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About EVISTA
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Important Safety Information
Prescribing Information
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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 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.

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

Important Safety Information for EVISTA® (raloxifene HCl tablets)

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.

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

If you already have or have had breast cancer, EVISTA does not treat it or prevent its return, and it does not reduce the risk of all forms of breast cancer.

Please read the safety information provided on this page. To enter the EVISTA Web site, click the button below.

Important Safety Information About EVISTA® (raloxifene HCl tablets)

You should not take EVISTA if you have had or are at risk for getting blood clots in the legs, lungs or eyes, as it may increase the risk of blood clots. Stop taking EVISTA and call your doctor if you have leg pain or warmth, swelling of the legs, hands or feet, chest pain, shortness of breath or a sudden vision change, as these may be signs of a blood clot. Being unable to move around for long periods may increase this risk. If you will need to be still for a long time, talk to your doctor about ways to reduce the risk of blood clots.

EVISTA does not increase the risk of a heart attack or stroke in women who have had or are at risk for a heart attack; however; EVISTA increases the likelihood of dying from stroke in these women, should one occur. Before taking EVISTA tell your doctor if you have had a stroke, a mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or believe you have other risk factors for stroke or a heart attack.

EVISTA is not right for everyone. You should only take prescription EVISTA if you are past menopause. Before taking EVISTA, talk to your doctor about all your medical conditions. If you are pregnant, nursing or may become pregnant, do not take EVISTA, as it may cause fetal harm. Women with liver or kidney disease should use EVISTA with caution. EVISTA should not be taken with estrogens in the form of pills, patches or injections. Side effects may include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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

Resources
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Learn more about osteoporosis, breast cancer, and general women's health by visiting these Web sites.

About Osteoporosis

National Institutes of Health, Osteoporosis and Related Bone Disease — National Resource Center
800-624-BONE or 202-223-0344
http://www.osteo.org

National Osteoporosis Foundation (NOF)
800-231-4222 or 202-223-2226
http://www.nof.org

U.S. Surgeon General's Report on Bone Health and Osteoporosis
http://www.surgeongeneral.gov/library/bonehealth

About Breast Cancer

American Cancer Society
800-ACS-2345 (800-881-2345)
http://www.cancer.org

Cancer Research and Prevention Foundation
800-227-2732
http://www.preventcancer.org

National Breast Cancer Coalition
800-622-2838
http://www.stopbreastcancer.org

National Cancer Institute (NCI)
800-4CANCER (800-422-6237)
http://www.cancer.gov

The Susan G. Komen Breast Cancer Foundation
800-I'M AWARE (800-462-9273)
http://www.komen.org/bci

Breast Cancer Network of Strength (formerly known as Y-ME National Breast Cancer Organization)
213-986-8338
http://www.networkofstrength.org

General Women's Health

National Women's Health Resource Center (NWHRC)
877-986-9472
http://www.healthywomen.org

Department of Health and Human Services, Office of Women's Health
National Women's Health Information Center
800-994-9662
http://www.4woman.gov

Nutrition

American Dietetic Association (ADA)
800-366-1655 (Consumer Nutrition Information and Referral)
http://www.eatright.org

National Digestive Diseases Information Clearinghouse
800-891-5389 or 301-654-3810
http://www.digestive.niddk.nih.gov

Exercise

American College of Sports Medicine (ACSM)
317-637-9200
http://www.acsm.org

Aging

Alliance for Aging Research
202-293-2856
http://www.agingresearch.org

National Institutes of Health (NIH) National Institute on Aging (NIA)
301-496-1752
http://www.nia.nih.gov

Social Organizations

General Federation of Women's Clubs (GFWC)
800-443-GFWC (800-443-4392)
http://www.gfwc.org

National Women's Health Resource Center (NWHRC)
877-986-9472
http://www.healthywomen.org

Department of Health and Human Services, Office of Women's Health
National Women's Health Information Center
800-994-9662
http://www.4woman.gov

Caregiver Resources
Being a caregiver has its special challenges and opportunities. Here are some useful Web sites with valuable information that can assist you as you support a friend, family member, or patient with osteoporosis or invasive breast cancer:

Caregiver.com
www.caregiver.com

CareGuide.com
www.careguide.com

Eldercare Locator
www.eldercare.gov

Foundation for Osteoporosis Research and Education
www.fore.org

Hormone Foundation
www.hormone.org

National Institutes of Health, Osteoporosis and Related Diseases — National Resource Center
www.osteo.org

North American Menopause Society
www.menopause.org



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.

If you already have or have had breast cancer, EVISTA does not treat it or prevent its return, and it does not reduce the risk of all forms of breast cancer.

Important Safety Information About EVISTA

You should not take EVISTA if you have had or are at risk for getting blood clots in the legs, lungs or eyes, as it may increase the risk of blood clots. Stop taking EVISTA and call your doctor if you have leg pain or warmth, swelling of the legs, hands or feet, chest pain, shortness of breath or a sudden vision change, as these may be signs of a blood clot. Being unable to move around for long periods may increase this risk. If you will need to be still for a long time, talk to your doctor about ways to reduce the risk of blood clots.

EVISTA does not increase the risk of a heart attack or stroke in women who have had or are at risk for a heart attack; however; EVISTA increases the likelihood of dying from stroke in these women, should one occur. Before taking EVISTA tell your doctor if you have had a stroke, a mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or believe you have other risk factors for stroke or a heart attack.

EVISTA is not right for everyone. You should only take prescription EVISTA if you are past menopause. Before taking EVISTA, talk to your doctor about all your medical conditions. If you are pregnant, nursing or may become pregnant, do not take EVISTA, as it may cause fetal harm. Women with liver or kidney disease should use EVISTA with caution. EVISTA should not be taken with estrogens in the form of pills, patches or injections. Side effects may include hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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