Generic Name and Formulations:
Ospemifene 60mg; tabs.
Duchesnay USA, Inc.
Indications for OSPHENA:
Treatment of moderate-to-severe dyspareunia due to menopause.
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 (Cat.X).
Endometrial cancer. Cardiovascular disorders.
Use for shortest duration consistent with treatment goals and risks. Increased risk of cardiovascular disorders, arterial vascular disease, and/or venous thromboembolism. Discontinue if thromboembolic or hemorrhagic stroke is suspected or occur. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of endometrial cancer. Consider the addition of a progestin in patients with an intact uterus to reduce endometrial hyperplasia risk. Known, suspected, or history of breast cancer: do not use. Severe hepatic impairment: not recommended. Reevaluate periodically. Nursing mothers.
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.
Hot flush, vaginal or genital discharge, muscle spasms, hyperhidrosis.
Tabs—100; blister pack—30 (2 X 15)