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.

Treat or Prevent Osteoporosis with EVISTA

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Osteoporosis Treatment EVISTA has been prescribed by healthcare professionals for more than 10 years to: Help make bones stronger Help stop thinning of the bone Increase bone mineral density Reduce the risk of spine fractures Osteoporosis Prevention In a 5-year study of women past menopause with normal to low bone mass, EVISTA increased BMD in the lumbar spine and hip. Among women with low bone mass of the lumbar spine, EVISTA reduced the risk of developing osteoporosis at that site. The average age of the women in the study was 54. In addition to taking EVISTA once daily, they also took daily calcium supplements (400-600 mg). Indication for EVISTA^® (raloxifene HCI tablets) EVISTA is indicated 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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