Monograph Details

Immune System > Immunomodulators
SYNAGIS
Manufacturer
MedImmune, Inc.
Legal Classification
Rx
Pharmacological Class
Antiviral monoclonal antibody (IgG1K).
Generic Name
Palivizumab 50mg/vial, 100mg/vial; pwd for IM inj after reconstitution; liq soln; preservative-free.
Indications
Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease (eg, infants with bronchopulmonary dysplasia or born ≤35 wks gestational age), or children with hemodynamically significant congenital heart disease).
Children
Give by IM injection into anterolateral thigh. 15mg/kg once per month before and during RSV season. Cardiopulmonary bypass: see literature. Divide doses >1mL into 2 inj sites.
Adults
Not applicable.
Precautions
Have epinephrine (1:1000) inj available. Pregnancy (Cat.C).
Adverse Reactions
Anaphylaxis, hypesensitivity reactions, upper respiratory infection/symptoms (eg, fever, wheezing), GI disturbances, otitis media, rash, hernia, increased SGOT.
How Supplied
Single-use vials (pwd)—1
Single-use vials (soln)—1
Additional Resources
Related Prescribing Note