complications. A neutralizing antibody gives antivenin efficacy. The current product approved by the U.S. Food and Drug Administration (FDA) in 2000 (CroFab®, BTG International Inc.), is a mixed monovalent immunoglobulin fragment derived from sheep but purified to avoid other antigenic proteins. While rare, immediate hypersensitivity reactions (symptoms of acute anaphylactoid reactions such as pruritus, urticaria or wheezing occurred in roughly 6% of patients in prospective studies and were generally mild) and delayed hypersensitivity (serum sickness occurred in 5-10% of patients in prospective studies) reactions have been reported.1 To achieve maximum efficacy, antivenin should be administer within six hours of the snake bite. insideout

References: Paul S. Auerbach, Wilderness Medicine, http://www.nim.nih.gov/ medlineplus/ency/article/000031.htm; accessed June 12, 2009 Tintinalli and Stapcynski, editors, Emergency Medicine: A Comprehensive Guide, 6th edition.

Most snake bites in the U.S. (Texas has the highest number of reported bites annually) come from members of the Crotalidae family, also known as pit vipers. This includes varieties such as rattlesnakes, water moccasins and copperheads. Here’s how they compare:

Most venomous The most venomous of these vipers would be the rattlesnake. They are responsible for the most fatalities in the U.S. annually.

48

Play it Safe. Avoiding snake bites is the best way to keep safe outdoors. Leave snakes alone. Don’t pick up any snake – even though you believe it’s not poisonous. When hiking, wear thick leather boots and long pants. Stay on the trails and out of tall, grassy areas. Use a walking stick to test ahead of you when entering any areas where you can’t see your feet. Avoid areas under rocks or logs and woodpiles. Remember, most snakes are harmless and most snake bites are not life threatening. Don’t try to determine if the snake is poisonous or not. Once bitten, stay calm and always seek medical assistance. The good news is that the majority of snake bites can be treated effectively when the victim is transported as soon as possible to a medical facility that has antivenin.

More but less Copperheads are responsible for the most reported bites, but their venom (in general) is considered to be sub-lethal. However, their bite is a medical emergency. You should seek immediate medical attention for a bite regardless of the type of snake.

A local expert or poison control center should be consulted prior to giving antivenin (1-800-222-1222). CroFab is made specifically from venom of the Eastern and Western Diamondback rattlesnakes, Mohave rattlesnakes and the cottonmouth or water moccasin snakes. The purpose of any antivenin is to bind the toxins in the venom and prevent both local and systemic results. CroFab has been used in Crotalid bites with good effect (reduced fasciotomy) and reductions in antivenin toxicity. To read an expanded discussion on snakebite treatments, go to www.biomedcentral.com/bmcemergmed, then select, “Unified Treatment Algorithm for the Management of Crotaline Snakebite in the United States: Results of an Evidence-Informed Consensus Workshop.” Source: Lavonas EJ. Unified Treatment Algorithm for the Management of Crotaline Snakebite in the United States: Results of an Evidence-Informed Consensus Workshop. Biomed Central. 2011; 11:2.

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Do • • •

• •

• •

Do stay calm! Call for medical assistance immediately! Do get away from the snake – many snakes can strike from quite a distance. Do minimize movement particularly of the affected extremity. A victim may need to be carried to a safe area. Do splint the affected area to keep it immobile. Do remove any rings, jewelry or potentially constricting clothing because swelling can occur. Do keep the affected area below the level of the heart. Do wash the area of the bite with soap and water.

EMS personnel should monitor the patient’s vital signs. A cool compress or moist dressing can minimize swelling and discomfort. Treat pain according to local protocols as necessary. Transport as soon as possible to the closest hospital that is able to treat the patient with antivenin. If access to medical care cannot be accomplished quickly, a light pressure dressing, such as an elastic bandage, may be applied. If necessary, contact the National Poison Control Center at (800) 222-1222 for additional instructions.

Don’t • • • • • • •

50

Don’t allow the snake bite victim to become excited and move around. Don’t apply a tourniquet. Don’t apply ice directly to the bite. Don’t cut the bite or try to suck out the venom by mouth. Don’t give the victim anything to eat or drink. Don’t raise the site of the bite above the level of the victim’s heart. Above all, don’t waste time hunting for the snake. If the snake has been killed, be careful. The head can still bite reflexively for up to an hour after the snake’s death.

insideout

Snake Bite Symptoms Pain, bruising, swel ling and necrosis of tissue at or around the bite site

Low blood pressure and high heart rate, which together equa ls shock

Blood clotting defects (presence of mini hemorrhages on the mucous membranes)

Depression and/or letha rgy

Decreased number of platelets in the blood (affects clotting times)

Nausea and excessive salivation

Packaged with Mix2Vial® Filter Transfer Set

Card iovascular and respiratory distress

In the United States, dog bites account for about 1 percent of all emergency room visits, including 44,000 cases per year of facial injuries.

Rabies Risk ❉ Today, the risk of rabies in the U.S. and Canada doesn’t come from Fido. It comes from wild animal  –  raccoons, skunks, foxes, coyotes – and mostly bats. So if you’re going into the wild, be aware. Bat bites or scratches can be small and go unnoticed. Call your doctor if you’ve been in close contact with a bat or wild animal. Bites are an urgent reason to seek medical attention, immediately. Reference: “Rabies” PubMed, www.ncbi.nlm.nih.gov/pubmedhealth

Available in the following potencies and color coded assay ranges

Beware: Dogs bite too Snakes aren’t the only things that can take a bite out of your summer fun. Fido can create his share of havoc, too. Young children are at the greatest risk for dog bites in the summer and are especially vulnerable to severe bites in the head and neck areas, according to a study quoted in U.S. News and World Report. Researchers analyzed 84 cases of dog bites in children. The findings were published in the March issue of Otolaryngology (head and neck surgery). It’s not clear why children are more likely to be bitten in the summer, but it may be because children spend more time outdoors playing with dogs in warmer months, the researchers suggested. Or it may be that dogs are generally more irritable in hot weather.

The study found that 27 percent of dog bite injuries were caused by family pets. The most common sites of bites to the head and neck were the cheeks (34 percent), lips (21 percent) and nose and ears (both 8 percent). Source: “Dog Bite Season is Around the Corner,” 12 Apr. 2009, John Davidson, http://blogs.denverpost.com/fetch

Potency

Diluent Size

500 IU FIX Range

10 mL

1000 IU FIX Range

10 mL

1500 IU FIX Range

10 mL

A9L14-15-US-10

Once Bitten:

For further information call: Grifols USA, LLC Professional Service: 888 GRIFOLS (888 474 3657) Customer Service: 888 325 8579 Fax: 323 441 7968 www.grifols.com Grifols Biologicals Inc. 5555 Valley Boulevard, Los Angeles, California 90032, USA

Spring 2011

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in our catalog Kogenate® FS with BIO-SET®

Free Trial Program

Our updated catalog now includes not only our most popular plasma products, but also products for contrast media, nephrology, and more! This revamped section is color-coded

Enroll today for up to

6

for easy identification and quick reference. Flip through and see what ASD Healthcare

free doses*

you are looking for may be found in a different section of the catalog, depending on its use. B:11.375”

S:10”

T:10.875”

* Subject to approval. Terms and conditions apply.

has to offer, and remember that the product

Is there a product you need, but don’t see in this catalog? An item you’ve been

For more information, visit kogenatefs.com or call 1-866-329-3449 (Monday through Friday, 8:30 am to 5:30 pm, ET).

ordering that you can’t find here? Don’t worry – our product offerings expand well beyond what is listed here. Call us today for

Ask your doctor if Kogenate® FS with BIO-SET® is right for you.

more information and personalized service.

Customer Service 800.746.6273 or www.asdhealthcare.com

Plasma Derivatives

BAYER, the Bayer Cross, and KOGENATE are registered trademarks of Bayer. BIO-SET is a registered trademark of Biodome SAS.

Pharmaceuticals

Contrast Media

Nephrology

Albumin 54

Vaccines 58

Astellas Pharma US

61

Rx 72

Antihemophelic 54

Specialty 58

Bayer 61

Medsurge 75

Immunologic 56

Biosurgery 60

Bracco 62

Hyper-Immune Globulin

57

Covidien 65 GE 70

©2011 Bayer HealthCare Pharmaceuticals Inc. All rights reserved 01/11 KN10000810

Spring 2011

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Albumin CODE

PRODUCT

P9045

500 iu

J7192

Kogenate FS

1000 iu

BYR

00026-3785-50

vial

J7192

Kogenate® FS

2000 iu

BYR

00026-3786-60

vial

J7192

Kogenate® FS

3000 iu

BYR

00026-3787-70

vial

J7192

Kogenate® FS w/BIO-SET®

250 iu

BYR

00026-3792-20

vial

®

BYR

00026-3783-30

vial

EQ. UNIT

MFR.

NDC #

PK/CS

Albumin 5%

250 ml

1

OCT

67467-0623-02

vial

P9047

Albumin 25%

50 ml

1

OCT

67467-0643-01

vial

P9047

Albuminar® 25%

50 ml

1

CSL

00053-7680-02

vial

J7192

Kogenate FS w/BIO-SET

500 iu

BYR

00026-3793-30

vial

P9047

Albuminar® 25%

100 ml

2

CSL

00053-7680-03

vial

J7192

Kogenate® FS w/BIO-SET®

1000 iu

BYR

00026-3795-50

vial

P9045

Albutein® 5% (Albumin)

250 ml

1

GFS

68516-5214-01

vial

J7192

Kogenate® FS w/BIO-SET®

2000 iu

BYR

00026-3796-60

vial

P9045

Albutein® 5% (Albumin)

500 ml

2

GFS

68516-5214-02

vial

J7192

Kogenate® FS w/BIO-SET®

3000 iu

BYR

00026-3797-70

vial

vial

J7192

®

Recombinate

250 iu

BAX

00944-2831-15

vial

vial

J7192

Recombinate®

500 iu

BAX

00944-2832-15

vial

J7192

Recombinate

1000 iu

BAX

00944-2833-15

vial

J7185

Xyntha™

250 iu

WYE

58394-0012-01

vial

P9047

Albutein® 25% (Albumin)

P9047

Albutein 25% (Albumin) ®

50 ml

1

100 ml

GFS

2

GFS

68516-5216-01 68516-5216-02

P9047

AlbuRx® 25%

50 ml

1

CSL

44206-0251-05

vial

P9047

AlbuRx® 25%

100 ml

2

CSL

44206-0251-10

vial

P9045

AlbuRx 5%

250 ml

1

CSL

44206-0310-25

vial

P9045

AlbuRx® 5%

500 ml

2

CSL

44206-0310-50

vial

J3490

Buminate 5% (Albumin)

6 x 250 ml

1

BAX

00944-0491-01

case

J3490

Buminate 5% (Albumin)

6 x 500 ml

2

BAX

00944-0491-02

case

J3490

Buminate 25% (Albumin)

10 x 20 ml

0.4

BAX

00944-0490-01

case

J3490

Flexbumin 25%

24 x 50 ml

1

BAX

00944-0493-01

case

J3490

Flexbumin 25%

12 x 100 ml

2

BAX

00944-0493-02

P9041

Plasbumin® 5% (Albumin)

50 ml

0.2

TAL

P9045

Plasbumin 5% (Albumin)

250 ml

1

TAL

P9046

Plasbumin 25% (Albumin)

20 ml

0.4

TAL

P9047

Plasbumin 25% (Albumin)

50 ml

1

P9047

Plasbumin® 25% (Albumin)

100 ml

P9043

Plasmanate® 5% (PPF)

50 ml

P9048

Plasmanate 5% (PPF)

Code

®

® ® ®

®

250 ml

PRODUCT

SIZE

®

®

®

J7185

Xyntha™

500 iu

WYE

58394-0013-01

vial

J7185

Xyntha™

1000 iu

WYE

58394-0014-01

vial

J7185

Xyntha™

2000 iu

WYE

58394-0015-01

vial

BAX

00944-2930-01

vial

Factor VIII (Immunoaffinity Purified. Derived from Human Plasma.) J7190

Hemofil® M

J7190

Hemofil M

500 iu

BAX

00944-2931-01

vial

J7190

Hemofil® M

1000 iu

BAX

00944-2932-01

vial

case

J7190

Hemofil M

1700 iu

BAX

00944-2933-01

vial

13533-0685-20

vial

J7190

Monoclate-P®

250 iu

CSL

00053-7656-01

vial

13533-0685-25

vial

J7190

Monoclate-P

500 iu

CSL

00053-7656-02

vial

13533-0684-16

vial

J7190

Monoclate-P®

1000 iu

CSL

00053-7656-04

vial

TAL

13533-0684-20

vial

J7190

Monoclate-P®

1500 iu

CSL

00053-7656-05

vial

2

TAL

13533-0684-71

vial

Factor VIII (Derived from Human Plasma. Contains von Willebrand Factor.)

0.2

TAL

13533-0613-20

vial

J7186

Alphanate®

250 iu

GFS

68516-4601-01

vial

vial

J7186

Alphanate®

500 iu

GFS

68516-4602-01

vial

J7186

Alphanate

1000 iu

GFS

68516-4603-02

vial

J7186

Alphanate

1500 iu

GFS

68516-4604-02

vial

J7187

Humate-P®

250 RCoF

CSL

00053-7615-05

vial

J7187

Humate-P

500 RCoF

CSL

00053-7615-10

vial

J7187

Humate-P®

1000 RCoF

CSL

00053-7615-20

vial

1

TAL

13533-0613-25

MFR.

