These highlights do not include all the information needed to use SYNAGIS safely and effectively. See full prescribing information for SYNAGIS.
SYNAGIS ® (palivizumab) injection , for intramuscular use
Initial U.S. Approval: 1998
INDICATIONS AND USAGE
Synagis is a respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease.
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Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (less than or equal to 35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD).
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The safety and efficacy of Synagis have not been established for treatment of RSV disease. (1)
DOSAGE AND ADMINISTRATION
15 mg per kg of body weight, administered intramuscularly prior to commencement of the RSV season and remaining doses administered monthly throughout the RSV season. (2.1)
Children undergoing cardio-pulmonary bypass should receive an additional dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly as scheduled. (2.1, 12.3)
DOSAGE FORMS AND STRENGTHS
Single-dose liquid solution vials: 50 mg per 0.5 mL and 100 mg per 1 mL. (3)
CONTRAINDICATIONS
Previous significant hypersensitivity reaction to Synagis. (4)
WARNINGS AND PRECAUTIONS
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Anaphylaxis and anaphylactic shock (including fatal cases), and other severe acute hypersensitivity reactions have been reported. Permanently discontinue Synagis and administer appropriate medications if such reactions occur. (5.1)
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As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder. (5.2)
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Palivizumab may interfere with immunological-based RSV diagnostic tests such as some antigen detection-based assays. (5.3, 12.4)
ADVERSE REACTIONS
Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact MedImmune at 1-877-633-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Safety and effectiveness in children greater than 24 months of age at the start of dosing have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2014
