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DM
Study design
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Secondary endpoints (TIS & CDASI improvement)
cITP
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Safety & Tolerability
DM
Adverse reactions
cITP
Adverse reactions
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DM
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cITP
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Frequently asked questions
Get answers to frequently asked questions about OCTAGAM 10%
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
What are the most common side effects seen with OCTAGAM 10%?
DM study
During the study, 10 of 95 patients (21%) in the OCTAGAM 10% treatment arm received premedication1,2
- Routine use of premedication was to be avoided, but if a patient had 2 consecutive infusion-related adverse reactions, premedication could be given2
During the study, use of premedication to alleviate potential adverse drug reactions was allowed and 0.9% of patients (1 of 116) received premedication.1
Is premedication required with OCTAGAM 10% infusions?
cITP study
No patient withdrew from the cITP study due to a drug-related adverse event2
Were there any patient withdrawals in the cITP clinical study?
What vial sizes are available for OCTAGAM 10%?
Where can I get more information about OCTAGAM 10%?
Tel: 1-844-646-4398
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Medical Information
[email protected]
Tel: 1-888-429-4535
What if my patients cannot tolerate their OCTAGAM 10% infusion and/or infusion rate?
How is OCTAGAM 10% supplied and stored?
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
- Do not freeze. Do not use frozen OCTAGAM 10%
- OCTAGAM 10% may be stored up to 9 months at room temperature ≤77°F (25°C) within the first 12 months of its shelf life
⁃ After storage at ≤77°F (25°C), the product must be used or discarded
What is the IgA content level in OCTAGAM 10%?
- OCTAGAM 10% [prescribing information]. Paramus, NJ: Octapharma USA Inc.; 2021.
- Data on file. Octapharma USA Inc.
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OCTAGAM 10% DM clinical
results video
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WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin intravenous (IgIV) products, including OCTAGAM 10% liquid. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients who receive IgIV products, including OCTAGAM 10% liquid. Patients predisposed to renal dysfunction include those with a degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IgIV products containing sucrose. OCTAGAM 10% liquid does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer OCTAGAM 10% liquid at the minimum dose and 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.
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.
INDICATIONs and Usage
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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