OSPHENA™ (ospemifene) tablets
Warnings
| WARNING: ENDOMETRIAL CANCER AND CARDIOVASCULAR DISORDERS See full prescribing information for complete boxed warning. 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. Adding a progestin to estrogen therapy reduces the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. 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 0.72 and 1.45 per thousand women, respectively vs. 1.04 and 0 per thousand women, respectively in placebo. For deep vein thrombosis, the incidence rate for OSPHENA 60 mg is 1.45 per thousand women vs. 1.04 per thousand women in placebo. See warnings and precautions below. |
Description
| OSPHENA (ospemifene) tablets, for oral use Initial U.S. Approval: 2013 OSPHENA is an estrogen agonist/antagonist. |
Clinical pharmacology
| Mechanism of Action: OSPHENA is an estrogen agonist/antagonist with tissue selective effects. Its biological actions are mediated through binding to estrogen receptors. This binding results in activation of estrogenic pathways in some tissues (agonism) and blockade of estrogenic pathways in others (antagonism). |
Indications and usage
| INDICATIONS AND USAGE: OSPHENA is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. |
Contraindications
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Precautions
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WARNINGS AND PRECAUTIONS:
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Adverse reactions
| ADVERSE REACTIONS Adverse reactions (≥1 percent) include: hot flush, vaginal discharge, muscle spasms, genital discharge, hyperhidrosis. To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. at 1-855-OSPHENA (1-855-677-4362) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Do not use fluconazole concomitantly with OSPHENA. Fluconazole increases serum concentrations of OSPHENA. Do not use rifampin concomitantly with OSPHENA. Rifampin decreases serum concentration of OSPHENA. USE IN SPECIFIC POPULATIONS See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide. |
Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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