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Indication:
For women, Gonal-f® (follitropin alfa for injection), Gonal-f® RFF (follitropin alfa for 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 Risk Information:
These products should be prescribed only by physicians specializing in fertility or reproductive health. Use of Gonal-f®, Gonal-f® RFF, or Gonal-f® RFF Pen by women can result in multiple births.
Gonal-f®, Gonal-f® RFF, and Gonal-f® RFF Pen are potent gonadotropins capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonal-f®, Gonal-f® RFF, and Gonal-f® RFF Pen 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®, Gonal-f® RFF, or Gonal-f® Pen should not be given to women with abnormal uterine bleeding, presence or enlargement of an ovarian cyst of undetermined origin or to women who are pregnant or nursing.
The most common side effects reported in women using Gonal-f®, Gonal-f® RFF, or Gonal-f® RFF Pen 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, and fatigue. Injection site reactions have been reported.
Please see accompanying prescribing information below for full disclosure.
RFF: Revised Formulation Female
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Thank you for your interest. The information provided on this site is intended for US healthcare professionals only. To help you get more information and educational resources about fertility, we are automatically directing you to FertilityLifeLines.com.
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