NDC #

PK/CS

Factor VIIa (Recombinant)

250 iu

®

®

®

® ®

®

J7189

NovoSeven® RT

1000 mcg

NOVO

00169-7010-01

vial

J7190

Koate®-DVI

250 iu

TAL

13533-0665-20

vial

J7189

NovoSeven® RT

2000 mcg

NOVO

00169-7020-01

vial

J7190

Koate®-DVI

500 iu

TAL

13533-0665-30

vial

J7189

NovoSeven® RT

8 mg

NOVO

00169-7040-01

vial

J7190

Koate -DVI

1000 iu

TAL

13533-0665-50

vial

J7189

NovoSeven® RT

5000 mcg

NOVO

00169-7050-01

vial

J3590

Wilate®

450iu RCo/5ml

OCT

67467-181-01

vial

J3590

Wilate®

900iu RCo/10ml

OCT

67467-181-02

vial

Factor VIII (Recombinant)

®

J7192

Advate w/Baxject II

250 iu

BAX

00944-2941-10

vial

Factor IX (Recombinant)

J7192

Advate® w/Baxject II

500 iu

BAX

00944-2942-10

vial

J7195

BeneFIX®

250 iu

WYE

58394-0003-06

vial

J7192

Advate w/Baxject II

1000 iu

BAX

00944-2943-10

vial

J7195

BeneFIX®

500 iu

WYE

58394-0002-06

vial

J7192

Advate® w/Baxject II

1500 iu

BAX

00944-2944-10

vial

J7195

®

BeneFIX

1000 iu

WYE

58394-0001-06

vial

J7192

Advate® w/Baxject II

2000 iu

BAX

00944-2945-10

vial

J7195

BeneFIX®

2000 iu

WYE

58394-0008-02

vial

J7192

Advate® w/Baxject II

3000 iu

BAX

00944-2946-10

vial

J7192

Helixate® FS

250 iu

CSL

00053-8131-02

vial

J7192

Helixate® FS

500 iu

CSL

00053-8132-02

vial

J7192

Helixate® FS

1000 iu

CSL

00053-8133-02

vial

J7192

Helixate® FS

2000 iu

CSL

00053-8134-02

vial

J7192

Helixate® FS

3000 iu

CSL

00053-8135-02

vial

J7192

Kogenate® FS

250 iu

BYR

00026-3782-20

vial

insideout

®

®

plasma derivatives

plasma derivatives

Kogenate® FS

SIZE

Antihemophilic

54

J7192

Factor IX (Prothrombin Concetrates. Derived from Human Plasma. Contains Factor II, VII, IX and X.) J7194

Bebulin® VH

500-700 iu

BAX

64193-0244-02

vial

J7194

Profilnine® SD

500 iu

GFS

68516-3201-1

vial

J7194

Profilnine® SD

1000 iu

GFS

68516-3202-2

vial

J7194

Profilnine® SD

1500 iu

GFS

68516-3203-2

vial

Spring 2011

55


Factor IX (Derived from Human Plasma)

5 gm

CSL

44206-0436-05

vial

J7193

AlphaNine® SD

500 iu

GFS

68516-3601-2

vial

J1459

Privigen®

10 gm

CSL

44206-0437-10

vial

J7193

AlphaNine SD

1000 iu

GFS

68516-3602-2

vial

J1459

Privigen

20 gm

CSL

44206-0438-20

vial

J7193

AlphaNine SD

1500 iu

GFS

68516-3603-2

vial

J7193

Mononine®

500 iu

CSL

00053-7668-02

vial

J7193

Mononine®

1000 iu

CSL

00053-7668-04

vial

® ®

Factor XIII (Derived from Human Plasma) NEW

J7199

Corifact PDS

1380 iu

CSL

63833-518-02

vial

Fibrinogen Concentrate J1680

RiaSTAP™

1 gm

CSL

63833-8915-01

vial

J1459

Privigen® ®

Immune Globulin Subcutaneous (Human) Liquid J3490

Hizentra™

5 ml

CSL

44206-451-01

vial

J3490

Hizentra

10 ml

CSL

44206-452-02

vial

J3490

Hizentra

20 ml

CSL

44206-454-04

vial

J1562

Vivaglobin

3 ml

CSL

00053-7596-01

vial

J1562

Vivaglobin®

10 ml

CSL

00053-7596-10

vial

J1562

Vivaglobin®

20 ml

CSL

00053-7596-20

vial

™ ™ ®

Anti-Inhibitor Coagulation Complexes (Derived from Human Plasma) J7198

Feiba® VH

500 iu

BAX

64193-0222-03

vial

J7198

Feiba® VH

1000 iu

BAX

64193-0222-04

vial

J7198

Feiba® VH

2500 iu

BAX

64193-0222-05

vial

Thrombate III®

500 iu

TAL

13533-0603-20

vial

Anti Thrombin (Recombinant) J3590

ATryn®

1750 iu

GTC

67386-521-51

vial

Desmopressin Acetate (Useful in Disorders of Hemostasis) J2597

Stimate® (Nasal Spray)

2.5 ml

CSL

00053-2453-00

vial

Immunologic CODE

PRODUCT

SIZE

MFR.

NDC #

PK/CS

Immune Globulin Intravenous (Human) Lyophilized

PRODUCT

SIZE

MFR.

NDC #

PK/CS

J1470

GamaSTAN® S/D

2 ml

TAL

13533-0635-04

vial

J1550

GamaSTAN S/D

10 ml

TAL

13533-0635-12

vial

TAL

13533-0631-06

10/pk

®

Rho(D) Immune Globulin J2788

HyperRHO® S/D mini-dose

50 mcg

J2790

HyperRHO S/D

300 mcg

TAL

13533-0631-02

syringe

J2790

RhoGAM® UF Plus*

300 mcg

OCD

0562-7805-01

syringe

®

J2788

MICRhoGAM UF Plus*

50 mcg

OCD

0562-7806-01

syringe

J2791

Rhophylac®

300 mcg

CSL

44206-0300-01

syringe

J2791

Rhophylac

300 mcg

CSL

44206-0300-10

10/pk

J2792

WinRho® SDF Liguid 1500 iu

300 mcg

CAN

53270-3300-01

vial

®

®

J2792

WinRho SDF Liguid 2500 iu

500 mcg

CAN

53270-3500-01

vial

Carimune® NF

3 gm

CSL

44206-0416-03

vial

J2792

WinRho® SDF Liguid 5000 iu

1000 mcg

CAN

53270-3100-01

vial

J1566

Carimune NF

6 gm

CSL

44206-0417-06

vial

J2792

WinRho SDF Liguid 15000 iu

3000 mcg

CAN

53270-3000-01

vial

J1566

Carimune® NF

12 gm

CSL

44206-0416-12

vial

1 ml

APO

60505-6071-00

vial

®

®

®

*Not sold in state of Florida.

Hepatitis B Immune Globulin J1573

HepaGam B®

J1573

HepaGam B

5 ml

APO

60505-6072-00

vial

CPT-90371

HyperHEP B® S/D

0.5 ml

TAL

13533-0636-03

syringe

CPT-90371

HyperHEP B® S/D

1 ml

TAL

13533-0636-02

syringe

CPT-90371

HyperHEP B® S/D

1 ml

TAL

13533-0636-01

vial

CPT-90371

HyperHEP B SD

5 ml

TAL

13533-0636-05

vial

C9105

Nabi-HB®

1 ml

BIOTEST

59730-4202-01

vial

C9105

Nabi-HB®

5 ml

BIOTEST

59730-4203-01

vial

2 ml

TAL

13533-0618-02

vial

J1572

Flebogamma® DIF 5%

2.5 gm

GFS

61953-0004-02

vial

J1572

Flebogamma® DIF 5%

5 gm

GFS

61953-0004-03

vial

J1572

Flebogamma® DIF 5%

10 gm

GFS

61953-0004-04

vial

J1572

Flebogamma DIF 5%

20 gm

GFS

61953-0004-05

vial

Flebogamma® DIF 10%

5 gm

GFS

61953-0005-01

vial

Flebogamma® DIF 10%

10 gm

GFS

61953-0005-02

vial

Flebogamma® DIF 10%

20 gm

GFS

61953-0005-03

vial

J1569

Gammagard Liquid

1 gm

BAX

00944-2700-02

vial

J1569

Gammagard Liquid

2.5 gm

BAX

00944-2700-03

vial

Rabies Immune Globulin

J1569

Gammagard Liquid

5 gm

BAX

00944-2700-04

vial

CPT-90375

HyperRAB® S/D

®

®

®

CPT-90375

®

HyperRAB S/D

10 ml

TAL

13533-0618-10

vial

CPT-90376

IMOGAM® Rabies-HT

300 iu/2 ml

SAN

49281-0190-20

vial

CPT-90376

IMOGAM Rabies-HT

1500 iu/10 ml

SAN

49281-0190-10

vial

1 ml

TAL

13533-0634-02

syringe

2.5 gm/50 ml

CSL

44206-3101-01

vial

J1569

Gammagard Liquid

10 gm

BAX

00944-2700-05

vial

J1569

Gammagard Liquid

20 gm

BAX

00944-2700-06

vial

J1561

Gamunex®

1 gm

TAL

13533-0645-12

vial

J1561

Gamunex®

2.5 gm

TAL

13533-0645-15

vial

Tetanus Immune Globulin

J1561

Gamunex®

5 gm

TAL

13533-0645-20

vial

J1670

J1561

®

Gamunex

10 gm

TAL

13533-0645-71

vial

Cytomegalovirus Immune Globulin Intravenous (Human)

J1561

Gamunex®

20 gm

TAL

13533-0645-24

vial

J0850

insideout

®

HyperTET® S/D

CytoGam®

Spring 2011

plasma contrast derivatives media

plasma derivatives

Code

J1566

Immune Globulin Intravenous (Human) Liquid

56

Hepatitis B Immune Globulin

Intramuscular Immune Globulins (Human)

Anti Thrombin III (Derived from Human Plasma) J7197

Hyper-Immune Globulin

57


Vaccines Code

PRODUCT

SIZE

MFR.

NDC #

PK/CS

Flu Q2035

Afluria® syringe

Q2035

Afluria vial ®

FluMist®

10 x 0.5 ml

MER

33332-0011-01

syringe

10 x 5 ml

MER

3333-0111-10

vial

10 x 0.2 ml

MEDI

66019-0109-10

sprayers

5 ml

NOV

66521-0114-10

vial

Q2037

Fluvirin® (10 dose vial)

Q2037

Fluvirin® syringe

10 x 0.5 ml

NOV

66521-0114-02

syringe

Q2038

FluZone pediatric syringe

10 x 0.25 ml

SAN

49281-0010-25

syringe

Q2038

FluZone®

10 x .5 ml

SAN

49281-0111-25

syringe

Q2038

FluZone®

10 x 5 ml

SAN

49281-0011-50

vial

Q2038

FluZone® HD

5 ml

SAN

49281-0387-65

syringe

GSK

®

G9035

Relenza

5 mg Diskhaler

G9035

Tamiflu

12 mg/ml 25 ml

00004-0810-95

suspension

G9035

Tamiflu

75 mg 10/bx

00004-0800-85

capsules

2.9 mg/5 ml

GNZ

58468-0070-01

vial

J9215

Alferon N®

5 mm iu (1 ml)

