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1 x 50 mg
1 x 100 mg
The recommended dose of palivizumab is 15 mg/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 commencement of the RSV season. The majority of experience, including the pivotal phase III clinical trials with palivizumab, has been gained with 5 injections during one season. Data, although limited, are available on greater than 5 doses, therefore the benefit in terms of protection beyond 5 doses has not been established. To reduce risk of rehospitalisation, it is recommended that children receiving palivizumab who are hospitalised with RSV continue to receive monthly doses of palivizumab for the duration of the RSV season.
For children undergoing cardiac bypass, it is recommended that a 15 mg/kg of body weight injection of palivizumab be administered as soon as stable after surgery to ensure adequate palivizumab serum levels. Subsequent doses should resume monthly through the remainder of the RSV season for children that continue to be at high risk of RSV disease.
Method of administration: Palivizumab is administered in a dose of 15 mg/kg of body weight once a month intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The injection should be given using standard aseptic technique. The volume (expressed in mL) of palivizumab to be administered at one-monthly intervals = [patient weight in kg] multiplied by 0.15. Injection volumes over 1 ml should be given as a divided dose.
Palivizumab is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season. Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months. Children less than 2 years of age and with haemodynamically significant congenital heart disease.
Known hypersensitivity to the active substance or to any of the excipients or other humanised monoclonal antibodies.
Allergic reactions including very rare cases of anaphylaxis and anaphylactic shock have been reported following palivizumab administration. In some cases, fatalities have been reported. Medicinal products for the treatment of severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, should be available for immediate use following administration of palivizumab.
A moderate to severe acute infection or febrile illness may warrant delaying the use of palivizumab unless, in the opinion of the physician, withholding palivizumab entails a greater risk. A mild febrile illness, such as mild upper respiratory infection, is not usually reason to defer administration of palivizumab.
As with any intramuscular injection, palivizumab should be given with caution to patients with thrombocytopenia or any coagulation disorder.
The efficacy of palivizumab when administered to patients as a second course of treatment during an ensuing RSV season has not been formally investigated in a study performed with this objective. The possible risk of enhanced RSV infection in the season following the season in which the patients were treated with palivizumab has not been conclusively ruled out by studies performed aiming at this particular point. Injections should be given within 3 hours after reconstitution. Any remaining contents should be discarded after use.
Rash, pyrexia, injection site reaction, apnea.
No formal interaction studies with other medicinal products were conducted, however no interactions have been described to date. In the phase III IMpact-RSV study in the premature and bronchopulmonary dysplasia paediatric population, the proportions of patients in the placebo and palivizumab groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents. Since the monoclonal antibody is specific for RSV, Palivizumab is not expected to interfere with the immune response to vaccines.
See prescribing information for full details.
Pregnancy and Lactation
Not relevant, this drug is not indicated for use in adults. Data on pregnancy and lactation are not available.
In clinical studies, three children received an overdose of more than 15 mg/kg. These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg. No medical consequences were identified in these instances. From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose. In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Incompatibilities: This agent should not be mixed with any medicinal product or diluents other than Water for Injections.
Storage: Store in a refrigerator (2ºC to 8ºC). Do not freeze. Store in the original container. Solution must be administered within 3 hours (at 20-24ºC) of reconstitution.
Shelf- life: Any remaining contents should be discarded after use.