1 INDICATIONS AND USAGE
Raloxifene hydrochloride tablet, USP is an estrogen agonist/antagonist indicated for:
Treatment and prevention of osteoporosis in postmenopausal women. (
1.1)
Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (
1.2).
Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. (
1.3)
Important Limitations: Raloxifene hydrochloride is not indicated for the treatment of invasive breast cancer, reduction of the risk of recurrence of breast cancer, or reduction of risk of noninvasive breast cancer. (
1.3)
1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women
Raloxifene hydrochloride tablets, USP are indicated for the treatment and prevention of osteoporosis in postmenopausal women
[see
Clinical Studies (14.1
,
14.2)].
1.2 Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis
Raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis
[see
Clinical Studies (14.3)].
1.3 Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer
Raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer
[see
Clinical Studies (14.4)].
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 (14.4)].
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 raloxifene hydrochloride tablets should be based upon an individual assessment of the benefits and risks.
Raloxifene hydrochloride does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting raloxifene hydrochloride tablets and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene hydrochloride.
Important Limitations of Use for Breast Cancer Risk Reduction
There are no data available regarding the effect of raloxifene hydrochloride on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of raloxifene hydrochloride.
Raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.
Raloxifene hydrochloride tablets are not indicated for the reduction in the risk of noninvasive breast cancer.