human immunoglobulin: clinical use

Prescribing considerations

• Confirm a licensed indication and individual clinical need under an experienced specialist.
• Assess hydration, renal function, thrombosis and hyperviscosity risk before infusion.
• Reactions are more likely with rapid infusion, first exposure, product switching, a long treatment gap, untreated infection or chronic inflammation.
• Maintain product and batch traceability.

Contraindications and cautions

• Hypersensitivity to human immunoglobulin or an excipient.
• Selective IgA deficiency with anti-IgA antibodies, because an IgA-containing product may cause anaphylaxis.

Monitoring

• Observe throughout infusion and after administration, with closer observation after first exposure, switching or a long treatment gap.
• Monitor renal function and urine output.
• Monitor for thrombosis, haemolysis, respiratory reactions and aseptic meningitis.
• Consider blood viscosity assessment when hyperviscosity risk is present.
• Interpret serology, direct antiglobulin tests and beta-D-glucan assays cautiously after infusion.

Clinical pharmacology

Intravenous administration makes IgG immediately available in the circulation before distribution between plasma and extravascular fluid. IgG and immune complexes are broken down through the reticuloendothelial system. Immunomodulatory actions are multifactorial and incompletely defined.

Formulation and product differences

• The selected intravenous solution contains predominantly IgG, with glycine and water for injections.
• It contains some IgA and is unsuitable in selective IgA deficiency with anti-IgA antibodies.
• It contains no sucrose, maltose or glucose as stabilisers.
• If dilution is clinically required, the specified glucose solution may affect blood glucose and requires consideration in diabetes.
• Do not mix it with other medicines or intravenous immunoglobulin products.

Solution for infusion

Route: Intravenous

Strengths: 100 mg/mL