HEMI

54746-0001-01

vial

J3490

Aloprim®

500 mg/30 ml

NABI

59730-0560-11

vial

50 ml

MEDI

62592-0720-50

vial

250 mg

MEDCO

65293-0001-01

10/pk

500 unit vial

CSL

63833-825-02

kit

J0583

Angiomax®

J3490

Berinert® Buphenyl

500 mg tabs

MEDI

62592-0496-03

btl

Buphenyl®

250 g

MEDI

62592-0188-64

btl

J9010

Campath®

30 mg/ml

BYR

50419-0357-03

3/pk

J1785

®

Cerezyme

200u

GNZ

58468-1983-01

vial

J1785

Cerezyme®

400u

GNZ

58468-4663-01

vial

C9274

®

CroFab

2 x 2 ml

BTG

00281-0330-10

pk

C9274

CroFab®

2 x 2 ml

BTG

50633-0110-12

vial

J9878

Cubicin®

500 mg

CUB

67919-0011-01

10/pk

J0894

Dacogen®

50 mg

MGI

62856-0600-01

vial

®

00173-0681-01

J1162

DigiFab

40 mg

BTG

50633-0120-11

vial

J7323

Euflexxa®

2.25 ml

FERR

55566-4100-01

3 syr/pk

J8499

Exjade®

125 mg/30 tabs

NOV

00078-0468-15

btl

Meningitis

J8499

Exjade®

250 mg/30 tabs

NOV

00078-0469-15

btl

CPT-90734

J8499

Exjade

500 mg/30 tabs

NOV

00078-0470-15

btl

J0180

Fabrazyme®

35 mg

GNZ

58468-0040-01

vial

J0180

Fabrazyme®

5 mg

GNZ

58468-0041-01

vial

J9395

Faslodex®

125 mg/2 x 2.5 ml

AZ

00310-0720-25

pk pk

CPT-90648

ActHIB®

SAN

Menactra® S/D

SAN

49281-0545-05

49281-0589-05

vial

5/pk

Polio CPT-90713

IPOL®

10 x 1 mdv

SAN

49281-0860-10

vial

Rabies CPT-90675

RabAvert®

1 ml

NOV

00078-0566-51

CPT-90715 CPT-90700

Adacel

10 x 0.5 ml

®

DAPTACEL®

SAN

10 x 1 mdv

SAN

49281-0400-10 49281-0286-10

®

J9395

Faslodex

250 mg/1 x 5 ml

AZ

00310-0720-50

J9155

Firmagon

240 mg injection

FERR

55566-840-01

J9155

Firmagon

5 mg diskhaler

FERR

55566-8301-01

vial

J9999

Folotyn™

20 mg

ALLOS

48818-0001-01

vial

vial

J9999

Folotyn

Q0166

Granisol™ Oral

pk

Tetanus

NEW

®

40 mg

ALLOS

48818-0001-02

vial

2 mg/10 ml 30 ml

PediatRx

52547-0801-30

btl

CPT-90714

DECAVAC™

10 x 0.5 ml

SAN

49281-0291-10

syringe

CPT-90702

Tet Dip Toxoid Adsorbed

10 x 0.5 ml

AKN

17478-0131-01

vial

J9999

Halaven

1 mg/2 ml SDV

EISAI

62856-0389-01

vial

J9315

Istodax®

10 mg

CEL

46026-983-01

1 kit

47783-0101-01

vial

54396-0801-01

vial

CPT-90702

Dip Tet Tox™ Adsorbed

10 x 1 mdv

SAN

49281-0278-10

vial

CPT-90703

Tet Tox Adsorbed

10 x 1 mdv

SAN

49281-0800-83

vial

CPT-90749 CPT-86700

Tet Tox™ Plain

7.5 ml

Tripedia®

SAN

0.5 ml

SAN

49281-0812-84 49281-0298-10

J3490

Aplisol®

J3490

Kalbitor®

vial

J3590

Krystexxa™

vial

Tuberculosis 5TU 1 ml

KING

42023-0104-01

vial

Aplisol®

5TU 5 ml

KING

42023-0104-05

vial

CPT-86580

Tubersol®

5 TU 1 ml

SAN

49281-0752-21

pk

CPT-86580

Tubersol®

5 TU 5 ml

SAN

49281-0752-22

pk

Typhoid

J9300

Mylotarg

J0220

Myozyme®

J8999

Nexavar®

J1640

Panhematin®

®

Panretin® 0.1% Gel

10 mg 8 mg SDV 2 ml

SAVIENT

5 mg/20 ml

HEM GRP

00008-4510-01

vial

50 mg

GNZ

58468-0150-01

vial

200 mg/120 tabs

BYR

00026-8488-58

btl

100 ml

OVA

67386-0701-54

vial

60 g

EISAI

64365-501-01

tube

J7335

®

Qutenza

1 patch/50 g gel

NEURO

49685-928-01

kit

J7335

Qutenza®

2 patch/50 g gel

NEURO

49685-928-02

kit

J1300

Soliris

300 mg/30 ml

ALX

25682-0001-01

vial

CPT-90691

Typhim Vi®

.05 ml

SAN

49281-0790-51

syringe

J7321

Supartz®

10 mg/ml

S&N

08363-7765-01

pk

CPT-90691

Typhim Vi

20 dose vial

SAN

49281-0790-20

vial

J8999

®

Targretin

75 mg SGC/100 tabs

EISAI

64365-502-01

btl

J8999

Targretin® 1% Gel

60 g

EISAI

64365-504-01

tube

J8999

Tasigna®

150 mg/28 caps

NOV

00078-0592-51

pk

CPT-90586

TheraCys®

w/diluent

SAN

49281-0880-01

vial

200 mg/28 caps

NOV

00078-0526-51

pk

5000 mg

TOPO

38423-0110-01

1 kit

®

Specialty Code

PRODUCT

J9264

Abraxane®

J2997

Activase Cathflo

J8999

Afinitor®

J8999

Afinitor

5 mg/28 tabs

NOV

J8999

Afinitor®

10 mg/28 tabs

NOV

insideout

SIZE

®

®

®

MFR.

NDC #

PK/CS

ABR

68817-0134-50

vial

J8999

Tasigna® Totect® Non-Returnable

2 mg

GNT

50242-0041-64

vial

J1190

2.5/28 tabs mg

NOV

00078-0594-51

pk

J2323

Tysabri®

300 mg (15 ml)

ELAN

59075-0730-15

vial

00078-0566-51

pk

J9025

Vidaza®

100 mg

PhM

59572-0102-01

vial

00078-0567-51

pk

J2357

Xolair®

GNT

50242-0040-62

vial

J3490

VPRIV

Shire

54092-0701-04

vial

150 mg 400 units/vial SDV

Spring 2011

pharmaceuticals contrast media

pharmaceuticals

Aldurazyme®

Ammonul®

Haemophilus Inflenzae B

58

J1931

59


Astellas Pharma US

Biosurgery Products Code

PRODUCT

SIZE

MFR.

NDC #

PK/CS

921028

Tisseel VH

2 ml

BAX

00944-4201-04

vial

921029

Tisseel VH

4 ml

BAX

00944-4201-08

vial

921030

Tisseel VH

10 ml

BAX

00944-4201-12

vial

921051VP

ValuPak 2 ml

6 x 1 ml

BAX

00944-4201-03

cs

ASD #

ValuPak 4 ml

6 x 2 ml

BAX

00944-4201-07

cs

6 x 5 ml

BAX

00944-4201-11

cs

description

size

NDC #

PK/CS

5 ml

00469-6501-89

1 each

size

NDC #

PK/CS

5041932005

5 vl/cs

MR

(1 cs TISSEEL Biologic-Only and 1 cs DUPLOJECT EASY PREP)

921052VP

mFR #

NEW

33195

6501-89

Lexiscan 0.4 mg/ 5 ml syr

(1 cs TISSEEL Biologic-Only and 1 cs DUPLOJECT EASY PREP)

921053VP

ValuPak 10 ml

60

921063

Easy Prep

6 x 1 ml

BAX

cs

921064

Easy Prep

6 x 2 ml

BAX

cs

921065

Easy Prep

6 x 5 ml

BAX

cs

921020

Duplocath 35 M.I.S.

BAX

ea

921021

Duplocath 180

BAX

ea

921022

Duplocath 25

BAX

ea

921023

DuoFlo Dispenser Kit

BAX

ea

921031

Spray Set for the Tissomat Spray Device

BAX

10/cs

600012

EasySpray Pressure Regulator

BAX

ea

600013

EasySpray Set

BAX

10/cs

921042

FibriJet 57 Duplotip

BAX

ea

921043

FibriJet 83 Duplotip

BAX

ea

921044

FibriJet 51 Duplotip

BAX

ea

921045

FibriJet 102 Duplotip

BAX

ea

921046

FibriJet 267 Duplotip

BAX

ea

921047

FibriJet 318 Duplotip

BAX

ea

921050

Duploreach 35 Extended Spray Applicator

BAX

6/cs

921134

DuploGrip Accessory Grip

6 x 2 ml

BAX

cs

921135

DuploGrip Accessory Grip

6 x 5 ml

BAX

cs

600029

DuploSpray MIS Applicators

30 cm

BAX

5/cs

600030

DuploSpray MIS Applicators

40 cm

BAX

5/cs

600033

DuploSpray MIS Applicators

20 cm

BAX

5/cs

600031

DuploSpray MIS Replacement Tips

BAX

10/cs

600036

Cannula DuploTip

20g x 10 cm

BAX

10/cs

600037

Cannula DuploTip

20g x 26 cm

BAX

10/cs

600038

Cannula DuploTip

20g x 32 cm

BAX

10/cs

934057

FloSeal Matrix Hemostatic Sealant

6 x 5 ml

BAX

cs

934050

FloSeal NT Matrix Hemostatic Sealant

6 x 5 ml

BAX

934055

FloSeal Reusable Endoscopic Applicator

1500181

FloSeal Endoscopic Applicator

934208

FloSeal Curved Applicator Tip

934210

FloSeal Curved Applicator Tip

934070

Bayer * ASD #

mFR #

description

MR NEW

36563

3278959

Eovist Vial 181.43 mg/ml

10 ml

NEW

37941

1658772

Gadavist 7.5 ml vial

7.5 ml

50419032511

20 vl/cs

NEW

37942

1641851

Gadavist 10 ml vial

10 ml

50419032512

20 vl/cs

37943

1665637

NEW

37944

Gadavist 15 ml vial

15 ml

50419032513

20 vl/cs

Gadavist 604.72 mg/ml vial

65 ml

50419032515

10 vl/cs

31349

1213321

Magnevist Inj syr

10 ml

5041918836

5 syr/cs

30512

1213347

Magnevist Inj syr

15 ml

5041918837

5 syr/cs

30513

1213727

Magnevist Inj syr

20 ml

5041918838

5 syr/cs

31350

1973676

Magnevist Vial

5 ml

5041918805

20 vl/cs

31351

1311935

Magnevist Vial

10 ml

5041918801

20 vl/cs

35324

1311745

Magnevist Vial

15 ml

5041918815

20 vl/cs

35323

3218450

Magnevist Vial

20 ml

5041918802

20 vl/cs

31352

1242668

Magnevist Vial pbp

50 ml

5041918858

10 vl/cs

31353

1240340

Magnevist Vial pbp

100 ml

5041918811

10 vl/cs

36896

1712603

Ultravist Vial 240 mg/ml

100 ml

5041934210

10 vl/cs

36897

1333343

Ultravist Vial 240 mg/ml pbp

200 ml

5041934221

10 vl/cs

36553

1731355

Ultravist Vial 300 mg/ml

50 ml

5041934405

10 vl/cs

cs

32054

1732957

Ultravist Vial 300 mg/ml

100 ml

5041934410

10 vl/cs

BAX

ea

36554

1288075

Ultravist Vial 300 mg/ml

125 ml

5041934412

10 vl/cs

BAX

6/cs

36555

1737550

Ultravist Vial 300 mg/ml

150 ml

5041934415

10 vl/cs

8 cm

BAX

ea

36556

1288802

Ultravist Vial 300 mg/ml pbp

200 ml

5041934421

10 vl/cs

10 cm

BAX

ea

36898

1289578

Ultravist Vial 300 mg/ml pbp

500 ml

5041934458

8 vl/cs

CoSeal™

2 ml

BAX

vial

36557

1761378

Ultravist Vial 370 mg/ml

50 ml

5041934605

10 vl/cs

934071

CoSeal™

4 ml

BAX

vial

36558

1761600

Ultravist Vial 370 mg/ml

100 ml

5041934610

10 vl/cs

934072

CoSeal™

8 ml

BAX

vial

36559

1761808

Ultravist Vial 370 mg/ml

150 ml

5041934615

10 vl/cs

934033

CoSeal™ Applicator tips

BAX

5/cs

36560

1762293

Ultravist Vial 370 mg/ml

200 ml

5041934620

10 vl/cs

934034

CoSeal™ Extended Applicator

BAX

10/cs

36561

1292630

Ultravist Vial 370 mg/ml pbp

250 ml

5041934625

10 vl/cs

934500

CoSeal™ Spray Accessory Kit

BAX

5/cs

36562

1332535

Ultravist Vial 370 mg/ml pbp

500 ml

5041934658

8 vl/cs

600021

CoSeal™ SpraySet

BAX

10/cs

600041

Adept ADH Reduction Sol

BAX

5/cs

insideout

CT

contrast media

pharmaceuticals

(1 cs TISSEEL Biologic-Only and 1 cs DUPLOJECT EASY PREP)

* No Bayer products shipped to Florida or Arizona.

