Lifelines for Health (vol 4): Exploring the Science of Mindfulness

Winter 2014 I Volume 4

A CHES Publication

Happy 5th Birthday Affordable Care Act: What Have You Done for Me Lately?

The Patient Notification System:

Have Yo u En r o ll ed??

FDA Asks for Input from Bleeding Disorders Community

Recognize Your Own

Resilience:

And Then Build On It

What Inhibitor Family Camp Means to Us:

It Just “Clicks” NHF Inhibitor Summit 2014:

It’s in the Bank

Hemophilia is TUBE-U-LAR! (Hemophilia References on TV)

Puzzling Cases?

Achieve response with the power and stability of the FVIII/vWF Complex*

FVIII

von Willebrand

Koate ˉ ®-DVI1,2: * Ko ate ˉ ®-DVI has not been investigated • Is indicated for the treatment of classical for efficacy in the treatment of von Willebrand disease, and hence hemophilia A is not approved for such usage • Demonstrates a mean biologic half-life of 16.12 hours ** A total of 306 bleeding episodes were • Contains naturally occurring vWF* treated. 82% of the bleeding episodes • Is well-tolerated with low risk (0.7%) of adverse reactions were treated adequately with a single infusion of FVIII • Is effective in a single dose** Important Safety Information Koate ˉ ®-DVI is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Hepatitis B vaccination is essential for patients with hemophilia A; vaccination is recommended at birth or at the time of diagnosis. Hepatitis A vaccination is also recommended for hemophilia patients who are hepatitis A seronegative.

When large or frequently repeated doses are required, patients of blood groups A, B, or AB should be monitored for signs of progressive anemia. ©2014 Kedrion Biopharma, Inc. All Rights Reserved. Printed in USA June 2014 KT-0077-00-2014

Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations. Reactions include tingling in the arm, ear, and face, blurred vision, headache, nausea, stomach ache, and jittery feeling.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see next page for Brief Summary of Koate ˉ ®-DVI Product Information. For Full Product Information, please visit www.koate-dviusa.com.

References: 1. Koate ˉ ®-DVI [prescribing information]. 2012. 2. Powell JS, Bush M, Harrison J, Abildgaard C, Vosburgh E, Thompson AR, Hurst D. Safety and efficacy of solvent/detergent- treated antihaemophilic factor with an added 80 degrees C terminal dry heat treatment in patients with haemophilia A. Haemophilia. 2000;6(3):140-9.

Koˉate®-DVI [Antihemophilic Factor (Human)] Brief Summary: Please see Koate ˉ ®-DVI Full Prescribing Information for complete product details.

Koate ˉ ®-DVI [Antihemophilic Factor (Human)] is a sterile, stable, purified, dried concentrate of human Antihemophilic Factor (AHF, Factor VIII) used to treat classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, Factor VIII. Koate-DVI ˉ contains naturally occurring von Willebrand factor, but has not been approved for the treatment of von Willebrand disease.

Warnings Koate-DVI ˉ is made from human plasma. It may contain infectious agents that can cause disease, such as viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk that the product will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.

Despite these measures, the product may carry a risk of transmitting infectious agents, including unknown infectious agents.

Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. Hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis. Hepatitis A vaccination is also recommended for hemophilic patients who are hepatitis A seronegative.

Precautions Koate-DVI ˉ is intended for the treatment of bleeding disorders arising from a deficiency in Factor VIII. This deficiency should be proven prior to administering Koate-DVI. ˉ Koate-DVI ˉ should be administered within 3 hours after reconstitution and should not be refrigerated after reconstitution. Administer only by the intravenous route, and use a filter needle prior to administering.

Koate-DVI ˉ contains levels of blood group isoagglutinins, which are not clinically significant when controlling relatively minor bleeding episodes. When large or frequently repeated doses are required, patients of blood groups A, B, or AB should be monitored by means of hematocrit for signs of progressive anemia, as well as by direct Coombs’ tests.

Product administration and handling of the infusion set

and needles must be done with caution. Place needles in sharps container after single use and discard all equipment including any reconstituted Koate-DVI ˉ product in accordance with biohazard procedures. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs.

Some viruses, such as parvovirus B19 or hepatitis A, are particularly difficult to remove or inactivate at this time.

Parvovirus B19 most seriously affects pregnant women and immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about 2 weeks later by a rash and joint pain. Evidence of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and pain in the belly.

Dark urine and a yellowed complexion are also common symptoms. Patients should be encouraged to consult their physician if such symptoms appear.

Pregnancy Category C Animal reproduction studies have not been conducted with Koate-DVI. It is also not known whether Koate-DVI ˉ can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Koate-DVI ˉ should be given to a pregnant woman only if clearly needed.

Pediatric Use Koate-DVI ˉ has not been studied in pediatric patients.

However, the previous formulation, Koate-HP, ˉ had been used extensively in pediatrics. Spontaneous adverse event reports with Koate-HP ˉ for pediatric use was similar to those reported for adult use.

Adverse Reactions Allergic-type reactions may result from the administration of Antihemophilic Factor (Human) preparations.

In clinical studies, 0.7% of infusions were associated with adverse reactions. All reactions were mild and included paraesthesia (numbness), blurred vision, headache, nausea, abdominal pain, and feeling jittery.

The information provided in this brief summary should not replace a conversation with your physician. It is important to talk to your physician about treatments that are appropriate for you.

For Koate ˉ ®-DVI Full Prescribing Information, please visit www.koate-dviusa.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Integrity, Accuracy, Empathy...

CONTENTS

FEATURE 13 I Exploring the Science of Mindfulness

Pain lives with individuals with hemophilia and inhibitors - and stress and anxiety are its two best friends who love to greet the whole family. Explore the wonders of ‘mindfulness’ with Dr. Maureen Strafford and discover how this practice could be the remedy to all of these unwelcomed guests.

COMMUNITY CHATTER

INSURANCE CORNER

5 I What Inhibitor Family Camp Means to Us: It Just “Clicks”

17 I Happy 5th Birthday ACA: What Have You Done for Me Lately?

Meet the Camarro’s! For many of our inhibitor campers, introductions aren’t necessary, as they are repeat guests at Inhibitor Family Camp.

Learn what camp means to them.

9 I NHF Inhibitor Summit 2014: It’s in the Bank Inhibitor mom (slash) veteran, Ashley Druckenmiller planned a trip to the National Hemophilia Foundation’s Inhibitor Summit this year in New Mexico. What she didn’t plan for was the education that her 8-year-old son received.

Find out how this trip may have changed his life forever.

Watch out for numero uno and be the first to know if yours (or your child’s) medications are ever recalled.

28 I FDA Asks for Input from Bleeding Disorders Community Select community members had a rare opportunity to express our needs to the Food & Drug Administration. The resources to witness some of those testimonies are provided here.

LIFELINES for HEALTH

22 I Recognize Your Own Resilience: And Then Build On It Everyone needs resilience to make it through certain days of their lives, especially if you’re a member of our group. Listen to Dr. Gary McClain’s pep talk as he gives us some pointers on improving our resilience, or perhaps just developing it for the first time.

29 I Hemophilia is Tube-u-lar!

27 I The Patient Notification System: H a v e You E nrol l ed??

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FAMILY MATTERS

FUN & INSPIRATION

BLOODLINES

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March will mark the Affordable Care Act’s 5th birthday. As this milestone approaches, this is a good to time to review some of the more favorable provisions that have taken effect in 2014.

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Hemophilia is appearing on different television series in an upward trend. Discover which shows have hosted these cameo appearances and what this could mean for our future.

30 I A Special Remembrance in Our Family We were grief-stricken by the loss of a loved one, Sarah (Phenix) Brewer, who will be missed by so many. This is an inhibitor camper’s ode to her passing.

CONTENTS

Letter From the Editors Welcome to the winter issue of the only newsletter dedicated to the inhibitor community! We don’t know about you, but it seems hard to believe that 2014 is already at its close. We still want a summer do-over!

Comprehensive Health Education Services (CHES) is thrilled that we may continue to be your resource for information that is pertinent and specific to your lives. As individuals who live with hemophilia and an inhibitor, we understand your challenges, struggles and concerns that are very different than having “just hemophilia”. Although each one of us face issues that are individually unique, what unifies us is that sense of knowing each other’s battles and triumphs.

WE ARE FAMILY! We are so excited to bring you this winter edition of LifeLines for Health. Our feature, Exploring the Science of Mindfulness focuses on a topic that CHES first presented at Inhibitor Family Camp 2011 and touched on in our premier edition of LifeLines for Health in 2013, that is now generating a lot of attention. As the opiate addiction and death rate continues to climb at an alarming rate, we as a nation are finally focusing on alternate ways to manage pain. As we all know in the inhibitor community, pain is a daily occurrence whether it is chronic pain or acute. The sad reality is that the inhibitor community will live with pain their entire life. There needs to be other methods in our toolbox to manage it besides medication. Mindfulness and meditation are techniques that can be used to help take the suffering out of pain.

Holdings, Inc.

Our Specialty Pharmacy is Experienced in Inhibitor Care The development of inhibitors is the most challenging problem that patients with hemophilia and their treaters face today.

• We advocate on behalf of patients • We simplify access to product

• Abogamos por pacientes

• Insurance assistance

• Simplificamos acceso a productos

• Individual packaging & shipping arrangements

• Proveemos asistencia de aseguranza • Coordinación de envío y empaque personalizado • Asistencia español

In our Community Chatter section, as always we www.nc-hs.com • customerservice@nc-hs.com bring you news of events and programs specific to the Toll-Free: 877.616.6247 • Fax: 877.777.5717 inhibitor community written by community members.

Our BloodLines section features information about a meeting held by the FDA on September 22, 2014 that asked the bleeding disorder community exactly what we need. WOW! The inhibitor community was well represented by 3-power house moms who gave LifeLines for HealthSM Disclaimers impassioned testimony as to what our daily lives look like (and as we all know, some days it ain’t pretty). BloodLines also features information about the Patient The views and opinions of our writers are not a Notification System that notifies consumers about product recalls. reflection of Comprehensive Health Education Our Insurance Corner section celebrates the ACA’s fifth birthday coming in 2015 and provides a retrospective of the positive changes it has brought to all individuals with a chronic condition. The Fun and Inspiration section is meant to provide the levity and triumphs we need and to celebrate as we navigate this path in our lives. We have added a new section this issue, Family Matters, written by Dr. Gary McClain. This section will focus on the psychosocial issues of managing life with a chronic condition. He has his work cut out for him!

Lastly, we want to hear from youour courageous family! What do you like, what should we include?

This is YOUR newsletter! We are so happy to bring it to you. Enjoy!

- Janet Brewer & Eric Lowe “Embrace change and recognize that life is in constant motion. When boundaries are seen as opportunities the world becomes a limitless place.”

-via Successories jbrewer@comphealthed.com l elowe@comphealthed.com

ServicesTM, Inc. (CHES), or its’ sponsors.

This newsletter is designed to provide a forum for community members to express their views from an open and honest platform. It is meant to provide a sharing of knowledge and experience meant to help one another. Nothing in this newsletter is meant to replace the advice of your HTC, medical professional team or insurance provider. You are always urged to seek the opinion of a healthcare professional for treatment and your specific insurance provider for information.

We take your privacy very seriously. We would never disclose your personal health information without your express written consent. We would never sell nor make available our secure database to anyone.

Articles and pictures may not be reproduced, published, and/or placed on websites without the express written permission of CHES. In every publication of LifeLines for HealthSM, we will provide links to other websites that are not owned or controlled by CHES or its sponsors. We cannot be responsible for privacy practices of other website owners, nor can we be responsible for the accuracy of the information provided.

