RSV and Synagis (palivizumab)

32-35 week GA infants may look healthier and stronger than 28-32 GA infants, but they are actually at the same stage of lung development—and at the same risk for a severe RSV infection. That's where Synagis^® comes in. It's the only monoclonal antibody with proven efficacy in protecting premature infants from severe RSV disease. Learn more.

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.

Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis. In post-marketing reports, very rare cases (<1 case per 100,000 patients) 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.