EVISTA® (raloxifene HCl) | Risk for Invasive Breast Cancer

Important Safety Information and Boxed Warning Prescribing Information Medication Guide

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

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. EVISTA is not indicated for the reduction in the risk of noninvasive breast cancer.

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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.

For additional information, please see the full Prescribing Information and Medication Guide.

EVISTA is a once-daily 60-mg tablet. Supplemental calcium and/or vitamin D should be added to diet if daily intake is inadequate.

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Important Safety Information and Boxed Warning


Invasive breast cancer is an important health concern for women. According to the American Cancer Society¹: Breast cancer is the most common type of cancer in women, of which most is invasive It was estimated that over 192,000 new cases of invasive breast cancer would occur among US women in 2009, most over age 50 Invasive breast cancer extends beyond the basement membrane of the breast ducts or lobules into the surrounding normal breast tissue The following widely accepted risk factors can help identify patients at increased risk for invasive breast cancer^3,4: Female gender Family history of breast cancer (first-degree relative) Previous breast biopsy History of atypical hyperplasia or lobular carcinoma in situ Advanced age at first live birth (or nulliparity) Early age at menarche Recent use of combined postmenopausal hormone therapy Greater-than-average breast density Age Simplify your evaluation When assessing the risk for invasive breast cancer in postmenopausal patients with osteoporosis, consider the “Big 3” for simplicity: Family history (first-degree relative) Personal risk factors Age Family history Having one or more first-degree relatives* with invasive breast cancer increases the risk of developing the disease.⁵ Additional evaluation may be required for some patients based on their family history 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. EVISTA is not indicated for the reduction in the risk of noninvasive breast cancer. Back to Top Personal risk factors Any previous breast biopsy A previous breast biopsy (normal or abnormal) is a risk factor for invasive breast cancer^3,7,8 If a patient had a previous breast biopsy and it was abnormal (eg, atypical hyperplasia), she would be at a significantly increased risk for invasive breast cancer Atypical hyperplasia increases invasive breast cancer risk approximately 4-fold⁹ Greater-than-average breast density Postmenopausal women with breast tissue rated as extremely dense have a 3-fold to 4-fold increased risk of breast cancer compared with postmenopausal women with low density⁷ Breast density is an independent risk factor for breast cancer, regardless of age¹⁰ Postmenopausal women with dense breasts may benefit from additional screening (eg, digital mammography, MRI, or ultrasound)¹¹ Back to Top Age The incidence of invasive breast cancer increases with age. Back to Top References: American Cancer Society. Cancer Facts & Figures 2009. Available at: http://www.cancer.org/docroot/STT/STT_0.asp?from=fast. Accessed October 7, 2009. CA Cancer J Clin. 2008;58:71-96. National Cancer Institute. Breast Cancer Risk Assessment Tool. Available at: http://www.cancer.gov/bcrisktool/. Accessed January 28, 2009. American Cancer Society. Breast Cancer Detailed Guide. Available at: http://www.cancer.org/Cancer/BreastCancer/DetailedGuide/index. Accessed December 3, 2009. American Cancer Society. Breast Cancer Facts & Figures 2007-2008. Available at: http://www.cancer.org/acs/groups/content/@nho/documents/document/bcfffinalpdf.pdf. Accessed January 28, 2009. Lancet. 2001;358;1389-1399. J Natl Cancer Inst. 2006;98:1215-1226. J Natl Cancer Inst. 2007;99:1695-1705. Cancer. 2007;109:180-187. J Natl Cancer Inst. 2006;98:1204-1214. J Natl Cancer Inst. 1995;87:1622-1629. National Cancer Institute. SEER Cancer Statistics Review 1975-2006. Table 4.10. Available at: http://seer.cancer.gov/csr/1975_2006/results_merged/sect_04_breast.pdf. Accessed October 15, 2009. Harrison's Principles of Internal Medicine. 16th ed. New York, NY: McGraw Hill Companies, Inc; 2005:2209.
Indications for EVISTA^® (raloxifene HCl tablets) EVISTA is indicated for the treatment of osteoporosis and for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. EVISTA is indicated for the prevention and treatment of osteoporosis in postmenopausal women. EVISTA is indicated for the prevention and treatment of osteoporosis in postmenopausal women and for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer. 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. EVISTA is not indicated for the reduction in the risk of noninvasive breast cancer. 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. For additional information, please see the full Prescribing Information and Medication Guide. EVISTA is a once-daily 60-mg tablet. Supplemental calcium and/or vitamin D should be added to diet if daily intake is inadequate.

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