Indications for SYNAGIS:
Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients: with a history of premature birth (≤35 weeks gestational age) and who are ≤6 months of age at the beginning of RSV season; with bronchopulmonary dysplasia that required medical treatment within the previous 6 months and who are ≤24 months of age at the beginning of RSV season; with hemodynamically significant congenital heart disease and who are ≤24 months of age at the beginning of RSV season.
Limitations of Use:
Not established for treatment of RSV disease.
Give by IM injection into anterolateral thigh. 15mg/kg once per month before and during RSV season. Cardiopulmonary bypass: see full labeling. Divide doses >1mL into 2 inj sites.
Have epinephrine (1:1000) inj available. Thrombocytopenia. Coagulation disorders. May interfere with RSV diagnostic tests (eg, antigen detection-based assays), viral culture assays. Pregnancy, nursing mothers: not indicated.
Antiviral monoclonal antibody (IgG1K).
Anaphylaxis, hypersensitivity reactions, fever, rash.
Single-use vials (soln)—1