EVISTA® (raloxifene HCl) | Educating Your Patients

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.

Please click the button below to enter the EVISTA Website for healthcare professionals. If you would like to visit the EVISTA Website for consumers, please click here.

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.

Advanced Search

Home

Important Safety Information and Boxed Warning


Your postmenopausal patients may want to understand more about the health risks they may face and learn what steps they can take to reduce their health risks. This section will help empower them to take charge of their health. Osteoporosis quick facts Invasive breast cancer quick facts Questions your patients may have about EVISTA Osteoporosis quick facts The following facts compiled by the National Osteoporosis Foundation¹ will help your patients better understand the disease and the importance of prevention and treatment, and realize that they are not alone in their fight against osteoporosis. Prevalence Osteoporosis is under recognized and under treated not only in Caucasian women, but also African-American women¹ Osteoporosis is a health threat for an estimated 55% of those 50 years of age and older in the US¹ 8 million women already have the disease¹ Fractures Up to 50% of women over age 50 will have an osteoporosis-related fracture in their remaining lifetime^2,3 Osteoporosis is responsible for more than 1.5 million fractures in women over 50 in the US annually⁴ $12.8 billion is the annual cost of osteoporotic fractures in the US for women over 50⁴ Prevention tips By making several basic yet effective lifestyle changes, your patients will be able to help their bones become their strongest, and help grow healthy new bone tissue as they age. Here are several areas of focus you may want to discuss with your patients: Nutrition: Get daily recommended amounts of calcium and vitamin D Exercise: Engage in regular weight-bearing exercise Healthy habits: Avoid smoking and excessive alcohol Treatment: Medication to prevent disease progression when appropriate Medications: Monitor certain medications that may cause bone loss (corticosteroids, anticonvulsants, and others)¹ Back to Top Invasive breast cancer quick facts Invasive breast cancer is the most common cancer among women in the United States.² About 2 out of 3 invasive breast cancers are found in women age 55 or older⁵ Early diagnosis results in better prognosis⁶ Back to Top Questions your patients may have about EVISTA 1. What is EVISTA? EVISTA is a type of prescription medicine. It is an estrogen agonist/antagonist, commonly called a Selective Estrogen Receptor Modulator (SERM). EVISTA is for women after menopause, and has more than one use: EVISTA treats and prevents osteoporosis by helping make your bones stronger and less likely to break; and if you have osteoporosis or are at high risk for invasive breast cancer, EVISTA can be used to lower your chance of getting invasive breast cancer. EVISTA will not totally get rid of your chance of getting invasive breast cancer. 2. Is EVISTA an estrogen or hormone? EVISTA is in a class of medications called estrogen agonist/antagonists, commonly known as a Selective Estrogen Receptor Modulator (SERM). EVISTA is not a hormone. In the bones, EVISTA appears to work like estrogen In the breasts, EVISTA appears to block estrogen from affecting the breasts Different SERMs have different indications.⁷ Only EVISTA is indicated for the treatment of osteoporosis in postmenopausa women and for invasive breast cancer risk reduction in postmenopausal women with osteoporosis. 3. Can EVISTA treat osteoporosis? Yes. EVISTA treats osteoporosis by helping to make your bones stronger and less likely to break. 4. Can EVISTA reduce the risk of invasive breast cancer? If you have osteoporosis or are at high risk for invasive breast cancer, EVISTA can be used to lower your chance of getting invasive breast cancer. EVISTA will not totally get rid of your chance of getting invasive breast cancer. Your doctor can estimate your risk of invasive breast cancer by asking you about your individual risk factors. You and your doctor should talk about whether the possible benefit of EVISTA in lowering your chance of getting invasive breast cancer is greater than its possible risks. EVISTA is not for use in premenopausal women (women who have not passed menopause). 5. What are the side effects of EVISTA? Serious and life-threatening side effects can occur while taking EVISTA. These include blood clots and dying from stroke. Increased risk of blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) have been reported with EVISTA. Women who have or have had blood clots in the legs, lungs, or eyes should not take EVISTA. Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking EVISTA. Before starting EVISTA, tell your doctor if you have had blood clots in your legs, lungs, or eyes, a stroke, mini-stroke (transient ischemic attack), or have an irregular heartbeat. The most common side effects of EVISTA are hot flashes, leg cramps, swelling of the feet, ankles, and legs, flu syndrome, joint pain, and sweating. Hot flashes are more common during the first 6 months after starting treatment. 6. How do I take EVISTA? Take one EVISTA tablet each day. You can take EVISTA any time of day, with or without food (it may be taken along with a calcium supplement and/or vitamin D), as your healthcare professional prescribes. 7. Can EVISTA be taken with estrogen? In clinical trials, EVISTA has not been studied in combination with any form of estrogen that comes in a pill, patch, or injection. EVISTA should not be taken with any of these forms of estrogen. 8. Can EVISTA be taken with aspirin or ibuprofen? There are no data that suggest you cannot take aspirin or ibuprofen with EVISTA. You should discuss all medications you are taking, including over-the-counter and herbal medications, with your healthcare professional. 9. How many women have been in clinical trials with EVISTA? EVISTA has been studied extensively with more than 37,000 women involved in various clinical studies.^8-10 10. How many prescriptions have been filled for EVISTA? Over 70 million prescriptions for EVISTA have been filled since the FDA initially approved it in 1997.¹¹ References: National Osteoporosis Foundation. Fast Facts. Available at: http://www.nof.org/osteoporosis/diseasefacts.htm. Accessed January 28, 2010. Arch Intern Med. 1991;151:2026-2032. J Bone Miner Res. 1995;10:175-177. J Bone Miner Res. 2007;22:465-475. 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. American Cancer Society. What are the key statistics for breast cancer? Available at: http://www.cancer.org/Cancer/BreastCancer/DetailedGuide/index. Accessed January 28, 2010. Manufacturers' prescribing information. JAMA. 2006;295:2727-2741. Breast Cancer Res Treat. 2001;65:125-134. N Engl J Med. 2006;355:125-137. Data on file, Lilly Research Laboratories (EVI20100430A).
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.

Prescribing Information | Medication Guide | Important Safety Information and Boxed Warning | Site Map | Contact Us

Privacy Statement | Terms of Use | Copyright