Spring 2011

61


Bracco mFR #

description

size

NDC #

5 ml

00270-1111-04

5/cs

Prohance 279.3 mg/ml 5 x 20ml

20 ml

00270-1111-03

5/cs

22820

1111-02

Prohance 279.3 mg/ml vl 5 x 15 ml

15 ml

00270-1111-02

5/cs

36620

1111-70

Prohance MP279.3 mg/ml btl 5 x 50 ml

50 ml

00270-1111-70

5/cs

22242

0455-40

Gastrografin 37% sol 120 ml 12/cs

120 ml

00270-0445-40

12/cs

35353

44535

Gastrografin Lemon sol 24 x 30 ml

30 ml

00270-0445-35

24/cs

21146

1411-11

Isovue M 200 41% vl 10 x 10 ml

10 ml

00270-1411-11

10/cs

26183

1411-25

Isovue M 200 41% 10 x 20 ml

20 ml

00270-1411-25

10/cs

21961

1412-15

Isovue M 300 61% 10 x 15 ml

15 ml

00270-1412-15

10/cs

17752

1314-30

Isovue 200 vl 10 x 50 ml

50 ml

00270-1314-30

10/cs

36668

1314-15

Isovue 200 vl 10 x 200 ml

200 ml

00270-1314-15

10/cs

36669

1317-05

Isovue 250 vl 10 x 50 ml

50 ml

00270-1317-05

10/cs

36670

1317-02

Isovue 250 btl 10 x 100 ml

100 ml

00270-1317-02

10/cs

36671

1317-09

Isovue 250 btl 10 x 150 ml

150 ml

00270-1317-09

10/cs

36672

1317-41

Isovue multi 250 10 x 200 ml

200 ml

00270-1317-41

10/cs

36673

1315-25

Isovue 300 61% 10 x 30 ml

30 ml

00270-1315-25

10/cs

21881

1315-30

Isovue 300 61% 10 x 50 ml

50 ml

00270-1315-30

10/cs

36614

1315-47

Isovue 300 61% btl 10 x 75 ml

75 ml

00270-1315-47

10/cs

32427

1315-35

Isovue 300 61% btl 10 x 100 ml

100 ml

00270-1315-35

10/cs

36615

1315-50

Isovue 300 61% btl 10 x 150 ml

150 ml

00270-1315-50

10/cs

36677

1315-41

Isovue multi 300 btl 10 x 200 ml

200 ml

00270-1315-41

10/cs

36678

1315-98

Isovue multi 300 btl 6 x 500 ml

500 ml

00270-1315-98

6/cs

36679

1316-01

Isovue 370 btl 10 x 50 ml

50 ml

00270-1316-01

10/cs

36680

1316-52

Isovue 370 btl 10 x 75 ml

75 ml

00270-1316-52

10/cs

36681

1316-35

Isovue 370 btl 10 x 100 ml

100 ml

00270-1316-35

10/cs

36682

1316-04

Isovue 370 btl 10 x 125 ml

125 ml

00270-1316-04

10/cs

36683

1316-37

Isovue 370 btl 10 x 150 ml

150ml

00270-1316-37

10/cs

36688

1316-41

Isovue multi 370 10 x 200 ml

200 ml

00270-1316-41

10/cs

Fluoroscopy - Routine Filled Colon Examination

36689

1316-98

Isovue multi 370 6 x 500 ml

500 ml

00270-1316-98

6/cs

36270

AP14

Polibar ACB Barium lq 14 oz 24/cs

36271

AP16

Polibar ACB Barium lq 16 oz 24/s

36759

816

E-Z Paque Enema Bag 454 g

36701

920

Empty Enema Bag

36702

935

Empty Enema Exacta Bag

Oral Contrast Agents - CT Barium 35356

7350

Readi-Cat Apple 24 x 450 ml

450 ml

32909-0735-03

24/cs

35355

7250

Readi-Cat Banana 24 x 250 ml

250 ml

32909-0725-07

24/cs

35357

7450

Readi-Cat Banana 24 x 450 ml

450 ml

32909-0725-03

24/cs

35366

721

Readi-Cat Barium1.3% 12 x 900 ml

900 ml

32909-4501-03

12/cs

35364

728

Readi-Cat Barium1.3% 24 x 450 ml

450 ml

32909-0728-01

24/cs

35365

724

Readi-Cat Barium1.3% 4 x 1900 ml

1900 ml

32909-4501-05

4/cs

35354

7150

Readi-Cat Berry 24 x 450 ml

450 ml

32909-0715-03

24/cs

35359

7650

Readi-Cat Creamy Van 24 x 250 ml

250 ml

32909-0755-07

24/cs

35358

7550

Readi-Cat Creamy Van 24 x 450 ml

450 ml

32909-0755-03

24/cs

35360

4503-07

Readi-Cat Mochaccino 24 x 450 ml

450 ml

32909-0775-03

24/cs

35363

729

Readi-Cat2 Barium 2.1% 12 x 900 ml

900 ml

32909-0723-03

12/cs

35361

723

Readi-Cat2 Barium 2.1% 24 x 450 ml

450 ml

32909-0723-01

24/cs

35362

726

Readi-Cat2 Barium 2.1% 4 x 1900 ml

1900 ml

32909-0723-02

4/cs

35370

4501-01

E-Z Cat Barium Conc 24 x 225 ml

225 ml

32909-0720-01

24/cs

35371

4501-07

E-Z Cat Barium Dry 50 x 23 gm

23 gm

00270-4501-07

50/cs

35372

4501-11

Esopho-Cat Barium 24 x 30 gm

30 gm

32909-0738-01

24/cs

35369

4507-01

Volumen 0.1% 24 x 450 ml

450 ml

32909-0945-03

24/cs

35373

4500-02

CT Enema Kit

00270-4500-02

12/cs

14 oz

00270-9005-04

24/cs

16 oz

00270-9005-06

24/cs

454 g

00270-9005-03

24/cs

00270-9003-02

48/cs

00270-9003-04

4/cs

00270-9012-03

24/cs

0265-20

Cholografin 52% vl 1 x 20 ml

20 ml

00270-0265-20

1/cs

31844

1410-30

Cystografin 18% btl 10 x 300 ml

300 ml

00270-1410-30

10/cs

36691

0149-60

Cystografin 30% 10 x 100 ml

100 ml

30270-0149-60

10/cs

29448

0149-57

Cystografin 30% btl 10 x 300 ml

300 ml

00270-0149-57

10/cs

Double Contrast Colon Examination

36692

0523-30

Sinografin 10 ml 10/pk

10 ml

30270-0523-30

10/cs

36513

9012-03

Super XL Empty Enema Kit 24/cs

36375

9001-01

E-Z Dose Polibar Kit 650 ml 6/cs

650 ml

00270-9001-01

6/cs

36269

L164

Polibar Liq 100% w/v 1900 ml4/cs

1900 ml

00270-9002-02

4/cs

36703

L168

Polibar Liq 105% w/v 1900 ml 4/cs

1900 ml

00270-9002-03

4/cs

6.2 oz

32909-0750-03

24/cs

6 oz

32909-0753-01

24/cs

00270-9031-02

144/cs

36693

0004-75

Fluid Admin Set - Large Bore

00270-0004-75

10/cs

36694

0051-10

Solution Transfer Device

00270-0051-10

10/cs

Routine Upper GI Examination

Contrast Media Products - MR 32442

5164-13

Multihance 529 mg 5 x 10 ml

10 ml

00270-5164-13

5/cs

32441

5164-14

Multihance 529 mg 5 x 15 ml

15 ml

00270-5164-14

5/cs

36622

5164-15

Multihance 529 mg/ml vl 5 x 20 ml

20 ml

00270-5164-15

5/cs

36621

5164-12

Multihance 529 mg/ml vl 5 x 5 ml

5 ml

00270-5164-12

5/cs

36623

5264-16

Multihance MP 529 mg/ml btl 5 x 50

50 ml

00270-5264-16

5/cs

36624

5264-17

Multihance MP 529 mg/ml btl 5 x 100

100 ml

00270-5264-17

5/cs

36618

1111-16

Prohance 279.3 mg/ml PFS 5 x 10 ml

10 ml

00270-1111-16

5/cs

36619

1111-45

Prohance 279.3 mg/ml PFS 5 x 17 ml

17 ml

00270-1111-45

5/cs

36617

1111-01

Prohance 279.3 mg/ml vl 5 x 10 ml

10 ml

00270-1111-01

5/cs

insideout

contrast media

36690

Adminstration Sets and Transfer Devices

contrast media

Prohance 279.3 mg/ml vl 5 x 5 ml

1111-03

PK/CS

CT / X-Ray

62

1111-04

36276

Oral Contrast Agents

CT /  X-Ray ASD #

36616

36061

9019-01

E-Z Paque 6.2 oz 24/cs

35700

9019-02

Ultra-R UD cups 24 x 6 oz

36915

9031-02

Flexible plastic straws

36716

9030-01

E-Z Paque 10 kg

10 kg

00270-9030-01

1/cs

36717

9030-02

Sensatrast 4.2 oz 24/cs

4.2 oz

00270-9030-02

24/cs

36056

9026-01

E-Z Paque 1200 g 8/cs

1200 g

32909-0750-01

8/cs

36060

9029-01

E-Z Paque 1900 ml 4/cs

1900 ml

32909-0186-01

4/cs

36062

9028-01

E-Z Paque 12 oz 24/cs

12 oz

32909-0186-02

24/cs

36063

9021-01

E-Z Paste 16 oz 12/cs

1 lb

32909-0770-01

12/cs

Spring 2011

63


Double Contrast Examination of Esophagus, Stomach and Duodenum 35699

9017-02

E-Z HD 250% w/v susp 24 x 12 oz

12 oz

32909-0764-01

24/cs

36059

9018-01

E-Z HD Pail 25 lb

25 lb

32909-0764-02

1/cs

Covidien MR (Gadolinium)

Fluoroscopy 36305

2700

Digibar 190 susp 232 gmud 24/cs

232 gm

33609-0270-19

24/cs

ASD #

36377

9027-01

Maxibar Suspension 120 ml 24/cs

120 ml

00270-9027-01

24/cs

Gastromark Bottles

35997

9020-01

E-Z Gas II Granules

10361-0793-01

36128

9021-02

E-Z Disc 10 Grain Tabs 778 btl

00270-9021-02

31115

9000-01

Varibar Barium Thin liq 148 g 24/cs

148 g

00270-9000-01

24/cs

36720

9000-02

Varibar Barium Nectar 240 ml 24/cs

240 ml

00270-9000-02

24/cs

36721

9000-04

Varibar Barium Thin Honey 250 ml 12/cs

250 ml

00270-9000-04

12/cs

36722

9000-05

Varibar Barium Honey 250 ml 12/cs

250 ml

00270-9000-05

12/cs

36723

9000-06

Varibar Barium Pudding 230 ml 12/cs

230 ml

00270-9000-06

12/cs

36725

9014-03

Enteroclysis Admin Kit 12/cs

36374

9014-06

Liquid Entero Vu13% 600 ml 12/cs

36734

9014-07

Entero Vu 24% 600 ml 12/cs

100 g

00270-9014-01

12/cs

00270-9014-03

12/cs

600 ml

00270-9014-06

12/cs

600 ml

00270-9014-07

12/cs

36613

3902-01

Loso Prep Cleansing Kit 24/cs

10361-0306-44

24/cs

36738

3902-02

Loso Prep Bowel Cleansing System

00270-3902-02

50/cs

Ultrasound Gels and Disinfecting Towelettes 6010-01

E-Z Gel 8 oz 12/cs

36150

6010-04

36261

PK/CS

300 ml

00019-1120-06

12 btl/cs

31116

117702

OptiMARK®

5 ml

00019-1177-02

10 vl/cs

31117

117704

OptiMARK®

10 ml

00019-1177-04

10 vl/cs

31118

117706

OptiMARK®

15 ml

00019-1177-06

10 vl/cs

31119

117708

OptiMARK®

20 ml

00019-1177-08

10 vl/cs

31124

117750

OptiMARK

50 ml

00019-1177-50

5 vl/cs

®

31120

117710

OptiMARK® Syringe

10 cc

00019-1177-10

10 syr/cs

31121

117715

OptiMARK Syringe

15 cc

00019-1177-15

10 syr/cs

31122

117720

OptiMARK® Syringe

20 cc

00019-1177-20

10 syr/cs

31123

117730

OptiMARK Syringe

30 cc

00019-1177-30

10 syr/cs

®

®

Tubing / Syringes

Virtual Colonoscopy - Patient Prepping and Laxatives

36307

NDC #

Optimark Syringes

Small Bowel/Enteroclysis Studies Entero Vu 13% 100 g Packets 12/cs

GastroMARK®

size

Optimark Bottles

36719

9014-01

112006

description

btl

Modified Barium Swallowing Studies

36724

mFR #

8 oz

30270-6010-01

12/cs

E-Z Gel in 5L Container 4/cs

30270-6010-04

4/cs

6045

E-Z Scanning Gel Clear 5L 4/cs

00270-6010-05

4/cs

36762

6010-02

E-Z Scan .25L Bottle 12/cs

00270-6010-02

12/cs

36763

6010-03

E-Z Scan in 5L Container 12/cs

00270-6010-03

12/cs

36764

Q89072

Sani-Coth Plus Towelettes

160 count

12/cs

31485

801018

Optistar MR® Mpak 2 x 60 ml Y

60"

50/cs

31486

801019

Optistar MR Mpak 2 x 60 ml Y

90"

50/cs

31483

801020

Optistar MR® Mpak 60 ml/25 ml Y

60"

50/cs

31484

801021

Optistar MR Mpak 60 ml/25 ml Y

90"

50/cs

31481

801103

Optistar MR® Syringe

25 ml

100 syr/cs

31482

801104

Optistar MR® Syringe

60 ml

50 syr/cs

®

®

Disposable Tubing 31488

801106

Optistar MR® Coiled Y-Tubing

60"

100/cs

31489

801107

Optistar MR Coiled Y-Tubing

90"

100/cs

90"

50/cs 50 syr/cs

®

Disposable Syringes 31487

801800

Optistar® LE Multipak 2 x 60 ml/90” Y

31497

801801

Optistar LE Syringe

60 ml

Sodium Chloride Inj, USP 0.9%

50 ml

®

Prefilled Sodium Chloride 31436

118875

00019-1188-75

10 syr/cs

Miscellaneous

contrast media 64

insideout

1550CW

Ready-Box Media Warmer LF MDL

1 each

Spring 2011

contrast media

31266

65


Optiray 300 (Glass)

