You've been prescribed BRAVELLE^®, a follicle-stimulating hormone (FSH). BRAVELLE^® can be administered by subcutaneous (SC) or intramuscular (IM) injections and is used for women undergoing ovulation induction and multiple follicular development in those who are able to produce and release eggs (ovulate).

BRAVELLE^® is a highly purified preparation of human follicle FSH, containing 75 IUs FSH with 2% luteinizing hormone (LH) activity. BRAVELLE^® stimulates eggs to mature in women whose ovaries are basically healthy but are unable to develop eggs. It is not used by women who suffer from ovarian failure.

BRAVELLE^® is usually used together with human chorionic gonadotropin (hCG), and is indicated for ovulation induction following pituitary suppression and multiple follicular development following pituitary suppression.

In Assisted Reproductive Technology (ART), BRAVELLE^® has demonstrated efficacy across a wide range of patient types (younger patients¹, older patients², donor oocyte patients³, and elevated body mass index (BMI) patients⁴).

BRAVELLE^® is available by prescription in 5mL vials containing 75 IU FSH with accompanying diluent.

BRAVELLEŽ administered SC in conjunction with hCG is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression. BRAVELLEŽ administered SC or IM, in conjunction with hCG, is indicated for ovulation induction in patients who have previously received pituitary suppression.

Important Safety Information

Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe BRAVELLEŽ. BRAVELLEŽ, like all gonadotropins, is a potent substance capable of causing mild to severe adverse reactions, including OHSS (incidence 6.0%), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. BRAVELLEŽ is contraindicated in women who have a high FSH level indicating primary ovarian failure; uncontrolled thyroid and adrenal dysfunction; an organic intracranial lesion such as a pituitary tumor; the presence of any cause of infertility other than anovulation; abnormal bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome; prior hypersensitivity to urofollitropins, purified. BRAVELLEŽ is contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. There are limited human data on the effects of BRAVELLEŽ when administered during pregnancy.

Please click here to see the side effects, contraindications, and other full Prescribing Information.

References:1. Marrs RP, Check JH, Schnell VL, et al, for the EMBRACE Study Group. Evaluation of mixed protocols with Bravelle (hFSH) and Repronex (hMG) to assess clinical efficacy (EMBRACE I) in patients (18-33 years) undergoing in vitro fertilization. Fertil Steril. 2003;79(suppl 2):S14-S15. Abstract P-10. 2. Keye WR Jr, Surrey MW, Van Voorhis BJ, et al, for the EMBRACE Study Group. Evaluation of mixed protocols with Bravelle (hFSH) and Repronex (hMG) to assess clinical efficacy (EMBRACE II) in patients (34-40 years) undergoing in vitro fertilization. Fertil Steril. 2003;79(suppl 2):S6-S7. Abstract O-3. 3. Kaufman RA, Gocial B, Crain JL, et al. Bravelle, a new, highly purified, human-derived FSH is effective and well tolerated in females participating as oocyte donors for in vitro fertilization. Today’s Ther Trends.2003;21:1-14. 4. Data on file, Ferring Pharmaceuticals, Inc.

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