Preserving Immunoglobulin Integrity
Octagam ® 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults. Octagam ® 10% is also indicated for the treatment of dermatomyositis (DM) in adults.
WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
Please see accompanying Full Prescribing Information for complete boxed warnings and additional important information.
Thrombosis may occur with immune globulin intravenous (IGIV) products, including octagam® 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or renal failure, administer octagam® 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Please see page 7 for additional Important Safety Information. Please see accompanying full Prescribing Information.
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Octapharma Has Pioneered A Number of Safety Innovations That Have Set the Standard For the Protein Products Industry
Octagam® 10% Manufacturing and Purification Process1-3
Formulated to Help Mitigate Tolerability Issues in Adults With Chronic ITP1,2,4
• pH of 4.5 – 5.0 to stabilize IgG molecules and avoid IgG aggregation
• Free of sucrose, fructose, and preservatives
• Low sodium (≤30 mmol/L)
• Trace amounts of IgA (on average 106 µg/mL)
Separate coagulation factors
Centrifugation 1 Remove additional thrombogenic factors
Gather IgG antibodies & remove impurities
(ie, plasma proteins, hemagglutinins [anti-A/B])
Cold-ethanol fractionation, precipitate II only
Inactivate enveloped viruses
Heparin-sepharose chromatography
Adjust IgG concentration Ultrafiltration/diafiltration (UF/DF)
Solvent/detergent (S/D) treatment 5 Remove S/D chemicals Cation exchange chromatography
Inactivate both enveloped and nonenveloped viruses
Incubation at low pH
Contraindications
7 Prevent aggregation, stabilize, and sterilize product UF/DF, maltose, bulk filtration
Octagam® 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam® 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity. Dosing and Administration
Patients with dermatomyositis are at increased risk for thromboembolic events; monitor carefully and do not exceed an infusion rate of 0.04 mL/kg/min.
Biochemical Profile That Resembles Native IgG1
• All 4 IgG subclasses are fully represented
• Physiologic Fc portion of IgG is maintained intact
Validated Viral Removal and Inactivation1,5,6
The manufacturing process has been validated for its capacity to remove and inactivate both enveloped and nonenveloped viruses.
Global Reduction Factor [log 10 ]
Warnings and Precautions
IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions to octagam® 10%. Epinephrine should be available immediately to treat any severe acute hypersensitivity reactions.
Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.
Falsely elevated blood glucose readings may occur during and after the infusion of octagam® 10% with testing by some glucometers and test strip systems.
Hyperproteinemia, increased serum osmolarity and hyponatremia may occur in patients receiving octagam® 10%.
= human immunodeficiency virus-1; PRV = pseudorabies virus; SBV = sindbis virus; MEV = mouse encephalomyelitis virus; PPV = porcine parvovirus.
Octagam® 10% Liquid Delivered Rapid and Sustained Results With A Proven
Clinical Response Within 7 Days After Initial Infusion (Mean, 1.8 Days)1-3*
A Sustained Clinical Response1,2,4
Endpoint (50 x 109/L)
The figure depicts the mean platelet count and the number of patients with bleeds reported during the first 7 days post initial treatment with octagam® 10% (n=66).
• 82% of patients (54 of 66) reached the clinical endpoint
– Mean time to reach clinical endpoint was 1.8 days after initial infusion
• 78% of patients (35 of 45) with bleeding at baseline reported no bleeding on day 7
– A decrease in severity of bleeding by day 7 was seen in 84% of patients (38 of 45)
A Rapid Infusion Rate Without Compromising Tolerability1,4
• 92% of the initial study phase patients (24 of 26) were titrated to initial maximum infusion rate of 6 mg/kg/min (360 mg/kg/hour)
• 60% of the subsequent patients (54 of 90) were titrated to the amended maximum infusion rate of 12 mg/kg/min (720 mg/kg/hour)
* In an open-label, phase 3 clinical trial, 66 adult patients (ages 17- 88) with chronic ITP were treated with octagam® 10% liquid 1 g/kg/day on 2 consecutive days. Infusion rate was adjusted according to tolerability up to a maximum of 12 mg/kg/min (720 mg/kg/hour) and then evaluated during a 21-day study period and at a 63-day follow-up visit.
Warnings and Precautions (continued)
Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to octagam® 10% treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.
The figure depicts the duration of response in patients that reached the clinical endpoint (50 x 109/L) within the first 7 days (54 of 66).
• Mean duration of the clinical response was 20.9 days
• At day 63, mean platelet count in 54 responders was 88 x109/L
Established Tolerability Profile1,2,4
• Premedication to alleviate potential infusion reactions was only used in one patient (0.9%)
• All drug-related adverse events (AEs) were mild or moderate in intensity and they all resolved
• One serious drug-related AE of a moderate headache (0.9% of subjects) was reported
• No cases of drug-related hemolysis, anaphylactic, or anaphylactoid reactions were reported
Warnings and Precautions (continued)
Aseptic meningitis syndrome may occur in patients receiving octagam® 10%, especially with high doses or rapid infusion.