CT (Iodine) ASD #

mFR #

description

size

NDC #

PK/CS

Optiray 350 (Glass) 00019-1333-11

12 btl/cs

31150

133211

Optiray™ 300

100 ml

00019-1332-11

12 btl/cs

31151

133216

Optiray™ 300

150 ml

00019-1332-16

12 btl/cs

31152

133221

Optiray™ 300

200 ml

00019-1332-21

12 btl/cs

31149

133206

Optiray™ 300

50 ml

00019-1332-06

25 btl/cs

Optiray™ 300 Pharmacy Bulk Pkg

500 ml

00019-1332-61

6 btl/cs

31157

133311

Optiray™ 350

100 ml

31158

133316

Optiray™ 350

150 ml

00019-1333-16

12 btl/cs

31159

133321

Optiray™ 350

200 ml

00019-1333-21

12 btl/cs

Optiray 300 (Plastic)

31160

133341

Optiray™ 350

75 ml

00019-1333-41

12 btl/cs

31153

31156

133306

Optiray™ 350

50 ml

00019-1333-06

25 vl/cs

133261

31154

133275

Optiray™ 300 Hand-held Syringe

50 ml

00019-1332-75

20 syr/cs

31155

133283

Optiray™ 300 Pl Syringe

100 ml

00019-1332-83

20 syr/cs

Optiray™ 300 Power Injector RFID

100 ml

00019-1332-00

20 syr/cs

Optiray 350 (Plastic) 31163

133375

Optiray™ 350 Hand-held Syringe

50 ml

00019-1333-75

20 syr/cs

Optiray 300 (RFID)

31161

133351

Optiray™ 350 Pharmacy Bulk Pkg

250 ml

00019-1333-51

12 btl/cs

32236

31162

133361

Optiray™ 350 Pharmacy Bulk Pkg

500 ml

00019-1333-61

6 btl/cs

31164

133377

Optiray™ 350 Power Injector Syringe

50 ml

00019-1333-77

20 syr/cs

31165

133381

Optiray™ 350 Power Injector Syringe

125 ml

00019-1333-81

20 syr/cs

31166

133383

Optiray™ 350 Power Injector Syringe

100 ml

00019-1333-83

20 syr/cs

31167

133391

Optiray™ 350 Power Injector Syringe

75 ml

00019-1333-91

20 syr/cs

Optiray 350 (RFID)

133200

Optiray 240 (Glass) 31143

132411

Optiray™ 240

100 ml

00019-1324-11

12 btl/cs

31144

132416

Optiray™ 240

150 ml

00019-1324-16

12 btl/cs

31145

132421

Optiray™ 240

200 ml

00019-1324-21

12 btl/cs

31142

132406

Optiray™ 240

50 ml

00019-1324-06

25 vl/cs

Optiray 240 (Plastic)

32237

133355

Optiray™ 350 Power Injector RFID

50 ml

00019-1333-55

20 syr/cs

31146

132475

Optiray™ 240 Hand-held Syr

50 ml

00019-1324-75

20 syr/cs

32238

133327

Optiray™ 350 Power Injector RFID

125 ml

00019-1333-27

20 syr/cs

31147

132481

Optiray™ 240 Power Injector Syr

125 ml

00019-1324-81

20 syr/cs

32239

133300

Optiray™ 350 Power Injector RFID

100 ml

00019-1333-00

20 syr/cs

32240

133385

Optiray™ 350 Power Injector RFID

75 ml

00019-1333-85

20 syr/cs

Optiray™ 240 Power Injector RFID

125 ml

00019-1324-27

20 syr/cs

Optiray 320 (Glass)

Optiray 240 (RFID) 32235

132427

Prefilled Sodium Chloride

31131

132311

Optiray™ 320

100 ml

00019-1323-11

12 btl/cs

32290

118827

Sodium Chloride Inj, RFID 0.9%

125 ml

00019-1188-27

20 syr/cs

31132

132316

Optiray™ 320

150 ml

0019-1323-16

12 btl/cs

31435

118881

Sodium Chloride Inj, USP 0.9%

125 ml

00019-1188-81

20 syr/cs

31133

132321

Optiray™ 320

200 ml

00019-1323-21

12 btl/cs

31134

132341

Optiray™ 320

75 ml

00019-1323-41

12 btl/cs

31128

132302

Optiray™ 320

20 ml

00019-1323-02

25 vl/cs

31129

132304

Optiray™ 320

30 ml

00019-1323-04

25 vl/cs

31130

132306

Optiray™ 320

50 ml

00019-1323-06

25 vl/cs

Disposable Syringes, Single Head Procedures 31507

800099

CT MPAK FL Syr HF

200 ml

00019-8000-99

50/cs

31508

800096

Frontload Syr w/hand

200 ml

00019-8000-96

50/cs

31467

601195

Connector Tubing

00019-6011-95

100/cs

Disposable Tubing 31263

844012

Y-Tube w/Dual chk vlv OptiVantage™

60"

50/cs

31137

132375

Optiray™ 320 Hand-held Syringe

50 ml

00019-1323-75

20 syr/cs

31366

844010

Y-Tube w/No chk vlv OptiVantage™

60"

50/cs

31135

132361

Optiray™ 320 Pharmacy Bulk Pkg

500 ml

00019-1323-61

6 syr/cs

31264

844011

Y-Tubing w/Sgl chk vlv OptiVantage™

60"

31138

132377

Optiray™ 320 Power Injector Syr

50 ml

00019-1323-77

20 syr/cs

31467

601195

Low Pressure Coiled Connector Tube

60"

31139

132381

Optiray™ 320 Power Injector Syr

125 ml

00019-1323-81

20 syr/cs

31376

810551

Transfer Set OptiVantage™

31140

132383

Optiray™ 320 Power Injector Syr

100 ml

00019-1323-83

20 syr/cs

31141

132391

Optiray™ 320 Power Injector Syr

75 ml

00019-1323-91

20 syr/cs

50/cs 00019-6011-95

100/cs 50/cs

contrast media

contrast media

Optiray 320 (Plastic)

Optiray 320 (RFID)

66

32231

132355

Optiray™ 320 Power Injector RFID

50 ml

00019-1323-55

20 syr/cs

32232

132327

Optiray™ 320 Power Injector RFID

125 ml

00019-1323-27

20 syr/cs

32233

132300

Optiray™ 320 Power Injector RFID

100 ml

00019-1323-00

20 syr/cs

32234

132385

Optiray™ 320 Power Injector RFID

75 ml

00019-1323-85

20 syr/cs

insideout

Spring 2011

67


Conventional CM ASD #

Urology

mFR #

description

size

NDC #

PK/CS

Conray 30 31110

mFR #

description

size

NDC #

PK/CS

Urology 95211

Conray™ 30

150 ml

00019-0952-11

12 btl/cs

Conray 43 31169

318309

Conray™ 43

250 ml

00019-3183-09

12 btl/cs

31170

318315

Conray™ 43

50 ml

00019-3183-15

50 vl/cs

Conray 60 31111

95309

Conray™

100 ml

00019-0953-09

12 btl/cs

31112

95311

Conray™

150 ml

00019-0953-11

12 btl/cs

31113

95313

Conray™

30 ml

00019-0953-13

50 vl/cs

31114

95315

Conray™

50 ml

00019-0953-15

50 vl/cs

Cysto-Contray™ II

250 ml

00019-0862-07

12 btl/cs

Cysto Conray 31108

ASD #

86207

MD Gastroview

31227

269004

Luer Locknuts (Ultraject™)

32377

50012M

Tad .035-.018 GW Sys

31258

601278

31259

601279

31260 31503

145 cm

1 each

High Pressure Ext Tubing w/RAT Adapter

10"

25/cs

High Pressure Ext Tubing w/RAT Adapter

20"

25/cs

601280

High Pressure Ext Tubing w/RAT Adapter

30"

25/cs

335563

Uro Drain Bags Sterile

31504

337205

Uro Drain Extension Tubing

31505

810555

Y Tube Adaptor CT9000® ADV/OptiStat™

31506

337200

Uro Drain Y-Connector

10/cs

31476

302050

Handifil

100/cs

31474

337210

FluiDrain LSS 10

10/cs

31475

337220

FluiDrain LSS 20

10/cs

31472

601281

High Pressure Ext Tubing w/ROT Adapter

31473

601277

Low Pressure Ext Tube

31471

335825

Disp Drainage Bag Non-sterile

31237

481605

MD-Gastroview™

120 ml

00019-4816-05

12 btl/cs

31239

481606

MD-Gastroview™

240 ml

00019-4816-06

12 btl/cs

31238

481604

MD-Gastroview™

30 ml

00019-4816-04

25 btl/cs

31125

131707

MD-76R™

100 ml

00019-1317-07

12 btl/cs

ASD #

31442

131711

MD-76R™

150 ml

00019-1317-11

12 btl/cs

Miscellaneous Syringes

31126

131709

MD-76R™

200 ml

00019-1317-09

12 btl/cs

31491

31127

131715

MD-76R™

50 ml

00019-1317-15

50 vl/cs

MD-76R

Hexabrix 31172

550508

Hexabrix™

100 ml

00019-5505-08

12 btl/cs

31441

550510

Hexabrix™

150 ml

00019-5505-10

12 btl/cs

31173

550521

Hexabrix™

200 ml

00019-5505-21

12 btl/cs

31174

550551

Hexabrix™

20 ml

00019-5505-51

10 vl/cs

31171

550506

Hexabrix™

50 ml

00019-5505-06

25 vl/cs

10 pk

10/cs 10/cs 00019-8105-55

50/cs

25/cs 00019-6012-77

100/cs 10/cs

Miscellaneous mFR #

302100

description

Syringe w/Handifil

size.

