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Gamunex-c Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL; soln for IV or SC infusion; preservative- and sucrose-free.
Pharmacological Class
Immune globulin.
How Supplied
Vials—1
Manufacturer
Generic Availability
NO
Gamunex-c Indications
Indications
Idiopathic thrombocytopenic purpura (ITP).
Gamunex-c Dosage and Administration
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
Contraindications
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Gamunex-c Boxed Warnings
Boxed Warning
Thrombosis, renal dysfunction, acute renal failure, osmotic nephrosis and death may occur with IGIV products in predisposed patients.
Gamunex-c Warnings/Precautions
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 Pharmacokinetics
See Literature
Gamunex-c Interactions
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.
Gamunex-c Adverse Reactions
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.
Gamunex-c Clinical Trials
See Literature
Gamunex-c Note
Notes
Report all infections suspected to be transmitted by Gamunex-C to (800) 520-2807.
Gamunex-c Patient Counseling
See Literature
Gamunex-c Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL; soln for IV or SC infusion; preservative- and sucrose-free.
Pharmacological Class
Immune globulin.
How Supplied
Vials—1
Manufacturer
Generic Availability
NO
Gamunex-c Indications
Indications
Chronic inflammatory demyelinating polyneuropathy (CIPD) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
Gamunex-c Dosage and Administration
Adult
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
Not established.
Gamunex-c Contraindications
Contraindications
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Gamunex-c Boxed Warnings
Boxed Warning
Thrombosis, renal dysfunction, acute renal failure, osmotic nephrosis and death may occur with IGIV products in predisposed patients.
Gamunex-c Warnings/Precautions
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 Pharmacokinetics
See Literature
Gamunex-c Interactions
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.
Gamunex-c Adverse Reactions
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.
Gamunex-c Clinical Trials
See Literature
Gamunex-c Note
Notes
Report all infections suspected to be transmitted by Gamunex-C to (800) 520-2807.
Gamunex-c Patient Counseling
See Literature
Gamunex-c Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL; soln for IV or SC infusion; preservative- and sucrose-free.
Pharmacological Class
Immune globulin.
How Supplied
Vials—1
Manufacturer
Generic Availability
NO
Gamunex-c Indications
Indications
Primary humoral immunodeficiency (eg, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Gamunex-c Dosage and Administration
Adult
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
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
Contraindications
IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Gamunex-c Boxed Warnings
Boxed Warning
Thrombosis, renal dysfunction, acute renal failure, osmotic nephrosis and death may occur with IGIV products in predisposed patients.
Gamunex-c Warnings/Precautions
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 Pharmacokinetics
See Literature
Gamunex-c Interactions
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.
Gamunex-c Adverse Reactions
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.
Gamunex-c Clinical Trials
See Literature
Gamunex-c Note
Notes
Report all infections suspected to be transmitted by Gamunex-C to (800) 520-2807.
Gamunex-c Patient Counseling
See Literature
