Ospemifene Disease Interactions

Ospemifene has not been adequately studied in women with breast cancer, therefore should not be used in women with known, suspected or with a history of breast cancer. Additionally, ospemifene is contraindicated in the presence of any known or suspected estrogen-dependent neoplasia.

There is a reported increase of stroke and deep vein thrombosis (DVT) in postmenopausal women receiving oral conjugated estrogens. Ospemifene should be prescribed for the shortest duration consistent with treatment goals, weighting risks and benefits for each woman. Ospemifene is contraindicated in women with active DVT, pulmonary embolism, active arterial thromboembolic disease (such as stroke or myocardial infarctions), or a history of any of these conditions. Other risk factors for cardiovascular disorders and/or venous thromboembolism such as hypertension, diabetes, smoking, hypercholesterolemia, obesity, lupus erythematosus (in personal or family history), should be evaluated and managed appropriately.

The use of ospemifene is contraindicated in women with any undiagnosed abnormal genital bleeding. There is an increased risk of endometrial hyperplasia and endometrial cancer in patients using estrogens. Adequate diagnostic measures should be undertaken to rule out malignancy in any postmenopausal woman with undiagnosed persistent or recurring abnormal genital bleeding.

Ospemifene should not be used in women with severe hepatic impairment, as the pharmacokinetics have not been studied in these patients. No clinically important differences were observed in women with mild to moderate hepatic impairment when compared to healthy women, therefore no dose adjustment is needed in these patients.