NDC #

PK/CS

100 ml

50 syr/cs

31492

600172

Syringe w/Handifil

130 ml

50 syr/cs

31493

600269

Syringe w/Handifil

150 ml

50 syr/cs

31494

601360

Syringe w/Handifil for Medrad Inj

150 ml

50 syr/cs

31495

601350

Syringe w/Handifil for Medrad Inj

200 ml

50 syr/cs

31496

600169

Syringe w/Handifil

260 ml

50 syr/cs

31498

900105

Illumena™ Syringe w/Handifil Disp

200 ml

50 syr/cs

31499

601590

Tripack Syringe

200 ml

50 syr/cs

Miscellaneous 14403

Fluid Admin Set, Large Bore

31544

265703

Sol Admin RX Burron Set

12 pk 00019-2657-03

12 pk

contrast media

contrast media

31542

68

insideout

Spring 2011

69


GE ASD #

mFR #

description

size

NDC #

PK/CS

MR 36780

J068

Omniscan 287 mg/ml vl 10 x 5 ml

5 ml

00407-0690-05

10/cs

36781

J100

Omniscan 287 mg/ml vl 10 x 10 ml

10 ml

00407-0690-10

10/cs

36782

J160

Omniscan 287 mg/ml pfs 10 x 10 ml

10 ml

00407-0690-12

10/cs

30563

J120

Omniscan 287 mg/ml vl 10 x 15 ml

15 ml

00407-0690-15

10/cs

36783

J170

Omniscan 287 mg/ml pfs 10 x 15 ml

15 ml

00407-0690-17

10/cs

36784

J140

Omniscan 287 mg/ml vl 10 x 20 ml

20 ml

00407-0690-20

10/cs

36785

J180

Omniscan 287 mg/ml pfs 10 x 20 ml

20 ml

00407-0690-22

10/cs

36787

J800

Omniscan 287 mg/ml 10 x 100 ml

100 ml

00407-0690-70

10/cs

36788

J640

Omniscan 287 mg/ml pfs 10 x 15 ml

15 ml

00407-0691-62

10/cs

36789

J650

Omniscan 287 mg/ml pfs 10 x 20 ml

20 ml

00407-0691-63

10/cs

NEW

70

36790

Y510

Omnipaque + 140mg/ml 10 x 50 ml

50 ml

00407-1401-52

10/cs

19648

Y101

Omnipaque 180mg/ml vl 10 x 10 ml

10 ml

00407-1411-10

10/cs

21201

Y102

Omnipaque 180mg/ml 10 x 20 ml

20 ml

00407-1411-20

10/cs

21202

Y203

Omnipaque 240 mg/vl 10 x 10 ml

10 ml

00407-1412-10

10/cs

30114

Y220

Omnipaque 240 mg/ml vl 10 x 20 ml

20 ml

00407-1412-20

10/cs

36795

Y520

Omnipaque + 240 mg/ml btl 10 x 50 ml

50 ml

00407-1412-30

10/cs

36796

Y522

Omnipaque + 240 mg/ml btl 10 x 100 ml

100 ml

00407-1412-33

10/cs

28889

Y524

Omnipaque + 240 mg/ml btl 10 x 150 ml

150 ml

00407-1412-34

10/cs

36797

Y526

Omnipaque + 240 mg/ml btl 10 x 200 ml

200 ml

00407-1412-35

10/cs

36798

Y212

Omnipaque 240 mg/ml btl 10 x 150 ml

150 ml

00407-1412-49

10/cs

28495

Y250

Omnipaque 240 mg/ml vl 10 x 50 ml

50 ml

00407-1412-50

10/cs

21799

Y213

Omnipaque 240 mg/ml btl10 x 100 ml

100 ml

00407-1412-60

10/cs

22823

Y306

Omnipaque 300 mg/ml vl 10 x 10 ml

10 ml

00407-1413-10

10/cs

10469

Y307

Omnipaque 300 mg/ml vl 10 x 30 ml

30 ml

00407-1413-30

10/cs

20225

Y308

Omnipaque 300 mg/ml vl 10 x 50 ml

50 ml

00407-1413-50

10/cs

36800

Y352

Omnipaque 300 mg/ml btl 10 x 50 ml

50 ml

00407-1413-51

10/cs

36801

Y356

Omnipaque 300 mg/ml btl 10 x 125 ml

125 ml

00407-1413-53

10/cs

36802

Y313

Omnipaque 300 mg/ml btl 10 x 100 ml

100 ml

00407-1413-60

10/cs

36803

Y530

Omnipaque + 300 mg/ml btl 10 x 50 ml

50 ml

00407-1413-61

10/cs

36804

Y531

Omnipaque + 300 mg/ml btl 10 x 75 ml

75 ml

00407-1413-62

10/cs

36805

Y532

Omnipaque + 300 mg/ml btl 10 x 100 ml

100 ml

00407-1413-63

10/cs

36806

Y534

Omnipaque + 300 mg/ml btl 10 x 150 ml

150 ml

00407-1413-65

10/cs

36807

Y536

Omnipaque + 300 mg/ml btl 10 x 200 ml

200 ml

00407-1413-66

10/cs

36808

Y538B

Omnipaque + 300 mg/ml btl 10 x 500 ml

500 ml

00407-1413-68

10/cs

30591

Y318

Omnipaque 300 mg/ml btl 10 x 150 ml

150 ml

00407-1413-90

10/cs

30181

Y415

Omnipaque 350 mg/ml btl 10 x 150 ml

150 ml

00407-1414-03

10/cs

36816

Y416

Omnipaque 350 mg/ml btl 10 x 200 ml

200 ml

00407-1414-04

10/cs

32961

Y410

Omnipaque 350 mg/ml vl 10 x 50 ml

50 ml

00407-1414-50

10/cs

36825

Y452

Omnipaque 350 mg/ml btl 10 x 50 ml

50 ml

00407-1414-51

10/cs

36828

Y413

Omnipaque 350 mg/ml btl 10 x 100 ml

100 ml

00407-1414-60

10/cs

36829

Y420

Omnipaque 350 mg/ml btl 10 x 125 ml

125 ml

00407-1414-76

10/cs

32944

Y540

Omnipaque + 350 mg/ml btl 10 x 50 ml

50 ml

00407-1414-89

10/cs

36831

Y541

Omnipaque 350 mg/ml btl 10 x 75 ml

75 ml

00407-1414-90

10/cs

insideout

Y542

Omnipaque + 350 mg/ml btl 10 x 100 ml

100 ml

00407-1414-91

10/cs

36833

Y544

Omnipaque + 350 mg/ml btl 10 x 150 ml

150 ml

00407-1414-93

10/cs

36834

Y546

Omnipaque + 350 mg/ml btl 10 x 200 ml

200 ml

00407-1414-94

10/cs

36835

Y548B

Omnipaque + 350 mg/ml btl 10 x 500 ml

500 ml

00407-1414-98

10/cs

CT 26548

V020

Visipaque 270 mg/ml btl 10 x 50 ml

50 ml

00407-2222-01

10/cs

36836

V025

Visipaque 270 mg/ml btl 10 x 100 ml

100 ml

00407-2222-02

10/cs

36837

V026

Visipaque 270 mg/ml btl10 x 150 ml

150 ml

00407-2222-03

10/cs

36838

V550

Visipaque + 270 mg/ml btl 10 x 50 ml

50 ml

00407-2222-16

10/cs

36839

V552

Visipaque + 270 mg/ml btl 10 x 100 ml

100 ml

00407-2222-17

10/cs

36840

V554

Visipaque + 270 mg/ml btl 10 x 150 ml

150 ml

00407-2222-19

10/cs

36841

V556

Visipaque + 270 mg/ml btl 10 x 200 ml

200 ml

00407-2222-21

10/cs

36842

V558B

Visipaque + 270 mg/ml btl 10 x 500 ml

500 ml

00407-2222-23

10/cs

36843

V550G

Visipaque 270 mg/ml btl 10 x 50 ml

50 ml

00407-2222-52

10/cs

36844

V552G

Visipaque 270 mg/ml btl 10 x 100 ml

100 ml

00407-2222-53

10/cs

36845

V554G

Visipaque 270 mg/ml btl 10 x 150 ml

150 ml

00407-2222-54

10/cs

36846

V556G

Visipaque 270 mg/ml btl 10 x 200 ml

200 ml

00407-2222-55

10/cs

21375

V040

Visipaque 320 mg/ml btl 10 x 50 ml

50 ml

00407-2223-01

10/cs

36847

V045

Visipaque 320 mg/ml btl 10 x 100 ml

100 ml

00407-2223-02

10/cs

30146

V046

Visipaque 320 mg/ml btl10 x 150 ml

150 ml

00407-2223-03

10/cs

36848

V047

Visipaque 320 mg/ml btl 10 x 200 ml

200 ml

00407-2223-04

10/cs

21378

V041

Visipaque 320 mg/ml btl 10 x 50 ml

50 ml

00407-2223-06

10/cs

36849

V560

Visipaque + 320 mg/ml btl 10 x 50 ml

50 ml

00407-2223-16

10/cs

36850

V562

Visipaque + 320 mg/ml btl 10 x 100 ml

100 ml

00407-2223-17

10/cs

36851

V564

Visipaque + 320 mg/ml btl10 x 150 ml

150 ml

00407-2223-19

10/cs

36852

V566

Visipaque + 320 mg/ml btl 10 x 200 ml

200 ml

00407-2223-21

10/cs

36853

V568B

Visipaque + 320 mg/ml btl 10 x 500 ml

500 ml

00407-2223-23

10/cs

contrast media

contrast media

CT

36832

Spring 2011

71


Rx ASD #

NEW

Description

NDC #

Manufacturer

Ancillary RX 19920

Cal Gluc 10% SDV 10 ml each

63323-0311-10

APP

20490

Carnitor 1 gm/5 ml SDV 5 x 5 ml

54482-0147-01

Sigma-Tau Pharmaceuticals

20490

Carnitor 1 gm/5 ml SDV 5 x 5 ml

54482-0147-01

Sigmaâ&#x20AC;&#x2030;-Tau Pharmaceuticals

11153

Diphenhydramne 50 mg Vl 25 x 1 ml

00641-0376-25

Baxter PPI

32986

Hydrogen Peroxide 3% Liq 16 oz each

00869-0871-43

Amerisourcebergen Drug Corporation

29417

Imodium Liq 4 oz

50580-0134-04

Johnson & Johnson

18679

Sod Thiosulfate 25% 50ml SDV

00517-5019-01

Amer Regent Lab

26656

Water Sterile FTV 25 x 10 ml

00409-4887-10

Hospira Worldwide

NEW

Antibiotics

00024-2791-50

Aventis Pharmaceuticals (Hmr)

00024-2792-10

Aventis Pharmaceuticals (Hmr)

34408

Feraheme 510 mg/17 ml SDV

59338-0775-01

Amag Pharmaceuticals

34409

Feraheme 510 mg/17 ml SDV 10/pk

59338-0775-10

Amag Pharmaceuticals

22668

Infed 50 mg/ml vl 10 x 2 ml

52544-0931-02

Watson Pharm

30696

Procrit 20 M un/ml Mdv 4 x 1 ml

59676-0320-04

Ortho Biotech Products

10982

Procrit 40 M un/ml vl 4 x 1 ml

59676-0340-01

Ortho Biotech Products

31310

Procrit 10 M un/ml 2ml MDV 4/pk

59676-0312-04

Ortho Biotech Products

10510

Procrit 10 M un/ml vl 6 x 1 ml

59676-0310-01

Ortho Biotech Products

37763

Nulecit Inj 62.5 mg/10 x 5 ml SDV

52544-0149-87

Watson Pharm

33100

Venofer SDV 10 x 5 ml

49230-0534-10

Fresenius USA Marketing

29962

Venofer 20 mg/ml SDV 25 x 5 ml

00517-2340-25

Amer Regent Lab

20686

Venofer 20 mg/ml vl 10 x 5ml (CKD)

00517-2340-10

Amer Regent Lab

29962

Venofer 20 mg/ml SDV 2 x 5 ml (CKD)

00517-2340-25

Amer Regent Lab

37214

Venofer 50 mg SDV 10 x 2.5 ml (Dialysis)

49230-0530-10

Fresenius USA Marketing

33100

Venofer 100 mg SDV 10 x 5 ml (Dialysis)

49230-0534-10

Fresenius USA Marketing

Ciprofloxacin 400 mg SDV 40 ml each

00409-4778-86

Hospira Worldwide

34185

Cefazolin 1 gm SDV 25/10 ml

00409-0805-01

Hospira Worldwide

32428

Cubicin Daptomycin 500mg vl

67919-0011-01

Cubist Pharmaceutical

24631

Cubicin Daptomycin 500mg 10/pk

67919-0011-01

Cubist Pharmaceutical

26086

Fortaz 1 gm vl pwd 10 x 25 ml

00173-0378-10

Glaxosmithkline

26708

Gentamicin 40 mg/ml FTV 25 x 2 ml

00409-1207-03

Hospira Worldwide

23421

Gentamicin Top 0.1% crm 15 gm

00168-0071-15

Fougera E and Co.

14181

Rocephin 1 gm vl each

00004-1964-04

Genentech USA

11778

Heparin 1000 u/ml MDV 25 x 30 ml

63323-0540-31

APP

26216

Vancomycin 500 mg FTV 10/bx

00409-4332-01

Hospira Worldwide

17773

Heparin sod 5 M un MDV 25 x 10 ml

63323-0047-10

APP

26111

Vancomycin 1 gm FTV 10/bx

00409-6533-01

Hospira Worldwide

36901

Heparin 1000 u/ml MDV 25 x 30 ml

25021-0400-30

Sagent Pharmaceuticals

36906

Heparin sod 5 M MDV vl 25 x 10 ml

25021-0402-10

Sagent Pharmaceuticals

28203

Vaccines, Hep. B

Aranesplysb 200 mcg SDV 1.0 ml

55513-0006-01

28198

Aranesplysb 25 mcg SDV 4 x 1 ml

55513-0002-04

Amgen Inc.

Aranesplysb 100 mcg SDV 4 x 1 ml

55513-0005-04

Amgen Inc.

Engerix adt 20 mcg p/f SDV 10 x 1 ml

58160-0821-11

Glaxosmithkline Vaccines

Engerix ped p/f sdv 10x0.5 ml

58160-0820-11

Glaxosmithkline Vaccines

36216

Engerix adult 20 mcg tiplok 5/pk

58160-0821-48

Glaxosmithkline Vaccines

22353

Recombivax df 40 mcg/ml pf 1 ml

00006-4992-00

Merck & Co.

Heparin

Amgen Inc.

28201

30326 30218

11480

Heparin sod 10V un MDV 25 x 1 ml

63323-0542-01

APP

11479

Heparin sod 5 M un MDV 25 x 1 ml

63323-0262-01

APP

11782

Heparin sod 1 mun/ml MDV 25 x 10 ml

63323-0540-11

APP

63304-0239-01

Ranbaxy

Inj. Vitamin D

28200

Aranesplysb 60 mcg SDV 4 x 1 ml

55513-0004-04

Amgen Inc.

28199

Aranesplysb 40 mcg SDV 4 x 1 ml

55513-0003-04

Amgen Inc.

NEW

37547

Calcitriol 0.25 mcg caps 100/btl

28194

Aranesplysb 100 mcg PFS 4 x .5 ml

55513-0025-04

Amgen Inc.

NEW

37548

Calcitriol 0.5 mcg caps 100/btl

63304-240-01

Ranbaxy

28196

Aranesplysb 200 mcg PFS 0.4 ml

55513-0028-01

Amgen Inc.

NEW

37813

Calcitriol Oral Solution 1 mcg 15 ml

00054-3120-41

Roxanne

28197

Aranesplysb 300 mcg PFS 0.6 ml

55513-0111-01

Amgen Inc.

31639

Calcitriol 1 mcg/ml amp 25 x 1 ml

00517-0132-25

Amer Regent Lab

28193

Aranesplysb 60 mcg PFS 4 x 0.3 ml

55513-0023-04

Amgen Inc.

23349

Calcitriol 1 mcg inj 50 x 1 ml

63323-0731-01

APP

28191

Aranesplysb 25 mcg PFS 4 x .42 ml

55513-0057-04

Amgen Inc.

28192

Aranesplysb 40 mcg PFS 4 x .4 ml

55513-0021-04

Amgen Inc.

NEW

28204

Aranesplysb 300 mcg SDV 1.0 ml

55513-0110-01

Amgen Inc.

NEW

37234

Hectorol 1 mcg caps 50/btl

58468-0124-01

Genzyme Renal

28195

Aranesplysb 150 mcg PFS 4 x 0.3 ml

55513-0027-04

Amgen Inc.

NEW

37299

Hectorol 2 mcg SDV 50 x 1 ml

58468-0126-01

Genzyme Renal

28202

Aranesplysb 150 mcg SDV 4 x 0.75 ml

55513-0053-04

Amgen Inc.

NEW

33635

Hectorol 2.5 mcg caps 50

58468-0121-01

Genzyme Renal

28140

Aranesp Plysb 500 mcg Pfs 1 ml

55513-0032-01

Amgen Inc.