What Inhibitor Family Camp Means to Us:

It Just “Clicks”

A Father’s Words

by Wayne Camarro

This is the second year my family has attended Inhibitor Family Camp at Victory Junction Camp. My wife Jackie and I went with our sons Jacob, age 9 who has Hemophilia A with an inhibitor and our son Harrison, age 17. Harry has Lenox Gastau Sydrome, which means he is non-ambulatory, non-verbal, is developmentally impaired and has a seizure disorder.

Attending camp gives Jake and our whole family a chance for fun, education, relaxation and friendship with other families that are or have gone through some of the same experiences with hemophilia and an inhibitor that we have.

We see it as a mini family vacation where we get to see old friends, make new ones, share experiences, learn new ways to cope, relax and ease pain.

It gives us a chance to see Jake playing with kids who understand him and all that he has been through. To see him make friends so fast warms my heart.

Inhibitor Family Camp gives Harry a chance to experience cool activities like archery and horseback riding for the first time, that he might not have had a chance to do otherwise because everything is adapted!

We have taken Harry to traditional campgrounds previously, but they tend to be over crowded and are typically not equipped to handle kids with special needs. At Inhibitor Family Camp the staff is very well versed in caring for kids of his ability level, which makes us so much more comfortable and makes it so much easier for him to participate. You can see it in the huge smile on his face!

For us as parents, Jackie and I get the benefit of attending informative sessions presented by medical professionals. Open group “jam” sessions with the other visiting parents are a favorite of mine.

We get to discuss topics such as how our kids’ siblings are dealing with this illness.

Having such a varied group together in one place and still being able to relate to each other’s struggles is truly amazing and not an experience that is easy to duplicate.

There is no worry that he’s not going to fit in or have other kids fear him or label him as different due to his condition. He just “clicks” with the other kids.

There is no awkward adjustment period for them to bond, they become fast friends in minutes and are off and running to the next fun activity.

We really look forward to getting a break from the day-to-day challenges of dealing with hemophilia and an inhibitor.

No matter how overwhelming things can seem at times, knowing we have our

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Wayne and oldest son, Harrison

Inhibitor Family Camp experiences to fall back on is huge.

We truly appreciate the effort that goes into making this event happen. Our sincere thanks for letting us be a part of the Inhibitor Family Camp family.

A Mother’s Words

by Jackie Camarro

There are many things I enjoy about the CHES Inhibitor Family Camp weekends.

I enjoy meeting families from all over the country. I enjoy the feeling of community you get when you know that the people around you understand what you are going through when raising a son diagnosed with hemophilia and an inhibitor.

It’s nice to not have to explain what hemophilia is and then add all that additional information needed to explain the inhibitor too. All you have to do is introduce yourself and say the diagnosis and the conversation has begun. It’s fun to participate in the Serious Fun camp experience too.

My favorite part of camp is interacting with other parents, listening to their story and realizing that we are a community of people with many similarities. I never would have had the opportunity to meet such awesome people and hear such inspiring stories.

These stories empower me and give me the strength to continue.

As many parents in the inhibitor family know, there are times that I, as

a parent have been worried about my child’s future. It is very hard to see your child in pain or to see him sad because he can’t do all the things his friends can do. It hurts when I see him become angry because of his medical condition.

For registration and program info on Inhibitor Family Camp, see page 10.

Inhibitor Family Camp is also great for my son.

He needs to know that he is not alone and that other children can relate to his situation too.

It’s nice to see him make new friends, laugh, play and do all sorts of fun things that can only be done at a Serious Fun Camp.

Jake intensely paints his pumpkin in honor of the weekend theme “Monster Mash”

COMMUNITY CHATTER

THE FIRST AND ONLY FACTOR VIII WITH A PROLONGED HALF-LIFE Visit ELOCTATE.com

Meet your CoRe Manager Nikita Lyons Murry E: Nikita.LyonsMurry@biogenidec.com T: 615-525-1003 This information is not intended to replace discussions with your healthcare provider.

Indications ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: control and prevention of bleeding episodes, perioperative management (surgical prophylaxis), and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. ELOCTATE is not indicated for the treatment of von Willebrand disease.

Important Safety Information Do not use ELOCTATE if you have had an allergic reaction to it in the past.

Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies, are breastfeeding, are pregnant or planning to become pregnant, or have been told you have inhibitors (antibodies) to Factor VIII. Allergic reactions may occur with ELOCTATE. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called, “inhibitors,” against ELOCTATE, which may stop ELOCTATE from working properly.

Common side effects of ELOCTATE are joint pain and general discomfort. These are not all the possible side effects of ELOCTATE. Talk to your healthcare provider right away about any side effect that bothers you or that does not go away, and if bleeding is not controlled after using ELOCTATE. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Brief Summary of full Prescribing Information on the next page.

© 2014 Biogen Idec Inc. All rights reserved. Printed in U.S.A. HFE-1006322-02 11/14

FDA-Approved Patient Labeling Patient Information ELOCTATE™ /el’ ok’ tate/ [Antihemophilic Factor (Recombinant), Fc Fusion Protein] Please read this Patient Information carefully before using ELOCTATE and each time you get a refill, as there may be new information.

This Patient Information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is ELOCTATE? ELOCTATE is an injectable medicine that is used to help control and prevent bleeding in people with Hemophilia A (congenital Factor VIII deficiency).

Your healthcare provider may give you ELOCTATE when you have surgery.

Who should not use ELOCTATE? You should not use ELOCTATE if you had an allergic reaction to it in the past.

What should I tell my healthcare provider before using ELOCTATE? Talk to your healthcare provider about: • Any medical problems that you have or had.

• All prescription and non-prescription medicines that you take, including over-the-counter medicines, supplements or herbal medicines.

• Pregnancy or if you are planning to become pregnant. It is not known if ELOCTATE may harm your unborn baby.

• Breastfeeding. It is not known if ELOCTATE passes into the milk and if it can harm your baby.

How should I use ELOCTATE? You get ELOCTATE as an infusion into your vein. Your healthcare provider will instruct you on how to do infusions on your own, and may watch you give yourself the first dose of ELOCTATE. Contact your healthcare provider right away if bleeding is not controlled after using ELOCTATE. What are the possible side effects of ELOCTATE? Common side effects of ELOCTATE are joint pain and general discomfort.

Allergic reactions may occur. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash or hives.

Your body can also make antibodies called, “inhibitors,” against ELOCTATE, which may stop ELOCTATE from working properly. Your healthcare provider may give you blood tests to check for inhibitors.

How should I store ELOCTATE? • Keep ELOCTATE in its original package.

• Protect it from light.

• Do not freeze.

• Store refrigerated (2°C to 8°C or 36°F to 46°F) or at room temperature [not to exceed 30°C (86°F)], for up to six months.

• When storing at room temperature: • Note on the carton the date on which the product is removed from refrigeration.

• Use the product before the end of this 6 month period or discard it.

• Do not return the product to the refrigerator.

Do not use ELOCTATE after the expiration date printed on the vial or, if you removed it from the refrigerator, after the date that was noted on the carton, whichever is earlier.

After reconstitution (mixing with the diluent): • Do not use ELOCTATE if the reconstituted solution is not clear to slightly opalescent and colorless.

• Use reconstituted product as soon as possible • You may store reconstituted solution at room temperature, not to exceed 30°C (86°F), for up to three hours. Protect the reconstituted product from direct sunlight. Discard any product not used within three hours.

What else should I know about ELOCTATE? Medicines are sometimes prescribed for purposes other than those listed here. Do not use ELOCTATE for a condition for which it was not prescribed. Do not share ELOCTATE with other people, even if they have the same symptoms that you have.

Manufactured by: Biogen Idec Inc. 14 Cambridge Center, Cambridge, MA 02142 USA U.S. License # 1697 44279-01 ELOCTATE™ is a trademark of Biogen Idec.

Issued June 2014

NHF Inhibitor Summit 2014:

by Ashley Druckenmiller

I

n the fall of 2006, our son was diagnosed with severe hemophilia at age 7 months; a few weeks later we were told he had an Inhibitor. I had some knowledge of hemophilia, but the Inhibitor word was completely new to me. I quickly went to the internet where I basically found out nothing more than what our HTC was telling me, which wasn’t much. Facebook wasn’t nearly as popular then and pharma companies didn’t have much on their websites either. As a person who likes to gather as much information as possible, I was frustrated. In 2007 we welcomed

Ashley’s oldest, Bode, partaking in the rocket launch at Inhibitor Family Camp this Fall

another baby boy to our family, who also had hemophilia and after open-heart surgery we learned he too had developed an Inhibitor. Now I had two babies in my house that had something going on I felt I knew very little about.

In the spring of 2008 I learned of the Inhibitor Summit Education Symposiums. We quickly signed up to attend one in Denver, CO. At that time in our lives we never knew if we would be in the hospital or out of the hospital but we knew one or all of us would make it to that 3 day meeting no matter what. When July rolled around and summit time was rapidly approaching, my youngest son was in the hospital with a port infection. Luckily

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It’s in the Bank

our HTC knew how important it was to us that we attend, so reluctantly they released us from the hospital, with a prescription for IV antibiotics and off to Denver we traveled.

At the time of the first meeting I didn’t realize how important these would become to me. We live in a tiny small town in Iowa, and we were not aware of any other patients who lived close to us who had hemophilia, much less an Inhibitor. Shortly after arriving at our first summit, our issues with port infections, PICC lines coming out, Hickman lines that didn’t stop bleeding which had to be removed, and nights with no sleep due to bleeds, seemed normal to those in attendance. Everyone was talking about the same issues we were having. I knew immediately that we were no longer “alone” in this Inhibitor world. Patients of all ages were there to share their knowledge and I took every opportunity to take it all in.

I could go on for days about the great information we take away from each summit. But what immediately comes to mind is a story about this past summer when we attended the summit in New Mexico. There was a session on the agenda that included the kids and the parents together and sports was the topic. I wasn’t too sure at the time how much my 8 year old could really take away from this meeting, but because all of his newfound friends were also attending, he sat attentively and actively participated in the discussion. I had no idea how much he would take away from those 60 minutes! About a month later just before soccer season was to start, he said he was going to go run around the block a few times. When I questioned why, his response was so that he needed to be in shape when soccer started and would hopefully not get a bleed from being out of shape. I was kind of blown away! I asked where he had heard that and he responded, those people in New Mexico at that meeting told me that. Well “those people” happened to be two physical therapists that spoke at the parents and kids sports discussion. I asked him what else they told him and he said, not to do a header in soccer. I was blown away again! He not only was active in the discussion that day in July, but here it is the end of August and he is putting to use not one, but two of the suggestions they gave that day.

The relationships we have gained by attending the summits are what really mean the most to me.

It’s great that everyone leaves with more education, but it’s even better that I leave every meeting with one more phone

an Innovative CHES Program

Everyone deserves a camp to call their own This program in specially designed to meet the needs and limitations of children with both, hemophilia & inhibitors. Immediate family members are also invited because we understand the value of having a tight-knit support unit behind these children. We play, learn, and grow while we build a stronger community.

To register, applicants must have an active inhibitor, or a history of an inhibitor within the last 12 months, and fall between the ages of 6-19. If you’re interested, please act now. Space is limited, and slots are filled on a first come, first-served basis for those who qualify.

Supported by an educational grant from

SPRING SESSION FALL SESSION

Presented by

Date: Friday, April 10th - Monday, April 13th Loction: The Painted Turtle, located in Lake Hughes, CA Registration: Friday, January 9th, 2015 Date: Friday, Oct. 16th - Monday, Oct. 19th Loction: Victory Junction, located in Randleman, NC Registration: Wednesday, July 1st, 2015

number of another Mom to call upon should I have a question. One of the first Moms I met at that summit in Denver, handed me her contact information and said, “call me anytime, 2:00 in the morning or 10:00 at night, it doesn’t matter, I’m here for you”. I thought “ya right, you really won’t care if I call you at 10pm with a question about a bleed?” I quickly realized she wasn’t joking, and neither were the many other Moms along the way who said the same thing. I have since given my name and number many times to those Moms, like I was many years ago, who had that deer in the headlights look, and said “call me anytime” and I follow that with, “I really mean it, call me anytime.”

