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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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Invasive Breast Cancer Risk Factors

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

Family history is an important risk factor for invasive breast cancer. However, only about 20% of women with invasive breast cancer have a family history of the disease; approximately 80% of women who get invasive breast cancer have no family history of the disease. These data are based on approximately 148,000 postmenopausal women participating in the Women's Health Initiative study wherein 2.2 percent (3,236) developed invasive breast cancer over 5 years. And even though it may seem like breast cancer is a younger woman's disease, about 80% of women diagnosed with breast cancer are age 50 or older.

All women should consult with their healthcare professional about their risk for invasive breast cancer. Becoming aware of your personal risk for invasive breast cancer is the first step toward awareness, early detection, and potential risk reduction.

The following are widely accepted risk factors for invasive breast cancer:

  • Female gender
  • Advancing age
  • Family history of invasive breast cancer (mother, sister, or daughter)
  • Previous breast biopsy (normal or abnormal)
  • First live birth after age 30 (or never giving birth)
  • First period before age 12
  • Increased breast density

Let's take a closer look at a few of these risk factors:

Age
Although younger women may perceive themselves as having a higher risk for invasive breast cancer than older women, about 80% of invasive breast cancer cases occur in women past 50. As a woman ages, her risk for developing invasive breast cancer increases:

  • From ages 30 to 39, 1 out of 233 women is expected to be diagnosed with invasive breast cancer
  • From ages 40 to 49, 1 out of 69 women is expected to be diagnosed with invasive breast cancer
  • From ages 50 to 59, 1 out of 38 women is expected to be diagnosed with invasive breast cancer
  • From ages 60 to 69, 1 out of 27 women is expected to be diagnosed with invasive breast cancer

The average age of menopause is 51. Shaded areas indicate postmenopausal population

U.S. women diagnosed with invasive breast cancer

Family History
Family history of invasive breast cancer (first-degree relative) is an important risk factor for developing breast cancer. For example, having one first-degree relative with breast cancer (mother, sister, or daughter) doubles your risk; and having two such relatives increases your risk of breast cancer by three times. However, about 80% of women with breast cancer have no family history.

Lifestyle
Several lifestyle factors may increase your risk of breast cancer, such as:

  • Having no children, or having your first child after age 30
  • Alcohol may increase your risk, increasing with the amount of alcohol consumed
  • Obesity for women past menopause
  • Physical inactivity throughout life; exercise may reduce invasive breast cancer risk

Personal Health History
Several factors in your personal health history may increase your risk of breast cancer:

  • Women who have undergone a previous breast biopsy
  • Women with dense breast tissue as observed on mammograms
  • Women with a personal history of non-cancerous changes in breast tissue
  • Women who began menstruation at an early age (before age 12) or went through menopause at a late age (after age 55)

Next: About EVISTA



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.