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Follistim AQ is used for:

Helping women who ovulate produce multiple eggs when participating in an Assisted Reproductive Technology (ART) program to become pregnant. It is also used to help induce ovulation in infertile women whose cause of infertility is not related to failure of the ovaries. Follistim AQ may also be used for other conditions as determined by your doctor.

Follistim AQ is a gonadotropin. It works by stimulating the ovaries to produce eggs.

Do NOT use Follistim AQ if:

• you are allergic to any ingredient in Follistim AQ or to streptomycin or neomycin
• you have uncontrolled thyroid or adrenal problems
• you have tumors of the ovaries, breast, or uterus
• you have tumors of the hypothalamus, brain, or pituitary gland
• you are pregnant
• you have heavy or irregular vaginal bleeding of unknown cause
• you have ovarian cysts or enlargement not due to polycystic ovarian syndrome
• you have failure of the ovaries

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

Before using Follistim AQ :

Some medical conditions may interact with Follistim AQ . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning 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, foods, or other substances

Some MEDICINES MAY INTERACT with Follistim AQ . However, no specific interactions with Follistim AQ are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Follistim AQ 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 Follistim AQ :

Use Follistim AQ as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Follistim AQ is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Follistim AQ at home, carefully follow the injection procedures taught to you by your health care provider.
• If Follistim AQ contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle. Wipe the injection site with an alcohol swab and then insert the syringe through the skin in the appropriate injection site (usually the upper thigh or buttocks). To be sure that the needle is not in a vein after inserting the needle into the skin, pull back on the plunger of the syringe while holding the syringe in place. If the syringe begins to fill with blood, the needle is in a vein. If this happens, remove the needle from the skin, throw the syringe away, and start the procedure again using new materials (drug, syringes, etc.).
• After giving the injection, cover the injection site with a small bandage, if necessary.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Follistim AQ , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Follistim AQ .

Important safety information:

• You will need to have a complete gynecological and hormone examination prior to starting therapy with Follistim AQ . Your partner should be evaluated for fertility potential.
• The use of Follistim AQ may result in multiple births (eg, twins). Discuss this possibility with your doctor.
• LAB TESTS, including estradiol blood levels or ultrasounds, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Follistim AQ is not recommended for use in the ELDERLY. Safety and effectiveness have not been confirmed.
• Follistim AQ is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Follistim AQ if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Follistim AQ is excreted in breast milk. Do not breast-feed while taking Follistim AQ .

Possible side effects of Follistim AQ :

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:

Breast tenderness; dizziness; dry skin; flu-like symptoms (fever, chills, muscle aches, joint pain, nausea); general body discomfort; headache; stomach discomfort; swelling.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; chest pain; diarrhea; fast, slow, or irregular heartbeat; indigestion; infrequent urination; nausea; pain or redness at the injection site; severe pelvic pain; sharp pain in the groin or calves; stomach pain or bloating; sudden, severe headache; vomiting; weakness; weight gain.

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 may include nausea; severe headache; severe stomach pain or swelling; shortness of breath; vomiting; weakness; weight gain.

Store Follistim AQ between 34 and 46 degrees F (2 and 8 degrees C) until the expiration date or at 77 degrees F (25 degrees C) for 3 months or until the expiration date, whichever occurs first. Once the rubber stopper of the cartridge has been pierced by a needle, the product can only be stored for a maximum of 28 days between 36 and 77 degrees F (2 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Follistim AQ out of the reach of children and away from pets.

General information:

• If you have any questions about Follistim AQ , please talk with your doctor, pharmacist, or other health care provider.
• Follistim AQ 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 Follistim AQ . 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.