Indicated for:

Treatment and Prevention of Osteoporosis in Postmenopausal Women:

• For the treatment and prevention of osteoporosis in postmenopausal women.

Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis:

• For the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.

Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer:

• For the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

EVISTA is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer.

For the indications in risk of invasive breast cancer the optimum duration of treatment is not known.

EVISTA should not be used for the primary or secondary prevention of cardiovascular disease or in postmenopausal women with documented coronary heart disease or at increased risk for coronary events.

There is no indication for premenopausal use of EVISTA. Safety of EVISTA in premenopausal women has not been established and its use is not recommended.

EVISTA is contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA. Women with active or past history of venous thromboembolism should not take EVISTA.

Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events.

EVISTA should be used with caution in patients with hepatic impairment. Safety and efficacy have not been established in patients with hepatic impairment.

Safety and efficacy have not been established in patients with moderate or severe renal impairment.

Limited clinical data suggest that some women with a history of marked hypertriglyceridemia (>5.6 mmol/L or >500 mg/dL) in response to treatment with oral estrogen or estrogen plus progestin may develop increased levels of triglycerides when treated with EVISTA. Women with this medical history should have serum triglycerides monitored when taking EVISTA.

Any unexplained uterine bleeding should be investigated as clinically indicated. EVISTA-treated and placebo treated groups had similar incidences of endometrial proliferation.

Concomitant administration of cholestyramine with EVISTA is not recommended.

The safety of concomitant use of EVISTA with systemic estrogens has not been established and its use is not recommended.

If EVISTA is given concomitantly with warfarin or other warfarin derivatives, prothrombin time should be monitored more closely when starting or stopping therapy with EVISTA.

EVISTA should be used with caution with certain other highly protein-bound drugs such as diazepam, diazoxide, and lidocaine. Although not examined, EVISTA might affect the protein binding of other drugs. Raloxifene is more than 95% bound to plasma proteins.

EVISTA is contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers.

GoToSource

• Reduction of cardiovascular disease. GoToSource    

• For premenopausal women. GoToSource

• Prevention and treatment of invasive breast cancer. GoToSource

• Reduce risk of developing dementia and cognitive impairment in postmenopausal women. GoToSource

• Treatment of male patients with active acromegaly. GoToSource

• Fibromyalgia. GoToSource

• Inhibit growth of uterine leiomyomas in premenopausal females. GoToSource

• Bone disease in patients with chronic kidney disease. GoToSource

Venous thromboembolism and fatal stroke. GoToSource

Pulmonary embolism. GoToSource

Increased risk of ovarian cancer. GoToSource

Lawsuits filed for ovarian cancer, strokes, deep vein thrombosis and pulmonary and retinal embolism.