Clinical Data

EVISTA is indicated for the prevention and treatment of osteoporosis in postmenopausal women, for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis, and for the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

In clinical trials, up to 8 years of research^1,2 and more than 37,000 patients^3-5 confirm the safety profile of EVISTA. EVISTA, an estrogen agonist/antagonist, commonly known as a SERM, may act differently in various tissues and organs. EVISTA appears to act as an estrogen agonist in the bones and an estrogen antagonist in the breast and uterus.

In this section, you can learn more about the clinical profile of EVISTA, including details on clinical trials, dosing guidelines, and complete safety information.

1. Curr Med Res Opin. 2005;21:1441-1452.
2. J Natl Cancer Inst. 2004;96:1751-1761.
3. JAMA. 2006;295:2727-2741.
4. Breast Cancer Res Treat. 2001;65:125-134.
5. N Engl J Med. 2006;355:125-137.

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Important Safety Information for EVISTA

Contraindications
EVISTA is contraindicated in nursing women and in women who are or may become pregnant, as it may cause fetal harm. EVISTA is also contraindicated in women with active or past venous thromboembolic events (VTEs), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Warnings and Precautions
In a study of postmenopausal women at high risk for cardiovascular disease taking EVISTA, there was no increase in the incidence of stroke; however, there was an increase in death due to stroke. EVISTA also did not increase or decrease the incidence of overall mortality, cardiovascular mortality, or heart attack. The risk-benefit balance should be considered in women at risk for stroke, such as those with prior stroke or transient ischemic attack (TIA), atrial fibrillation, hypertension, or cigarette smoking. EVISTA should be used with caution in patients with hepatic impairment or moderate/severe renal impairment since safety and efficacy have not been established in these patients. The safety of concomitant use of EVISTA with systemic estrogens has not been established and its use is not recommended.

Adverse Reactions
The common adverse reactions considered to be drug related:

Adverse reactions occurring in the clinical trials at a frequency ≥2.0% in either group and in more EVISTA-treated women than in placebo-treated women include:

The majority of adverse reactions occurring during the osteoporosis prevention and treatment studies were mild and generally did not require discontinuation of therapy.

Please see Contraindications, Warnings and Precautions, and Adverse Reactions sections of full Prescribing Information for other Important Safety Information.