Composition: Palivizumab 50mg and 100mg.
Presentation: Powder and solvent for solution for injection.
Storage and stability: Store at 2-8C. Do not freeze. Store in original container. Administer solution within three hours of preparation.
Action: Antiviral. Palivizumab is a humanised IgG monoclonal antibody directed to the respiratory syncytial virus (RSV).
Indications: Prevention of serious lower respiratory tract disease requiring hospitalisation caused by (RSV). It is for treatment in children who are born at 35 weeks of gestation or less and who are less than six months of age at the onset of the RSV season, or in children who are less than two years of age and have received treatment for bronchopulmonary dysplasia within the last six months.
Contraindications: Hypersensitivity to any ingredient or to other humanised monoclonal antibodies.
Dosage and administration: Recommended dose is 15mg/kg of body weight, given once a month during anticipated periods of RSV risk in the community. Where possible, the first dose should be administered prior to start of the RSV season. Subsequent doses should be administered monthly throughout the RSV season. See summary of product characteristics (SPC) for reconstitution of injection and preferred site and mode of administration.
Overdosage: No medical consequences were identified at doses of 20.25mg/kg, 21.1 mg/kg and 22.27mg/kg in trials.
Precautions: Data regarding more than five injections during one season are not available. Give with caution to patients with thrombocytopenia or any coagulation disorder. See SPC for further details.
Drug interactions: No interactions described to date.
Side effects: Fever, injection site reactions, nervousness, upper respiratory infection, rhinitis, cough, wheeze. Uncommon adverse reactions include leucopenia, rash, diarrhoea, vomiting, AST increase, ALT increase, abnormal liver function, viral infection and pain. Antibody to palivizumab was observed in approximately 1 per cent of patients during the first course of therapy.
Net price: 50mg vial £424, 100mg vial £706.
Supplier: Abbott Laboratories Ltd, Abbott House, Norden Road, Maidenhead, Berkshire SL6 4XE. Tel 01628 773355.
Legal class: POM.