Indications for GAMUNEX-C:
Primary humoral immunodeficiency (eg, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Give by IV or SC inj. 300–600mg/kg IV every 3–4 weeks. Initial infusion rate: 1mg/kg/min for first 30mins; may increase gradually to 8mg/kg/min if tolerated. Risk of renal dysfunction or thrombosis: give at minimum practicable infusion rate (<8mg/kg/min). Initial weekly SC dose = 1.37 x previous IGIV dose (in grams)/Number of weeks between IGIV doses. To convert dose to mL, multiply calculated dose (in grams) by 10. SC infusion: 20mL/hr/site. Dose adjustments, measles exposure: see full labeling.
300–600mg/kg IV every 3–4 weeks. Initial infusion rate: 1mg/kg/min for first 30mins; may increase gradually to 8mg/kg/min if tolerated. SC inj: not established.
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Thrombosis, renal dysfunction, acute renal failure, osmotic nephrosis and death may occur with IGIV products in predisposed patients.
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. 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. Monitor for aseptic meningitis, hemolysis, hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Contains human plasma; monitor for possible infection transmission. Have epinephrine inj available. Pregnancy (Cat.C). Nursing mothers: not evaluated.
May affect response to live virus vaccines. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May cause false positive direct or indirect Coombs' test.
IV: headache, cough, inj site reaction, nausea, pharyngitis, urticaria; SC: infusion site reactions, headache, fatigue, arthralgia, pyrexia; renal dysfunction (may be fatal), hypersensitivity reactions; rare: hemolytic anemia, aseptic meningitis syndrome (esp. high dose of 2g/kg and/or rapid infusion), TRALI, thrombosis, hyperproteinemia.
Note: Report all infections suspected to be transmitted by Gamunex-C to (800) 520-2807.