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|Gonal-f Powder

Gonal-f Powder

Gonal-f Powder is used for:

The treatment of infertility in women.The treatment of infertility not caused by testicular malfunction. Gonal-f Powder may also be used to treat other conditions as determined by your doctor.

Gonal-f Powder is a human follicle-stimulating hormone.

It is used to treat infertility in women by stimulating the ovaries to produce eggs.It is used to treat male infertility by increasing sperm count. Gonal-f Powder is usually given with other medicines.

Do NOT use Gonal-f Powder if:

• you are allergic to any ingredient in Gonal-f Powder
• you are allergic to sucrose, sodium phosphate, or benzyl alcohol
• you have uncontrolled thyroid or adrenal problems
• you have pituitary tumor or other brain lesion or tumor
• you have hormone-sensitive tumors
• you have primary ovarian failure (your ovaries do not make eggs)
• you are pregnant or think you may be pregnant
• you have cancer in your female organs (ovaries, breast, uterus)
• you have heavy or irregular bleeding from your uterus or vagina
• you have ovarian cysts or enlargement, not due to polycystic ovary syndrome (PCOS)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gonal-f Powder:

Some medical conditions may interact with this medicine. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines or other substances
• if you have urinary tract bleeding
• if you have an adrenal gland or thyroid problem
• if you have permanent damage to the testes
• if you have swollen, enlarged, or painful ovaries
• if you have blood-clotting problems or breathing problems

Some MEDICINES MAY INTERACT with Gonal-f Powder. Tell your health care provider if you are taking any other medicines.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Gonal-f Powder may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gonal-f Powder:

Use Gonal-f Powder as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gonal-f Powder comes with an additional patient leaflet. Read it carefully.
• Gonal-f Powder is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Gonal-f Powder at home, carefully follow the injection procedures taught to you by your health care provider.
• If Gonal-f Powder contains particles, is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Do not touch the needle or allow it to touch any surface.
• The duration of treatment will be determined by your health care provider.
• It is recommended that a couple using Gonal-f Powder has intercourse daily, starting on the day before the injection of Gonal-f Powder.
• If you miss a dose of Gonal-f Powder, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Gonal-f Powder.

Important safety information:

• Women will need to have a complete gynecological and hormone evaluation prior to starting therapy with Gonal-f Powder. Your partner should be evaluated for fertility problems.
• Men will need to have a complete medical and hormone evaluation before starting therapy with Gonal-f Powder.
• Gonal-f Powder may cause multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births.
• Do not reuse needles, syringes, or other materials. Dispose of properly after use.
• LAB TESTS, such as ultrasound or drawing an estradiol level, may be required to monitor your progress. Be sure to keep all doctor and lab appointments.
• Gonal-f Powder is not for use in the ELDERLY. Safety and effectiveness have not been confirmed.
• Gonal-f Powder is not for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Gonal-f Powder if you are pregnant or think you may be pregnant. Check with your health care provider about the risks and benefits of using Gonal-f Powder while breast-feeding.

Possible side effects of Gonal-f Powder:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; abnormal menses; back pain; breast pain; constipation; coughing; dizziness; enlarged abdomen; fever; flu-like symptoms; frequent urination; gas; headache; hot flushes; indigestion; injection site bruising, pain, or swelling; malaise; migraine; mood changes; oral infection; pain; painful menstruation; runny nose; sinus inflammation; spotting; sore throat; toothache; vaginal bleeding between menstrual periods; upper respiratory tract infection; vaginal discharge.

Breast pain or enlargement; fatigue; pain at the injection site (redness, bruising, swelling, and itching).

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Bladder or urination problems; chest pain; confusion; genital infection; multiple births; one-sided weakness; ovarian hyperstimulation syndrome (stomach pain or bloating; nausea; vomiting; diarrhea; weight gain; infrequent urination; pounding in the chest); sharp pain in the stomach area, groin, or calves; trouble breathing; worsening of asthma; urinary tract infection (painful urination).

Chest pain; severe headache; sharp pain in calves or groin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms of overdose may include nausea; severe headache; severe stomach pain or swelling; vomiting; weakness; weight gain.

Store Gonal-f Powder in the refrigerator (36 to 46 degrees F; 2 to 8 degrees C) until the expiration date. It can be kept at room temperature (68 to 77 degrees F; 20 to 25 degrees C) for up to 1 month or until the expiration date, whichever comes first. Once Gonal-f Powder is mixed, it should be used immediately. Do not store medicine that has been mixed. Protect from light. Do not freeze. Keep Gonal-f Powder out of the reach of children and away from pets.

General information:

• If you have any questions about Gonal-f Powder, please talk with your doctor, pharmacist, or other health care provider.
• Gonal-f Powder is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Gonal-f Powder. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.