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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). The first dose of Synagis should be administered prior to commencement of the RSV season.
Eligibility criteria for prophylaxis of high-risk infants, young children:
Infants with chronic lung disease of prematurity
Infants and children younger than 24 months of age who receive medical therapy (supplemental oxygen, bronchodilator, diuretic or chronic corticosteroid therapy) within six months before the start of the RSV season (a maximum of five monthly doses).
Infants born before 32 weeks’ gestation (31 weeks, 6 days or less)
Infants born at or before 28 weeks’ gestation who may benefit from prophylaxis during the RSV season, whenever that occurs during the first 12 months of life. Infants born at 29 to 32 weeks of gestation may benefit from prophylaxis up to 6 months of age (a maximum of five monthly doses).
Infants born at 32 weeks’ to less than 35 weeks’ gestation (32 weeks, 0 days through 34 weeks, 6 days)
A change has been made in the recommendation for infants in this category so that these infants receive a maximum of three doses. Therefore, recommendations have been modified to reduce the risk of RSV hospitalization during the period of greatest risk (the first 3 months of life) among infants with consistently identified risk factors for hospitalization.
Synagis prophylaxis should be limited to infants in this age group who are at greatest risk of hospitalization due to RSV, namely infants younger than 3 months of age at the start of the RSV season or born during the RSV season and who are likely to have an increased risk of exposure to RSV. Epidemiologic data suggest that RSV infection is more likely to occur and more likely to lead to hospitalization for infants in this gestational age group when either of the following two risk factors is present: infant attends child care or infant has a sibling younger than 5 years of age.
Prophylaxis may be considered for infants from 32 through less than 35 weeks’ gestation (32 weeks, 0 days through 34 weeks, 6 days) who are born less than three months before the onset or during the RSV season and for whom at least one of the two risk factors is present. Infants in this gestational age category should receive prophylaxis only until they reach 3 months of age and should receive a maximum of three monthly doses; many will receive only one or two doses before they reach 3 months of age. Once an infant is older than 90 days of age, the risk of hospitalization attributable to RSV lower respiratory tract disease is reduced. Administration of Synagis is not recommended for these infants after they reach 90 days of age.