Ospemifene

DEA Class; Rx

Common Brand Names; Osphena

Indicated for the treatment of moderate to severe vaginal dryness and dyspareunia, symptoms of atrophic vaginitis due to menopause.

Undiagnosed abnormal genital bleeding

Known or suspected estrogen-dependent neoplasia

History of, or active DVT or PE

History of, or active arterial thromboembolic disease (eg, stroke, MI)

Known or suspected pregnancy or women who may become pregnant

Documented hypersensitivity to drug or ingredients

• Hot flush (7.5%)
• Vaginal discharge (3.8%)
• Muscle spasms (3.2%)
• Hyperhidrosis (1.6%)
• Genital discharge (1.3%)
• Hypersensitivity
• Angioedema
• Rash
• Rash, erythematous
• Generalized rash
• Pruritus
• Urticaria
• Neoplasms: Benign, malignant and unspecified, endometrial hyperplasia, endometrial cancer
• Vascular disorders: Deep vein thrombosis, thrombosis, pulmonary embolism

Manage risk factors for cardiovascular disorders, arterial vascular disease (eg, hypertension, DM, smoking, hypercholesterolemia, obesity), and/or venous thromboembolism to reduce risk for progression to serious disease

Increased risk of stroke reported in year 1 and persisted; should thromboembolic or hemorrhagic stroke occur or be suspected, therapy should be discontinued immediately

Venous thromboembolism (VTE) reported; if VTE occurs or suspected, discontinue immediately; when possible, discontinue therapy 4-6 weeks before surgery of the type associated with thromboembolism during prolonged periods of immobilization

Increased risk for endometrial hyperplasia (see Black Box Warnings)

Has not been studied in women with breast cancer; do not use with known or suspected breast cancer or history of breast cancer

Do not use with severe hepatic impairment (not studied)

May initiate or increase occurrence of hot flashes in some women

Contraindicated in women who are or may become pregnant; if a woman becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus

Unknown if excreted in human breast milk

Do not breastfeed