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). Octagam® 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
Convenient, Ready-to-Use Liquid Formulation
• Does not need to be reconstituted
• Tamper-evident packaging
• Latex free
• 36-month shelf-life when kept refrigerated (+2°C to + 8°C [36°F to 46°F]) from date of manufacture1
– Within this shelf-life, the product may be stored up to 9 months at room temperature (≤+25°C [77°F])
– After storage at ≤+25°C (77°F) the product must be used or discarded
– Do not use after expiration date
– Do not freeze. Do not use frozen product
• Choice of filling sizes to meet individual needs
Available In 5 Vial Sizes to Meet Individual Needs
NDC # 68982-850-0168982-850-0268982-850-0368982-850-0468982-850-05
WARNING: THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
Please see accompanying Full Prescribing Information for complete boxed warnings and additional important information.
Thrombosis may occur with immune globulin intravenous (IGIV) products, including octagam® 10%. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 10% does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or renal failure, administer octagam® 10% at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
Important Safety Information
Contraindications
Octagam® 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam® 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
Dosing and Administration
Patients with dermatomyositis are at increased risk for thromboembolic events; monitor carefully and do not exceed an infusion rate of 0.04 mL/kg/min.
Warnings and Precautions
IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions to octagam® 10%. Epinephrine should be available immediately to treat any severe acute hypersensitivity reactions.
Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure.
Falsely elevated blood glucose readings may occur during and after the infusion of octagam® 10% with testing by some glucometers and test strip systems.
Hyperproteinemia, increased serum osmolarity and hyponatremia may occur in patients receiving octagam® 10%.
Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to octagam® 10% treatments. Risk factors for hemolysis include high doses and non-O-blood group. Closely monitor patients for hemolysis and hemolytic anemia.
Aseptic meningitis syndrome may occur in patients receiving octagam® 10%, especially with high doses or rapid infusion.
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
Octagam® 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
Adverse Reactions (observed in >5% of clinical study subjects)
Chronic Immune Thrombocytopenic Purpura: headache, fever, increased heart rate. Dermatomyositis: headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, infusions site reactions.
References: 1. Octagam® 10% Full Prescribing Information. Paramus, NJ: Octapharma USA Inc; rev March 2022. 2. Octapharma, Data on File. 2014. 3. Buchacher A, Kaar W. Intravenous immunoglobin G from human plasma—purification concepts and important quality criteria. In: Bertolini J, Goss N, Curling J, eds. Production of Plasma Proteins for Therapeutic Use. Paramus, NJ: John Wiley & Sons, Inc; 2013. 4. Robak T, Mainau C, Pyringer B, et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam® 10%) in patients with immune thrombocytopenia. Hematology. 2010;15(5):351-359. 5. Dichtelmüller HO, Biesert L, Fabbrizzi F, et al. Contribution to safety of immunoglobulin and albumin from virus partitioning and inactivation by cold ethanol fractionation: a data collection of Plasma Protein Therapeutics Association member companies. Transfusion. 2011;51(7):1412-1430. 6. Dichtelmüller HO, Biesert L, Fabbrizzi F, et al. Robustness of solvent/detergent treatment of plasma derivatives: a data collection of Plasma Protein Therapeutics Association member companies. Transfusion. 2009;49(9):1931-1943.
Octapharma Bringing Innovative, Lifesaving Therapies to Patients Around the World
Why Choose octagam® 10% Liquid?
• Formulated to mitigate tolerability issues in adults with chronic ITP1,2,4
• Manufactured to preserve the structural and functional integrity of IgG2,3
• Rapid and sustained response in adults with chronic ITP1,4
• A high rate of infusion without compromising tolerability1,4
• Convenient, ready-to-use, easy-to-store, liquid formulation1,2
• Flexible storage
– 36-month shelf-life when kept refrigerated (+2°C to + 8°C [36°F to 46°F]) from date of manufacture1
– Within this shelf-life, the product may be stored up to 9 months at room temperature (≤+25°C [77°F])
www.octagamusa.com
Adverse Reactions (observed in >5% of clinical study subjects)
Chronic Immune Thrombocytopenic Purpura: headache, fever, increased heart rate.
Dermatomyositis: headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, infusions site reactions.
Please see page 7 for additional Important Safety Information.
Please see accompanying full Prescribing Information.
Octapharma USA, Inc.
117 W. Century Road Paramus, NJ 07652 Tel: 201-604-1130
IgCares/Reimbursement Assistance
usreimbursement@octapharma.com Tel: 800-554-4440
Medical Affairs
usmedicalaffairs@octapharma.com
For all inquiries relating to drug safety, or to report adverse events, please contact our local Drug Safety Officer: Tel: 201-604-1137 | Cell: 201-772-4546 | Fax: 201-604-1141 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.