Materials

IMPORTANT SAFETY
INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION, AND ACUTE RENAL FAILURE

Thrombosis may occur with immune globulin intravenous (IgIV) products, including OCTAGAM 5% 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 5% 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 5% liquid does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction, or acute renal failure, administer OCTAGAM 5% 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 5% 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 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. OCTAGAM 5% liquid contains maltose, a disaccharide sugar, which is derived from corn. Patients known to have corn allergies should avoid using OCTAGAM 5% liquid.

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 5% liquid with testing by some glucometers and test strip systems.

Hyperproteinemia, increased serum osmolarity, and hyponatremia may occur in patients receiving OCTAGAM 5% liquid.

Aseptic meningitis syndrome may occur in patients receiving OCTAGAM 5% liquid, especially with high doses or rapid infusion.

Hemolysis that is either intravascular or due to enhanced red blood cell sequestration can develop subsequent to treatment with OCTAGAM 5% liquid. Risk factors for hemolysis include high doses and non–O–blood group. Closely monitor patients for hemolysis and hemolytic anemia.

Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).

OCTAGAM 5% 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 and nausea. The most serious adverse reactions in treatment with OCTAGAM 5% liquid have been immediate anaphylactic reactions, aseptic meningitis, and hemolytic anemia.

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.

INDICATION AND USAGE

OCTAGAM® 5% [Immune Globulin Intravenous (Human)] liquid is indicated for the treatment of primary humoral immunodeficiency (PI).