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Important Safety Information and Boxed Warning
Prescribing Information
Medication Guide
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Ask the following questions from the National Cancer Institute1 when assessing a patient’s risk for invasive breast cancer:

1. Does the patient have a history of any breast cancer or ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)?
2. What is the patient’s age?
3. What was the patient’s age at time of her first menstrual period?
4. What was the patient’s age at her first live birth of a child?
5. How many first-degree relatives (mothers, sisters, and/or daughters) have had breast cancer?
6. Has the patient ever had a breast biopsy?
    6a. How many breast biopsies (positive or negative) has the patient had?
    6b. Has the patient had at least one breast biopsy with atypical hyperplasia?
7. What is the patient’s race/ethnicity?

Use the National Cancer Institute Breast Cancer Risk Assessment Tool available at http://www.cancer.gov/bcrisktool to calculate your patient’s risk based on answers to the above questions. The resulting calculations will identify and explain your patient's 5-year and lifetime risk for invasive breast cancer.

National Cancer Institute Breast Cancer risk Assessment
Reference:
  1. National Cancer Institute. Breast Cancer Risk Assessment Tool. Available at: http://www.cancer.gov/bcrisktool. Accessed September 16, 2009.
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.

EVISTA is indicated for the prevention and treatment of osteoporosis in postmenopausal women.

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 in postmenopausal women at high risk of invasive breast cancer.

EVISTA is indicated 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.

Important Safety Information for EVISTA

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:
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:
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
  • 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.