At the summits my children have been able to feel “normal”. They get to be around other children who stick themselves with a needle, have buttons sticking out of their chest, use a wheelchair if needed, and back home those things are just not understood by their peers.

This fall while traveling to Inhibitor Family Camp, we were

changing planes in Atlanta and at our gate we ran in to 4 families who had attended the Summit with us this past summer. While the boys were eager to talk about their flights and sports and play catch up, I was dropping our stuff with a fellow Inhibitor Mom and running down the hall to grab a quick lunch for my family.

Those kinds of friendships aren’t developed every day and I’ve never once taken for granted how much my Inhibitor Family means to me.

Learn more at InhibitorFamilyCamp.org

in New Mexico” told me to do so and so.

In the long term, we want our kids to be healthy and happy, and while hemophilia and inhibitors aren’t going away anytime soon, we make the best of it. We think about that map, where our friends are

Ashley’s youngest, Brystol, showing off his wild side at Inhibitor Family I love that my Camp this Fall boys can look at the US map, name their hemophilia friends and when located, and as a mom I still think about we talk about where those folks live, we that first mom who gave me her phone really cover the entire map. How many number. The one who really meant it other opportunities in life provide us when she said, “call me anytime” and with a chance to meet folks from all over I think of all of the other parents and the United States who are dealing with caregivers who have since been able to the same rare disease? Each year at the be connected by attending a summit. The summits we are able to add to that map map links us by roads and interstates but and as my boys get older I hope that they our Inhibitor Family stays connected in so can also add to that bank of information many other ways. in their brain. That bank of “those people

COMMUNITY CHATTER

Half the volume

Twice the factor*

ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is now available in a 2000 IU FVIII vial with a reconstitution volume of only 10 mL. * That’s TWICE the amount of factor of the largest vial available for other FVIII/VWF products,1-4 so patients may require: • Less volume

Learn more at alphanate.com

• Less time • Fewer syringes

Isn’t it time you tried ALPHANATE? Indications ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) is indicated for: • Control and prevention of bleeding in patients with hemophilia A • Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand disease (VWD) in whom desmopressin (DDAVP®) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery

Important Safety Information ALPHANATE is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

Anaphylaxis and severe hypersensitivity reactions are possible. Should symptoms occur, treatment with ALPHANATE should be discontinued, and emergency treatment should be sought.

Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products. Development of alloantibodies to VWF in Type 3 von Willebrand disease (VWD) patients has been occasionally reported in the literature.

Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors.

Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human).

Rapid administration of a FVIII concentrate may result in vasomotor reactions.

Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

The most frequent adverse events reported with ALPHANATE in >5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain, and fatigue.

Please see brief summary of ALPHANATE full Prescribing Information on adjacent page.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

References: 1. ALPHANATE® (antihemophilic factor/von Willebrand factor complex [human]) Prescribing Information. Grifols. 2. CSL Behring. Humate P Package Insert. August 2013; 3. Octapharma.

Wilate Package Insert. January 2012; 4. Kedrion. Koate-DVI Package Insert. August 2012.

For more information: Grifols Biologicals Inc. Tel. 888-GRIFOLS (888-474-3657)

Grifols Biologicals Inc. 5555 Valley Boulevard, Los Angeles, 90032 CA - USA www.grifols.com

© 2014 Grifols Inc.

www.grifols.com Tel. 888-GRIFOLS (888 474 3657)

All rights reserved.

Printed in USA.

July 2014

A817-0714

ALPHANATE®

Antihemophilic Factor/von Willebrand Factor Complex (Human) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Alphanate safely and effectively. See full prescribing information for Alphanate.

ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX [HUMAN]) Sterile, lyophilized powder for injection.

Initial U.S. Approval: 1978 --------------------------INDICATIONS AND USAGE -----------------------Alphanate is an Antihemophilic Factor/von Willebrand Factor Complex (Human) indicated for: • Control and prevention of bleeding in patients with hemophilia A. • Surgical and/or invasive procedures in adult and pediatric patients with von Willebrand Disease in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery.

----------------------DOSAGE AND ADMINISTRATION -------------------For Intravenous use only.

Alphanate contains the labeled amount of Factor VIII expressed in International Units (IU) FVIII/vial and von Willebrand Factor:Ristocetin Cofactor activity in IU VWF:RCo/vial.

Hemophilia A: Control and prevention of bleeding episodes • Dose (units) = body weight (kg) x desired FVIII rise (IU/dL or % of normal) x 0.5 (IU/kg per IU/dL).

----------------------WARNINGS AND PRECAUTIONS -------------------• Anaphylaxis and severe hypersensitivity reactions are possible.

Should symptoms occur, treatment with Alphanate should be discontinued, and emergency treatment should be sought.

• Development of activity-neutralizing antibodies has been detected in patients receiving FVIII containing products. Development of alloantibodies to VWF in Type 3 VWD patients has been occasionally reported in the literature.

• Thromboembolic events may be associated with AHF/VWF Complex (Human) in VWD patients, especially in the setting of known risk factors.

• Intravascular hemolysis may be associated with infusion of massive doses of AHF/VWF Complex (Human).

• Rapid administration of a FVIII concentrate may result in vasomotor reactions.

• Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk.

----------------------------ADVERSE REACTIONS --------------------------The most frequent adverse events reported with Alphanate in > 5% of patients are respiratory distress, pruritus, rash, urticaria, face edema, paresthesia, pain, fever, chills, joint pain and fatigue.

To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals Inc. at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

---------------------USE IN SPECIFIC POPULATIONS -------------------• Pregnancy: No human or animal data. Use only if clearly needed.

• Pediatric Use: Hemophilia A - Clinical trials for safety and effectiveness have not been conducted. VWD - Age had no effect on PK.

• Frequency of intravenous injection of the reconstituted product is determined by the type of bleeding episode and the recommendation of the treating physician. von Willebrand Disease: Surgical and/or invasive procedure in adult and pediatric patients except Type 3 undergoing major surgery • Adults: Pre-operative dose of 60 IU VWF:RCo/kg body weight; subsequent doses of 40-60 IU VWF:RCo/kg body weight at 8-12 hour intervals post-operative as clinically needed.

• Pediatric: Pre-operative dose of 75 IU VWF:RCo/kg body weight; subsequent doses of 50-75 IU VWF:RCo/kg body weight at 8-12 hour intervals post-operative as clinically needed.

--------------------DOSAGE FORMS AND STRENGTHS -----------------• Alphanate is a sterile, lyophilized powder for intravenous injection after reconstitution, available as 250, 500, 1000, 1500 and 2000 IU FVIII in single dose vials.

----------------------------CONTRAINDICATIONS --------------------------• Patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components.

Grifols Biologicals Inc. 5555 Valley Boulevard Los Angeles, CA 90032, U.S.A. U.S. License No. 1694

3041048-BS Revised: 06/2014

L

iving with hemophilia presents its own set of challenges, as we all know, but adding inhibitors into the mix complicates the problem dramatically. Sadly, pain is (and probably always will be) a common part of life with inhibitors. Not to mention everything else it brings to the entire household, like stress and anxiety.

Mindfulness and meditation can be great ways for someone in pain to ease his/ her suffering without the risks of opiate overuse. It can also help everyone living with inhibitors, patient or not, lower stress and anxiety levels. It’s easy for some to raise a skeptical brow on such methods, but if you’re ‘mindful’ of these approaches, you might be surprised of what can come out of them.

We’ve asked expert, Dr. Maureen Strafford, of Tufts University School of Medicine in Boston, MA to offer us her expert guidance on what exactly mindfulness is and how we can use it to our advantage.

Exploring the Science of Mindfulness

by Dr. Maureen Strafford

Mindfulness is a word that we are hearing about quite a bit these days. In January, Time Magazine had a cover story called “The Mindful Revolution” with the subtitle “Finding peace in a stressedout, digitally dependent culture may just be a matter of thinking differently.” Do a search on Amazon and 9,893 books are found with the word “Mindfulness” in the title, including a book by U.S. Congressman Tim Ryan called “A Mindful Nation.” One might think that “Mindfulness” has just been discovered

by our 21st century society. In fact, mindfulness and the use of mindfulness meditation techniques can be traced back to ancient meditative and contemplative

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practices and are seen in many, if not all, religious traditions.

However, the practice of mindfulness techniques --- practiced in a non-religious, secular manner --- with the introduction of such techniques into health care settings, the classroom, the corporate world and even in the locker rooms of national athletic teams --- has increased dramatically over the last several decades.

In 1979, Dr. Jon Kabat-Zinn introduced mindfulness meditation into mainstream medicine when the University of Massachusetts Stress Reduction Clinic was begun at the University of Massachusetts Medical Center in Worcester, MA. Patients with a variety of medical problems attended an 8-week, once a week meeting with a group of other patients and a leader.

This course was called Mindfulness-Based-StressReduction (MBSR) and has now expanded to thousands of hospitals across the world where many thousands of patients have found improvement in symptoms including anxiety, pain, and depression from a wide array of diagnoses.

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But what do we mean when we say Mindfulness? The definition of Dr. Jon Kabat-Zinn has been widely quoted.

“Mindfulness means paying attention in a particular way; on purpose, in the present moment and nonjudgmentally.”

We have all experienced being “mindless.” We park our car in the morning and when we return at the end of the day, we have no memory where the car is. Where was our mind when we were parking our car? We were certainly “not paying attention on purpose.” We have also experienced how one thought can spiral into an entire narrative usually of doom and gloom or negative self-descriptions or we can create a fantasy pleasurable scene and miss the unfolding of the present moment. We may experience pain and fear and anxiety that leads to panic that leads to increased suffering. Mindfulness slows down the reactive, out of control thinking called rumination. Mindfulness can help us observe the moments when our pain is different, diminishes, even disappears.

The word nonjudgmental is so important.

When we stop labeling every experience as good or bad, we eliminate the reactivity that causes us additional suffering.

The way we “practice” mindfulness starts with the formal practice of sitting meditation, or movement practices such as yoga, tai chi, or walking meditation.

There is no “right” or “wrong” way to sit and meditate. The breath is a good anchor for our attention because it is always there and has a changing quality to it. We may attend to the breath and have the shopping list for dinner pop into our heads and pull our attention away. As a parent firmly but lovingly moves the wandering child away from the dangerous road, so too with attention to the breath, we bring our attention back to the breath without judgment – no statements that “I’m a lousy meditator” or “This isn’t working.”

With this commitment to attention and awareness, we move away from reactivity and rumination and the tendency of the mind to create entire scenarios and screenplays that may be pleasant or unpleasant and move into the vibrant experience of the present.

While MBSR courses were blossoming all over this country and internationally over the last several decades, research on MBSR was also exploding and describing the positive effects of this practice on both physical and mental health. Research --including a fascinating look at the brain

with tools such as functional MRI (a scan of the brain where areas that are stimulated “light” up on the scan) --- began to suggest that indeed the brain can change and areas where anxiety, anger, and fear “reside” in the brain have been shown to quiet down when a person meditates.

Of great interest is that the practice of

mindfulness may have long-lasting effects and that the “brain” does indeed change.

