Respiratory syncytial virus (RSV) affects almost all children before the age of two. But for babies born at 35 weeks GA or less, and those with certain heart or lung problems, RSV can lead to serious infections and hospitalization. That's where Synagis (palivizumab) comes in. It's the only monoclonal antibody with shown efficacy in helping to protect these infants from severe RSV disease. Learn more.
Synagis may be appropriate for babies and children at a significantly elevated risk for severe RSV disease. This includes infants born at less than 36 weeks gestation, a large number of which are born between 32 and 35 weeks gestation, and children with hemodynamically significant congenital heart disease or chronic lung disease.
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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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