"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
There is no specific antidote for OSPHENA.
OSPHENA is contraindicated in women with any of the following conditions:
- Undiagnosed abnormal genital bleeding
- Known or suspected estrogen-dependent neoplasia
- Active DVT, pulmonary embolism (PE), or a history of these conditions
- Active arterial thromboembolic disease [for example, stroke and myocardial infarctions (MI)], or a history of these conditions
- Hypersensitivity (for example, angioedema, urticaria, rash, pruritus) to OSPHENA or any ingredients
- OSPHENA is contraindicated in women who are or may become pregnant. OSPHENA may cause fetal harm when administered to a pregnant woman. Ospemifene was embryo-fetal lethal with labor difficulties and increased pup deaths in rats at doses below clinical exposures, and embryo-fetal lethal in rabbits at 10 times the clinical exposure based on mg/m². If this drug is used during pregnancy, or if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.
Last reviewed on RxList: 3/13/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Osphena Information
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