The “ruts” created by years of rumination, anxiety, and worry begin to “smooth over” as practice time increases. Mindfulness meditation --- even after the basic 8 week MBSR course --- has demonstrated a strengthening of the immune system, significant amelioration of depression comparable to the use of anti-depressant medications and improvement in the symptoms of Attention Deficit Disorder (ADD). The quality and quantity of excellent clinical research on the beneficial effects of mindfulness has exploded and drawn the attention of neuroscientists and other basics research scientists. Teachers, health care providers, veterans suffering from PTSD, prisoners, children and patients with a wide array of symptoms and challenges improve the symptoms of their diseases, diminish the risk of caretaker burnout, and uniformly report an improved quality of life, including improved relationships.

So how does one learn “Mindfulness” and how does one implement the changes mindfulness can stimulate?

We practice! The “formal” practice complements and strengthens the “informal” practice.

The formal practice is the time we take to “practice” observing our experience in a different way. We can practice sitting and using the breath as our anchor. We can practice yoga and observe our movements in a mindful manner.

We use the skills learned and practiced during formal sitting meditation to observe the simple activities of daily life with an energized and creative curiosity. This is the “informal practice” of mindfulness when we observe the sensation of the splash of water on our face, the feel of the weather on the skin, the taste of a small morsel of food and in this “informal”

practice, we experience life in a more deeply felt manner with less reactivity and suffering. We also experience benefits in the informal practice of mindfulness when we have pain or anxiety. We may observe moments when our pain is intense and moves to areas of our body and even a moment when the pain disappears. We learn that we are not our thoughts and we can move away from the “over and over” rumination of our worried mind.

How does one train or learn more about mindfulness and how to include it as part of a health self-care regimen?

There are now programs throughout the US, many based in hospitals that may be covered by health insurance. There are also therapists who have been trained in MBSR and offer traditional 8-week MBSR courses. A review of the UMass Center for Mindfulness website - http:// www.umassmed.edu/cfm/ - is a wonderful place to start in understanding the training required for MBSR teaching. A web search for MBSR courses and teachers in your area will be a productive place to start and after reviewing the UMass site, you will have good questions to ask when looking for MBSR courses. While programs are more limited for children, local mindfulness teachers can guide one in finding well-qualified teachers for children. There are increasing resources in books and apps that will also be helpful and asking your child’s pediatrician and

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teachers can also be a helpful place to start. The 8-week MBSR course is very helpful if doing it on your own is more difficult, and the group format adds to the insights gained as one progresses through the course.

For those who are interested in more individual work or want to investigate a bit more on your own before committing to an MBSR course, there are many books, online courses and apps to help you.

We have a wealth of resources to learn about Mindfulness and the effect on health, well-being and relationships.

But even before one Internet search or

book is ordered, remember we always have our breath. Our anchor. Sitting here reading, take a moment to find your place in your seat. Slowly bring attention to bringing your shoulders back, and moving your body into a more upright position, slowly close your eyes if that feels comfortable where you are and bring your attention to that part of your body where the breath is noted – the nostrils, the upper chest, the belly. Notice how the quality of the breath changes with breathing in and breathing out. Notice how thoughts –“I don’t have time right now.” “I think this is not going to work.” “I can’t forget to send the check.” pop into the mind like popcorn being cooked. And with the gentle firmness and kindness of the parent moving the child off the dangerous road, bring your attention back to the breath. Some days, you may find yourself pulling the wandering mind back after every breath. That’s practice …. not “bad” meditation because there is no “good” or “bad” meditation. A great start to understanding mindfulness is with you at all times --- your breath.

As a parent, you might find it helpful to do some practice and observe the positive effects with yourself before introducing some of the practices to your child. The introduction of mindfulness into the classroom has found positive results. Better classroom management and calmer children result when mindfulness has been utilized and teachers feel less stress as well. Programs such as the Mind-Up Program (www. thehawnfoundation.org/mindup) and Mindful Schools (www. mindfulschools.org) have established programs for teachers and schools.

An overview of some of the books, programs and apps available might be helpful as you seek out more information about mindfulness and how to help yourself and your family with dealing with the stress of everyday life and the particular stress of learning healthy coping strategies for chronic medical conditions.

Dr. Maureen Strafford, Associate Professor of Anesthesia and Pediatrics, Tufts University School of Medicine. The study of the effects of pediatric pain and the positive effects of mindfulness has been a career long concentration.

Suggested Resources: This is a small list of what is available as you investigate mindfulness. You will be amazed at the wealth of information available, and hopefully, these will be a good place to start. YouTube and the App Store provide many other tools that you may find helpful.

Getting Started

Peruse the website of the Center where the application of mindfulness in medicine and healthcare began. There is lots of information here.

Online Courses

http://www.umassmed.edu/cfm/

This is a great way to start if you cannot attend a live MBSR (Mindfulness-Based-Stress-Reduction) course. The online course is taught by one of the senior teachers at UMass.

For more general information on mindfulness, check out Anderson Cooper on 60 Minutes as he went on a 3-day, weekend retreat of mindfulness with Jon Kabat-Zinn.

UCLA has an incredible center for Mindfulness and online courses are available here as well with excellent and experienced teachers.

http://www.umassmed.edu/cfm/stress-reduction/mbsr-online/

http://www.cbsnews.com/news/the-newly-mindful-anderson-cooper/

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http://marc.ucla.edu/body.cfm?id=112

For Children & Teens Great resource for information about mindfulness in the schools. A very detailed curriculum that is in place in many schools to teach children about stress, mindfulness and coping skills.

Dr. Amy Salzman is a pediatrician who has developed programs for children. She has wonderful tapes and a book on mindfulness for children, especially young children. http://www.stillquietplace.com Gina Biegel is a therapist who has developed and researched a program on mindfulness for teens. At her website, you can access many of her tapes, her workbook for teens and a wonderful CD for “stressed teens.”

http://www.mindfulschools.org

http://www.stressedteens.com

A very detailed curriculum that is in place in many schools to teach children about stress, mindfulness and coping skills.

Susan Kaiser Greenland has published a book called The Mindful Child and it is written for parents and incorporates many helpful tools for teaching mindfulness to children.

http://thehawnfoundation.org/ mindup/

For Parents

Everyday Blessings: The Inner Work of Mindful Parenting For all parents who find the most important job of parenting sometimes stressful, Jon and Myla Kabat-Zinn have published a wonderful book on the topic of Mindful Parenting that is a delight to read and a great resource. It is now in a second edition.

http://www.susankaisergreenland.com

Pain

The following are helpful when one is interested in helping manage pain.

The Minfulness Solution to Pain Step-by-Step Techniques for Chronic Pain Management,

by Jackie Gardner-Nix http://www.amazon.com/Mindfulness-Solution-Pain-StepStep/dp/1572245816

http://www.amazon.com/EverydayBlessings-Inner-Mindful-Parenting/dp/0786883146 Full Catastrophe Living (Revised Edition): Using the Wisdom of Your Body and Mind to Face Stress, Pain, and Illness Another book which is a guideline to the format of an 8-week MBSR course is also in a revised edition and written by Jon Kabat-Zinn. http://www.amazon.com/FullCatastrophe-Living-Revised-Illness/ dp/0345536932/ref=sr_1_1?s=books&ie= UTF8&qid=1418857428&sr=1-1

Mindfulness Meditation for Pain Relief Guided Practices for Reclaiming Your Body and Your Life, by Jon Kabat-Zinn http://www.soundstrue.com/store/mindfulnessmeditation-for-pain-relief-535.html Mindful.org A great website to start for Mindfulness and Pain Management. Below is a direct link to the pain management portion of the site. http://www.mindful.org/Health%20and%20Healing/mindfulness-and-painmanagement—start-here

Apps

Devices to Try

Headspace is a great resource online as well as an app that is a very helpful introduction to mindfulness practice.

As described on their website, “Muse detects your brain signals during guided focused attention exercise. It provides valuable feedback that you use to train your brain today and over time.” For some, this interesting interaction between the visual of seeing on a screen how you are agitated or able to calm down is very helpful.

https://www.headspace.com

http://www.choosemuse.com

Apps for your iPhone, ipad or other tablet are numerous.

Some are tools for helping you in your practice --reminders, guided meditation recordings, suggestions for mindful breaks during a busy day.

Finally, if you are interested in a new tool that gives a “visual” about your mind quieting down, take a look at a new device called “Muse.”

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HAPPY

TH

BIRTHDAY ACA:

WHAT HAVE YOU DONE FOR ME LATELY??

by Janet Brewer, M. Ed.

B

y the time this arrives in your mailbox, The Affordable Care Act will be moving closer to its’ fifth birthday. President Obama signed the ACA into law on March 10, 2010. What a wild and crazy ride it has been since that time. Love it or hate it, it is here to stay, at least for now.

Predicting what the politicians may do in this current political climate is like raising teenagers. For purposes of this article, let’s just reflect on the positive changes that the ACA has had for all individuals with a pre-existing, chronic condition. This year, 2014 marked a crucial year in which many important provisions were phased in.

1. My Fair... Insurance?

It prohibited discrimination against pre-existing conditions or gender in the individual/small group market. This was significant because the law prohibited against discrimination for children when it was first implemented. Now, insurance companies can no longer discriminate against anyone based on pre-existing conditions. It also prohibits insurance companies from charging higher rates due to gender or health status.

2. Sky’s the Limit It eliminated annual limits on insurance coverage.

Lifetime caps on most benefits were considered prohibited in most health insurance policies issued/ renewed on or after September 23, 2010. ACA began phasing out annual dollar limits for plans issued after March 23, 2010. No annual dollar limits are allowed on most covered benefits beginning January 1, 2014.

3. Hold On Loosely

four.) The tax credit is advanceable, so it can lower your premium payments each month, rather than making you wait for tax time. It’s also refundable, so even moderate-income families can receive the full benefit of the credit. These individuals may also qualify for reduced cost-sharing (copayments, coinsurance, and deductibles). http://www.hhs.gov/ healthcare/ Not all states have opted to expand Medicaid coverage. Twenty-eight states have expanded it to include: Arkansas, Arizona, California, Colorado, Connecticut, Delaware, DC, Hawaii, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, West Virginia.

5. Just a Click Away One of the most exciting items to be phased in was the Health Insurance Marketplace. Finally there is a place for individuals to purchase insurance coverage without access to employer insurance. Individuals and small businesses will also have access to affordable (this is debatable) and qualified health benefit plans in competitive marketplaces. Starting in 2014, Congress now gets their health care coverage from the marketplace. Open enrollment began on 11/15/14 and continues through 2/15/15. So far, unlike last year, www.HealthCare.gov the website where you may begin your search for a health plan has not garnered attention for long wait times and crashing with alarming regularity. It is informative, easy to read and easily navigated.

6. Prevention is Key Although not implemented in 2014, the list of preventive services that in-network providers must offer is lengthy. Annual well visits must now be covered, as well as certain immunizations, and more. You may view these services broken down by preventive services for adults, women, and children at: https://www.healthcare.gov/preventive-carebenefits/children/ The Take-Away The law is not perfect, we all knew this going in (including the president), but it’s a start. The piece of mind that many of us now have knowing that lifetime caps have been eliminated, our children can stay on our insurance until they are 26 and that we can no longer be denied coverage because of a preexisting condition makes living with hemophilia and an inhibitor just a little less stressful!

Many of us are facing open-enrollment January 1, 2015 and the marketplace is open until 2/15/15 Your insurance benefits cannot be dropped if you at www.HealthCare.gov if you don’t have employerchoose to participate in a clinical trial for cancer or based insurance. Or maybe you might just want other life-threatening diseases. to shop around and see what is available on the healthcare.gov site, you may now anonymously 4. Extra Credit compare what insurance plans are available to Tax credits to make it easier for the middle class to you and what they will cost you. For an excellent afford insurance will become available for people with resource on how to compare plans, understand the income between 100% and 400% of the poverty line marketplace, or just insurance in general, we highly who are not eligible for other affordable coverage. (In recommend NHF’s Personal Health Insurance Toolkit 2010, 400% of the poverty line comes out to about downloadable at www.hemophilia.org/sites/default/ $43,000 for an individual or $88,000 for a family of files/document/files/Personal-Health-InsuranceToolkit.pdf. It is a very comprehensive guide to understanding your insurance options to Editor’s Note: We had the pleasure of having Michelle Rice (Vice President, Public Policy help you make the most informed decision & Stakeholder Relations of NHF) present this information at one of our FVII Retreats this possible.

