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OSPHENA
Menopause and HRT
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Drug Name:

OSPHENA Rx

Generic Name and Formulations:
Ospemifene 60mg; tabs.

Company:
Duchesnay USA, Inc.

Therapeutic Use:

Indications for OSPHENA:

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

Adult:

60mg once daily with food.

Children:

Not applicable.

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.

Boxed Warning:

Endometrial cancer. Cardiovascular disorders.

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.

Pharmacological Class:

Estrogen (agonist/antagonist).

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.

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

Tabs—90

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