Very rare cases of anaphylaxis (<1 case per 100,000 patients) have been reported following re-exposure to Synagis® (see ADVERSE REACTIONS, Post-Marketing 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.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis, mutagenesis and reproductive toxicity studies have not been 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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