June and it was fabulous! Thank you again Michelle! ~Janet~

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INSURANCE CORNER

KogenateÂŽ FS, antihemophilic factor (recombinant)

Adult prophylaxis with Kogenate FS. Your life. Your treatment.

Kogenate FS for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A1 SELECTED IMPORTANT SAFETY INFORMATION You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS. For additional important risk and use information, please see Important Safety Information and brief summary on the following pages.

Kogenate FS is available by prescription only. Please ask your healthcare provider if Kogenate FS is right for you.

Your treatment for preventing bleeds 15.2 x fewer bleeds in adults with prophylaxis (regular use) vs

on-demand using Kogenate® FS antihemophilic factor (recombinant)1 Kogenate FS: Proven protection to reduce bleeding events Median annual bleed rate (ABR)1,2 (P<0.0001)

On-demand (n=42)

Prophylaxis (n=42)

Bleeds per year

Bleeds per year*

Range: 0-104.1

Range: 0-19.8

*52% of people receiving prophylaxis experienced 0 bleeds per year.1 Median=The middle value of a set of numbers placed in numerical order.

Adults infusing with Kogenate FS regularly (n=42) experienced an average of 2 bleeds annually, compared with those infusing on-demand (n=42), who experienced 37 bleeds annually (P<0.0001)1,2 Adult prophylaxis study design: 84 previously treated males with severe hemophilia A, aged 15 to 50 years, received Kogenate FS either 3 times/week or on demand after a bleed. The primary endpoint was bleeding frequency. Bleeding frequency was analyzed after a median follow-up period of 1.4 years1,2

INDICATIONS Kogenate® FS antihemophilic factor (recombinant) is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A. Kogenate FS is used to prevent or control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Kogenate FS when you have surgery. Kogenate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). Kogenate FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly.

Kogenate FS is not used to treat von Willebrand disease.

IMPORTANT SAFETY INFORMATION You should not use Kogenate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Kogenate FS. Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

References: 1. Kogenate FS with Vial Adapter [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2014. 2. Manco-Johnson MJ, Kempton CL, Reding MT, et al.

Randomized, controlled, parallel-group trial of routine prophylaxis vs. on-demand treatment with sucrose-formulated recombinant factor VIII in adults with severe hemophilia A (SPINART) [published corrigendum appears in J Thromb Haemost. 2014;12(1):119-122]. J Thromb Haemost. 2013;11(6):1119-1127.

3. Data on file. Bayer HealthCare LLC; 2014.

Bayer, the Bayer Cross, and Kogenate are registered trademarks of Bayer. © 2014 Bayer HealthCare Pharmaceuticals Inc. All rights reserved. Printed in USA 11/14 2

PP-575-US-1270

Kogenate FS: Proven protection to reduce joint bleeds Median number of joint bleeds per person per year1,3 On-demand (n=42)

Prophylaxis (n=42)

Joint bleeds per year

Joint bleeds per year*

Range: 0-80.1

Range: 0-18.4

*62% of people receiving prophylaxis experienced 0 joint bleeds per year.3

Adults infusing with Kogenate FS regularly (n=42) experienced an average of 2 joint bleeds annually, compared with those infusing on-demand (n=42), who experienced 29 joint bleeds annually1,2

Prophylaxis reduced bleeds regardless of patient age, bleeding history, and absence or presence of target joints1

Please ask your healthcare provider if Kogenate FS is right for you.

IMPORTANT SAFETY INFORMATION (CONT’D) You could have an allergic reaction to Kogenate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, lightheaded, dizziness, nausea or a decrease in blood pressure.

Your body can also make antibodies, called “inhibitors,” against Kogenate FS, which may stop Kogenate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII. Other common side effects of Kogenate FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away.

Call your healthcare provider right away if bleeding is not controlled after using Kogenate FS. For additional important risk and use information, please see brief summary on the following page or visit http://www.kogenatefs.com/prescribing-information.jsp.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

3

Kogenate FS (kō-jen-ate) Antihemophilic Factor (Recombinant) Formulated with Sucrose Brief Summary of Patient Product Information This leaflet summarizes important information about Kogenate FS. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Kogenate FS. If you have any questions after reading this, ask your healthcare provider.

Do not attempt to self-infuse unless you have been taught how by your healthcare provider or hemophilia center.

What is Kogenate FS? Kogenate FS is a medicine used to replace clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A (also called “classic” hemophilia). Hemophilia A is an inherited bleeding disorder that prevents blood from clotting normally.

Kogenate FS is used to prevent or control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Kogenate FS when you have surgery. Kogenate FS can reduce the number of bleeding episodes when used regularly (prophylaxis). Kogenate FS can reduce the risk of joint damage in children.

Kogenate FS is not used to treat von Willebrand Disease.

Who should not use Kogenate FS? You should not use Kogenate FS if you • are allergic to rodents (like mice and hamsters).

• are allergic to any ingredients in Kogenate FS. Tell your healthcare provider if you are pregnant or breast-feeding because Kogenate FS may not be right for you.

What should I tell my healthcare provider before I use Kogenate FS? Tell your healthcare provider about all of your medical conditions.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines, such as over-thecounter medicines, supplements, or herbal remedies.

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

Tell your healthcare provider if you have been told that you have inhibitors to factor VIII (because Kogenate FS may not work for you).

What are the possible side effects of Kogenate FS? You could have an allergic reaction to Kogenate FS. Call your healthcare provider right away and stop treatment if you get • rash or hives • itching • tightness of the chest or throat • difficulty breathing • light-headed, dizziness • nausea • decrease in blood pressure Your body can also make antibodies, called “inhibitors,” against Kogenate FS, which may stop Kogenate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

Other common side effects of Kogenate FS are • Local injection site reactions (pain, swelling, irritation at infusion site) • Infections from implanted injection device Tell your healthcare provider about any side effect that bothers you or that does not go away.

Finding veins for injections may be difficult in young children. When frequent injections are required your child's healthcare provider may propose to have a device surgically placed under the skin to facilitate access to the bloodstream. These devices may result in infections.

These are not all the possible side effects with Kogenate FS. You can ask your healthcare provider for information that is written for healthcare professionals.

How do I store Kogenate FS? Do not freeze Kogenate FS. Store Kogenate FS at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Within this period, Kogenate FS may be stored for a period of up to 12 months at temperatures up to +25°C or 77°F. Record the starting date of room temperature storage clearly on the unopened product carton. Once stored at room temperature, do not return the product to the refrigerator. The product then expires after storage at room temperature, or after the expiration date on the product vial, whichever is earlier. Store vials in their original carton and protect them from extreme exposure to light.

Reconstituted product (after mixing dry products with wet diluent) must be used within 3 hours and cannot be stored.

Throw away any unused Kogenate FS after the expiration date.

Do not use reconstituted Kogenate FS if it is not clear to slightly cloudy and colorless.

What else should I know about Kogenate FS and hemophilia A? Medicines are sometimes prescribed for purposes other than those listed here.

Do not use Kogenate FS for a condition for which it is not prescribed. Do not share Kogenate FS with other people, even if they have the same symptoms that you have.

This leaflet summarizes the most important information about Kogenate FS. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Kogenate FS that was written for healthcare professionals.

Resources at Bayer available to the patient: For Adverse Reaction Reporting contact: Bayer Medical Communications 1-888-84-BAYER (1-888-842-2937) Contact Bayer to receive more product information: Kogenate FS Customer Service 1-888-606-3780 Bayer Reimbursement HELPline 1-800-288-8374 For more information, visit www.kogenatefs.com

Bayer HealthCare LLC Whippany, NJ 07981 USA U.S. License No. 8 (License Holder: Bayer Corporation) http://www.kogenatefs.com/ 6809902BS

Recognize Your Own Resilience: And Then Build On It

by Dr. Gary McClain, PhD

T

wo steps forward, one step back. Two steps forward…

If you are living with the challenges of a chronic condition – or if your family member is – then this phrase most likely has special meaning to you. The successes, the frustrations, and those unexpected curveballs that can come your way.

But, yet you keep yourself going, one step at a time. How do you do it?

Psychologists call that resilience. The ability to recover or adjust to misfortune or change. In other words, picking yourself up, dusting yourself off, and getting back on the path.

How’s your resilience these days?

My clients who are living with a chronic condition – and learning to roll with the ups and downs – often tell me that this experience has taught them to recognize their own resilience. They are able to tap into sources of strength, and to be resourceful, in ways they never thought possible. Yet, at the same time, one of those curveballs, or a series of curveballs, can leave you wondering if you’re all that resilient after all.

So you might ask: Are some people more resilient than others? In other words, is resilience a gift that some of are given while others aren’t so lucky? Actually, no. The good news is that resilience can be learned by following some basic guidelines for practicing resilience-building skills to develop a more resilient mindset. And practicing these skills can also help you to further strengthen your resilience. Kind of like toning up at the gym.

Here’s how to get started: 1. Take an inventory

2. Stay Hopeful

Use the past as a teacher. Think about the rough spots that you have hit over the years. What’s gone well for you? And not so well? Life’s tough lessons can leave us with a gift: experience. Review how you have dealt with challenges in the past. Use that learning to take an inventory of what’s in your resilience toolbox. This will help you to identify your strengths as well as to better understand what tools you want to add.

And then, decide to believe in yourself. Being a resilient person starts with believing in your own potential. Bolster your own selfesteem by giving yourself a daily pep talk, with messages like “I can do it” and “I’m ready to handle whatever comes my way.” Intention leads to action.

Decide to focus on what’s going right in your life.

Take the time to recognize the simple pleasures that exist all around you. Remind yourself of everything that is good in your life. Tell that bleak voice of negativity to be quiet, while you pay more attention to what’s possible.

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3. Stay connected to your support network

Who’s in your court? Make a list of the people in your life that you count on to stand by your side when you need a listening ear, and who count on you in return. Stay in touch with them on a regular basis, including regular check-ins with each other. Schedule time together.

Reach out when you’re feeling alone. Vent when you need to. Be supported and give support in return.

We are all in this together!

4. Laugh (or at least smile)

Having a sense of humor is a great antidote for stress. And let’s face it, sometimes you just gotta stand back, shake your head, and laugh. Better yet, find someone who can have a laugh along with you. Humor helps you to maintain your perspective and avoid getting caught up in the downward spiral of helplessness.

Humor and resilience go hand in hand.

5. Maintain your self-care

It (almost) goes without saying that, to be resilient, you need to feel your best. That means staying on top of your health by getting regular check-ups, staying in touch with your healthcare team between visits, being compliant with your treatment, and maintaining your self-care routine. By the way, this goes for children and parents! Just had to throw that in.

Concluded on pg. 26

FAMILY MATTERS

Indications for FEIBA [Anti-Inhibitor Coagulant Complex] FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: • Control and prevention of bleeding episodes • Use around the time of surgery • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

Detailed Important Risk Information for FEIBA [Anti-Inhibitor Coagulant Complex]

WARNING: EVENTS INVOLVING CLOTS THAT BLOCK BLOOD VESSELS • Blood clots that block blood vessels and their effects have been reported during postmarketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with a risk of forming blood clots.

• If you experience any of these side effects, call your doctor right away.

