Bleeding disorders:
Indications for: GAMUNEX-C
Idiopathic thrombocytopenic purpura (ITP).
Adults and Children:
Give by IV infusion at a rate of 1mg/kg/min for first 30mins; if tolerated, may increase to max 8mg/kg/min. 1g/kg once daily given on 2 consecutive days or 0.4g/kg once daily given on 5 consecutive days. If adequate response after first 1g/kg dose, may withhold second dose. Risk of renal dysfunction or thrombosis: give at minimum practicable infusion rate (<8mg/kg/min). Expanded fluid volumes: high dose regimen not recommended.
GAMUNEX-C Contraindications:
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis, renal dysfunction, acute renal failure, osmotic nephrosis and death may occur with IGIV products in predisposed patients.
GAMUNEX-C Warnings/Precautions:
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.
GAMUNEX-C Classification:
Immune globulin.
GAMUNEX-C Interactions:
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.
Adverse Reactions:
Headache, vomiting, fever, nausea, back pain, rash; 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.
Generic Drug Availability:
NO
How Supplied:
Vials—1
Miscellaneous immune disorders:
Indications for: GAMUNEX-C
Chronic inflammatory demyelinating polyneuropathy (CIPD) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
Adult Dosage:
Give by IV infusion at a rate of 2mg/kg/min for first 30 mins; if tolerated, may increase to max 8mg/kg/min. Loading dose: 2g/kg given in divided doses over 2–4 consecutive days. Maintenance: 1g/kg given over 1 day or two doses of 0.5g/kg given on two consecutive days, every 3 weeks. Risk of renal dysfunction or thrombosis: give at minimum practicable infusion rate (<8mg/kg/min).
Children Dosage:
Not established.
GAMUNEX-C Contraindications:
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis, renal dysfunction, acute renal failure, osmotic nephrosis and death may occur with IGIV products in predisposed patients.
GAMUNEX-C Warnings/Precautions:
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.
GAMUNEX-C Classification:
Immune globulin.
GAMUNEX-C Interactions:
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.
Adverse Reactions:
Headache, fever, chills, hypertension, rash, nausea, asthenia; 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.
Generic Drug Availability:
NO
How Supplied:
Vials—1
Primary immune deficiency:
Indications for: GAMUNEX-C
Primary humoral immunodeficiency (eg, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Adult Dosage:
Give by IV or SC inj. 300–600mg/kg IV every 3–4 weeks. Initial infusion rate: 1mg/kg/min for first 30mins; if tolerated, may increase gradually to 8mg/kg/min. 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.
Children Dosage:
300–600mg/kg IV every 3–4 weeks. Initial infusion rate: 1mg/kg/min for first 30mins; if tolerated, may increase gradually to 8mg/kg/min. SC inj: not established.
GAMUNEX-C Contraindications:
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Boxed Warning:
Thrombosis, renal dysfunction, acute renal failure, osmotic nephrosis and death may occur with IGIV products in predisposed patients.
GAMUNEX-C Warnings/Precautions:
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.
GAMUNEX-C Classification:
Immune globulin.
GAMUNEX-C Interactions:
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.
Adverse Reactions:
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.
Generic Drug Availability:
NO
How Supplied:
Vials—1
