EVISTA® (raloxifene HCl) | With Osteoporosis and at Risk for Invasive Breast Cancer

Important Safety Information and Boxed Warning Prescribing Information Medication Guide

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.

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.

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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:

• 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.

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Important Safety Information and Boxed Warning


For your postmenopausal patient with osteoporosis, you may already be considering her vertebral fracture risk. But she may also be at risk for invasive breast cancer. With EVISTA^® (raloxifene HCl tablets), you can do more to reduce both risks. Only EVISTA reduces the risk of both vertebral fractures and invasive breast cancer in postmenopausal women with osteoporosis. EVISTA reduces risk for first vertebral fracture EVISTA increases BMD at the lumbar spine and femoral neck compared with placebo EVISTA reduces markers of bone turnover to premenopausal range EVISTA reduces risk for invasive breast cancer EVISTA reduces risk for invasive breast cancer in women followed for up to eight years EVISTA reduces risk for first vertebral fracture In the Multiple Outcomes of Raloxifene (MORE) trial, EVISTA significantly reduced the risk for first vertebral fracture in 3 years in postmenopausal women with osteoporosis: $First vertebral fracture risk reduction at 3 years$ The MORE clinical trial included 7,705 postmenopausal women with osteoporosis (mean age 67 years; mean T-scores at initiation of trial were -2.6 at the spine and -3.2 at the femoral neck²)³. All were given calcium (500 mg/day) and vitamin D (400-600 IU/day).³ Back to Top EVISTA increases BMD at the lumbar spine and femoral neck compared with placebo In the MORE trial, EVISTA also increased BMD at the lumbar spine and femoral neck while decreasing vertebral fracture risk, regardless of whether or not patients had a vertebral fracture upon study entry. † p<.001 compared with baseline. ‡ Placebo vs EVISTA. p<.001. Individual results may vary. All women received daily supplements of 500 mg of calcium and 400-600 IU of choleciferol (vitamin D)³ EVISTA reduced the incidence of vertebral fractures whether or not patients had a vertebral fracture upon study entry The decrease in incidence of vertebral fracture was greater than could be accounted for by increase in BMD alone Back to Top EVISTA reduces markers of bone turnover to premenopausal range In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial: Back to Top EVISTA reduces risk for invasive breast cancer In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, EVISTA significantly reduced the risk for invasive breast cancer over 4 years in postmenopausal women with osteoporosis^¶: ^¶Reduction in risk for invasive breast cancer was a secondary endpoint in the MORE trial. In the MORE trial, only 12.4% of women in the EVISTA group and 12.1% of women in the placebo group reported a family history of breast cancer⁸ Back to Top In the 4-year Continuing Outcomes Relevant to EVISTA (CORE) trial, EVISTA reduced the risk for invasive breast cancer: EVISTA reduces risk for invasive breast cancer in women followed for up to eight years In the Continuing Outcomes Relevant to EVISTA (CORE) 8-year follow-up trial, EVISTA (60 mg, n = 1,355) significantly reduced the risk for invasive breast cancer compared with placebo (n = 1,286) in a subset of postmenopausal women followed for up to 8 years from randomization in MORE through the end of CORE.^,10,11 MORE participants who elected to participate in the CORE trial were not rerandomized; women who had been assigned to 120 mg/day in MORE were reassigned to 60 mg/day in CORE¹⁰ The Raloxifene Use for the Heart (RUTH) trial confirmed the invasive breast cancer risk reduction efficacy demonstrated by EVISTA in the MORE and CORE trials. EVISTA is not recommended for the patient population studied in the RUTH trial Reduction in risk for invasive breast cancer was a primary endpoint. Back to Top References: Data on file, Lilly Research Laboratories (EVI200011002). Data on file, Lilly Research Laboratories (EVI199910005). JAMA. 1999;282:637-645. Data on file, Lilly Research Laboratories (EVI20090420). J Bone Miner Res. 1996;11:1531-1538. Data on file, Lilly Research Laboratories (EVI20090130). Data on file, Lilly Research Laboratories (EVI20070730). Breast Cancer Res Treat. 2001;65:125-134. Data on file, Lilly Research Laboratories (EVI20070913). J Natl Cancer Inst. 2004;96:1751-1761. Data on file, Lilly Research Laboratories (EVI20070813B).
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: 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.

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