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Gammagard Liquid Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 10% (100mg/mL); liq for IV or SC infusion; preservative-, sucrose- and latex-free.
Pharmacological Class
Immune globulin.
How Supplied
Single-use bottle (1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL, 30g/300mL)—1
Manufacturer
Gammagard Liquid Indications
Indications
As a maintenance therapy to improve muscle strength and disability in multifocal motor neuropathy.
Gammagard Liquid Dosage and Administration
Adult
Individualize. Administer by IV infusion 0.5‒2.4g/kg/month based on clinical response at initial rate of 0.5mL/kg/hr (0.8mg/kg/min); maintenance rate: increase up to 5.4mL/kg/hr (9mg/kg/min) if tolerated. Risk of renal dysfunction or thrombotic events: give at the minimum practicable infusion rate; max rate <3.3mg/kg/min. Dose adjustments: see full labeling.
Children
Not established.
Gammagard Liquid Contraindications
Contraindications
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.
Gammagard Liquid Boxed Warnings
Not Applicable
Gammagard Liquid 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, delayed hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Antibody formation. Risk of transmission of blood-borne diseases. Have epinephrine inj available. Elderly. Pregnancy (Cat.C). Nursing mothers.
Gammagard Liquid Pharmacokinetics
See Literature
Gammagard Liquid 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.
Gammagard Liquid Adverse Reactions
Adverse Reactions
Headache, chest discomfort, muscle spasms, muscle weakness, nausea, oropharyngeal pain, pain in extremity; pulmonary embolism, blurred vision, renal dysfunction (may be fatal), hyperproteinemia, increased serum viscosity, hyponatremia; rare: hemolytic anemia, aseptic meningitis syndrome (esp. high dose of 2g/kg), TRALI, thrombosis.
Gammagard Liquid Clinical Trials
See Literature
Gammagard Liquid Note
Not Applicable
Gammagard Liquid Patient Counseling
See Literature
Gammagard Liquid Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 10% (100mg/mL); liq for IV or SC infusion; preservative-, sucrose- and latex-free.
Pharmacological Class
Immune globulin.
How Supplied
Single-use bottle (1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL, 30g/300mL)—1
Manufacturer
Gammagard Liquid Indications
Indications
Primary immunodeficiency (eg, congenital or X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
Gammagard Liquid Dosage and Administration
Adults and Children
<2yrs: not established. ≥2yrs: Individualize. IV infusion: 300‒600mg/kg every 3‒4 weeks at initial rate of 0.5mL/kg/hr (0.8mg/kg/min) for 30mins; maintenance rate: increase every 30mins (if tolerated) up to 5mL/kg/hr (8mg/kg/min). Risk of renal dysfunction or thrombotic events: give at the minimum practicable infusion rate; max rate <3.3mg/kg/min. SC infusion: initial dose is 1.37 x previous IV dose divided by # of weeks between IV doses. Maintenance dose is based on clinical response and target IgG trough level. Initial infusion rate: ≥40kg: 30mL/site at 20mL/hr/site; <40kg: 20mL/site at 15mL/hr/site. Maintenance infusion rate: ≥40kg: 30mL/site at 20‒30mL/hr/site; <40kg: 20mL/site at 15‒20mL/hr/site. Dose adjustments: see full labeling.
Gammagard Liquid Contraindications
Contraindications
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.
Gammagard Liquid Boxed Warnings
Not Applicable
Gammagard Liquid 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, delayed hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Antibody formation. Risk of transmission of blood-borne diseases. Have epinephrine inj available. Elderly. Pregnancy (Cat.C). Nursing mothers.
Gammagard Liquid Pharmacokinetics
See Literature
Gammagard Liquid 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.
Gammagard Liquid Adverse Reactions
Adverse Reactions
IV: headache, fatigue, pyrexia, nausea, chills, rigors, pain in extremity, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, pharyngolaryngeal pain, rash, arthralgia, myalgia, oedema peripheral, pruritus, cardiac murmur. SC: also infusion site reactions, increased heart rate, increased systolic BP, upper abdominal pain, ear pain. Both: renal dysfunction (may be fatal), hyperproteinemia, increased serum viscosity, hyponatremia; rare: hemolytic anemia, aseptic meningitis syndrome (esp. high dose of 2g/kg), TRALI, thrombosis.
Gammagard Liquid Clinical Trials
See Literature
Gammagard Liquid Note
Not Applicable
Gammagard Liquid Patient Counseling
See Literature
