RSV Overview
Respiratory syncytial virus (RSV) is ubiquitous and easily spread: approximately two-thirds of all infants are
infected with RSV during the first year of life and almost 100% are infected by the age of two years.1,2
Most of these RSV infections cause minor upper respiratory illness and cold-like symptoms. However, in certain high-risk
pediatric patients, RSV infection may cause serious lower respiratory tract disease. It has been estimated in some U.S.
communities that between 50% and 80% of bronchiolitis hospitalizations of children under 2 years of age that occur from
November through April are due to RSV.3 Nationwide, it has been estimated that RSV infection causes up
to 125,000 infant hospitalizations annually.3-5
This section provides details on the RSV virus, RSV epidemiology, and RSV transmission. Data on RSV-related hospitalizations are also included.
Important Safety Information
Synagis® (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease and is administered by intramuscular injection. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). Synagis has been used in more than one million children in the U.S. since its introduction in 1998. The first dose of Synagis should be administered prior to commencement of the RSV season. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.
Synagis should not be used in pediatric patients with a history of severe prior reaction to Synagis or its components. Cases of anaphylaxis were reported following re-exposure to Synagis and severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on re-administration of Synagis. In post-marketing reports, cases of severe thrombocytopenia (platelet count <50,000/microliter) have been reported.
In clinical trials, the most common adverse events occurring at least 1% more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seen in children with CHD. There have also been post-marketing reports of injection site reactions.
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