Raloxifene Therapy Guidelines

Introduction to Raloxifene

The American College of Clinical Oncology recommends Raloxifene (60 mg daily) for postmenopausal women for treatment and prevention of osteoporosis, and for reduction of invasive breast cancer risk in those with osteoporosis or at high risk of breast cancer, with a standard duration of 5 years for breast cancer risk reduction 1, 2

Postmenopausal women ≥35 years of age with a 5-year projected absolute breast cancer risk ≥1.66% (according to the NCI Breast Cancer Risk Assessment Tool) are candidates for Raloxifene therapy, as are women diagnosed with lobular carcinoma in situ (LCIS) or osteoporosis requiring treatment 1, 2, 3
Premenopausal women, and women with a history of deep vein thrombosis, pulmonary embolism, stroke, or transient ischemic attack should not be given Raloxifene 1, 2, 4

Raloxifene reduces the risk of estrogen receptor-positive invasive breast cancers (90% risk reduction), but does not reduce the risk of estrogen receptor-negative cancers or noninvasive breast cancer 5
Common side effects of Raloxifene include leg cramps, peripheral edema, influenza-like symptoms, and may accentuate hot flushes in early menopause 5, 6, 7
Raloxifene is a first-line therapy option for younger postmenopausal women with osteoporosis, and has favorable effects on lipid profile, reducing total and LDL cholesterol 3, 6

Calcium (1,200 mg daily) and vitamin D (600-800 IU daily) supplementation is recommended for patients taking Raloxifene, along with regular bone mineral density testing, breast exams, and mammograms 3, 2
Raloxifene may be used longer than 5 years in postmenopausal women with osteoporosis, with continued efficacy and acceptable safety profile, but the benefit-risk ratio should be considered for women using Raloxifene primarily for breast cancer risk reduction without osteoporosis 2, 4
The National Comprehensive Cancer Network recommends that best candidates for long-term raloxifene therapy are postmenopausal women ≥35 years old, with osteoporosis requiring ongoing treatment, or with a 5-year projected breast cancer risk ≥1.66% or with lobular carcinoma in situ (LCIS), and without contraindications to therapy 2, 8