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GAMUNEX-C
Bleeding disorders
Miscellaneous immune disorders
Primary immune deficiency
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Drug Name:

GAMUNEX-C Rx

Generic Name and Formulations:
Immune Globulin (human) 1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL; soln for IV or SC infusion; preservative- and sucrose-free.

Company:
Grifols Biologicals, Inc.

Therapeutic Use:

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.

Contraindications:

IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.

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.

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.

Pharmacological Class:

Immune globulin.

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 Availability:

NO

How Supplied:

Vials—1

Indications for GAMUNEX-C:

Treatment of chronic inflammatory demyelinating polyneuropathy (CIPD) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.

Adult:

Give by IV infusion at a rate of 2mg/kg/min for first 30 mins; may increase to max 8mg/kg/min, if tolerated. 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.

Contraindications:

IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.

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.

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.

Pharmacological Class:

Immune globulin.

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:

Note: Report all infections suspected to be transmitted by Gamunex-C to (800) 520-2807.

Generic Availability:

NO

How Supplied:

Vials—1

Indications for GAMUNEX-C:

Primary humoral immunodeficiency (eg, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).

Adult:

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.

Children:

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.

Contraindications:

IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.

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.

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.

Pharmacological Class:

Immune globulin.

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:

Note: Report all infections suspected to be transmitted by Gamunex-C to (800) 520-2807.

Generic Availability:

NO

How Supplied:

Vials—1

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