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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 Assisted Reproductive Technology (ART) program.
For men, Gonal-f® is also indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the main 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. Patients should let their doctor know of any allergic reactions to recombinant FSH preparations or other product ingredients. Patients should also inform their doctor of a history of cancer of the sex organs or brain and uncontrolled thyroid or adrenal disease before starting or continuing treatment. Women with a history of abnormal bleeding from the uterus or vagina, swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment. Gonal-f® and Gonal-f® RFF are potent gonadotropic substances capable severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women, which can result hospitalization. Women should inform their doctor if they experience severe stomach pain, vomiting, bloating, or weight gain while taking Gonal-f® or Gonal-f RFF®. The most common side effects are headache, ovarian cysts, upset stomach, and sinus infections in women taking Gonal-f® or Gonal-f® RFF. The most common side effects in men taking Gonal-f® are skin acne, breast pain and growth, and tiredness. Needle injections may cause some discomfort.

For more information, refer to the prescribing and patient information offered below and talk to your doctor.


© EMD Serono, Inc. CIM Last Update 2008-09-16
This site contains medical information that is intended for residents of the United States only and is not meant to substitute for the advice provided by a medical professional. Always consult a physician if you have health concerns. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Policy.

This site contains information that is intended for US residents only. Canadian residents should consult the EMD Serono Canada Inc. Web site at www.emdserono.ca for information on products and services approved in Canada.

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