You should not use FEIBA if: • You had a previous severe allergic reaction to the product (reactions causing discomforts that are damaging and life threatening) • You have signs of development of small blood vessel clots throughout the body • You have sudden blood vessel clots or blocked blood vessels, (e.g., heart attack or stroke) Events involving blood clots blocking blood vessels can occur with FEIBA, particularly after receiving high doses and/or in patients with risk factors for clotting.

Please see next page for continued FEIBA Detailed Important Risk Information.

MORE TREATMENT OPTIONS

1 A clinical trial showed FEIBA prophylaxis reduced annual bleed FEWER BLEEDS 1 rates when compared with on-demand treatment.*

FEWER BLEEDS1

74

7.9 median ABR with prophylaxis treatment vs 28.7 median ABR with on-demand treatment

74 66

FEWER JOINT BLEEDS2 ABR for joint bleeds was reduced from 22.9 in the on-demand arm to 6.0 in the prophylaxis arm

DECREASE IN NEW FEWER 2 *The FEIBA PROOF clinical study was a multicenter, open-label, randomized prospective clinical2, ns trial of 36 hemophilia A TARGET JOINTS JOINT BLEEDS

and B patients with inhibitors receiving FEIBA for prophylaxis or on-demand treatment for 12 months. 17 patients were randomized to receive FEIBA prophylaxis, and 19 patients were randomized to receive FEIBA for acute bleeding episodes.2

66

Detailed Important Risk Information for DECREASE IN NEW Coagulant Complex] continued FEIBA [Anti-Inhibitor TARGET JOINTS2,ns

Infusion of FEIBA should not exceed a dose of 100 units per kg body weight every 6 hours and daily doses of 200 units per kg of body weight.

Maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute.

At first sign or symptom of a sudden blood vessel clot or blocked blood vessel (e.g., chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain), stop FEIBA administration promptly and seek emergency medical treatment.

Allergic-type hypersensitivity reactions, including severe, sometimes fatal allergic reactions that can involve the whole body, can occur following the infusion of FEIBA. If you experience any of these signs or symptoms, stop FEIBA administration immediately and seek emergency medical treatment.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most frequent side effects observed during the prophylaxis trial were anemia, diarrhea, bleeding into a joint, signs of hepatitis B surface antibodies, nausea, and vomiting.

The serious side effects seen with FEIBA are allergic reactions and clotting events involving blockage of blood vessels, which include stroke, blockage of the main blood vessel to the lung, and deep vein blood clots.

Call your doctor right away about any side effects that bother you during or after you stop taking FEIBA. Please see brief summary of FEIBA Prescribing Information on next page.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

1. FEIBA Prescribing Information. Westlake Village, CA: Baxter Healthcare Corporation; November 2013.

2. Antunes SV, Tangada S, Stasyshyn O, et al. Randomized comparison of prophylaxis and on-demand regimens with FEIBA NF in the treatment of haemophilia A and B with inhibitors. Haemophilia. 2013;20:65-72.

Baxter and Feiba are registered trademarks of Baxter International Inc. (c) Copyright 2014, Baxter Healthcare Corporation. All rights reserved. USBS/145/14-0043

FEIBA [Anti-Inhibitor Coagulant Complex] For Intravenous Use, Lyophilized Powder for Solution Brief Summary of Prescribing Information. Please see package insert for full Prescribing Information.

WARNING: THROMBOEMBOLIC EVENTS • Thromboembolic events have been reported during post-marketing surveillance following infusion of FEIBA, particularly following the administration of high doses and/or in patients with thrombotic risk factors.

• Monitor patients receiving FEIBA for signs and symptoms of thromboembolic events.

INDICATIONS AND USAGE FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: • Control and prevention of bleeding episodes • Perioperative management • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX. CONTRAINDICATIONS • Known anaphylactic or severe hypersensitivity reactions to FEIBA or any if its components, including factors of the kinin generating system.

• Disseminated intravascular coagulation (DIC).

• Acute thrombosis or embolism (including myocardial infarction).

WARNINGS AND PRECAUTIONS Thromboembolic Events Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur with FEIBA, particularly following the administration of high doses (above 200 units per kg per day) and/or in patients with thrombotic risk factors [see ADVERSE REACTIONS].

Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment with FEIBA should be weighed against the potential risk of these thromboembolic events.

Monitor patients receiving more than 100 units per kg of body weight of FEIBA for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue the infusion and initiate appropriate diagnostic and therapeutic measures.

Hypersensitivity Reactions Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur following the infusion of FEIBA. The symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. These reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of FEIBA and provide appropriate supportive care.

Transmission of Infectious Agents Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, and the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk has been minimized by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections and by inactivating and removing certain viruses during the manufacturing process [see DESCRIPTION in full Prescribing Information]. Despite these measures, the product may still potentially transmit human pathogenic agents.

There is also the possibility that unknown infectious agents may still be present.

All infections thought by a physician to have been possibly transmitted by this product should be reported by the physician or other healthcare providers to Baxter Healthcare Corporation, at 1-800-423-2862 (in the U.S.) and /or to FDA Med Watch (1-800-FDA-1088 or www.fda.gov/medwatch).

ADVERSE REACTIONS The most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

The serious adverse reactions seen with FEIBA are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

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.

The safety assessment of FEIBA is based on the review of the data from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes and a prospective trial that compared the use of FEIBA prophylactically versus on-demand treatment.

The adverse reactions reported from two prospective clinical trials in which FEIBA was used for the treatment of acute bleeding episodes were chills, chest pain, chest discomfort, dizziness, dysgeusia, dyspnea, hypoesthesia, increase of inhibitor titer (anamnestic response), nausea, pyrexia, and somnolence. Specifically, the first trial was a multicenter randomized, double-blind trial in 15 hemophilia A subjects with inhibitors to factors VIII. The second trial was a multicenter FEIBA study conducted in 44 hemophilia A subjects with inhibitors, 3 hemophilia B subjects with inhibitors and 2 acquired factor VIII inhibitor subjects. Of the 489 infusions used to treat acute bleeds during the second trial, 18 (3.7%) caused minor transient reactions of chills, fever, nausea, dizziness and dysgeusia. Out of 49 subjects, 10 (20%) had a rise in their inhibitor titers after treatment with FEIBA. Five of these subjects (50%) had increases that were, tenfold or more, and 3 (30%) of these subjects received factor VIII or IX concentrates within 2 weeks prior to treatment with FEIBA. These anamnestic rises were not associated with decreased efficacy of FEIBA. Table 2 lists the adverse reactions in >5% of subject reported in the randomized, prospective prophylaxis trial comparing FEIBA prophylaxis with on-demand treatment in 36 hemophilia A and B subjects with inhibitors to factors VIII or IX. The trial population included 33 (92%) subjects with hemophilia A and 3 (8.3%) subjects with hemophilia B. Four (11%) subjects were ≥7 to <12 years of age, 5 (14%) were ≥12 to <16 years of age, and 27 (75%) were ≥16 years of age. A total of 29 (80.6%) subjects were Caucasian, 3 (8.3%) Asian, 2 (5.6%) Black/African American, and 2 (5.6%) other. The subjects received a total of 4,513 infusions (3,131 for prophylaxis and 1,382 for on-demand). Adverse reactions were defined as adverse events that occurred (a) within 24 hours after being infused or (b) adverse events assessed related or possibly related or (c) adverse events for which the investigator’s or sponsor’s opinion of causality was missing or indeterminate.

Table 2 Prophylaxis Study Adverse Reactions (ARs) in >5% of Subjects MedDRA System Organ Class Blood And Lymphatic System Disorders Gastrointestinal Disorders Investigations Musculoskeletal And Connective Tissue Disorders

Preferred Term

Number Number of of ARs Subjects

Percent of Subjects (N=36)

Anemia

2

2

5.6

Diarrhea Nausea Vomiting Hepatitis B Surface Antibody Positive

2 2 2

2 2 2

5.6 5.6 5.6

4

4

11.1

Hemarthrosis

5

3

8.3

Post-Marketing Experience Because post-marketing reporting of adverse reactions is voluntarily 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.

BLOOD AND LYMPHATIC SYSTEM DISORDERS: disseminated intravascular coagulation CARDIAC DISORDERS: tachycardia, flushing RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: bronchospasm, wheezing GASTROINTESTINAL DISORDERS: abdominal discomfort SKIN AND SUBCUTANEOUS TISSUE DISORDERS: pruritus GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: malaise, feeling hot, injection site pain DRUG INTERACTIONS Concomitant Medications Consider the possibility of thrombotic events when systemic antifibrinolytics such as tranexamic acid and aminocaproic acid are used during treatment with FEIBA. No adequate and wellcontrolled studies of the combined or sequential use of FEIBA and recombinant factor VIIa or antifibrinolytics have been conducted. Use of antifibrinolytics within approximately 6 to 12 hours after the administration of FEIBA is not recommended.

Baxter and Feiba are trademarks of Baxter AG, Vienna, Austria. Baxter, Feiba and Baxject are trademarks of Baxter International Inc., registered in the U.S. Patent and Trademark Office.

Baxter Healthcare Corporation, Westlake Village, CA 91362 USA U.S. License No. 140 Issued Nov 2013 USBS/145/14-0043

Recognize Your Own Resilience:

6. Update your knowledge – continuously

Stay abreast of the newest thinking about what you can do to take the best possible care of yourself, and how your loved ones can take care of themselves. Medical science is constantly on the move, so keep up with what’s new in treating your condition. Be your own expert.

Knowledge is power!

And Then Build On It

(continued from pg. 22)

7. Keep your problem-solving muscles exercised

When you bump up against a new challenge, go off by yourself and do some brainstorming. Define the challenge.

Review your strengths, as well as the resources that you have to draw upon to solve it. Come up with a potential solution. By going through this process, you will have a clearer idea of what you can do, including what’s under your control, what you can’t control, and where you need help. This is resilience in action.

8. Accept that life is always changing

Humans are hard-wired to avoid change. But we know that life keeps moving, and that means that nothing stays the same forever. In other words, we aren’t in control of everything that occurs in our lives, even if we think we should be. Fighting change is like fighting against yourself, and your own potential for growth. So give up the battle and go with the flow. You’ll be surprised at how much more energy and optimism you’ll have.

9. Know who to ask for help, and then ask

Keep your resource list up to date. Part of being resilient is keeping track of the resources that you can draw upon when you need them. People who are willing and able to step in and lend you a hand or give you some guidance. Services and organizations that you can enlist. Information sources that you can tap into. Resilience doesn’t mean doing it alone, it means asking for help when you need it.

10. Have a vision for the future

Now, back to the hope thing. Take time to create a vision for the person that you want to be in life – how you want to live, what you want to accomplish, what you can do to be there for the people that you care about. Having a vision for our future motivates you to be more resilient.

While you’re at it, create a vision for your family. Think: Optimistic. Realistic.

Flexible.

11. And when the going gets tough… Remember that the tough go shopping

Shrink shopping, that is. If you need some additional help in strengthening those resilience muscles, then talking with a mental health professional can give you some additional perspective and help you develop new resilience skills as you face life’s challenges.

Two steps forward, one step back. But two steps forward again. Look how far you’ve come in the face of a lot of challenges. Celebrate your own resilience! And challenge yourself to build even more resilience into your life!

Gary McClain, PhD, LMHC, is a therapist, patient advocate, and author, specializing in helping clients deal with the emotional impact of chronic and life-threatening illnesses, as well as their families and professional caregivers. He works with them to understand and cope with their emotions, to learn about their lifestyle and treatment options, to maintain compliance with medical regimens, to communicate effectively with the medical establishment, and to listen to their own inner voice as they make decisions about the future. His email is: gary@JustGotDiagnosed.com. He welcomes your questions and comments.

