Medications and Drugs

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Brand Names: Bravelle

Generic Name: urofollitropin (Pronunciation: UE roe FOL i TROE pin)

• What is urofollitropin (Bravelle)?
• What are the possible side effects of urofollitropin (Bravelle)?
• What is the most important information I should know about urofollitropin (Bravelle)?
• What should I discuss with my healthcare provider before using urofollitropin (Bravelle)?
• How should I use urofollitropin (Bravelle)?
• What happens if I miss a dose (Bravelle)?
• What happens if I overdose (Bravelle)?
• What should I avoid while using urofollitropin (Bravelle)?
• What other drugs will affect urofollitropin (Bravelle)?
• Where can I get more information?

What is urofollitropin (Bravelle)?

Urofollitropin is a purified form of a hormone called follicle-stimulating hormone (FSH). FSH is important in the development of follicles (eggs) that are produced by the ovaries in women.

Urofollitropin is used to treat infertility in women whose own natural FSH is not sufficient in stimulating follicles to mature. Urofollitropin also is used to help the ovaries produce multiple eggs for use in "in vitro" fertilization.

Urofollitropin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of urofollitropin (Bravelle)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition.

Stop using urofollitropin and call your doctor at once if you have any symptoms of OHSS:

• severe pelvic pain;
• swelling of your hands or legs;
• stomach pain and swelling;
• shortness of breath;
• weight gain;
• nausea, vomiting, diarrhea; or
• urinating less than usual.

Less serious side effects may include:

• mild stomach upset, constipation;
• mild pelvic pain, cramps;
• breast tenderness;
• skin rash;
• hot flashes;
• acne; or
• pain, swelling, redness, itching, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about urofollitropin (Bravelle)?

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS). This syndrome may be more likely to occur within the first 10 days after receiving the last dose in a treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any symptoms of OHSS: severe pelvic pain, swelling of the hands or legs, stomach pain and swelling, shortness of breath, weight gain, diarrhea, nausea or vomiting, and urinating less than usual.

Using this medicine can increase your chances of having a multiple pregnancy (twins, triplets, quadruplets, etc). A multiple pregnancy is a high-risk pregnancy for the mother and for the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.

Although urofollitropin can help you become pregnant, this medication is in the FDA pregnancy category X. This means that using the medication once you are pregnant can cause birth defects in the baby. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

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