"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
Treatment and Prevention of Osteoporosis in Postmenopausal Women
EVISTA (raloxifene) is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies].
Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis
EVISTA (raloxifene) is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies].
Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer
EVISTA (raloxifene) is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see Clinical Studies].
The effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see Clinical Studies]. Twenty-seven percent of the participants received drug for 5 years. The long-term effects and the recommended length of treatment are not known.
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. Healthcare professionals can obtain a Gail Model Risk Assessment Tool by dialing 1-800-545-5979. Currently, no single clinical finding or test result can quantify risk of breast cancer with certainty.
After an assessment of the risk of developing breast cancer, the decision regarding therapy with EVISTA (raloxifene) should be based upon an individual assessment of the benefits and risks.
EVISTA (raloxifene) does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting EVISTA (raloxifene) and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with EVISTA (raloxifene) .
Important Limitations of Use for Breast Cancer Risk Reduction
- There are no data available regarding the effect of EVISTA (raloxifene) on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of EVISTA (raloxifene) .
- EVISTA (raloxifene) is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.
- EVISTA (raloxifene) is not indicated for the reduction in the risk of noninvasive breast cancer.
DOSAGE AND ADMINISTRATION
The recommended dosage is one 60 mg EVISTA (raloxifene) tablet daily, which may be administered any time of day without regard to meals [see CLINICAL PHARMACOLOGY)].
For the indications in risk of invasive breast cancer the optimum duration of treatment is not known [see Clinical Studies].
Recommendations for 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.
Dosage Forms And Strengths
60 mg, white, elliptical, film-coated tablets (not scored). They are imprinted on one side with LILLY and the tablet code 4165 in edible blue ink.
EVISTA (raloxifene) 60 mg tablets are white, elliptical, and film coated. They are imprinted on one side with LILLY and the tablet code 4165 in edible blue ink. They are available as follows:
|Bottle (count)||NDC Number|
|30 (unit of use)||NDC 0002-4165-30|
|100 (unit of use)||NDC 0002-4165-02|
Storage and Handling
Store at controlled room temperature, 20º to 25ºC (68º to 77ºF) [see USP]. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20º to 25ºC (68º to 77ºF); that results in a mean kinetic temperature calculated to be not more than 25ºC; and that allows for excursions between 15º and 30ºC (59º and 86ºF) that are experienced in pharmacies, hospitals, and warehouses.
Eli Lilly and Company., Indianapolis, IN 46285, USA. FDA Rev date: 9/13/2007
Last reviewed on RxList: 10/2/2007
This monograph has been modified to include the generic and brand name in many instances.
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