Drug Detail:Raloxifene (Raloxifene [ ra-lox-i-feen ])
Drug Class: Hormones / antineoplastics Selective estrogen receptor modulators
Usual Adult Dose for Osteoporosis
60 mg orally per day
Comments:
- For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
- When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
- Treatment and prevention of osteoporosis in postmenopausal women.
- Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
Usual Adult Dose for Prevention of Osteoporosis
60 mg orally per day
Comments:
- For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
- When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
- Treatment and prevention of osteoporosis in postmenopausal women.
- Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
Usual Adult Dose for Prevention of Breast Cancer
60 mg orally per day
Comments:
- For treatment or prevention of osteoporosis, advise patients to add supplemental calcium and/or vitamin D if daily intake is inadequate.
- When this drug is used to reduce the risk of invasive breast cancer, the optimum duration of treatment is not known.
Uses:
- Treatment and prevention of osteoporosis in postmenopausal women.
- Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and/or at high risk of invasive breast cancer.
Renal Dose Adjustments
- Mild Renal Impairment (CrCl 51 to 80 mL/min): Data not available.
- Moderate and Severe Renal Impairment (CrCl 50 mL/min or less): Use with caution.
Liver Dose Adjustments
Hepatic Impairment: Use with caution.
Precautions
US BOXED WARNING:
- Increased risk of deep vein thrombosis and pulmonary embolism have been reported. Women with active or past history of venous thromboembolism should not take this drug.
- Increased risk of death due to stroke occurred in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider the risk-benefit balance in women at risk for stroke.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available.
Other Comments
Administration Advice:
- Administer this drug any time of day without regard to meals.
General:
- 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 of 1.66% or greater (based on the modified Gail model).
- Clinical trial findings suggest this drug lacks estrogen-like effects on the uterus and breast tissue.
- Overdosage: There is no specific antidote.
Monitoring:
- Breast exams and mammograms (prior to and during treatment)
Frequently asked questions
- How does Evista (raloxifene) work?
