EVISTA® (raloxifene HCl): Info for Healthcare Professionals

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

Important limitations of use for breast cancer risk reduction are as follows: There are no data available regarding the effect of EVISTA on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of EVISTA, EVISTA is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence, and EVISTA is not indicated for the reduction in the risk of noninvasive breast cancer.

This Web site is designed to help you learn about EVISTA, and the types of patients who could benefit. For a list of all indications, click here.

Over 56 million prescriptions for EVISTA have been filled since FDA approval in 1997.⁸

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Lancet. 2006;367:2010-2018.
American Cancer Society. Breast Cancer Facts & Figures 2005-2006.
Available at: http://www.cancer.org/downloads/STT/CAFF2005BrF.pdf. Accessed January 12, 2007.
Curr Med Res Opin. 2005;21:1441-1452.
J Natl Cancer Inst. 2004;96:1751-1761.
JAMA. 2006;295:2727-2741.
Breast Cancer Res Treat. 2001;65:125-134.
N Engl J Med. 2006;355:125-137.
Data on file. Eli Lilly and Company (EVI20070727).

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Important Safety Information for EVISTA

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE

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. Consider risk-benefit balance in women at risk for stroke.

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.