Raloxifene Hydrochloride

RALOXIFENE HYDROCHLORIDE- raloxifene hydrochloride tablet, film coated
AvPAK

WARNING–INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE

  • Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene HCl (5.1). Women with active or past history of venous thromboembolism should not take raloxifene HCl (4.1).
  • Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke ( 5.2, 14.5).

1 INDICATIONS AND USAGE

1.1 Treatment and Prevention of Osteoporosis in Postmenopausal Women

Raloxifene hydrochloride (HCl) 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 HCl tablets, USP 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 HCl tablets, USP 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 HCl tablets, USP should be based upon an individual assessment of the benefits and risks.

Raloxifene HCl tablets, USP does not eliminate the risk of breast cancer. Patients should have breast exams and mammograms before starting raloxifene HCl tablets, USP and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene HCl tablets, USP.

Important Limitations of Use for Breast Cancer Risk Reduction

  • There are no data available regarding the effect of raloxifene HCl tablets, USP on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of raloxifene HCl tablets, USP.
  • Raloxifene HCl tablets, USP are not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.
  • Raloxifene HCl tablets, USP are not indicated for the reduction in the risk of noninvasive breast cancer.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

The recommended dosage is one 60 mg raloxifene HCl tablet, USP daily, which may be administered any time of day without regard to meals [see Clinical Pharmacology (12.3)] .

For the indications in risk of invasive breast cancer the optimum duration of treatment is not known [see Clinical Studies (14.3,14.4)] .

2.2 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 to 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.

3 DOSAGE FORMS AND STRENGTHS

60 mg, white to off-white, elliptical shaped, film-coated tablets debossed with “AN057” on one side and plain on the other side.

4 CONTRAINDICATIONS

4.1 Venous Thromboembolism

Raloxifene HCl, USP is contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism and retinal vein thrombosis [see Warnings and Precautions (5.1)] .

4.2 Pregnancy, Women Who May Become Pregnant and Nursing Mothers

Raloxifene HCl, USP is contraindicated in pregnancy, in women who may become pregnant and in nursing mothers [see Use in Specific Populations (8.1,8.3)] . Raloxifene HCl, USP may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

In rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m 2) and hydrocephaly was observed in fetuses at doses ≥10 mg/kg (≥4 times the human dose based on surface area, mg/m 2). In rat studies, retardation of fetal development and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses ≥1 mg/kg (≥0.2 times the human dose based on surface area, mg/m 2). Treatment of rats at doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose based on surface area, mg/m 2) during gestation and lactation produced effects that included delayed and disrupted parturition; decreased neonatal survival and altered physical development; sex- and age-specific reductions in growth and changes in pituitary hormone content; and decreased lymphoid compartment size in offspring. At 10 mg/kg, raloxifene disrupted parturition, which resulted in maternal and progeny death and morbidity. Effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed.

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