Palivizumab

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Palivizumab
Mass / length primary structure 148  kDa
Identifier
External IDs
Drug information
ATC code J06 BB16
DrugBank BTD00097
Drug class monoclonal antibody

Palivizumab is a monoclonal antibody , which for disease prevention of respiratory syncytial virus is used (RSV) infections in children. Palivizumab is not suitable for treating pre-existing RSV infections. Adult treatments are not indicated.

Mode of action

Palivizumab works as a passive immunization . The antibody binds to the A epitope of the fusion protein (F protein) of the RS virus, which is highly conserved in all RSV isolates, and thereby prevents the virus from entering the cell and thus preventing infection. The F protein of RS viruses is a glycoprotein on the surface of the virus that is necessary for the fusion of viral and cellular membranes . This fusion is an important step in the virus' entry into the cell. The antibody is effective against RSV subtypes A and B.

application areas

Palivizumab is approved for use in children at high risk of RSV disease to prevent the serious lower respiratory tract diseases caused by RSV:

  • for children who were born before the 36th week of pregnancy and who are younger than 6 months at the start of the RSV season.
  • in children under 2 years of age treated for bronchopulmonary dysplasia within the last 6 months .
  • in children under 2 years of age with congenital heart defects.

Due to the very high costs of palivizumab, immunization is primarily recommended in Germany for premature babies with bronchopulmonary dysplasia; in other cases an individual decision is recommended. The number needed to treat ( number needed to treat ) for immunization with palivizumab is 17 How many children must be treated statistically to a avoid hospitalization by RSV infection.

Palivizumab is given by intramuscular injection at a dose of 15 mg per kilogram of body weight . Due to the half-life of the antibody of around 18 to 20 days, the immune protection must be renewed monthly during the RSV season (in Central Europe November to April).

Contraindications and side effects

Palivizumab should not be used in cases of known hypersensitivity to palivizumab or other humanized antibodies. The most common side effects are diarrhea, fever, swelling and redness at the injection site, and nervousness. Allergic reactions have been observed, but cases of anaphylaxis are very rare (less than 1/10000). The rarely observed formation of antibodies to palivizumab does not appear to be clinically relevant.

Manufacturing

Palivizumab is a humanized IgG1-type antibody. The antibody is genetically engineered in the stable mouse myeloma cell line NS0. In contrast to traditionally manufactured immune sera, the genetic engineering of palivizumab means that there is no risk of pathogens such as HIV being transmitted if it is improperly manufactured . Palivizumab was developed by the American biotechnology company MedImmune . For the European market, the antibody is produced by Boehringer Ingelheim and sold by AbbVie under the name Synagis.

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