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Brand Names: Follistim, Follistim AQ, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen

Generic Name: follicle stimulating hormone (injectable) (Pronunciation: PAH lich cull STIM u lay ting HORE moan)

• What is follicle stimulating hormone (Gonal-f RFF)?
• What are the possible side effects of follicle stimulating hormone (Gonal-f RFF)?
• What is the most important information I should know about follicle stimulating hormone (Gonal-f RFF)?
• What should I discuss with my healthcare provider before using follicle stimulating hormone (Gonal-f RFF)?
• How should I use follicle stimulating hormone (Gonal-f RFF)?
• What happens if I miss a dose (Gonal-f RFF)?
• What happens if I overdose (Gonal-f RFF)?
• What should I avoid while using follicle stimulating hormone (Gonal-f RFF)?
• What other drugs will affect follicle stimulating hormone (Gonal-f RFF)?
• Where can I get more information?

What is follicle stimulating hormone (Gonal-f RFF)?

Follicle stimulating hormone (FSH) is a naturally occurring hormone. FSH is important in the development of follicles (eggs) produced by the ovaries. FSH is also important in the development of sperm.

Follicle stimulating hormone is used to stimulate a follicle (egg) to develop and mature. It is used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature. Follicle stimulating hormone is also used to stimulate the development of multiple eggs for in vitro fertilization. Follicle stimulating hormone can be used by men to increase the production of sperm.

Follicle stimulating hormone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of follicle stimulating hormone (Gonal-f RFF)?

Stop using follicle stimulating hormone and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);
• confusion, severe dizziness, severe headache; or
• difficulty breathing.

Approximately 5% of patients treated with follicle stimulating hormone develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms.

Other side effects may also occur. Notify your doctor if you experience

• ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
• nausea, vomiting, diarrhea, or flatulence (gas);
• fever or chills;
• headache;
• dizziness;
• rapid pulse or heart rate;
• muscle or joint weakness or aching;
• breast tenderness;
• spotting or menstrual changes;
• pain, swelling, or irritation at the injection site; or
• dry skin, a rash, or hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about follicle stimulating hormone (Gonal-f RFF)?

Treatment with follicle stimulating hormone increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.