Generic Name and Formulations:
 Palivizumab 50mg/vial, 100mg/vial; liq soln for IM inj; preservative-free.

Company:
MedImmune, Inc.
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.

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.

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.

Pharmacological Class:

Antiviral monoclonal antibody (IgG1K).

Adverse Reactions:

Anaphylaxis, hypersensitivity reactions, fever, rash.

How Supplied:

Single-use vials (soln)—1