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Ospemifene

Endometrial Cancer ; Cardiovascular Disorders

Endometrial Cancer

  • OSPHENA is an estrogen agonist/antagonist with tissue selective effects.  In the endometrium, OSPHENA has estrogenagonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed and random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding

Cardiovascular Disorders

  • There is areported increased risk of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age)who received daily oral conjugated estrogens (CE) [0.625 mg]-alone therapy over 7.1 years as part of the Women’s Health Initiative(WHI).
  • In the clinical trials for OSPHENA (duration of treatment up to 15 months), the incidence rates of thromboembolic and hemorrhagic stroke were 1.13 and 3.39 per thousand women years, respectively in the OSPHENA 60 mg treatment group and 3.15 and 0 with placebo. The incidence of DVT was 2.26 per thousand women years (2 reported cases) in the OSPHENA 60 mg treatment group and 3.15 per thousand women years (1 reported case) with placebo. OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.

OSPHENA should be prescribed for the shortest duration consistent with treatment goals and risks for the individual woman.


Patient Counseling Information

OSPHENA

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Ospemifene

Updated February 2019