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Important Considerations:
Gonal-f^® RFF Pen (follitropin alfa injection) is indicated for use in infertile patients with oligo-anovulation and in patients undergoing ART. Gonal-f^® RFF Pen (follitropin alfa injection) should only be prescribed by physicians specializing in fertility or reproductive health. Gonal-f^® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. Gonal-f^® is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use Gonal-f^®. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

Important Considerations:
Women: Gonal-f^® (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f^® is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
Men: Gonal-f^® (follitropin alfa for injection) is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. Gonal-f^® (follitropin alfa for injection) should only be prescribed by physicians who are thoroughly familiar with infertility problems and their management. Gonal-f^® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonal-f^® is contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, sex hormone dependent tumors of the reproductive tract and accessory organs, and an organic intracranial lesion such as a pituitary tumor; and in women who exhibit abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin and pregnancy. Women who are pregnant or nursing should not use Gonal-f^®. The most common side effects in patients using Gonal-f^® include headache, ovarian cysts, nausea and upper respiratory infections in women and in men, acne, breast pain and growth, and fatigue. Injection site reactions were also reported. Reports of multiple births have been associated with Gonal-f^® treatment. For complete product details, see the full prescribing information.

For complete product details, please read the Prescribing Information offered below.

• Full Prescribing Information for the Gonal-f^® RFF Pen (follitropin alfa injection)
• Full Prescribing Information for Gonal-f^® RFF (follitropin alfa for injection)
• Full Prescribing Information for Gonal-f^® (follitropin alfa for injection) Multi-Dose

© EMD Serono, Inc. CIM Last Update 2008-09-16
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