IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF GONAL-F® (follitropin alfa for injection):
What are the uses of Gonal-f® (follitropin alfa for injection), Gonal-f® RFF*(follitropin alfa for injection), and Gonal-f® RFF* Pen (follitropin alfa injection)?
Gonal-f® Multi-Dose, Gonal-f® RFF, and Gonal-f® RFF Pen are 3 products that contain follitropin alfa, which is similar to the human hormone follicle-stimulating hormone, referred to as FSH. FSH belongs to a group of human reproductive hormones.
Gonal-f® Multi-Dose, Gonal-f® RFF, and Gonal-f® RFF Pen are used in certain infertile women to help with ovulation (production and release of a mature egg) and pregnancy. Gonal-f® will not help women whose ovaries no longer work because of a condition called Primary Ovarian Failure. Gonal-f® may also be used in women who are in an Assisted Reproductive Technology (ART) program such as in vitro fertilization to help their ovaries make more eggs.
Gonal-f® Multi-Dose can also be prescribed to increase sperm production in men with a rare condition that affects sperm production.
All 3 products should be prescribed only by doctors specializing in infertility problems and their treatment.
Who should not use Gonal-f®, Gonal-f® RFF, and Gonal-f® RFF Pen?
Gonal-f® Multi-Dose, Gonal-f® RFF, and Gonal-f® RFF Pen should not be used in patients who are pregnant or think they might be pregnant, in patients with primary ovarian failure (the ovaries no longer produce eggs), or in patients with allergies to recombinant human FSH products or any other ingredients in the medication.
Patients with cancer of the sex organs or brain, or with uncontrolled thyroid or adrenal disease, should not use Gonal-f® Multi-Dose, Gonal-f® RFF, or Gonal-f® RFF Pen. Women with a history of abnormal bleeding from the uterus or vagina or with swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment.
What are the possible side effects of Gonal-f®, Gonal-f® RFF, and Gonal-f® RFF Pen?
The lowest dose expected to achieve the desired results should be used. A doctor should monitor a woman’s response often to avoid overdose, which can lead to serious side effects, including blood clots.
Women should contact their doctor if severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting, or weight gain are experienced during treatment. These could be signs of a rare but serious condition known as Ovarian Hyperstimulation Syndrome, or OHSS, which can result in hospitalization.
Use of Gonal-f® Multi-Dose, Gonal-f® RFF, or Gonal-f® RFF Pen by a woman can be associated with fertilization of more than 1 egg. This can lead to complications for the woman and the birth of 2 or more babies.
The most common side effects reported by women were headache, ovarian cysts, upset stomach, and sinus infection. The most common side effects reported by men taking Gonal-f® Multi-Dose were skin pimples, breast pain and growth, and tiredness. Injections may cause some discomfort.
*RFF, Revised Formulation Female
© 2013 EMD Serono, Inc. and its affiliates.