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Once-daily Osphena® is the first and only treatment for moderate to severe vaginal dryness and/or dyspareunia that is non-hormonal, comes in an oral tablet and acts locally to improve the condition of specific vaginal tissue.*,3,4
In two randomized, double-blind, placebo-controlled, parallel-group, Phase 3 studies in women† with moderate to severe dyspareunia due to menopause, Osphena® significantly improved patients’ most bothersome symptom of moderate to severe dyspareunia.1
OSPHENA (ospemifene) is indicated for:
See full prescribing information for complete boxed warning
Endometrial Cancer
OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Perform adequate diagnostic measures, including directed and random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Cardiovascular Disorders
Estrogen-alone therapy has an increased risk of stroke and deep vein thrombosis (DVT). OSPHENA 60 mg had cerebral thromboembolic and hemorrhagic stroke incidence rates of 1.13 and 3.39 per thousand women years, respectively vs. 3.15 and 0 per thousand women years, respectively with placebo. For deep vein thrombosis the incidence rate for OSPHENA 60 mg is 2.26 per thousand women years (2 reported cases) vs. 3.15 per thousand women years (1 reported case) with placebo.
Manage appropriately any risk factors for cardiovascular disorders, arterial vascular disease (e.g., hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (e.g., personal history or family history of VTE, obesity, and systemic lupus erythematosus).
If feasible, discontinue OSPHENA at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism or during periods of prolonged immobilization.
Endometrial Cancer
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.
Breast 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 or with a history of breast cancer.
Severe Hepatic Impairment
OSPHENA should not be used in women with severe hepatic impairment.
Adverse Reactions
The most common adverse reactions (> 1%) with OSPHENA are: hot flush, vaginal discharge, muscle spasms, headache, hyperhidrosis, vaginal hemorrhage, night sweats.
Drug interactions:
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.
OSPHENA (ospemifene) is indicated for:
Endometrial Cancer
OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Perform adequate diagnostic measures, including directed and random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Cardiovascular Disorders
Estrogen-alone therapy has an increased risk of stroke and deep vein thrombosis (DVT). OSPHENA 60 mg had cerebral thromboembolic and hemorrhagic stroke incidence rates of 1.13 and 3.39 per thousand women years, respectively vs. 3.15 and 0 per thousand women years, respectively with placebo. For deep vein thrombosis the incidence rate for OSPHENA 60 mg is 2.26 per thousand women years (2 reported cases) vs. 3.15 per thousand women years (1 reported case) with placebo.
OSPHENA (ospemifene) is indicated for:
Endometrial Cancer
OSPHENA is an estrogen agonist/antagonist with tissue selective effects. In the endometrium, OSPHENA has estrogen agonistic effects. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Perform adequate diagnostic measures, including directed and random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.
Cardiovascular Disorders
Estrogen-alone therapy has an increased risk of stroke and deep vein thrombosis (DVT). OSPHENA 60 mg had cerebral thromboembolic and hemorrhagic stroke incidence rates of 1.13 and 3.39 per thousand women years, respectively vs. 3.15 and 0 per thousand women years, respectively with placebo. For deep vein thrombosis the incidence rate for OSPHENA 60 mg is 2.26 per thousand women years (2 reported cases) vs. 3.15 per thousand women years (1 reported case) with placebo.
