NOVAREL^® (chorionic gonadotropin for injection, USP) is a human chorionic gonadotropin (hCG) that is used to stimulate egg release (ovulation) in the infertile woman who has not ovulated, and whose cause of infertility is not due to primary ovarian failure. Before administering NOVAREL^®, patients have usually received previous treatment with gonadotropins, such as BRAVELLE^® (urofollitropin for injection, purified), MENOPUR^® (menotropins for injection, USP) or REPRONEX^® (menotropins for injection, USP).

NOVAREL^® is available by prescription in 10 mL multiple-dose vials containing 10,000 USP units with accompanying diluent.

NOVAREL^® is indicated for induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with urofollitropins or human menotropins.

Important Safety Information:
NOVAREL^® should be used in conjunction with urofollitropin or human menopausal gonadotropins only by physicians thoroughly experienced with infertility treatment. Principal serious adverse reactions are: OHSS; enlargement or rupture of ovarian cysts with resultant hemoperitoneum; multiple births; and arterial thromboembolism. NOVAREL^® is contraindicated in women with precocious puberty, androgen-dependent neoplasm, and prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman. Combined HCG/PMS (pregnant mare’s serum) therapy has been noted to induce high incidences of external congenital anomalies in the offspring of mice, in a dose-dependent manner. The potential extrapolation to humans has not been determined.

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