The recommended and FDA-approved dose of Synagis is 15 mg/kg of body weight administered by intramuscular (IM) injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season.1
Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season.1 The efficacy of Synagis at doses less than 15 mg/kg, or of dosing less frequent than monthly throughout the RSV season, has not been established.1
Compliance with monthly dosing helps protect high-risk infants and children against severe RSV disease and RSV-related hospitalizations.2 In one study, regular monthly dosing with Synagis resulted in significant reductions in RSV-related hospitalizations vs. placebo (10.6% for placebo vs. 4.8% for Synagis, P <0.001)2:
Cradle with CareSM offers text appointment reminders, information, and emails and mailings to support parents throughout the Synagis dosing process.
For patients undergoing cardiopulmonary bypass, administer a dose of Synagis as soon as possible after the procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered every 28 to 30 days throughout the RSV season. Synagis serum levels have been shown to decline by 58% after cardiopulmonary bypass.5*
Synagis is currently supplied in single-dose vials containing either 50 mg or 100 mg of product. Vials are used for single dose only and are currently available in a liquid solution. Synagis is supplied as a single-dose vial and does not contain preservatives. Do not re-enter the vial after withdrawal of drug; discard any unused portion. Only administer one dose per vial.
BPD = bronchopulmonary dysplasia; CHD = congenital heart disease.
*The clinical significance of this reduction is unknown.
Identifying patients at high risk for severe RSV disease can be complicated.
Use RSViD, our digital assessment tool, to help assess your patients’ risk for severe RSV disease.
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Safety and efficacy were established in children 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 recommended dose of Synagis is 15 mg/kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season.
The efficacy of Synagis at doses less than 15 mg/kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.
Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis. Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to Synagis. Other acute hypersensitivity reactions, which may be severe, have also been reported on initial exposure or re-exposure to Synagis. The relationship between these reactions and the development of antibodies to Synagis is unknown. If a significant hypersensitivity reaction occurs with Synagis, its use should be permanently discontinued. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of Synagis. As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder. Palivizumab may interfere with immunological-based RSV diagnostic tests, such as some antigen detection-based assays.
Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. In post-marketing reports, cases of severe thrombocytopenia (platelet count <50,000/microliter) and injection site reactions have been reported.