- Undiagnosed abnormal genital bleeding
- Known or suspected estrogen-dependent neoplasia
- Active deep vein thrombosis (DVT), pulmonary embolism (PE), or a history of these conditions
- Active arterial thromboembolic disease (e.g., stroke and myocardial infarction) or a history of these conditions
- Hypersensitivity (e.g., angioedema, urticaria, rash, pruritus) to OSPHENA or any of its ingredients
- OSPHENA is contraindicated in women who are or may become pregnant. OSPHENA may cause fetal harm when administered to a pregnant woman.
WARNINGS AND PRECAUTIONS
Risk factors for cardiovascular disorders, arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VYE) (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus), should be managed appropriately.
If feasible, OSPHENA should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism or during periods of prolonged immobilization.
OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has agonistic effects.
An increased risk of endometrial cancer has been reported with the use of unopposed estrogen therapy in a woman with a uterus. The greatest risk appears to be associated with prolonged use and estrogen dose. Adding a progestin to postmenopausal estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.
OSPHENA 60 mg has not been adequately studied in women with breast cancer; therefore, it should not be used in women with known or suspected breast cancer.
Severe Hepatic Impairment
OSPHENA should not be used in women with severe hepatic impairment.
The most common adverse reactions (> 1%) include: hot flush, vaginal discharge, muscle spasms, headache, hyperhidrosis, vaginal hemorrhage, night sweats.
- Do not use estrogens or estrogen agonist/antagonist concomitantly with OSPHENA
- Do not use fluconazole or ketoconazole concomitantly with OSPHENA
- Do not use rifampin concomitantly with OSPHENA. Rifampin decreases serum concentrations of OSPHENA.
Co-administration of OSPHENA with drugs that inhibit CYP3A4 and CYP2C9 may increase the risk of OSPHENA-related adverse reactions. OSPHENA is highly protein-bound. Use cautiously with highly protein-bound drugs as use with other highly protein-bound drugs may lead to increased exposure of that drug or ospemifene.
Please see Full Prescribing Information for OSPHENA (ospemifene) tablets, including Boxed Warning, regarding Endometrial Cancer and Cardiovascular Disorders, and Patient Information at osphena.com/hcp.