July 26, 2016
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Osphena

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Osphena

Overdosage
Contraindications

OVERDOSE

There is no specific antidote for OSPHENA.

CONTRAINDICATIONS

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.
This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/13/2015

Overdosage
Contraindications

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