EVISTA (raloxifene HCl) - Protect her bones. Protect her breasts.
EVISTA (raloxifene HCl) - Protect her bones.
EVISTA (raloxifene HCl) - Protect her breasts.
2-in-1 Profile of EVISTA
2-in-1 Profile of EVISTA
Target Patients
Target Patients
Clinical Data
Clinical Data
Tools and Resources
Tools and Resources
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Safety Profile

Over 56 million prescriptions for EVISTA have been filled since FDA approval in 1997

Demonstrated Safety Profile
In clinical trials, up to 8 years of research1,2 and more than 37,000 patients3-5 demonstrate the safety profile of EVISTA. Selective estrogen receptor modulators (SERMs), like EVISTA, may act differently in various tissues and organs. EVISTA appears to act like an estrogen agonist in the bones and an estrogen antagonist in the breast and uterus.

EVISTA has shown:

  • No increased risk for uterine cancer, ovarian cancer, or endometrial hyperplasia in clinical trials vs placebo1
  • A neutral effect on the uterus

Important Safety Information

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.

Please see Contraindications, Warnings and Precautions, and Adverse Reactions sections of full Prescribing Information for other Important Safety Information.

Venous Thromboembolic Event (VTE) Facts
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.

Combined Annual Incidence Rate of DVT and PE in Women in the United States

VTEs — Important information for EVISTA from the MORE clinical trial:

  • EVISTA increased the risk of venous thromboembolism 2-3 fold over placebo in postmenopausal women with osteoporosis whose average age was 67 years8,9
VTE Risk in the MORE Trial: Year-by-Year Analysis
  • Overall, the average number of VTEs expected yearly for 1,000 women treated with EVISTA is 3.510
  • Overall, the average number of PEs expected yearly for 1,000 women treated with EVISTA is 1.110

VTEs — Safety considerations when screening women for therapy with EVISTA

  • Women with active or past history of VTEs should NOT be prescribed EVISTA
  • 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
  • 69% of all patients in the MORE trial who experienced a DVT or PE (n=64) had concomitant risk factors for DVT/PE, such as prolonged immobilization and prior history of VTE11

Appropriate Patients for EVISTA
EVISTA is indicated for the prevention and treatment of osteoporosis in postmenopausal women, for the reduction of risk of invasive breast cancer in postmenopausal women with osteoporosis, and for reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

  1. Curr Med Res Opin. 2005;21:1441-1452.
  2. J Natl Cancer Inst. 2004;96:1751-1761.
  3. JAMA. 2006;295:2727-2741.
  4. Breast Cancer Res Treat. 2001;65:125-134.
  5. N Engl J Med. 2006;355:125-137.
  6. Data on file, Eli Lilly and Company (EVI20070727).
  7. Arch Intern Med. 1998;158:585-593.
  8. JAMA. 1999;282:637-645.
  9. J Clin Endocrinol Metab. 2002;87:3609-3617.
  10. Obstet Gynecol. 2004;104:837-844.
  11. J Stroke Cerebrovasc Dis. 2003;12:247. Abstract.
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