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How should I use follicle stimulating hormone?

Use follicle stimulating hormone exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Gonal-F and Follistim AQ should only be administered subcutaneously. Follistim may be administered as a subcutaneous injection (injection under the skin) or intramuscular injection (injection into the muscle). If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and give the injection. Do not inject this medication if you are not sure how.

Do not shake the vial, but gently swirl until the solution is clear. Do not inject any medication that is discolored or that has particles in it.

Gonal F ampules and Follistim should be used immediately after mixing.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Follistim AQ should only be used with the Follistim Pen.

Store unmixed vials of follicle stimulating hormone at room temperature or in the refrigerator away from light, moisture, and heat.

Store the Follistim AQ cartridges in the refrigerator until the expiration date printed on the cartridge. Alternatively, the cartridges can be stored at room temperature for up to 3 months or until the expiration date, whichever comes first. Once the rubber stopper on the cartridge has been pierced by a needle, the product must be used within 28 days.

Store mixed multi-dose vials of Gonal-F in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius), protected from light. Throw away any unused medication 28 days after mixing.

What happens if I miss a dose?

Contact your doctor if you miss a dose of follicle stimulating hormone.

What happens if I overdose?

An overdose of follicle stimulating hormone is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice if an overdose is suspected.

Symptoms of a follicle stimulating hormone overdose are not known.

What should I avoid while using follicle stimulating hormone?

There are no restrictions on food, beverages, or activity during treatment with follicle stimulating hormone unless otherwise directed by your doctor.

What are the possible side effects of follicle stimulating hormone?

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.