Gamunex-c

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders
  • Miscellaneous immune disorders
  • Primary immune deficiency

Gamunex-c Generic Name & Formulations

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

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

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

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

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

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