33705

Hectorol 4 mcg 50 x 2 ml

58468-0123-01

Genzyme Renal

11230

Epogen S3 3 M un/ml vl 10 x 1 ml

55513-0267-10

Amgen Inc.

NEW

37232

Zemplar 1 mcg caps 30/btl

00074-4317-30

Abbott Labs/Onc

11295

Epogen S4 4 M Un/ml Vl 10 x 1 ml

55513-0148-10

Amgen Inc.

NEW

37233

Zemplar 2 mcg caps 30/btl

00074-4314-30

Abbott Labs/Onc

11294

Epogen S2 2 M Un/ml Vl 10 x 1 ml

55513-0126-10

Amgen Inc.

20967

Zemplar 2 mcg/ml vl 25 x 1 ml

00074-4637-01

Abbott Labs/Onc

32194

Zemplar 4 mcg caps 30/btl

00074-4315-30

Abbott Labs/Onc

10001

Zemplar 5 mcg/ml 25 x 1 ml FTV

00074-1658-01

Abbott Labs/Onc

10002

Zemplar 5 mcg/ml 25 x 2 ml FTV

00074-1658-02

Abbott Labs/Onc

37381

Zemplar 10 mcg/2 ml mdv 25 x 2 ml

00074-1658-05

Abbott Labs/Onc

11296

Epogen S10 10 M un/ml vl 10 x 1 ml

55513-0144-10

Amgen Inc.

11177

Epogen M10 20 mun/2ml Mdv10 x 2 ml

55513-0283-10

Amgen Inc.

11508

Epogen M20 20 mun/ml Mdv 10 x 1 ml

55513-0478-10

Amgen Inc.

NEW

NEW

insideout

23349

Calcitriol 1 mcg amp 50 x 1 ml

63323-0731-01

App

29151

Hectorol 0.5 mcg caps 50/btl

58468-0120-01

Genzyme Renal

nephrology

nephrology

Ferrlecit 62.5 mg/5 ml amp 10 x 5 ml Ferrlecit 62.5 mg/5 ml vl 10 x 5 ml

28516

ESAs

72

35151 37769

Spring 2011

73


Other Rx 17674

Acetamin 325mg tab ud 100

51079-0002-20

Udl Laboratories

20363

Activase cathflo 2 mg SDV

50242-0041-64

Genentech USA

Medsurge

31842

Aplisol 5tu 10test vl 1 ml

42023-0104-01

Jhp Pharmaceuticals

32464

Atropine lfs syr 10 ml 0.1 mg/ml

00409-4911-34

Hospira Worldwide

10093

Clonidine 0.1 mg tab 100/btl

00228-2127-10

Actavis

27537

Dextrose 25 gm ansyr 50 ml each

00409-7517-16

Hospira Worldwide

27969

ASD #

description

manufacturer

pk/cs

Alcohol Swabticks 3'S

Dynarex

25/box

General

26223

Dextrose 50% vl 25 x 50 ml

00409-6648-02

Hospira Worldwide

14819

Alcohol Prep Pad (non-sterile)

Dynarex

200/box

21538

Diphenhydramine 25 mg tab ud 100

51079-0967-20

Udl Laboratories

35009

Alcohol Prep Pad Med. (sterile)

Dynarex

200/box

32474

Apron Gowns Disposable 28" x 46" (Plastic)

Busse

144/case

10704

Diphenhydramin 25 mg cap 100/btl

00185-0648-01

Sandoz

27730

Epinep lfshld syg 10 ml nondl

00409-4921-34

Hospira Worldwide

32710

Catheter Cap (injectable) Latex Free

Molded

100/box

27229

Epinep 1:10000 18g abjct 10ml

00409-4901-18

Hospira Worldwide

18784

Catheter Cap (dead end / non-injectable)

B. Braun

100/box

27906

Gelfoam 12-7 mm spg 12/pk

00009-0315-08

Pfizer Pharm

26860

Chloraprep Single Swabstick

Tacy Med

48/box

34930

Glucose tab orange 10/pk

38396-0543-64

Amerisourcebergen Drug Corporation

32684

Cotton Tip Applicators 6" Sterile 2’s

Solon

100/box

10063

Insulin Hum R 100 u/ml vl 10 ml

00002-8215-01

Eli Lilly & Co

Dialysis Recliner – 6 Position

Winco

1/ea.

34660

Levaquin 500 mg SDV 20 ml

50458-0164-20

Jom

32475

Drape Sheet 18 x 26 (other sizes available)

Busse

50/bx

32794

Lido 0.5% FTV 50 ml each

00409-4275-01

Hospira Worldwide

26857

Drape Sheet 40" x 48" 2 ply

Tidi

100/case

27029

Lidocaine 1% ansyr syg 5 ml each

00409-9137-05

Hospira Worldwide

36048

Drape Sheet 40" x 90" 3 ply

Tidi

50/cs

26662

Lidocaine 1% ftv 50ml each

00409-4276-02

Hospira Worldwide

34089

Emesis Basin 9"

Medline

250/case

26662

Lidocaine 1% ftv 50ml each

00409-4276-02

Hospira Worldwide

35908

Hemastix Test Strips

Siemens

50/box

14719

Loperamide 2 mg 100 cap

00378-2100-01

Mylan Pharmaceutical

32709

Hemoband (non-sterile)

Hemoband

1/ea.

36031

Mannitol 25% FTV 25 x 50 ml

00409-4031-01

Hospira Worldwide

32761

Luer Lock End Caps – Blue

Molded

100/box

17448

Mannitol 25% SDV 25 x 50 ml

00517-4050-25

Amer Regent Lab

18318

Medicine Cups 1 oz

Dynarex

100/box

32324

Metoclopram 10 mg/2ml FTV 2

00409-3414-01

Hospira Worldwide

32538

Oxygen Mask Rebreather – Adult

Allied

1/ea.

32320

Pain Ease Spray mist 3. oz

00386-0008-02

Gebauer Company

15184

Oxygen Nasal Cannula – Adult

Allied

1/ea.

26843

Pain ease 3.5 oz spray

00386-0008-03

Gebauer Company

14844

Povidone/Iodine Prep Pads (PVP Pads)

Dynarex

100/box

10486

Pneumovax 23 5dose vl 2.5 ml

00006-4739-00

Merck & Co.

14840

Povidone/ Iodine Swabsticks (1 per pack)

Dynarex

50/box

28053

Povidone/Iodine Swabsticks (3 per pack)

Dynarex

75/box

11151

Promethazine 25 mg/ml amp 25 x 1 ml

00641-1495-35

Baxter PPI

18782

Sod Chl .9% 1000 cc bag 12/cs

00264-7800-00

B. Braun Medical

32754

Recirculating Connector (Male to Male)

Molded

100/box

32414

Shoe Covers – Blue (one size fits all)

Dynarex

150/pairs

10032

Sod Chl 0.9 Excl 24 x 500 ml sol

00264-7800-10

B.Braun Medical

11199

Sod Chl Conc 23.4% SDV 25 x 30 ml

00517-2930-25

Amer Regent Lab

26355

Skin Staple Remover Kits

Busse

1/ea.

Hospira Worldwide

20941

Suture Removal Kits

Busse

1/ea.

Dynarex Corp

15598

Table Paper 21" x 225' Smooth

14815

Tape Remover Pads (Sterile)

27615

Sod Bic 8.4% Ls syg 50 ml each

34835

Triple Anti Oint Foil 144 x .9 gm

00409-6637-34

Tidi

12/case

Dynarex

100/box

20609

Tubersol 5tu 10 test vl 1 ml

49281-0752-21

Sanofi Pasteur

11062

Tums e-x x/s fruit tab 96/pk

00766-0739-66

Glaxosmithkline

32643

Transducer Protector (w/luer lock)

Molded

100/case

Tube Occluding Clamp (hemostats) Blue

Molded

100/bag

Water Ster SDV 25 x 20 ml

00517-3020-25

Amer Regent Lab

26552

Water Ster FTV 25 x 20 ml

00409-4887-20

Hospira Worldwide

20568

Towel 3 ply 13.5" x 18" White 500/CS

Graham

500/case

25875

Underpad 17" x 24" (blue) Chux

Dynarex

300/case

32605

Urinals w/Cover – Plastic (disposable)

Perigon

50/case

33864

Urinals w/Cover – Plastic (disposable)

Medline

Each

15601

Wash Cloths 10" x 13.5" (blue/disposable)

Graham

500/case

nephrology

nephrology

12598

32755

74

insideout

Spring 2011

75


Sharps containers

Face masks and shields

17710

Sharps Container 2 gallon - Red (# 8961)

Kendall

20/case

34204

Face Shield – Full Length (no visor)

Precept

1/ea.

22352

Sharps Container 2 gallon - Red (# 8970) Square

Kendall

20/case

18534

Mask (ear loop) Blue

Dynarex

50/box

36603

Sharps Container 3 gallon - Red (# 852221) Square

Kendall

10/case

14837

Mask (molded) Blue

Dynarex

50/box

32727

Sharps Container 3 gallon - Red (#8964)

Kendall

20/case

18544

Mask (ear loop) w/Face Shield Blue

Dynarex

50/bx

23163

Sharps Container 8 gallon - Red (# 8980) Square

Kendall

10/case

32042

Sharps Container 8 gallon - Red (#8980S) Slide Lid

Kendall

10/case

11973

Sharps Container 18 gallon - Red

Kendall

1/ea.

11262

Accuchek Comfort Curve Test Strip

Roche

100 strips

32623

Sharps Container – Brackets 2 and 3 gallon

Kendall

1/ea.

11265

Accuchek Comfort Curve Control Solution

Roche

1/box

32328

Ascensia Breeze Gluc. Blood Strips

Bayer

50 strips

34128

Bicarb PH II Test Strips (100 per bottle)

SerimResearch

5/btls

SerimResearch

6/btls

Lifescan

2/v

Thermometers 13281

Filac Probe Covers

Kendall

500/box

34124

Chlorine Test Strips (100 per bottle)

32742

Genius Probe Covers

Kendall

2100/case

23596

One Touch Ultra Control Solution 4ml

14167

Tempa Dot Thermometers (Oral and Axil)

3M

100/box

32640

Peracetic Acid Reagent Strips (100 per bottle)

ETS HACH

6/btls

24456

Thermoscan Sure Temp Plus 690

Welch Allyn

Each

32641

Residual Peroxide Reagent Strips (100 per bottle)

ETS HACH

5/btls

32765

Thermoscan Sure Temp Probe Covers

Welch Allyn

1000/cs

32628

Total Chlorine Test Kit

ETS HACH

1/kit

25572

Thermoscan Probe Covers

Welch Allyn

800/box

32642

Total Chlorine Refill 5 x 100

ETS HACH

1/kit

34130

Water Hardness Reagent Strips (50 per bottle)

SerimResearch

6/btls

Sempermed

100/box

Tape Durapore Tape 1" x 10 yards (Cloth / Silk)

3M

12/rolls

Durapore Tape 2" x 10 yards (Cloth / Silk)

3M

6/rolls

19089

Gloves Powder Free – Vinyl (Small)

33234

Durapore / Single Use 1" x 1.5 yards (Cloth/Silk)

3M

100/rolls

22274

Gloves Powder Free – Vinyl Exam (Medium)

Dynarex

100/box

32338

Hypo-Pore Tape 1" x 10 yards (Paper)

Dukal

12/rolls

19091

Gloves Powder Free – Vinyl (Large)

Sempermed

100/box

32577

Hypo-Silk Cloth Tape 1" x 10 yards

Dukal

12/rolls

28282

Gloves SFE Touch Latex PF (Small)

Dynarex

100/box

19140

Micropore Tape 1" x 10 yards (Paper)

3M

12/rolls

28283

Gloves SFE Touch Latex PF (Medium)

Dynarex

100/box

32535

Micropore / Single Use 1" x 1.5 yards (Paper)

3M

100/rolls

28284

Gloves SFE Touch Latex PF (Large)

Dynarex

100/box

32536

Transpore Tape 1" x 1.5 yards (Clear Plastic)

3M

500/rolls

28285

Gloves SFE Touch Latex PF ( X-Large)

Dynarex

100/box

14151

Transpore Tape 1" x 10 yards (Clear Plastic)

3M

12/rolls

32407

Gloves Sterile – Latex (Medium) Sm and Lg available

Dynarex

50/pairs

32413

Gloves- Nitrile- powder free-small

Dynarex

100/box

32412

Gloves- Nitrile- powder free-medium

Dynarex

100/box

32411

Gloves-Nitrile-powder free- large

Dynarex

100/box

32410

Gloves- Nitrile- powder free- x-large

Dynarex

100/box

Needles 18g x 1"

Terumo

100/box

34440

Bandage Strip 1" x 3 " (plastic)

Dukal

100/box

32553

Bandage Strip 3/4" x 3" (plastic)

Dukal

100/box

19216

Bandage Flex Strip 1" x 3"

Dynarex

100/box

19204

Bandage Sheer Strip 1" x 3"

Dynarex

100/box

32594

Gauze 2" x 2" (non-sterile) 8 Ply

Dukal

5000/case

32595

Gauze Pads 2" x 2" 8 Ply (sterile) 2's

Dukal

1500/case

18984

Needles 18g x 1.5"

Terumo

100/box

32597

Gauze 4" x 4" 12 ply N/S 2000/CS

Dukal

2000/case

11072

Needles 20g x 1"

