Follistim® (follitropin beta for injection) is indicated for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. Follistim® is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

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Infertility -- Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.

Follistim® (follitropin beta for injection) is contraindicated in women who exhibit:Prior hypersensitivity to recombinant hFSH products.A high circulating FSH level indicating primary ovarian failure.Uncontrolled thyroid or adrenal dysfunction.Tumor of the ovary, breast, uterus, hypothalamus or pituitary gland.Pregnancy.Heavy or irregular vaginal bleeding of undetermined origin.Ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS).

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Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Neoplasms -- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Ovarian Cysts -- General term for CYSTS and cystic diseases of the OVARY.

Hypertrophy -- General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA).

Polycystic Ovary Syndrome -- A complex disorder characterized by infertility, HIRSUTISM; OBESITY; and various menstrual disturbances such as OLIGOMENORRHEA; AMENORRHEA; ANOVULATION. Polycystic ovary syndrome is usually associated with bilateral enlarged ovaries studded with atretic follicles, not with cysts. The term, polycystic ovary, is misleading.

Follistim® (follitropin beta for injection) should be used only by physicians who are experienced in infertility treatment.

Follistim® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) (see WARNINGS-Overstimulation of the Ovary During Follistim® Therapy) with or without pulmonary or vascular complications (see WARNINGS-Pulmonary and Vascular Complications) and multiple births (see WARNINGS-Multiple Births).

Gonadotropin therapy requires the availability of appropriate monitoring facilities (see PRECAUTIONS-LaboratoryTests).