WARNINGS
Very rare cases of anaphylaxis (<1 case per 100,000 patients) have been reported following re-exposure to Synagis® (see ADVERSE REACTIONS, POSTMARKETING EXPERIENCE). Rare severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure to Synagis®. If a severe hypersensitivity reaction occurs, therapy with Synagis® should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on readministration of Synagis®. If anaphylaxis or severe allergic reactions occur, administer appropriate medications (e.g., epinephrine) and provide supportive care as required.
PRECAUTIONS
General:
Synagis® is for intramuscular use only. As with any intramuscular injection, Synagis® should be given with caution to patients with thrombocytopenia or any coagulation disorder.
The safety and efficacy of Synagis® have not been demonstrated for treatment of established RSV disease.
The single-use vial of Synagis® does not contain a preservative. Lyophilized Synagis® must be used within 6 hours of reconstitution. Administration of either reconstituted Synagis® or liquid Synagis® should occur immediately after withdrawal from vial. The vial should not be re-entered. Discard any unused portion.
Drug Interactions:
No formal drug-drug interaction studies were conducted. In Trial 1, the proportions of patients in the placebo and Synagis® groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenesis, mutagenesis and reproductive toxicity studies have not performed.
Pregnancy:
Pregnancy Category C: Synagis® is not indicated for adult usage and animal reproduction studies have not been conducted. It is also not known whether Synagis® can cause fetal harm when administered to a pregnant woman or could affect reproductive capacity.
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