Indications for GAMMAPLEX 5%:
Primary humoral immunodeficiency (eg, common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Adults and Children:
<2yrs: not established. Individualize. ≥2yrs: 300–800mg/kg by IV infusion every 3–4 weeks at a rate of 0.5mg/kg/min for 15mins, if tolerated may increase at 15 min intervals up to max 4mg/kg/min. Risk of thrombosis, volume overload, renal dysfunction or acute renal failure: give at the minimum practicable infusion rate. See full labeling.
Previous severe reaction to human immune globulin. Hereditary intolerance to fructose. Infants and neonates without established sucrose or fructose tolerance. IgA deficiency with antibodies against IgA.
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, overweight, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion prior to initiation. Assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Discontinue if hypersensitivity reactions occur; have epinephrine available. Monitor for aseptic meningitis; consider a thorough neurological examination. Monitor for hemolysis and hemolytic anemia; consider measuring baseline hemoglobin or hematocrit and approx. 36–96hrs post-infusion in high risk patients. Monitor for pulmonary adverse reactions; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) is suspected. Volume overload. Risk of transmission of infectious agents. Elderly. Pregnancy. Nursing mothers.
May interfere with immune response to live virus vaccines. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May cause false (+) serological test results or (+) direct or indirect antiglobulin (Coombs’) test.
Headache, pyrexia, nasal congestion/edema, fatigue, nausea, hypertension, rash, hypotension, infusion site reaction, vomiting, myalgia, chills, tachycardia, chest pain/discomfort, pain, dizziness, malaise, dysuria, dry skin; thrombosis, aseptic meningitis syndrome (esp. with high doses or rapid infusion), hemolysis, hemolytic anemia, TRALI. Also ITP: pruritus, dehydration, arthralgia.