IMPORTANT SAFETY INFORMATION AND INDICATION
Important Safety Information and Indication
Important Safety Information
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.
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.
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.
The most common adverse reactions reported in >5% of subjects during a clinical trial were headache, fever, and increased heart rate. The most serious adverse reaction in treatment with OCTAGAM 10% liquid during a clinical trial was headache.
Indication and usage
OCTAGAM® 10% [Immune Globulin Intravenous (Human)] liquid is indicated for adult patients with chronic immune thrombocytopenic purpura (ITP) to rapidly raise platelet counts to control or prevent bleeding.
For all inquiries relating to drug safety, or to report adverse events, please contact the Octapharma USA Safety Officer at 201-604-1137, or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