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FAMILY MATTERS

THE PATIENT NOTIFICATION SYSTEM H AV E Y OU E N ROLLE D??

notifies PNS registrants. Every effort is made for this contact to occur within 24 hours. As a form of checks and balances, each registrant receives a letter via first class mail to ensure that notification has occurred.

The Committee of Ten Thousand, Hemophilia Federation of America, National Hemophilia Foundation, Alpha-1 Foundation and the Immune Deficiency Foundation, founded the Patient Notification System in 1998.

Each of these organizations are key stake holders in the plasma-derived and recombinant analog industry. The system is operated by Stericycle, Inc, an independent organization that specializes in pharmaceutical notifications. Itsâ&#x20AC;&#x2122; purpose is to notify users of plasma or recombinant products whether or not a product has been recalled.

Governed by an advisory panel made up of patient groups, the FDA and industry representatives, the PNS is administered by the Plasma Protein Therapeutics Association. All the major plasma-derived and recombinant product manufacturers fund the PNS.

Enrollment in the Patient Notification System (PNS) is completely free and confidential. As a registrant, you will provide your general contact information, including your preferred method of contact; email, telephone or fax. Email is encouraged, as it is the quickest form of communication. If a product therapy is withdrawn or recalled, the manufacturer contacts Stericycle, Inc, which then

Registration is quick and easy. Log on to www.PatientNotificationSystem.org or call 1-888-UPDATE-U (1-888-873-2838). As always, it is important to maintain accurate infusion logs and record the lot number, product name and manufacturer to maximize effectiveness of the system.

Resources: www.PatientNotificationSystem.org

Editorâ&#x20AC;&#x2122;s Note: I was recently a speaker at two different events this fall and asked each audience how many of them knew about the PNS. I was shocked that less than 1% of the individuals in both groups (different parts of the country) knew about it. Both groups were comprised of patient/ consumer parents, individuals and product manufacturers. That being said, I will be certain my sons register under their own names (not mine) now that they are both over 18. One more step on that road to independence! ~Janet~

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Food & Drug Administration Asks for Input from Bleeding Disorders Community On September 22, 2014, the Food and Drug Administration (FDA) as part of the renewal of the Prescription Drug User Fee Act began holding a series of Patient Focused Drug Development meetings starting with the bleeding disorders community. Their purpose was for individuals affected by Hemophilia A, Hemophilia B, vonWillebrand Disease and other heritable bleeding disorders to share their perspective on how a bleeding disorder impacts their life on a daily basis. They were also seeking patients’ perspectives on available therapies for these disorders. It was a very rare opportunity to speak directly to individuals that make decisions about OUR healthcare.

Selected panelists needed to submit answers to specific topics by August 22, 2014 in order to be chosen. We as a community were lucky to be represented by Amanda Heisey, Debbie Porter and Sonji Wilkes-all very experienced moms with children with an inhibitor. You

may read Debbie’s moving testimony at http://www.hemophiliafed.org/newsstories/2014/09/an-inhibitor-mom-sharesher-story-with-the-fda/.

With a panel of 10 participants to include parents, individuals and stakeholders affected by a bleeding disorder, there was a LOT to discuss, especially in regards to inhibitors.

Although as of this publication date, it is too late to add your thoughts and concerns about the topics below, comments may be seen in the Division of Dockets Management between 9:00 am and 4:00 pm, Monday through Friday, and will be posted to the docket at http://www. regulations.gov.

In addition, transcripts will be posted as soon as they are available at http://www.fda. gov/BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ucm401761. htm

Below are the pre-screening topics that panelists responded to for selection

Topic 1 included: The effects of your bleeding disorder that matter most to you •

•

Of all of the symptoms that you experience because of your condition, which one to three symptoms (bleeding or non-bleeding) have the most significant impact on your life?

(Examples may include joint damage/pain, infections, prolonged and heavy bleeding with menstruation, fatigue, etc.).

Are there specific activities that are important to you, but that you cannot do at all, or as well as you would like, because of your condition?

Please describe, using specific examples (Examples may include participating in physical activities, attending work/school, and family/ social activities, etc.).

•

How have your condition and its’ symptoms changed over time?

•

What worries you most about your condition?

and at http://www.regulations.gov at the Division of Dockets Management.

Hardcopies or CD-ROMs will also be available after submission of a Freedom of Information request. Written requests are to be sent to: Division of Freedom of Information (ELEM1029) Food and Drug Administration 12420 Parklawn Dr., Element Bldg.

Rockville, MD 20857 Resources: http://www.regulations.gov/ Federal Register/Vol. 79, No. 131/Wednesday, July 9, 2014/Notices 38909

Topic 2 included: Perspectives on current approaches to treatment •

What are you currently doing to treat your condition or its’ symptoms? (Examples may include blood transfusions, replacement therapies, over-the-counter products, and/or other therapies).

•

How well do these treatments work for you?

•

What are the most significant disadvantages or complications of your current treatment, and how do they affect your daily life?

•

How has your treatment changed over time and why?

•

What aspects of your condition are not improved by your current treatment regimen?

•

What treatment has had the most positive impact on your life?

•

If you could create your ideal treatment, what would it do for you (Examples, what specific things would you look for in an ideal treatment)?

•

If you had the opportunity to consider participating in a clinical trial studying experimental treatments, what things would you consider when deciding whether or not to participate?

BLOODLINES

I

t’s like an old, outplayed, re-run in your life. Or if you’re like me, and you’re blessed with little ones in the house, you might describe it as “just another day of watching Disney’s Frozen”. The familiar scene goes something like this…

You and your significant other have plans with his or her friends (who you’ve never met before) to enjoy a night on the town. Things go smoothly, just as your expectations perceive, but then comes your tell - your inability to keep your condition secret. Perhaps you’re carpooling and you have to request a front seat because your legs need the extra room, or maybe you have a limp that won’t go away no matter how hard you over-compensate. Whatever it is, it’s there, and it just “outed” you. By the way, I don’t try to hide the fact that I have hemophilia, but I probably do avoid it a bit unless the opportunity (or perhaps “obligation”) presents itself. Besides, the very opposite approach of just blurting it out would just be weird. It would be like saying, “Hi, I’m Olaf, and I like warm hugs!”

Hemophilia is Tube-u-lar!

So there lays the kicker that instigates the proverbial little question from one of your new acquaintances, “what is hemophilia?” Sometimes I take pleasure in explaining it all, and in a way, talking about myself.

But if I’m not in the mood, it just gets old. Although, there does seem to be a decline in this familiar question. Is hemophilia becoming more mainstream? Could there be a day when hemophilia is as wellknown as cancer? And if so, will the boob-tube be partially responsible? I’ll let you decide for yourself, but here’s some of the evidence that I’ve gathered for your consideration.

by Eric Lowe

Royal Pains – Pilot Season 1, Episode 1 Aired June 4, 2009 Tucker Bryant (played by Ezra Miller, who has starred in popular shows such as Californication and Law & Order: SVU, and in films like The Perks of Being a Wallflower (w/ Emma Watson), and recently announced

by Warner Bros. to play The Flash in 2018) is a teenage heir to the blender industry, who is left home alone in the Hamptons. After an accident in his father’s Ferrari, he suffers delayed injuries.

Dr. Hank Lawson is about to leave the Bryant mansion when Tucker collapses to the floor from chest pains. Hank begins to investigate Tucker…

Hank Why didn’t you tell me you were a hemophiliac?

Tucker Dude, my chest is killing me!

Hank Where’s your factor 8 supply?

Tucker Bottom drawer, next to my aquarium.

Hank Okay, Libby, go. Just try to stay calm. Stay with me, Pal. Stay with me! Tucker, stay with me!

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Some viewers criticized this portion of the script by asking, “what person with a medical condition like this hides it?” Well… individuals with hemophilia, to name one.

As we mature into adulthood, most of us develop the realization that it’s no longer an embarrassment to reveal this personal statistic about ourselves. But in the awkward years of adolescence and teens, no one wants to be reminded that they are different, reliant on others, or fragile and weak. So while some might say the dialogue was a bit artificial, I would say, “on the contrary!”

Once Hank patches up Tucker, MacGyver-style, he sees him off in a chopper to a lifesaving end. Out of concern, Libby (Tucker’s girlfriend) asks Hank if Tucker is in pain. Hank’s reply, “Hemophiliacs live in pain. He’ll be okay.” Hmm, once again, sounds like the writer knows what he’s talking about. But perhaps that’s because he consulted his father, an oral surgeon who has experience with bleeding disorders, for the creation of Tucker. Additionally, Royal Pains has an onsite physician who is responsible for all of the medical research of the show.

Kudos for accuracy and for helping to make hemophilia a mainstream condition, as Tucker has returned in a handful of episodes!

A Special Remembrance in Our Family This year, on July 31st, Janet and her family suffered a devastating loss. Janet’s oldest, Chris, held his wife in his arms as he said goodbye to his best friend.

Sarah (Phenix) Brewer spent most of her time helping others. She was a tutor, camp director, OT, loving wife and an inspiration to all.

Noah Evans, (pictured left) a repeat camper of ours, was one of many who were touched by Sarah’s beauty, and affected by her loss. He’s also a very gifted young man. This painting was crafted by Noah in remembrance of Sarah.

Donations in Sarah’s honor may be made to the Sarah Phenix Memorial Fund at Rockland Trust (www.rocklandtrust.com) to support Dream Day on Cape Cod; a camp for children with rare and life threatening disorders where she was the Program Director.

Simpsons – Brother from the Same Planet Season 4, Episode 14 Aired Feb. 4, 1993 Bart is neglected by Homer and pursues a better father figure by joining the Big Brother program. Upon this discovery, Homer directs his revenge by donating his time as a big brother to an orphan. Out of jealousy, Homer finds himself in a fistfight with Tom, Bart’s new Big Brother. At the conclusion of the episode, Homer gets his boy back, and they reminisce about the recent fight with Tom.

Scene: Inside the Simpson’s residence Bart: Remember when Tom had you in that headlock and you screamed, “I’m a hemophiliac!” and when he let you go, you kicked him in the back?

Homer: Yeah.

Bart: Will you teach me how to do that?

Homer: Sure, boy. First, you gotta shriek like a woman and keep sobbing until he turns away in disgust. That’s when it’s time to kick some back. And then when he’s lying down on the ground...

Bart: Yeah.

Homer: Kick him in the ribs.

Bart: Yeah.

Homer: Step on his neck.

An old friend of mine once told me of a reference of hemophilia in a Simpson’s episode where Bart mentioned he beat up a hemophiliac at school. Whether this distasteful airing actually took place or not, I can’t confirm.

But with much relief, I was unable to locate such a reference in my findings.

Some may find this reference in Brother from the Same Planet mildly offensive, but I find it to be more in the neutral area of the spectrum. In 1993, The Simpson’s was a monstrously popular series. This episode received a rating of 14.9 on the Nielsen rating system, which translates to approximately 13.9 million viewing households. For that, I say, “thank you for getting our name out there.”

Fun fact: The role of Tom was originally created for Tom Cruise, but he repeatedly refused it. Phil Hartman eventually played the character.

FUN & INSPIRATION

True Blood – Hopeless Season 5, Episode 6 Aired July 15, 2012 Within the community of vamps, Russell Edgington (the corrupt, former King of Mississippi) is captured by Bill and Eric and is put in a cell at the Authority (the vampires’ own government.) Roman (Christopher Meloni, best known for his role as Detective Elliot Stabler in Law & Order: SVU) welcomes them with open arms for a job well done. Roman decides that he’s going to execute Russell immediately, calling for a toast.

You have to wonder what the writers’ thought processes were on this one. It may have gone something like this, “A time for celebration calls for a great drink! ...but vampires don’t drink rare wines. Let’s Google ‘Rare Blood’ instead!” However it happened, thanks for the shout out, HBO! It just reminds us that we’re a rare blood, I mean breed.

