July 2, 2016
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Aside from possible ovarian hyperstimulation [see WARNINGS AND PRECAUTIONS] and multiple gestations [see WARNINGS AND PRECAUTIONS], little is known concerning the consequences of acute overdosage with BRAVELLE® .


BRAVELLE® is contraindicated in women who exhibit:

  • Prior hypersensitivity to BRAVELLE® or urofollitropins
  • High levels of FSH indicating primary ovarian failure [see INDICATIONS AND USAGE]
  • Pregnancy BRAVELLE® may cause fetal harm when administered to a pregnant woman [see Use In Specific Populations]. BRAVELLE® is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.
  • Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see INDICATIONS AND USAGE]
  • Sex hormone dependent tumors of the reproductive tract and accessory organ
  • Tumors of pituitary gland or hypothalamus
  • Abnormal uterine bleeding of undetermined origin
  • Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome
This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/28/2014


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