Immune globulin intravenous

GAMMAGARD S/D is an Immune Globulin Intravenous (Human) indicated for: Treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age or older. Prevention of bacterial infections in hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL). Prevention and/or control of bleeding in adult chronic idiopathic thrombocytopenic purpura (ITP) patients. Prevention of coronary artery aneurysms associated with Kawasaki syndrome in pediatric patients. Primary Immunodeficiency (PI) GAMMAGARD S/D is indicated for the treatment of primary immunodeficiency (PI) associated with defects in humoral immunity, in adults and children two years and older.

GAMMAGARD S/D, Immune Globulin Intravenous (Human), supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. GAMMAGARD S/D also contains a spectrum of antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanisms of action of IgG in GAMMAGARD S/D have not been fully elucidated.

For Intravenous Use Only Intravenous Use Only Indication Recommended Dosage Duration PI 300-600 mg/kg Every 3 to 4 weeks CLL 400 mg/kg Every 3 to 4 weeks ITP 1g/kg Maximal 3 doses on alternate days Kawasaki Syndrome. Single 1g/kg or 400 mg/kg for 4 consecutive days Begin within 7 days of onset of fever Administer concomitant aspirin therapy: 80-100 mg/kg/day in four divided doses

GAMMAGARD S/D is contraindicated in patients who have a history of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D with <1µg/mL IgA in a 5 % solution. History of anaphylactic or severe systemic hypersensitivity reactions to the administration of GAMMAGARD S/D <1µg/mL IgA in a 5 % solution.

Boxed warning (thrombosis, renal dysfunction, and acute renal failure •): Thrombosis may occur with immune globulin products, including GAMMAGARD S/D. 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. Thrombosis may occur in the absence of known risk factors. IgA-deficient patients with antibodies to IgA are at greater risk of severe hypersensitivity reactions and anaphylactic reactions. Monitor renal function, including blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. Thrombosis may occur. Monitor for signs and symptoms of thrombosis and assess blood viscosity for those at risk for hyperviscosity. Aseptic Meningitis Syndrome (AMS) has been reported.

The most common adverse reactions reported in ≥ 5% of clinical trial subjects occurring during or within 48 hours of an infusion were headache, nausea, chills, asthenia (fatigue), pyrexia, upper abdominal pain, diarrhea, back pain, hyperhidrosis, and flushing. There were no serious adverse events that were attributed to GAMMAGARD S/D in the clinical trials. In postmarketing surveillance, serious adverse reactions reported with GAMMAGARD S/D were anaphylaxis, acute renal failure, myocardial infarction, cerebral vascular accident, transient ischemic attack, deep vein thrombosis, pulmonary embolism, aseptic meningitis, acute hemolysis, and TRALI. The most common adverse reactions observed in ≥ 5% of patients during the clinical trials were headache, nausea, chills, fatigue, pyrexia, upper abdominal pain, diarrhea, back pain, infusion site pain, hyperhidrosis and flushing.

Admixtures of GAMMAGARD S/D with other drugs and intravenous solutions have not been evaluated. It is recommended that GAMMAGARD S/D be administered separately from other drugs or medications which the patient may be receiving. Do not mix the product with human IGIV products from other manufacturers. Passive transfer of antibodies may transiently impair the immune responses to live attenuated vaccines, such as measles, mumps, rubella, and varicella. Inform the immunizing physician of recent therapy with GAMMAGARD S/D so that appropriate precautions can be taken. Passive transfer of antibodies may interfere with the immune response to live vaccines, such as measles, mumps, and rubella.

Store GAMMAGARD S/D at a temperature not to exceed 25ºC (77ºF) for 24 months. Do not Freeze.