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FDA Approved Treatment for Painful Intercourse (Dyspareunia) Due to Menopause
Date:2/27/2013

ed, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Breast Cancer: Osphena has not been adequately studied in women with breast cancer; therefore Osphena should not be used in women with known or suspected breast cancer or with a history of breast cancer.

Severe Hepatic Impairment: Do not use Osphena in women with severe hepatic impairment as it has not been studied.

Adverse Reactions: In clinical studies, the more commonly reported adverse reactions (greater than or equal to 1 percent) in patients treated with Osphena 60 mg compared to placebo were: hot flush (7.5 percent vs. 2.6 percent), vaginal discharge (3.8 percent vs. 0.3 percent), muscle spasms (3.2 percent vs. 0.9 percent), hyperhidrosis (1.6 percent vs. 0.6 percent), and genital discharge (1.3 percent vs. 0.1 percent).

Drug Interactions

  •     Do not use estrogens or estrogen agonists/antagonists or fluconazole concomitantly with Osphena.
  •     Moderate to Strong CYP3A4 inhibitors (e.g., ketoconazole, fluconazole) will increase Osphena (ospemifene) drug concentrations while moderate to strong CYP3A4, CYP2C9, or CYP2C19 inducers (e.g. rifampin) will decrease Osphena (ospemifene) drug concentrations.
  •     Coadministration of Osphena with drugs that inhibit CYP3A4 and CYP2C9 may increase the risk of Osphena related adverse reactions.
  •     Osphena had no effect on the pharmacokinetics of a single 10 mg dose of warfarin. The effect of Osphena on International Normalized Ration (INR) or prothrombin time (PT) was not studied.
  •     Osphena (ospemifene) is highly protein bound. Use cautiously with highly protein bound drugs as use with other highly protein-bound drugs may lead to increase exp
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