Palivizumab

Palivizumab is a recombinant humanized monoclonal antibody produced by DNA technology in mouse myeloma cells.

Palivizumab is indicated for the prevention of serious lower respiratory tract diseases caused by Respiratory Syncytial Virus (RSV) that require hospitalization in children at high risk for RSV disease:

• children born in the 35th week of pregnancy or earlier and younger than 6 months at the beginning of the RSV season.
• Children < 2 years of age who have been treated for bronchopulmonary dysplasia within the last 6 months
• Children < 2 years with hemodynamically significant congenital heart defects.

Dosage and method of administration: The recommended dosage is 15 mg palivizumab/kg body weight (bw). It should be administered once a month during the period of increased risk of RSV infection in the population. Only incomplete clinical data are available for > 5 applications. The benefit in terms of protection beyond 5 doses is not assured.

It is recommended that children who receive palivizumab and are hospitalized with RSV continue to receive palivizumab at monthly intervals for the duration of the RSV season to avoid further hospitalization. It is recommended that children undergoing surgery using a cardiopulmonary bypass are given a 15 mg/kg bw palivizumab injection as soon as they are postoperatively stable to ensure adequate levels of palivizumab serum. During the remainder of the RSV season, subsequent doses should be continued on a monthly basis in children who are still at high risk of developing RSV infection.

Route of administration: Palivizumab is administered intramuscularly, preferably in the anterolateral side of the thigh. Due to the risk of damage to the sciatic nerve, the glutaeus muscle should not be routinely chosen as the injection site. The injection should be administered using a standard aseptic technique. Injection volumes greater than 1 ml should be administered as divided doses.

Hypersensitivity to the active substance or to any other component, or to other humanised monoclonal antibodies. Allergic reactions are known to occur, including very rare cases of anaphylaxis and anaphylactic shock. In some cases deaths have been reported. Drugs should be available for the immediate treatment of severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, after administration of palivizumab.

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