Primary immune deficiency:
Indications for OCTAGAM:
Primary humoral immunodeficiency (eg, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Adults and Children:
Individualize. 300‒600mg/kg by IV infusion every 3‒4 weeks at infusion rate of 0.5mg/kg/min, if tolerated may increase at 30min intervals to 1mg/kg/min, then 2mg/kg/min, then up to max 3.33mg/kg/min. Risk of measles exposure and receives <400mg/kg every 3‒4 weeks, may increase to at least 400mg/kg; if exposed, give as soon as possible. Risk of renal dysfunction/failure or thrombosis: give at the minimum practicable infusion rate; max: <3.3mg/kg/min. See full labeling.
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Thrombosis. Renal dysfunction and acute renal failure.
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Ensure adequate hydration. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Corn allergy. Discontinue if hypersensitivity reactions occur; have epinephrine available. Monitor for aseptic meningitis, hemolysis and delayed hemolytic anemia; consider measuring baseline hemoglobin or hematocrit and approx. 36–96hrs post-infusion if patients are high risk. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Antibody formation. Risk of transmission of blood-borne diseases. Elderly. Pregnancy (Cat.C). Nursing mothers.
Avoid live viral vaccines for ≥3 months. Concomitant nephrotoxic drugs: increased risk of acute renal failure. Falsely elevated results with some blood glucose tests (eg, GDH-PQQ based or glucose-dye-oxidoreductase methods); use glucose-specific method only.
Headache, nausea; renal dysfunction (may be fatal), hyperproteinemia, increased serum viscosity, hyponatremia; rare: hemolytic anemia, aseptic meningitis syndrome (esp. with high doses or rapid infusion), TRALI, thrombosis.