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Important Safety Information and Boxed Warning
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Medication Guide
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Absolute difference in selected events among women taking EVISTA
In an analysis* of the Multiple Outcome of Raloxifene (MORE) trial, the benefits of EVISTA decreasing vertebral fractures and invasive breast cancer risks were greater than the increase in venous thromboembolism in women with or without baseline vertebral fractures.1

Important considerations

  • The recommended dosing of EVISTA in the prescribing information is one 60-mg tablet once a day. The Multiple Outcomes of Raloxifene Evaluation (MORE) trial included a 120 mg/d group. Please note that data from that dose group is not presented
  • These charts show 4-year fracture data, while Table 4 of the label shows 3-year fracture data from the MORE trial
  • These charts discuss adverse events and other data reported from the trial that may not be consistent with the overall trial database, other EVISTA clinical trials, or postmarketing experience with EVISTA. The full Prescribing Information for EVISTA may reflect additional or different information
  • Invasive breast cancer and safety events are presented for patients without or with a vertebral fracture on these charts, while these outcomes are presented for patients pooled together in the label
  • Individual results may vary. The risk/benefit assessment should be done on an individual patient basis

Absolute difference in selected events among women taking EVISTA

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Venous thromboembolic event (VTE) facts

Venous thromboembolic event data from the MORE|| clinical trial

  • A venous thromboembolic event, such as deep vein thrombosis (DVT) or pulmonary embolism (PE), is a blood clot that originates in the veins. It is not a blood clot that originates in the arterial system
  • The most serious adverse reaction to EVISTA was VTE
  • During an average study drug exposure of 2.6 years, VTE occurred in about 1 out of 100 patients treated with EVISTA. Highest VTE risk was observed during the first few months of therapy
  • Twenty-six women treated with EVISTA had a VTE compared with 11 placebo-treated women. The hazard ratio was 2.4 (95% CI 1.2-4.5)
  • EVISTA increased the risk of venous thromboembolism to 2- to 3- fold over placebo in postmenopausal women with osteoporosis whose average age was 67 years3,4
||Multiple Outcomes of Raloxifene Evaluation (MORE) trial.

VTEs—safety considerations when screening women for therapy with EVISTA

  • Women with active or past history of VTEs should NOT be prescribed EVISTA
  • In clinical trials, women treated with EVISTA had an increased risk of VTEs. The greatest risk for DVT and PE occurs within the first 4 months
  • Because immobilization increases the risk for VTEs, EVISTA should be discontinued at least 72 hours prior to and during prolonged immobilization. Therapy with EVISTA should be resumed only after the patient is fully ambulatory. In addition, women should be advised to move around periodically during prolonged travel. The risk-benefit balance should be considered in women at risk for thromboembolic disease for other reasons, such as CHF, superficial thrombophlebitis, and active malignancy

Increased risk of DVT and PE has been reported with EVISTA use. EVISTA is contraindicated in women with active or past history of VTE, including DVT, PE, and retinal vein thrombosis.

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References:
  1. Curr Med Res Opin. 2010;26:71-76.
  2. Data on file, Lilly Research Laboratories (EVI20091120).
  3. JAMA. 1999;282:637-645.
  4. J Clin Endocrinol Metab. 2002;87:3609-3617.
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.