Gammaplex, a sterile liquid of

Uses

Allogeneic bone marrow transplantation, Guillain-Barre syndrome, Hepatits A, Immunodeficiency, Increase platelet count in patients with idiopathic thrombocytopenic purpura, Kawasaki disease, Measles attack in immunocompromised patients, Prevention of infections after bone marrow transplantation, Primary antibodies deficiency, Primary rubella in pregnant women

Dosage

Gammaplex, a sterile liquid of dosage

IV-

• Prevention of infections after bone marrow transplantation: 500 mg/kg/wk.
• Increase platelet count in patients with idiopathic thrombocytopenic purpura: 400 mg/kg/day for 2-5 consecutive days.
• Kawasaki disease: 1.6-2 g/kg in divided doses over 2-5 days.
• Guillain-Barre syndrome: 400 mg/kg/day for 5 consecutive days, repeat 4 wkly if needed.
• Allogenic bone marrow transplantation: 500 mg/kg/wk, starting 7 days before transplantation and for up to 3 mth after transplantation.
• Primary antibodies deficiency Initial: 400-800 mg/kg, then 200 mg/kg 3 wkly. Maintenance: 200-800 mg/kg/mth. For secondary immunodeficiency syndromes: 200-400 mg/kg 3-4 wkly.

IM-

• Hepatits A: 500 mg.
• Measles attack in immunocompromised patients Prevention: 750 mg within 6 days after exposure. To modify an attack: 250 mg.
• Primary rubella in pregnant women: 750 mg.

Side Effects

Dizziness, light-headedness, nausea, vomiting, allergic and cutaneous reactions. Local pain and tenderness at the site of inj. IV admin may lead to systemic effects such as headache, chills and fever.

Precaution

Increased risk of acute renal failure in patients with renal impairment, DM, hypovolaemia, overweight, concomitant nephrotoxic medicinal products or >65 yr. High infusion rate may increased risk of adverse reactions. Ensure adequate hydration prior to IV infusion of immunoglobulin. Monitor urine output and serum creatinine levels during treatment. Avoid concurrent use of loop diuretics during IV infusion of immunoglobulin. Live vaccines should generally be given 3 wk before or 3 mth after admin of normal immunoglobulin. Different formulations and brands of human normal immunoglobulins may not be equivalent, thus individual literature should be consulted. Pregnancy and lactation.

Interaction

May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.

Pregnancy & Breastfeeding use

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Patients with selective immunoglobulin A deficiency. Prior anaphylactic reactions to immunoglobulin, blood or other blood-derived preparations.

Storage Condition

Store at 2-8° C.

Innovators Monograph

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