Terumo

100/box

Needles 10993

32693

Gauze 4" x 4" 12 ply (sterile)

Dukal

100/box

18985

Needles 21g x 1.5"

Terumo

100/box

32796

Gauze 4 x 4 8 Ply (sterile) 2's

Dukal

1200/box

11065

Needles 23g x 1"

Terumo

100/box

24274

Gauze 2" x 2" 8 Ply (sterile) 2's

Dynarex

100/box

11058

Needles 25g x 5/8"

Terumo

100/box

13275

Telfa Pads 2" x 3" Sterile

Kendall

100/box

32344

Op-Site IV3000 2 3/8" x 2 3/4"

S/N

100/box

32346

Op-Site IV3000 4" x 4 3/4"

S/N

50/box

32345

Op-Site Flexgrid 4" x 4 3/4"

S/N

50/box

32578

Tegaderm 2 3/8" x 2 3/4" (compare to 3M brand)

Dukal

100/box

32741

Tegaderm 4" x 4 3/4" (compare to 3M brand)

Dukal

50/box

14163

Tegaderm 2 3/8" x 2 3/4" 3M Brand

3M

100/box

18528

Tegaderm 4" x 4 3/4" 3M Brand

32743

Topper Sponge Sterile 4" x 3"

32357 32358

insideout

3M

50/box

Dukal

50/box

Zorband (Large) 1" x 2 3/4" (compare to Sureseal)

Exel

100/box

Zorband ( XL) 1 1/4" x 2 3/4"(compare to Sureseal)

Exel

100/box

Fistula needles 32361

Fistula Needles 15g x 1" w/Back Eye 12" TB

Exel

50/box

32362

Fistula Needles 16g x 1" w/Back Eye 12" TB

Exel

50/box

32360

Fistula Needles 17g x 1" w/Back Eye 12" TB

Exel

50/box

32560

Fistula Needles 17g x 1.25" w/Back Eye 12" TB

Exel

50/box

32359

Fistula Needles 15g x 1" w/o B/E 12" TB

Exel

50/box

nephrology

nephrology

Gloves

14137 14138

Bandages

76

Test strips

Spring 2011

77


Duopross syringes 32575

3cc 21g x 1.5" Low Dead Space safety syringe

Duopross

12789

Safety Syringe 3 cc 22 g x 1.5" (BD# 309593)

B/D

100/box

100/box

12811

Safety Syringe 3 cc 25 g x 5/8" (BD# 309592)

B/D

100/box

32571

1cc 22g x 1 x 1.5" Renal Max

Duopross

100/box

18734

Safety Syringe 5 cc Luer Lock (BD# 305558)

B/D

50/box

32570

1cc 22g x 1.5" Renal Safe safety syringe

Duopross

100/box

19561

Safety Syringe 5 cc 21 g x 1.5" (BD# 305561)

B/D

50/box

32576

1cc 25g x 5/8" Safety TB Syringe

Duopross

100/box

12784

TB Safety Syringe 1 cc 25 g x 5/8" (BD#305554)

B/D

100/box

34418

Insulin Syringe 1cc 29g x 1/2"

Duopross

100/box

12785

TB Safety Syringe 1 cc 27 g x 1/2" (BD# 305553)

B/D

100/box

34915

Safety Syringe 3cc 23g x 1"

Duopross

100/box

19521

Safety Syringe 1 cc Insulin 29 g x 1.5"

Kendall

100/box

Terumo

100/box

19519

Safety Syringe 1 cc 28 g x 1/2"

Kendall

100/box

Syringes 32680

Insulin Syringe 1 cc 27g x 1/2"

Kendall – Safety syringes

32562

Insulin Syringe 1 cc 29g x 1/2"

Terumo

100/box

19518

Safety Syringe 1 cc 25 g x 5/8"

Kendall

100/box

22686

Syringe 1 cc 27g x 1/2" Allergy (Low Dead Space)

Terumo

100/box

19525

Safety Syringe 3 cc 20 g x 1 x 1.5"

Kendall

100/box

18993

TB Syringe 1 cc 25G x 5/8"

Terumo

100/box

19302

Safety Syringe 3 cc 21 g x 1"

Kendall

100/box

32352

TB Syringe 1 cc 25g x 5/8" (Zero Dead Space)

Exel

100/box

19303

Safety Syringe 3 cc 21 g x 1 x 1.5"

Kendall

100/box

11033

Syringe 1 cc w/Luer Lock

Terumo

100/box

32367

Safety Syringe 3 cc 22 g x 1"

Kendall

100/box

18995

Syringe 3 cc w/Luer Lock

Terumo

100/box

19528

Safety Syringe 3 cc 22 g x 1.5"

Kendall

100/box

18996

Syringe 3 cc 20g x 1" w/Luer Lock

Terumo

100/box

19304

Safety Syringe 3 cc 23 g x 1"

Kendall

100/box

18997

Syringe 3 cc 21g x 1" w/Luer Lock

Terumo

100/box

19530

Safety Syringe 3 cc 25 g x 5/8"

Kendall

100/box

18998

Syringe 3 cc 22g x 1" w/Luer Lock

Terumo

100/box

19536

Safety Syringe 6 cc 20 g x 1.5"

Kendall

50/box

Safety Syringe 6 cc 21 g x 1 x 1.5"

Kendall

50/box

11053

Syringe 3 cc 23g x 1"

Terumo

100/box

19308

11049

Syringe 3 cc 25g x 5/8"

Terumo

100/box

19531

Safety Syringe 6 cc Luer Lock

Kendall

50/box

19000

Syringe 5 cc w/Luer Lock

Terumo

100/box

19300

Safety Syringe 12 cc 20 g x 1 x 1.5"

Kendall

50/box

11031

Syringe 10 cc w/Luer Lock

Terumo

100/box

19301

Safety Syringe 12 cc 21 g x 1 x 1.5"

Kendall

50/box

19535

Safety Syringe 12 cc Luer Lock

Kendall

50/box

19003

Syringe 10 cc 21g x 1"

Terumo

100/box

33579

Syringe 20 cc w/Luer Lock

Terumo

50/box

11403

Syringe 30 cc w/Luer Lock

Terumo

25/box

11407

Syringe 60 cc w/Luer Lock

Terumo

25/box

12786

TB Syringe 1 cc 25g x 5/8" (BD# 309626)

B/D

100/box

12881

TB Syringe 1 cc (w/o needle) (BD# 309602)

B/D

100/box

10645

Syringe 10 cc Luer Lock (BD# 309604)

B/D

100/box

10638

Syringe 10 cc 21g x 1" (BD# 309642)

B/D

100/box

37116

Syringe 3 cc Luer Lock (BD# 309657)

B/D

200/bx

12791

Syringe 3 cc 20g x 1.5" (BD# 309579)

B/D

100/box

12792

Syringe 3 cc 20g x 1" (BD# 309578)

B/D

100/box

12794

Syringe 3 cc 21g x 1" (BD# 309575)

B/D

100/box

12795

Syringe 3 cc 22g x 1.5" (BD# 309574)

B/D

100/box

12796

Syringe 3 cc 22g x 1" (BD# 309572)

B/D

100/box

12797

Syringe 3 cc 23g x 1" (BD# 309571)

B/D

100/box

12799

Syringe 3 cc 25g x 1" (BD# 309581)

B/D

100/box

12882

Syringe 30 cc Luer Lock (BD# 309650)

B/D

40/box

12814

Syringe 5 cc 21g x 1.5" (BD# 309633)

B/D

100/box

B/D – Safety syringes

78

23970

BD Integra 3 cc 22 g x 1.5" Low Dead Space

B/D

100/box

23969

BD Integra 3 cc 23 g x 1" Low Dead Space

B/D

100/box

12782

Insulin Safety Syringe 1 cc 29 g x 1.5" (BD# 329464)

B/D

500/case

18735

Safety Syringe 10 cc Luer Lock (BD# 305559)

B/D

50/box

19562

Safety Syringe 10 cc 21 g x 1.5" (BD# 305564)

B/D

50/box

12884

Safety Syringe 3 cc Luer Lock (BD# 309606)

B/D

100/box

12808

Safety Syringe 3 cc 21 g x 1.5" (BD# 309595)

B/D

100/box

insideout

Our Customer Service Representatives are here for you. During our regular business hours, or during an after-hours emergency, you can count on ASD Healthcare to provide you the products and the service you need, when you need them.

Customer Service 800.746.6273 Call 8 am – 6:30 pm CST

nephrology

nephrology

B/D – Syringes

Call ASD Healthcare today to experience our superior service, get connected with a dedicated Account Manager, and start enjoying the benefits of working with ASD Healthcare. For more information, please visit www.asdhealthcare.com or call us at 866.746.6273.

Spring 2011

79


in the works Grifols provides the following product choices:

The Hospital for Sick Children in Montreal Canada is sponsoring an observational study to compare the burden of hemophilia patents in developing countries with that of patients living in developed countries. The proposed study will quantify the burden of arthropathy, physical disability and quality of life in boys with hemophilia in Brazil. This study will also provide an opportunity to compare these outcomes to those observed in Canada where the dominant therapy has become life-long prophylaxis. This study is not yet open for participant recruitment. Estimated completion date is December 2013. The psychosocial effect of living with hemophilia is the topic of a survey started in Africa, Asia, Europe, North America and South America in May 2011. Sponsored by Novo Nordisk, this observational survey seeks to identify and quantify the key psychosocial issues affecting hemophilia patients in their daily lives and how these factors affect treatment outcomes, compliance, health and general well-being.

For further information call: Grifols USA, LLC Professional Service: 888 GRIFOLS (888 474 3657) Customer Service: 888 325 8579 Fax: 323 441 7968 www.grifols.com

80

Grifols Biologicals Inc. 5555 Valley Boulevard, Los Angeles, California 90032, USA insideout

COL07-4-US-10

Inspired by nature

An 18-month interventional study is recruiting participants globally to evaluate the efficacy and safety of a prophylactic treatment with recombinant activated FVII in reducing the frequency of joint bleeds and the development of joint damage in children with hemophilia A who develop high-titer inhibitors. This study is designed to gain evidence of the advantage of the prophylactic, daily treatment with recombinant activated FVII as compared to the conventional on-demand therapy in reducing the bleeding frequency and

preserving the orthopedic status in hemophilic children with inhibitors. Trials sponsored by Gambro Lundia AB and conducted globally will study the use of Evodial ® in patients requiring heparinfree dialysis. Estimated study completion date is January 2012. This study is not yet open for participant recruitment. Massachusetts General Hospital seeks to determine safe and effective ways to raise vitamin D levels while monitoring effects on the immune system in a study it is sponsoring. Infection is the second-leading cause of death in individuals requiring dialysis treatment for kidney failure. The study seeks to confirm new research that suggests this high risk may be due in part to low levels of vitamin D. MD Scientific is conducting an interventional study to evaluate the use of sodium bicarbonate to reduce the incidence of contrast induced chronic kidney injury in patients with kidney disease. The study is currently recruiting participants 18 years and older in 13 states throughout the U.S. An observational study focusing on hospitalized patients with H1N1 virus is scheduled to be completed this September. One of the study’s goals is to help understand the course of the illness and the characteristics of people who do not do well. The study will also try to learn more about how different treatments and prior vaccination for the flu affects the course of H1N1 virus. Source: Clinical Trials.gov, U.S. National Institutes of Health, Web 23 May 2011

Spring 2011

81


Developed Specifically for the Treatment of von Willebrand Disease von Willebrand Factor/Coagulation Factor VIII Complex (Human)

■ High purity VWF/FVIII complex ■ Double virus inactivated ■ Physiologic 1:1 ratio of VWF and FVIII ■ Parallel pharmacokinetic profiles for FVIII and VWF ■ Clinical efficacy, safety, and tolerability proven in adult and pediatric populations

wilate® is a von Willebrand Factor/ Coagulation Factor VIII Complex (Human) indicated for the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD), as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated.

■ Rapidly dissolved in a small volume ■ Convenient dosing

For More Information, please Contact Us

Two convenient vial sizes

Octapharma USA, Inc. 121 River Street Suite 1201 Hoboken, NJ 07030 201-604-1130 www.octapharma.com

■ 450 IU VWF:RCo and 450 IU FVIII activities in 5 mL ■ 900 IU VWF:RCo and 900 IU FVIII activities in 10 mL

Customer Service: uscustomerservice@octapharma.com 866-766-4860

■ Includes Mix2Vial™ transfer device

rapidly dissolved in a small injection volume, may help save time during administration.

12

9

6

Important safety information: wilate® is contraindicated for individuals with a history of anaphylactic or severe systemic reaction to human plasma-derived products, any ingredient in the formulation, or components of the container. Thromboembolic events have been reported in VWD patients receiving coagulation factor replacement therapies. FVlll activity should be monitored to avoid sustained excessive FVlll levels. wilate® is made from human plasma. The risk of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease agent, cannot be completely eliminated. The most common adverse reactions to treatment with wilate® in patients with VWD have been urticaria and dizziness. The most serious adverse reactions to treatment with wilate® in patients with VWD have been hypersensitivity reactions.

Medical Affairs: usmedicalaffairs@octapharma.com 888-429-4535 Reimbursement: usreimbursement@octapharma.com Tel: 800-554-4440 Fax: 800-554-6744 www.wilateusa.com


InsideOut Spring Edition