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DM
Study design
Study endpoints overview
Primary endpoint (TIS improvement)
Secondary endpoints (TIS & CDASI improvement)
cITP
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DM
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cITP
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DM
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cITP
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DM in adults
The most common ARs reported in >5% of patients during a clinical study were: headache (42%; 40 of 95), pyrexia (19%; 18 of 95), nausea (16%; 15 of 95), vomiting (8%; 8 of 95), chills (7%; 7 of 95), musculoskeletal pain (7%; 7 of 95), and blood pressure increased (6%; 6 of 95).1
cITP in adults
The most common ARs observed at a rate of >5% in patients in clinical studies were: headache (25%; 29 of 116), pyrexia (15%; 17 of 116), heart rate increased (11%; 13 of 116).1
DM study
During the study, 10 of 95 patients (21%) in the OCTAGAM 10% treatment arm received premedication1,2
cITP study
No patient withdrew from the cITP study due to a drug-related adverse event2
OCTAGAM 10% is available in a broad range of presentations, including 2 g, 5 g, 10 g, 20 g, and 30 g single-use bottles.1
OCTAGAM 10% may be stored in the refrigerator for 36 months at 36°F to 46°F (2°C to 8°C).1
WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
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.
Contraindications
OCTAGAM 10% liquid is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin and in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
Warnings and Precautions
OCTAGAM 10% liquid may cause hypersensitivity in patients with a corn allergy. OCTAGAM 10% liquid contains maltose, which is derived from corn.
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% liquid with testing by some glucometers and test strip systems.
Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving OCTAGAM 10% liquid.
Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to treatment with OCTAGAM 10% liquid. 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% liquid, especially with high doses or rapid infusion.
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
OCTAGAM 10% liquid is made from human plasma and may contain infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
Adverse Reactions
cITP - The most common adverse reactions reported in >5% of study subjects were headache, fever, and increased heart rate.
DM - The most common adverse reactions reported in >5% of study subjects were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and infusion site reactions.
You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.
OCTAGAM® is a registered trademark of Octapharma AG.
Please click here for Full Prescribing Information, including BOXED WARNING.
OCTAGAM® 10% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of chronic immune thrombocytopenic purpura (cITP) to rapidly raise platelet counts to control or prevent bleeding in adults and for dermatomyositis (DM) in adults.
Please click here for Full Prescribing Information, including BOXED WARNING.
Please see full Prescribing Information, including BOXED WARNING.
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