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.

Starting EVISTA

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If you have recently been prescribed EVISTA, or even if you are already taking EVISTA, you may have many questions, including how it works, how and when to take it, possible interactions with other drugs, and more. These questions are designed to give you an overview of EVISTA and how it can help you reduce your individual health risks. Select a question below to get started: What is EVISTA? How do I take EVISTA? What are the side effects of EVISTA? Can EVISTA treat my osteoporosis? Can EVISTA reduce my risk of invasive breast cancer? Is EVISTA an estrogen or hormone? Can EVISTA be taken with estrogen? How many women have been in clinical trials with EVISTA? How many prescriptions have been filled for EVISTA? Why is it important to keep taking EVISTA? What is EVISTA? EVISTA is a type of prescription medicine called an estrogen agonist/antagonist, commonly called a Selective Estrogen Receptor Modulator (SERM). EVISTA is for women past menopause, and has more than one use: Preventing and treating osteoporosis by helping make bones stronger Reducing the risk of invasive breast cancer while treating osteoporosis Reducing the risk of invasive breast cancer for postmenopausal women who are at high risk for invasive breast cancer Back to Top How do I take EVISTA? EVISTA is a daily pill that can be taken once a day, any time you wish, with food or without. If you are preventing or treating osteoporosis, EVISTA can also be taken along with supplemental calcium and vitamin D. Back to Top What are the side effects of EVISTA? Serious and life-threatening side effects can occur while taking EVISTA. 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. The most common side effects are hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. Hot flashes are more common during the first 6 months after starting treatment. In clinical trials, side effects were usually mild enough that most women did not stop taking EVISTA. These are not all the side effects of EVISTA. Tell your healthcare professional about any side effect that bothers you or that does not go away. If you have any problems or questions that concern you while taking EVISTA, ask your healthcare professional or pharmacist for more information. Back to Top Can EVISTA treat my osteoporosis? EVISTA treats osteoporosis in women past menopause by helping to stop the thinning of bone, increasing bone mineral density, and reducing the risk of spine fractures. Back to Top Can EVISTA reduce my risk of invasive breast cancer? If you have postmenopausal osteoporosis, EVISTA can be used to lower your chance of getting invasive breast cancer. If you do not have osteoporosis, but are past menopause and at high risk for invasive breast cancer, EVISTA may also be used to lower your risk of getting invasive breast cancer. EVISTA will not completely get rid of your chance of getting invasive breast cancer. Your doctor can estimate the risk of invasive breast cancer by assessing your personal 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. Note: 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. Back to Top Is EVISTA an estrogen or hormone? EVISTA is NOT a hormone, like estrogen. It's called an estrogen agonist/antagonist, which means it works 2 ways in your body. It’s interesting to know that EVISTA acts like estrogen in some tissues, and has the opposite effect of estrogen in other tissues. In your bones, EVISTA appears to mimic the effect of estrogen, helping to make your bones stronger In your breasts, EVISTA appears to block the effect of estrogen, reducing your risk for invasive breast cancer Back to Top 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. Back to Top 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 up to 8 years. Back to Top How many prescriptions have been filled for EVISTA? Over 70 million prescriptions for EVISTA have been filled since FDA approval in 1997. Data Source: National Prescription Audit (NPA). IMS Health, April 2010. Back to Top Why is it important to keep taking EVISTA? Your doctor prescribed EVISTA because you are a woman past menopause who: Has low bone mass, or Has osteoporosis, or Is at high risk for invasive breast cancer In order to get the most benefit out of taking EVISTA, it’s important to keep taking EVISTA every day and follow your doctor’s dosing instructions. 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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