Information for Healthcare Professionals

Indications for EVISTA^® (raloxifene HCl tablets)
EVISTA is indicated for:

The treatment and prevention of osteoporosis in postmenopausal women
The reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis
The reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer

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 HCI tablets)

What is the most important information I should know 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. Do not take EVISTA if you:

Have had blood clots in your legs, lungs or eyes.
Are pregnant, nursing or may become pregnant, as EVISTA may cause fetal harm.

What should I tell my doctor before taking EVISTA?

Talk to your doctor about all your medical conditions including:

If you have had blood clots in your legs, lungs or eyes.
If you have had a stroke, mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or think you have other risk factors for stroke or heart attack.
EVISTA should not be used for prevention of heart disease.
If you are premenopausal. Only take prescription EVISTA if you are past menopause.
If you have liver or kidney disease. 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.
If you have taken estrogen in the past and had a high increase of triglycerides (a kind of fat in the blood).

What are the possible side effects of EVISTA?

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.

What are the possible drug interactions with EVISTA?

If you take warfarin (Coumadin®, Jantoven®) or other courmarin blood thinners, you may need to do a blood test (protrombin time, pro-time or INR) when you first start or if you need to stop taking EVISTA. Your doctor may need to adjust the dose of your warfarin or other coumarin blood thinners.
EVISTA should not be taken with cholestyramine or estrogens.

For additional Important Safety Information, please see the Medication Guide and full Prescribing Information, including Boxed Warning.

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For many women past menopause, regular screenings for invasive breast cancer (such as mammograms) and osteoporosis remind them how important it is to maintain a healthy lifestyle. In addition to what you’re already doing to protect your bones, there are lifestyle changes you can make that can help you reduce the risk of invasive breast cancer. Acquire Healthy Habits Exercise Most Days of the Week Learn More with Online Resources Acquire Healthy Habits Maintain a Healthy Diet Maintaining a healthy diet past menopause is an important part of a healthy lifestyle. Here are things you can do to acquire a healthy diet: Use portion control to help achieve and maintain a healthy weight Consume at least 5 servings of fruits and vegetables daily Eat whole grains instead of processed (refined) grains Reduce your intake of processed and red meats Take Supplements that Your Doctor Recommends If you are treating or preventing osteoporosis, your doctor may recommend that you take supplemental calcium and/or Vitamin D. Quit Smoking Smoking is detrimental to your overall health. If you smoke and have thought about quitting, now is the time to take charge. Reduce Alcohol Consumption Research has shown that more than 2 alcoholic beverages each day may increase certain health risks in women past menopause. Talk with your healthcare professional to better understand the health risks related to alcohol consumption. Back to Top Exercise Most Days of the Week Aim to incorporate at least 30 minutes of moderate to vigorous exercise into your day at least 5 times a week. Exercising for longer periods of time, between 45 to 60 minutes, is preferred. Before beginning a new exercise program, you should consult with your doctor. Back to Top Learn More with Online Resources To learn more tips for staying healthy past menopause, visit the following sources: About Invasive 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 About Osteoporosis National Institutes of Health, Osteoporosis and Related Bone Diseases—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 International Osteoporosis Foundation (IOF) (International Call) 011 41 22 994 0100 http://www.osteofound.org U.S. Surgeon General's Report on Bone Health and Osteoporosis http://www.surgeongeneral.gov/library/bonehealth Back to Top
Indication for EVISTA^® (raloxifene HCI 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. Indication for EVISTA^® (raloxifene HCI tablets) EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Indication for EVISTA^® (raloxifene HCI tablets) EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. 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. Indications for EVISTA^® (raloxifene HCI tablets) EVISTA is indicated for: The treatment and prevention of osteoporosis in postmenopausal women The reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis The reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer 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. Before Taking EVISTA 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 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.

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