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Synagis Generic Name & Formulations
Legal Class
Rx
General Description
Palivizumab 50mg/vial, 100mg/vial; liq soln for IM inj; preservative-free.
Pharmacological Class
Antiviral monoclonal antibody (IgG1K).
How Supplied
Single-use vials (soln)—1
Manufacturer
Synagis Indications
Indications
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.
Synagis Dosage and Administration
Adult
Not applicable.
Children
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.
Synagis Contraindications
Not Applicable
Synagis Boxed Warnings
Not Applicable
Synagis Warnings/Precautions
Warnings/Precautions
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.
Synagis Pharmacokinetics
See Literature
Synagis Interactions
Not Applicable
Synagis Adverse Reactions
Adverse Reactions
Anaphylaxis, hypersensitivity reactions, fever, rash.
Synagis Clinical Trials
See Literature
Synagis Note
Not Applicable
Synagis Patient Counseling
See Literature
