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PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION

BRAVELLE® (urofollitropin for injection, purified)

BRAVELLE® (urofollitropin for injection, purified) is a prescription medicine that contains hormones. BRAVELLE contains follicle stimulating hormone and luteinizing hormone activity. These hormones stimulate healthy ovaries to make eggs. BRAVELLE is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.

Do not use BRAVELLE if you: have ovaries that are not able to make eggs even with the use of hormones, are pregnant or think you may be pregnant, have problems with your thyroid gland or adrenal gland that are not controlled by taking medicine, have tumors in your female organs (including breasts), have a tumor of your pituitary gland or any other tumor in your brain, or have heavy or irregular vaginal bleeding and the cause is not known. Do not use BRAVELLE if you have a known previous allergic reaction to these medications.

BRAVELLE may cause serious side effects. They sometimes stimulate the ovaries too much. This is called ovarian hyperstimulation syndrome (OHSS) and can be a serious medical problem. OHSS may cause pelvic pain or breathing problems, or it may make you urinate less. In rare cases, patients with this problem have had serious lung problems. BRAVELLE can also cause blood clots and strokes. Call your doctor or get medical help right away if you have: severe pelvic pain, nausea, vomiting, diarrhea, sudden weight gain, trouble breathing, or decreased or no urination. BRAVELLE may cause pregnancies with twins or more than two babies at the same time, miscarriages, birth defects, and pregnancies located outside the uterus. Do not use BRAVELLE if you are nursing. The most common side effects with BRAVELLE are stomach cramps, headache, bloating, hot flashes, and breathing problems.

Please see full Prescribing Information for BRAVELLE.