Osphena Generic Name & Formulations
Ospemifene 60mg; tabs.
Treatment of moderate to severe dyspareunia or vaginal dryness due to menopause.
Osphena Dosage and Administration
60mg once daily with food.
Undiagnosed abnormal genital bleeding. Known or suspected estrogen-dependent neoplasia. Active DVT, pulmonary embolism, or history of. Active arterial thromboembolism (eg, stroke, MI, or history of). Known or suspected pregnancy.
Osphena Boxed Warnings
Endometrial cancer. Cardiovascular disorders.
Increased risk of endometrial cancer in women with intact uterus (adding progestins has been shown to reduce endometrial hyperplasia risk). Evaluate if undiagnosed persistent or recurring abnormal genital bleeding occurs. Increased risk of cardiovascular disorders (eg, MI, stroke, VTE); discontinue if suspected or occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Use for shortest duration consistent with treatment goals and risks. Known, suspected, or history of breast cancer: do not use. Severe hepatic impairment: not recommended. Reevaluate periodically. Nursing mothers: not recommended.
Avoid concomitant other estrogens or estrogen agonists/antagonists. Antagonized by rifampin. Potentiated by fluconazole (avoid), ketoconazole. May affect or be affected by highly protein-bound drugs. May increase risk of adverse reactions with concomitant CYP3A4 and CYP2C9 inhibitors.
Osphena Adverse Reactions
Hot flush, vaginal discharge/hemorrhage, muscle spasms, headache, hyperhidrosis, night sweats.
Osphena Clinical Trials
Osphena Patient Counseling