GONAL-F (Follitropin Alfa)

What is this medication?

Gonal-F is used to treat infertility in women who cannot ovulate. Gonal-F is not effective in women with primary ovarian failure (when the ovaries are unable to produce an egg).

Gonal-F is also used in men to stimulate sperm production. This medicine is not effective in men with primary testicular failure (when the testicles are unable to produce sperm).

Gonal-F is often used together with another medication called human chorionic gonadotropin (hCG).

Gonal-F may also be used for purposes not listed in this medication guide.

How should I use this medication?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You must remain under the care of a doctor while using Gonal-F.

Gonal-F is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

You may need to mix Gonal-F with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.

To get pregnant, you may need to have sex daily for several days in a row. The timing of sex and medication dosing is important for Gonal-F to work.

You will need frequent medical tests.

If you use this medicine to get pregnant, you may also need occasional ultrasound exams. Based on your blood work, you may need to stop having sex for a short time. Follow your doctor's instructions very carefully.

When refrigerated, take the medicine out of the refrigerator and allow it to reach room temperature before injecting your dose. Do not heat the medicine.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What if I miss a dose?

Call your doctor for instructions if you miss a dose.

How should I store this medication?

Storing this medicine unopened (not in use):

Refrigerate (do not freeze) and use until expiration date; or

Store at room temperature protected from light, and use within 3 months or until expiration date.

Storing this medicine opened (in use):

Store in a refrigerator (do not freeze), or at room temperature protected from light.

Use within 28 days.

What are the possible side effects of using this medication?

Get emergency medical help if you have signs of an allergic reaction:

• hives;
• difficulty breathing;
• swelling of your face, lips, tongue, or throat.

Some women using this medicine develop ovarian hyperstimulation syndrome (OHSS), a potentially life-threatening condition. Stop using this medicine and call your doctor right away if you have symptoms of OHSS during or shortly after using Gonal-F:

• severe pain in your lower stomach, nausea, vomiting, diarrhea;
• bloating, rapid weight gain;
• little or no urination; or
• trouble breathing.

Also call your doctor at once if you have:

• severe pelvic pain on one side;
• a cough with bloody mucus;
• fever, sore throat, swollen glands;
• a lump or swelling in your testicles;
• signs of acute respiratory distress syndrome--fever with shortness of breath or rapid breathing; or
• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

Common side effects of Gonal-F may include:

• redness, swelling, or bruising where an injection was given;
• an ovarian cyst;
• headache, tiredness;
• breast pain or swelling;
• stuffy nose, sneezing, sinus pain;
• acne; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.