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|Bravelle

Bravelle

Bravelle is used for:

Treating infertility in women who have not responded to other therapy.

Bravelle is a human follicle-stimulating hormone. It works by stimulating the ovaries to produce eggs.

Do NOT use Bravelle if:

• you are allergic to any ingredient in Bravelle
• you are pregnant
• you have uncontrolled thyroid or adrenal gland problems; hormone-sensitive tumors; infertility for reasons other than absence of ovulation; heavy or irregular vaginal bleeding of unknown cause; ovarian failure, cysts, or enlargement of unknown cause; or a brain lesion or tumor

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

Before using Bravelle :

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

• if you 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
• if you have adrenal gland or thyroid disease

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

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

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

• Bravelle is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Bravelle at home, carefully follow the injection procedures taught to you by your health care provider.
• To use Bravelle , first break open the diluent ampule by snapping it at the neck, keeping the dot on the ampule facing away from you. When breaking open ampules, you may use gauze, paper towels, or tissues to protect your fingers.
• Draw up the recommended amount of diluent into a syringe, then break open the ampule containing the powder (using the same technique as above) and add the diluent to the powder by slowly pushing in the plunger of the syringe. Gently roll the ampule between your fingers but do not shake. The solution should be clear and free of particles.
• Draw up the solution for injection. The ampule can be held at an angle or turned upside down to remove all the solution. Use a different syringe for this or switch needles just prior to injection. Needles with a higher gauge (25 and higher) are smaller and more comfortable to the patient. Be sure all air bubbles are tapped out of the syringe.
• Wipe the injection site with an alcohol swab, then insert the syringe through the skin in the appropriate injection site (usually the upper thigh or buttocks).
• If using this as an intramuscular (IM; into a muscle) injection, 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 (medicine, syringes, etc.)
• After giving the injection, cover the injection site with a small bandage if necessary.
• If Bravelle contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use immediately after mixing. Throw away any unused portion.
• 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 Bravelle , contact your doctor for instructions.

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

Important safety information:

• You and your partner should have had a complete gynecological and hormone evaluation prior to starting therapy with Bravelle .
• Contact your doctor immediately if any of the following occur: severe stomach pain or bloating, nausea, vomiting, diarrhea, weight gain, difficulty breathing, infrequent urination.
• Bravelle may cause multiple births (eg, twins). Talk with your health care provider about the risk of multiple births.
• LAB TESTS, such as estradiol levels and ultrasounds, will be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Bravelle is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Bravelle in excreted in breast milk. Do not breast-feed while using Bravelle .

Possible side effects of Bravelle :

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; headache; hot flashes; nausea; stomach pain; vaginal bleeding.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloating; chills; continuing diarrhea; fever; infrequent urination; nausea; pain or redness at the injection site; severe headache; severe pelvic pain; severe stomach pain or swelling; shortness of breath; swelling of the lower legs; 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.

Store Bravelle at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Use immediately after mixing. Discard unused material. Keep Bravelle , as well as needles and syringes, out of the reach of children and away from pets.

General information:

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