The next time you decide to take a stroll through the desolate roads of Bon Temps, Louisiana at night, wrap your neck in a silver chain and put a stake in your pocket, because you never know who might be salivating over your yummy blood.

Parents: beware that this series is anything but easy on the ears and eyes. Please use extreme caution if you plan to view this show with your children.

Roman My boys, my boys! Where are my boys?! From here on out, (Eric & Bill) officially known as the guys who took down Russell Edgington. How’s that sound? Well done, well done.

Rosalyn Roman, that looks like a very special bottle of blood.

Roman Why yes, it is, Rosalyn. Eighteenth-century, Austrian hemophiliac, not that I know too much about these fancy, antique bloods. All I know is that it cost a (censored) load of money. Sit. Sit.

Family Guy Stu and Stewie’s Excellent Adventure Season 4, Episode 30 (Part 3 of Stewie Griffin: The Untold Story) Aired May 21, 2006 Most viewers who have witnessed The Family Guy series hold a strong opinion of it - whether on one side of the spectrum, or the other. Whatever our stance is, I hope we can all appreciate the tithes between this edgy, animated sitcom and our community. Alex Borstein, voice of Lois Griffin on the series, is a carrier who has a daughter.

Alex’s daughter is also a carrier, and she grew up with her hemophiliac brother, who is coincidentally named Evan.

The intention of introducing a “hemophiliac baby” into this episode was not a poke at the medical condition itself. The idea was to place an overwhelming amount of delicate objects in harm’s way. And in this case, harm’s way can be defined as Peter whirling through the air from a catapult launch.

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As Peter is launched into the air from a catapult, and flying over nearby homes, we cut to the interior room of a neighbor’s house with his baby.

Neighbor Excellent! These dominos are set up exactly as I want them – right next to the good china. Now I’ll just place this priceless Faberge’ egg right in the center, right next to my newborn, hemophiliac baby.

Peter flies towards the neighbor’s home and falls just short of coming through the window. He stands up and piers in the window.

Peter Hey, those yours?

Neighbor Yeah.

Peter Oh! Hey those are all really nice things.

Neighbor Thank you. You hear that Evan? We were complimented.

Marcus Welby, MD – The Daredevil Gesture Season 1, Episode 25 Aired Mar 17, 1970 Larry Bellows was home-schooled until age 12 out of concern by his protective mother. His peers were aware of his condition up until age 17 when he moved to a new school. Now Larry is dead-set on keeping his condition a secret so that he can experience the adventures that life has to offer, as well as the treatment that all hemophiliacs desire, indifference.

Scene: New school’s office

Dr. Welby

and your Nobody, except Mr. Craddock here, the school nurse, ilia. hemoph the about ng anythi know homeroom teacher will tely absolu know will class your in girls The boys and nothing.

Principle Craddock explain to But it’s up to you to explain to them, or not to ties. activi n certai from d excuse be them why you’ll Larry

I can, I can handle that.

Principle Craddock

promise Okay Larry, now in return, let us hear your solemn No hage. hemorr a on bring to happen will g that nothin or out violent games, no horsing around… either in school of it.

Larry You have my word, sir.

Principle Craddock

Doctor, I’ll give your number to the school nurse.

Dr. Welby I’ll send Tell her she can always reach me, or Dr. Kiley. d. on-han kept be to over the frozen plasma

I’m inclined to call this one the “diamond in the rough”, as I came across it entirely by chance. As somewhat of a film connoisseur, I rented one of Steven Spielberg’s earliest films, The Duel, which I recommend. The DVD extras outlined Spielberg’s earliest work, Marcus Welby, M.D.

being one of them. Ironically, the short clip that was chosen for the extras came from this episode that mentioned “hemophilia”. The script sample is the very same clip I speak of.

You can imagine the unexpected perk of my ears with this discovery.

Not all, but the majority of concerns that are addressed in this episode are freakishly accurate. Dr. Welby (Robert Young) and his partner, Dr. Kiley (James Brolin), have

So there you have it. Five examples that may be making our lives a little easier by helping others understand hemophilia (or at least familiarizing the general public with the name.) Perhaps one day, when we tell someone we have hemophilia, the response might be “oh, I know a little something about that”, or “I see - what deficiency are you?” instead of “what’s that?” I hope you’ve enjoyed my reviews, and are interested to know that we’re gaining popularity in TV.

a serious discussion about the background and outlook of hemophilia. They’re sure to highlight newly developing drugs (remember, this is 1970), like cryoprecipitate and other coagulants, as well as their ability to help hemophiliacs become independent with home injections in the near future. The financial benefits of home injections, other self-care methods, and all-around avoidance of hospital admissions were also pointed out. Dr. Welby describes Larry’s mother as “the classic picture of a carrier” with references of being overprotective, and having feelings of guilt for passing hemophilia onto her son with little to no symptoms of her own.

The episode doesn’t stop there. As Larry experiences an elbow bleed, he and his mother have discussions of spontaneous bleeding, and seasonal bleeding patterns with Dr. Welby.

Welby suggests feelings of excitement and stress can predict onset of these types of bleeds.

Other issues addressed include untimely bleeds that spoil trips and other big plans, divorced parents, and the fear that Larry’s sister has of passing this condition down to children of her own.

As someone who didn’t live through the 70’s, I can only imagine the uplifting inspiration of hope that was passed onto the viewers that were living with hemophilia and who witnessed this episode when it first aired.

In today’s viewing world, this series would be portrayed as hokey and unrealistic, by most.

But keeping in mind the time and culture of the series, I think almost everyone in this community would enjoy and appreciate The Daredevil Gesture. This episode alone can be streamed on Amazon for just two dollars.

This, by no means, is a complete list of televised hemophilia. If you’ve found other references to hemophilia in the television world, please share by writing to me at: elowe@compheathed.com

FUN & INSPIRATION

A treatment for hemophilia B PROTECTION * FROM BLEEDS

Starting with at least a week between prophylaxis infusions Dosing regimen can be adjusted based on individual response. *Protection is the prevention of bleeding episodes using a prophylaxis regimen.

To learn more, contact CoRe Manager Nikita Lyons-Murry at nikita.lyonsmurry@biogenidec.com or call 615-525-1003.

INDICATIONS AND IMPORTANT SAFETY INFORMATION Indications ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein, is a recombinant DNA derived, coagulation factor IX concentrate indicated in adults and children with hemophilia B for: • Control and prevention of bleeding episodes • Perioperative management • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.

Important safety information Do not use ALPROLIX if you are allergic to ALPROLIX or any of the other ingredients in ALPROLIX. Tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have any allergies and all your medical conditions, including if you are pregnant or planning to become pregnant, are breastfeeding, or have been told you have inhibitors (antibodies) to factor IX. Allergic reactions may occur with ALPROLIX. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives.

Your body can also make antibodies called “inhibitors” against ALPROLIX, which may stop ALPROLIX from working properly.

ALPROLIX may increase the risk of formation of abnormal blood clots in your body, especially if you have risk factors for developing clots.

Common side effects of ALPROLIX include headache and abnormal sensation of the mouth. ese are not all the possible side effects of ALPROLIX. Talk to your healthcare provider right away about any side effect that bothers you or does not go away, and if bleeding is not controlled using ALPROLIX. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Brief Summary of full Prescribing Information on the next page for additional safety information. is information is not intended to replace discussions with your healthcare provider.

©2014 Biogen Idec. All rights reserved.

FIX-1007929 09/2014

ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], Lyophilized Powder for Solution For Intravenous Injection.

What are the possible side effects of ALPROLIX™?

FDA Approved Patient Information

Allergic reactions may occur. Call your healthcare provider or get emergency treatment right away if you have any of the following symptoms: hives, chest tightness, wheezing, difficulty breathing, or swelling of the face.

ALPROLIX™ /all’ pro liks/ [Coagulation Factor IX (Recombinant), Fc Fusion Protein]

Please read this Patient Information carefully before using ALPROLIX™ and each time you get a refill, as there may be new information. This Patient Information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is ALPROLIX™?

ALPROLIX™ is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia B. Hemophilia B is also called congenital Factor IX deficiency.

Your healthcare provider may give you ALPROLIX™ when you have surgery.

Who should not use ALPROLIX™?

You should not use ALPROLIX™ if you are allergic to ALPROLIX™ or any of the other ingredients in ALPROLIX™. Tell your healthcare provider if you have had an allergic reaction to any Factor IX product prior to using ALPROLIX™.

What should I tell my healthcare provider before using ALPROLIX™?

Tell your healthcare provider about all of the medicines you take, including all prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal medicines.

Tell your doctor about all of your medical conditions, including if you: • • •

are pregnant or planning to become pregnant. It is not known if ALPROLIX™ may harm your unborn baby. are breastfeeding. It is not known if ALPROLIX™ passes into breast milk or if it can harm your baby. have been told that you have inhibitors to Factor IX (because ALPROLIX™ may not work for you).

How should I use ALPROLIX™?

ALPROLIX™ should be administered as ordered by your healthcare provider. You should be trained on how to do infusions by your healthcare provider. Many people with hemophilia B learn to infuse their ALPROLIX™ by themselves or with the help of a family member.

See the Instructions for Use for directions on infusing ALPROLIX ™. The steps in the Instructions for Use are general guidelines for using ALPROLIX™. Always follow any specific instructions from your healthcare provider. If you are unsure of the procedure, please ask your healthcare provider.

Do not use ALPROLIX™ as a continuous intravenous infusion.

Contact your healthcare provider immediately if bleeding is not controlled after using ALPROLIX™.

Common side effects of ALPROLIX™ include headache and abnormal sensation in the mouth.

ALPROLIX™ may increase the risk of forming abnormal blood clots in your body, especially if you have risk factors for developing blood clots.

Your body can also make antibodies called, “inhibitors,” against ALPROLIX™, which may stop ALPROLIX™ from working properly.

Your healthcare provider may need to test your blood for inhibitors from time to time.

These are not all the possible side effects of ALPROLIX™.Talk to your healthcare provider about any side effect that bothers you or that does not go away.

How should I store ALPROLIX™?

Store ALPROLIX™ vials at 2°C to 8°C (36°F to 46°F). Do not freeze.

ALPROLIX™ vials may also be stored at room temperature up to 30°C (86°F) for a single 6 month period.

If you choose to store ALPROLIX™ at room temperature: • • •

Note on the carton the date on which the product was removed from refrigeration.

Use the product before the end of this 6 month period or discard it. not return the product to the refrigerator.

Do not use product or diluent after the expiration date printed on the carton, vial or syringe.

After Reconstitution: •

•

Use the reconstituted product as soon as possible; however, you may store the reconstituted product at room temperature up to 30°C (86°F) for up to 3 hours.

Protect the reconstituted product from direct sunlight.

Discard any product not used within 3 hours after reconstitution.

Do not use ALPROLIX™ if the reconstituted solutionis cloudy, contains particles or is not colorless.

What else should I know about ALPROLIX™?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use ALPROLIX™ for a condition for which it was not prescribed. Do not share ALPROLIX™ with other people, even if they have the same symptoms that you have.

Manufactured by Biogen Idec Inc. 14 Cambridge Center Cambridge, MA 02142 U.S. License #1697

89 E. Washington Street Hanson, MA 02341-1125

CHES Mission To Inspire awareness and selfreliance for patients with chronic health conditions, their families, and their communities.

Editors in Chief Janet Brewer, M. Ed. Eric Lowe

Publication Designer Eric Lowe

Contributing Writers: Janet Brewer, M. Ed. Eric Lowe Wayne & Jackie Camarro Ashley Druckenmiller Dr. Maureen Strafford Dr. Gary McClain, PhD

Contributing Editors: Stephen Brewer

Contributing Content and Production: Joan Ward

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