Synagis - palivizumab
What is Synagis?
Synagis is found in the form of a powder and solvent to form a solution for injection. Contains the active substance palivizumab.
What is Synagis used for?
Synagis is indicated for the prevention of severe diseases of the lower respiratory tract (lungs) caused by respiratory syncytial virus (RSV) that require hospitalization. it is used in the following groups of children, who are at high risk of contracting the disease:
- babies younger than six months born prematurely by five or more weeks (with gestational age of 35 weeks or less);
- children less than two years of age who have been treated for bronchopulmonary dysplasia (changes in lung tissue usually found in premature babies) in the past six months;
- children under the age of two born with severe heart disease.
The medicine can only be obtained with a prescription.
How is Synagis used?
Synagis is given once a month during periods when RSV is expected to be at risk in the community, ie November to April in the Northern Hemisphere. If possible, the first dose should be given before the critical season begins. Patients typically receive a total of five injections, one per month, into the thigh muscle.
How does Synagis work?
The active substance in Synagis, palivizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) designed to recognize and attach to a specific structure (called an antigen). Palivizumab was created to bind to a protein called fusion protein A which is found on the surface of the VRS. When palivizumab binds to this protein, the virus is no longer able to enter the body's cells, particularly those of the lungs, which helps prevent RSV infections.
How has Synagis been studied?
The main study of Synagis involved 1,502 high-risk children comparing Synagis with placebo (a dummy treatment) over one RSV epidemic season. A second study was also conducted in which Synagis was compared with placebo in 1,287 children born with heart disease. In both studies, the main measure of effectiveness was the number of children who were hospitalized with RSV infection.
What benefit has Synagis shown during the studies?
Synagis was more effective than placebo in reducing RSV-related hospitalizations: during the study, 5% of the children treated with Synagis and 11% of the children treated with placebo were hospitalized for RSV infection. 55% In children born with heart disease, the reduction was 45%.
What is the risk associated with Synagis?
The most common side effects seen with Synagis (seen in 1 to 10 patients in 100) are diarrhea, fever, injection site reactions (injection site pain and inflammation) and nervousness. For the full list of side effects reported with Synagis, see the package leaflet.
Synagis must not be used in people who may be hypersensitive (allergic) to palivizumab, to any of the other ingredients or to other "humanized" monoclonal antibodies.
Why has Synagis been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Synagis's benefits are greater than its risks for the prevention of serious lower respiratory tract conditions requiring hospitalization caused by RSV in children at high risk of the disease. from VRS. The committee recommended the granting of a marketing authorization for Synagis.
Learn more about Synagis
On August 13, 1999, the European Commission granted Abbott Laboratories Limited a "marketing authorization" for Synagis, valid throughout the European Union. The "marketing authorization" was renewed on August 13, 2004 and on 13 August 2009.
For the full version of Synagis EPAR click here.
Last update of this summary: 08-2009
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