Gammagard Liquid

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

Gammagard Liquid Generic Name & Formulations

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

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