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Indication:
For women, Gonal-f® (follitropin alfa for injection), Gonal-f® RFF (follitropin alfa injection) and Gonal-f® RFF Pen (follitropin alfa injection) are indicated for 1) 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 and 2) for the development of multiple follicles in the ovulatory patient participating in an ART program.
Gonal-f® is also 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.
Important Safety Information:
These products should only be prescribed by physicians specializing in fertility or reproductive health. Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births.
Gonal-f® and Gonal-f® RFF are potent gonadotropins capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary complications. Gonal-f® and Gonal-f® RFF are 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. Additionally, Gonal-f® and Gonal-f® RFF should not be given to women with abnormal bleeding, presence or enlargement of an ovarian cyst of undetermined origin, or who are pregnant or nursing.
The most common side effects reported in women using Gonal-f® and Gonal-f® RFF include headache, abdominal pain, enlarged abdomen, ovarian cysts, nausea, and upper respiratory infections. Men using Gonal-f® have commonly reported acne, breast pain and growth, fatigue. Injection site reactions have been reported.
Please see accompanying prescribing information below for full disclosure.
RFF: Revised Formulation Female
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