Go SearchAdvanced Search
Important Safety Information and Boxed Warning
Prescribing Information
Medication Guide
Select Safety Information
Select Safety Information
Evista may reduce the risk for fracture in your postmenopausal patients with osteoporosis: Learn more

According to the National Osteoporosis Foundation, risk factors for osteoporosis include:

  • Female gender
  • Age
  • Family history of osteoporosis
  • Caucasian or Asian descent
  • Low body mass
  • Slender body build
  • Early estrogen deficiency
  • Smoking
  • Excessive use of alcohol
  • Low-calcium diet
  • Sedentary lifestyle

Postmenopausal women may also be vulnerable to vertebral fracture,1 which is the most common type of osteoporotic fracture.2

  • Vertebral fractures lead to an increased risk for subsequent vertebral fractures3
  • 20% of women will experience another fracture within the first year after an initial vertebral fracture4

Frequency of selected outcomes in women without previous vertebral fracture

Vertebral fracture is more common than other events in postmenopausal women with osteoporosis.

Event rates in postemenopausal women without preexisting vertebral fractures

Data reflect event rates only. They are not a comparison of the severity of events.

Absence of first fracture reduces probability of subsequent fractures6,7

At T-score -3.0, absolute fracture risk was 24% in women with prevalent vertebral fracture(s) compared with 7% in women without prevalent fracture(s), for a threefold difference.†,8

2-year fracture risk in postmenopausal women with and without prevalent vertebral fracture

†Data are from pooled placebo groups from the Fracture Prevention Trial and Multiple Outcomes of Raloxifene Evaluation (MORE) trial.

References:
  1. Lancet. 2006;367:2010-2018.
  2. America's Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation. Washington, DC: National Osteoporosis Foundation; 2002:2, 5-7.
  3. Osteoporos Int. 1999;10:214-221.
  4. JAMA. 2001;285:320-323.
  5. J Am Geriatr Soc. 2004;52:1543-1548.
  6. Osteoporos Int. 2005;16:306-312.
  7. J Bone Miner Res. 2000;15:721-739.
  8. Osteoporos Int. 2007;18:761-770.
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 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.