Human immunoglobulin-G

Human immunoglobulin-G (IgG) is a sterile liquid preparation of purified IgG obtained from human plasma pools. It is used for primary immunodeficiency, combined antibiotic therapy for severe bacterial or viral infections, A-/hypogammaglobulinemia, Idiopathic Thrombocytopenic Purpura (ITP), Guillain-Barre Syndrome, and Kawasaki Syndrome.

• Primary immunodeficiency
• Severe bacterial or viral infections (combined with antibiotics)
• A-/Hypogammaglobulinemia
• Idiopathic Thrombocytopenic Purpura (ITP)
• Guillain-Barre Syndrome
• Kawasaki Syndrome

Neonates and Infants:

• 5 ml (250 mg)/kg body weight daily for 3 days; further infusion may be required depending on clinical course

Adults:

• Severe infections and A-/Hypogammaglobulinemia: 2500-5000 mg single dose (Children: 50-150 mg/kg) IV infusion
• ITP: 200-400 mg/kg daily for 5 days
• Guillain-Barre Syndrome: 400 mg/kg daily for 5 days
• Kawasaki Syndrome: 400 mg/kg daily for 5 days or 2000 mg daily IV infusion (start within 7 days of symptom onset)

Common Side Effects:

• Back pain, chills
• Flushing (warmth in face, ears, neck and trunk)
• Dizziness, headache, nausea
• Decreased blood pressure, muscle pain
• Slow heart rate, wheezing

Serious Side Effects:

• Shock (dyspnea, wheeze, chest pain, hypotension)
• Renal failure, aseptic meningitis
• Thrombosis, hemolytic anemia

Precautions:

• Manufactured from human plasma, potential to transmit viruses
• Risk of thrombosis (elderly, prolonged immobilization, hypercoagulable conditions)
• Patients with IgA antibodies have greater risk of severe hypersensitivity reactions
• Renal dysfunction (ensure patients are not volume-depleted before administration)
• Live vaccines (measles, mumps, rubella, varicella) should be given at least 3 weeks before or 3 months after immunoglobulin administration
• After large bolus (>200 mg/kg) administration, delay live vaccines for 6 months

Contraindications:

• History of anaphylactic or severe systemic hypersensitivity to human normal immunoglobulin

Drug Interactions:

• May interfere with immune response to live measles, mumps, rubella and varicella vaccines; vaccines should be given at least 3 weeks before or 3 months after immunoglobulin administration

Use in Pregnancy: Safety not established; parvovirus B-19 infection cannot be excluded which may cause fetal disturbances (abortion, hydrops fetalis, fetal death); use only if expected benefit justifies potential risk.

Use in Lactation: Use has not been evaluated in nursing mothers; caution required.

Renal Impairment: Renal failure reported; monitor renal function; ensure patients are not volume-depleted; use minimum dose and infusion rate.

Hepatic Impairment: No specific precautions; however liver function disorders and jaundice with increased ALT/AST may occur.