PREGNYL®

(chorionic gonadotropin for injection, USP)

Selected Safety Information

Contraindications

PREGNYL is contraindicated in patients with prior allergic reaction to human chorionic gonadotropin (hCG).

Warnings and Precautions

PREGNYL should be used in conjunction with human menopausal gonadotropins. Only physicians experienced in infertility treatment should prescribe PREGNYL.

Anaphylaxis has been reported with urinary-derived hCG products.

The principal serious adverse reactions associated with PREGNYL are (1) ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion, (2) rupture of ovarian cysts with resultant hemoperitoneum, (3) multiple births, and (4) arterial thromboembolism.

Adverse Reactions

Other adverse reactions associated with PREGNYL use include headache, restlessness, depression, fatigue, edema, and pain at the site of injection.

Hypersensitivity reactions, both localized and systemic in nature, have been reported.

Before prescribing PREGNYL, please read the accompanying Prescribing Information.

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WOMN-1154693-000303/18