Evista [raloxifene hydrochloride] is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds.
EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women, for reduction in 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.
On September 14, 2007, Steven K. Galson, then director of the United States Food and Drug Administration's Center for Drug Evaluation and Research announced authorization of the sale of raloxifene to prevent invasive breast cancer in post-menopausal women
For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet, if daily intake is inadequate.
- Treatment and Prevention of Osteoporosis in Postmenopausal Women
- Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis
- Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer.
High risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (LCIS) or atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥ 1.66% (based on the modified Gail model). Among the factors included in the modified Gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth.. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.
EVISTA does not eliminate the risk of breast cancer. Patients should be advised to have breast examination and mammograms before starting EVISTA and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with EVISTA.
Contraindications and Special precautions:
- Past or present history of venous thromboembolism
- Pregnant and lactating mothers
EVISTA is a teratogenic drug, hence it is to be avoided in pregnant or would be pregnant or lactating mothers.
- Hepatic insufficiency
- Past history of breast cancer since EVISTA has not been fully studied in women who have a history of breast cancer.
- EVISTA is not for use in pre menopausal women.
It should be used with caution in patients taking highly protein bound drugs such as
In patients taking concomitant warfarin or other coumarin derivatives, prothrombin times should be closely monitored when starting or stopping raloxifene treatment. Concomitant use of EVISTA [raloxifene hydrochloride] with systemic estrogens or cholestyramine is not recommended.
- hot flushes
- leg cramps
- sleep disorders
- peripheral edema
- vaginal bleeding
- endometrial carcinoma
- thromboembolic events
The recommended dosage is one 60 mg EVISTA tablet daily,. There are no food interactions and hence can be taken any time during the day.
Calcium and Vitamin D Supplementation
For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.
Postmenopausal women require an average of 1500 mg/day of elemental calcium.
Total daily intake of calcium above 1500 mg has not demonstrated additional bone benefits while daily intake above 2000 mg has been associated with increased risk of adverse effects, including hypercalcemia and kidney stones.
The recommended intake of vitamin D is 400-800 IU daily. Patients at increased risk for vitamin D insufficiency (e.g., over the age of 70 years, nursing home bound, or chronically ill) may need additional vitamin D supplements. Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D supplementation and measurement of 25-hydroxyvitamin D should be considered.
- Drug Today, July-September 2005 Edition, page 829-830
- Pharmacology and Pharmacotherapeutics, R.S.Satoskar, S.D.Bhandarkar, S.S.Ainapure, Revised 17th Edition, pg 990.