New medicines
Subgam
 Composition: Human normal immunoglobulin. Each millilitre contains 140–180mg
human protein of which at least 95 per cent is immunoglobulin G.
Presentation: Solution for subcutaneous infusion or intramuscular injection,
depending on the indication.
Class: Immune sera and immunoglobulins.
Indications: Replacement therapy in adults and children in primary immunodeficiency
syndromes. Replacement therapy in myeloma or chronic lymphatic leukaemia
with severe secondary hypogammaglobulinaemia and recurrent infections.
Dosage: Dependent on the indication and may need to be individualised
for each patient depending on pharmacokinetic and clinical response.
A loading dose of 0.2–0.5g/kg may be required. Maintenance doses
are administered at repeated intervals to reach a cumulative monthly
dose of 0.4–0.8g/kg. See SPC.
Precautions: Patients could develop shock if Subgam is accidentally administered
into a blood vessel. The recommended infusion rate stated in the SPC
should be adhered to. Patients should be closely monitored and carefully
observed for any adverse events throughout the infusion period. See SPC.
Contraindications: Must not be given intravenously. Must not be administered
intramuscularly in cases of severe thrombocytopenia and in other disorders
of haemostasis.
Side effects: Adverse reactions such as chills, headache, fever, vomiting,
allergic reactions, nausea, arthralgia, low blood pressure and moderate
low back pain may occur occasionally.
Legal category: POM
Net price: 2ml vial £11.20, 5ml vial £28, 10ml vial £56.
Contact details: Bio Products Laboratory, Dagger Lane, Elstree, Herts
WD6 3BX (tel 020 8258 2200).
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