Gammagard Liquid

— THERAPEUTIC CATEGORIES —
  • Miscellaneous immune disorders
  • Miscellaneous musculoskeletal disorders
  • Primary immune deficiency
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Takeda Pharmaceutical Company

    Generic Availability

    NO

    Mechanism of Action

    Gammagard Liquid supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. It also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanism of action of IgG in Gammagard Liquid have not been fully elucidated.

    Gammagard Liquid Indications

    Indications

    To improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

    Limitations of Use

    Not studied in immunoglobulin-naive patients with CIDP. Not studied for periods longer than 6 months as maintenance therapy in CIDP.

    Gammagard Liquid Dosage and Administration

    Adult

    Individualize. Administer by IV infusion. Induction dose: 2g/kg divided over 2–5 consecutive days at an initial infusion rate of 0.5mL/kg/hr (0.8mg/kg/min). Maintenance dose: 1g/kg divided over 1–4 consecutive days, every 3 weeks; may gradually increase infusion rate to max 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

    Boxed Warning

    Thrombosis. Renal dysfunction. Acute renal failure.

    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; consider discontinuing 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. Nursing mothers.

    Gammagard Liquid Pharmacokinetics

    Elimination

    Half-life: ~35 days (IV).

    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, pyrexia, anemia, leukopenia, neutropenia, illness, blood creatinine increased, dizziness, migraine, somnolence, tremor, nasal dryness, abdominal pain upper, vomiting, chills, nasopharyngitis, pain in extremity; 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

    Takeda Pharmaceutical Company

    Mechanism of Action

    Gammagard Liquid supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. It also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanism of action of IgG in Gammagard Liquid have not been fully elucidated.

    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

    Boxed Warning

    Thrombosis. Renal dysfunction. Acute renal failure.

    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; consider discontinuing 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. Nursing mothers.

    Gammagard Liquid Pharmacokinetics

    Elimination

    Half-life: ~35 days (IV).

    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

    Takeda Pharmaceutical Company

    Mechanism of Action

    Gammagard Liquid supplies a broad spectrum of opsonizing and neutralizing IgG antibodies against a wide variety of bacterial and viral agents. It also contains a spectrum of antibodies capable of interacting with and altering the activity of cells of the immune system as well as antibodies capable of reacting with cells such as erythrocytes. The role of these antibodies and the mechanism of action of IgG in Gammagard Liquid have not been fully elucidated.

    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

    Boxed Warning

    Thrombosis. Renal dysfunction. Acute renal failure.

    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; consider discontinuing 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. Nursing mothers.

    Gammagard Liquid Pharmacokinetics

    Elimination

    Half-life: ~35 days (IV).

    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

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