• Menopause and HRT

Osphena Generic Name & Formulations

General Description

Ospemifene 60mg; tabs.

Pharmacological Class

Estrogen (agonist/antagonist).

How Supplied



Generic Availability


Osphena Indications


Treatment of moderate to severe dyspareunia or vaginal dryness due to menopause.

Osphena Dosage and Administration


60mg once daily with food.


Not applicable.

Osphena Contraindications


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.

Osphena Boxed Warnings

Boxed Warning

Endometrial cancer. Cardiovascular disorders.

Osphena Warnings/Precautions


Increased risk of endometrial cancer in women with intact uterus (adding progestins has been shown to reduce endometrial hyperplasia risk). Evaluate if undiagnosed persistent or recurring abnormal genital bleeding occurs. Increased risk of cardiovascular disorders (eg, MI, stroke, VTE); discontinue if suspected or occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Use for shortest duration consistent with treatment goals and risks. Known, suspected, or history of breast cancer: do not use. Severe hepatic impairment: not recommended. Reevaluate periodically. Nursing mothers: not recommended.

Osphena Pharmacokinetics

See Literature

Osphena Interactions


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.

Osphena Adverse Reactions

Adverse Reactions

Hot flush, vaginal discharge/hemorrhage, muscle spasms, headache, hyperhidrosis, night sweats.

Osphena Clinical Trials

See Literature

Osphena Note

Not Applicable

Osphena Patient Counseling

See Literature