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Gammaplex 10% Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 5g/50mL, 10g/100mL, 20g/200mL; liq for IV infusion; sucrose-, maltose-, preservative- and latex-free.
Pharmacological Class
Immune globulin.
How Supplied
Single-use bottle—1
Manufacturer
Generic Availability
NO
Gammaplex 10% Indications
Indications
Chronic immune thrombocytopenic purpura (ITP).
Gammaplex 10% Dosage and Administration
Adult
Individualize. 1g/kg (10mL/kg) given on 2 consecutive days by IV infusion at a rate of 0.5mg/kg/min for 15mins, if tolerated may increase at 15min intervals up to max 8mg/kg/min. Risk of thrombosis, volume overload, renal dysfunction or acute renal failure: give at the minimum practicable infusion rate. See full labeling.
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 15min intervals up to max 8mg/kg/min. Risk of thrombosis, volume overload, renal dysfunction or acute renal failure: give at the minimum practicable infusion rate. See full labeling.
Gammaplex 10% Contraindications
Contraindications
Previous severe reaction to human immune globulin. IgA deficiency with antibodies against IgA.
Gammaplex 10% Boxed Warnings
Not Applicable
Gammaplex 10% 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. 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.
Gammaplex 10% Pharmacokinetics
See Literature
Gammaplex 10% Interactions
Interactions
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.
Gammaplex 10% Adverse Reactions
Adverse Reactions
Headache, migraine, pyrexia; thrombosis, aseptic meningitis syndrome (esp. with high doses or rapid infusion), hemolysis, hemolytic anemia, TRALI. Also ITP: vomiting, nausea, arthralgia, dehydration.
Gammaplex 10% Clinical Trials
See Literature
Gammaplex 10% Note
Not Applicable
Gammaplex 10% Patient Counseling
See Literature
Gammaplex 10% Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 5g/50mL, 10g/100mL, 20g/200mL; liq for IV infusion; sucrose-, maltose-, preservative- and latex-free.
Pharmacological Class
Immune globulin.
How Supplied
Single-use bottle—1
Manufacturer
Generic Availability
NO
Gammaplex 10% Indications
Indications
Primary humoral immunodeficiency (eg, common variable immunodeficiency, X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Gammaplex 10% Dosage and Administration
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 15min intervals up to max 8mg/kg/min. Risk of thrombosis, volume overload, renal dysfunction or acute renal failure: give at the minimum practicable infusion rate. See full labeling.
Gammaplex 10% Contraindications
Contraindications
Previous severe reaction to human immune globulin. IgA deficiency with antibodies against IgA.
Gammaplex 10% Boxed Warnings
Not Applicable
Gammaplex 10% 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. 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.
Gammaplex 10% Pharmacokinetics
See Literature
Gammaplex 10% Interactions
Interactions
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.
Gammaplex 10% Adverse Reactions
Adverse Reactions
Headache, migraine, pyrexia; thrombosis, aseptic meningitis syndrome (esp. with high doses or rapid infusion), hemolysis, hemolytic anemia, TRALI. Also ITP: vomiting, nausea, arthralgia, dehydration.
Gammaplex 10% Clinical Trials
See Literature
Gammaplex 10% Note
Not Applicable
Gammaplex 10% Patient Counseling
See Literature
