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). Severe acute hypersensitivity reactions, estimated to be rare, (<1 case per 1,000 patients) have also been reported on initial exposure or re-exposure to Synagis (see ADVERSE REACTIONS, Post-Marketing Experience). If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on readministra-tion of Synagis. If anaphylaxis or severe allergic reactions occur, administer appropriate medications (e.g., epineph-rine) 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-dose vial of Synagis does not contain a preservative. Administration of Synagis should occur immediately after dose withdrawal from the 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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