Bravelle

Generic Name: urofollitropin purified (URE-oh-FOL-i-TROE-pin)
Brand Name: 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 have a tumor in certain parts of the brain (eg, pituitary gland) or your female organs (eg, ovaries, breast, uterus), an enlarged ovary or ovarian cyst, or ovaries that no longer make eggs (ovarian failure)
  • you are pregnant or think you may be pregnant
  • you have abnormal vaginal bleeding and the cause is not known
  • you have thyroid, pituitary, or adrenal gland problems that are not controlled

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

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

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 pregnant, 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
  • if you or a family member has had a blood clot
  • if you are very overweight
  • if you have asthma, adrenal gland problems, pituitary gland problems, thyroid problems, or bleeding or clotting problems
  • if you have a history of twisting of the ovaries (ovarian torsion), ovarian cysts, or stomach surgery

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

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.

  • An extra patient leaflet is available with Bravelle. Talk to your pharmacist if you have questions about this information.
  • Bravelle is administered as an injection. If you are using Bravelle at home, carefully follow the injection procedures taught to you by your health care provider.
  • Do not use Bravelle if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • 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 to find out what to do.

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

Important safety information:

  • This drug may raise the chance of getting pregnant with more than 1 baby. The risk of pregnancy outside of the womb (ectopic pregnancy) is also raised. Discuss any questions or concerns with your doctor.
  • This drug may cause enlarged ovaries. If your ovaries get too big, your doctor may tell you that you should not have sex. This may cause an ovarian cyst to burst. Discuss any questions or concerns with your doctor.
  • Use of this drug may raise the risk of severe side effects (eg, blood clots, lung problems, ovarian cysts that burst). Blood clots have sometimes led to the loss of an arm or leg. Rarely, these side effects have been deadly. Discuss any questions or concerns with your doctor.
  • This drug may raise the risk of ovarian torsion in women with certain conditions. This can cause damage to the ovary by cutting off blood flow. Discuss any questions or concerns with your doctor.
  • Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may happen in some women who use this drug. OHSS can cause blood clots or can cause fluid to build in the stomach, chest, or heart. Call your doctor right away if you have severe or persistent stomach pain or bloating, nausea, vomiting, or diarrhea; sudden weight gain; shortness of breath; or decreased urination.
  • If you have used medicines like Bravelle more than 1 time to get pregnant, the risk of having tumors in your ovaries may be raised.
  • You will need to have ultrasounds done while using Bravelle. This will be used to watch for enlarged ovaries.
  • LAB TESTS, including hormone levels and pregnancy tests, may be performed while you use Bravelle. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: Bravelle may cause harm to the fetus. If you suspect that you could be pregnant, contact your doctor right away. It is not known if Bravelle in found 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:

Headache; hot flashes; nausea; stomach cramps, fullness, or pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast pain or enlarged breasts; calf, leg, or arm pain, swelling, redness, or tenderness; change in balance; chance in color of skin to a bluish color (eg, on the lips, hail beds, fingers, toes); changes in speech or vision; chest, jaw, or arm pain; confusion; coughing up blood; fainting; one-sided weakness; pale skin; shortness of breath; sudden, severe nausea or vomiting; unusual sweating; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Bravelle:

Before mixing, store Bravelle refrigerated or at room temperature, between 37 and 77 degrees F (3 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Use immediately after mixing. Discard any unused medicine. 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Bravelle or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Bravelle. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Bravelle. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Bravelle.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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