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GAMMAGARD LIQUID
Miscellaneous musculoskeletal disorders
Primary immune deficiency
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Drug Name:

GAMMAGARD LIQUID Rx

Generic Name and Formulations:
Immune globulin (human) 10% (100mg/mL); liq for IV or SC infusion; preservative-, sucrose- and latex-free.

Company:
Baxter

Therapeutic Use:

Indications for GAMMAGARD LIQUID:

As a maintenance therapy to improve muscle strength and disability in multifocal motor neuropathy.

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.

Contraindications:

IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.

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.

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.

Pharmacological Class:

Immune globulin.

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.

How Supplied:

Single-use bottle (1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL, 30g/300mL)—1

Indications for GAMMAGARD LIQUID:

Primary immunodeficiency (eg, congenital or X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).

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.

Contraindications:

IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.

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.

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.

Pharmacological Class:

Immune globulin.

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.

How Supplied:

Single-use bottle (1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL, 30g/300mL)—1

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