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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.

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Screening Methods

There are tests to screen for both invasive breast cancer and osteoporosis. Talk to your healthcare professional about when you should first begin screening, and how often to repeat these tests. Click on each section to find the latest methods and recommendations for taking action.

Screening for Osteoporosis
Getting the proper tests in order to correctly diagnose osteoporosis is important. These tests may also help predict your chances of developing osteoporosis in the future. If necessary, your healthcare professional can use this information to plan the best course of treatment for you.

  • X-ray: If your back has been hurting, if you have lost height or your posture has changed, your healthcare professional may order an x-ray of your spine. An x-ray is a test that can produce an image of the bones or organs of the body and thus can be used to find out if you have broken any of the bones in the spine, which are called vertebrae. However, an x-ray is not as accurate as a bone mineral density test in determining bone mass. X-rays can only detect bone loss after 30% of your skeleton has already been depleted.
  • Bone Mineral Density (BMD) Test: The most common test for osteoporosis is the DXA (Dual Energy X-Ray Absorptiometry), which your healthcare professional may call a "bone mineral density" test or "bone scan." This is a painless, specialized x-ray that measures whether you are losing bone in your hip and spine.

    DXA measures your bone mineral density and compares it to the average score of a "young normal" healthy adult. Your result, called a "T-score," reflects how far off your bone mineral density is from that of an average healthy adult. Scores are measured in negative points, which indicate your risk for breaking a bone.

    *Although these definitions are needed to diagnose osteoporosis, they should not be used alone to determine treatment.
    BMD tests can:
    • Detect low bone density before a fracture occurs
    • Confirm a diagnosis of osteoporosis if you have already broken a bone
    • Help predict your chances of a future fracture
    • Help determine your rate of bone loss
    Talk to your healthcare professional about when to begin bone mineral density testing, and how often to repeat it.

Screening for Breast Cancer
There is no certain way to predict who will get breast cancer, so it is important to get regular screening to help detect any cancer at the earliest possible stage. The goal of screening is to find cancers when they are small and localized because early detection increases the chances that treatment will work. Below are recommended exams for all women past menopause.

  • Breast Self-Exam (BSE): This is something you should do at least once every month. Your healthcare professional can show you how to examine your own breasts, and you'll learn to recognize any changes as you become familiar with the feel of your breast tissue. Contact your healthcare professional if you notice unusual changes such as:
    • Lump or thickening in the breast, underarm or nearby
    • Nipple tenderness or discharge, or a nipple that turns inward into the breast
    • Change in the size or shape of the breast
    • Red, swollen, dimpled, or scaly skin on the breast or nipple
    • Pain or other symptoms that don't go away
  • Clinical Breast Exam: At your regular check-up, your healthcare professional will feel for lumps in the entire breast, underarm and collarbone area, and look for visual changes like a rash or differences in size and shape of the breasts and/or nipples. They may also check for a nipple discharge. The American Cancer Society recommends having this exam every 3 years before age 40, and every year after that.
  • Women 40 and above should have a mommogram every year
    Mammogram: This is a low-dose x-ray of the breasts that can detect abnormalities of the breast including invasive breast cancer while the tumor is still too small to feel with a clinical or self-exam. The American Cancer Society recommends getting a mammogram every year beginning at age 40. Getting one regularly is especially important for women over the age of 50.

Depending on your individual risk factors, your healthcare professional may recommend more frequent screening, or additional tests.

Next: Healthy Living



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.