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 to increase sperm production in men with a rare condition called hypogonadotropic hypogonadism.
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 in 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.
*RFF Revised Formulation Female
This information is not intended to replace discussion with your doctor. See full prescribing information for complete disclosure.