Ralista - Evista (Raloxifene Hydrochloride)

 

 ^_Ralista

Raloxifene Hydrochloride

 

PACKAGING INFORMATION

RALISTA - Blister pack of 10 tablets

 

 

COMPOSITION

Each film-coated tablet contains

 

Raloxifene Hydrochloride ............. 60 mg

 

INDICATIONS

Treatment and Prevention of Osteoporosis in Postmenopausal Women 

RALISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

 

Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis 

RALISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis.

 

Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer 

RALISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

 

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. 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 RALISTA should be based upon an individual assessment of the benefits and risks.

 

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

 

Important limitations of use for breast cancer risk reduction

 

There are no data available regarding the effect of raloxifene on invasive breast cancer incidence in women with inherited mutations (BRCA1, BRCA2) to be able to make specific recommendations on the effectiveness of raloxifene.

RALISTA is not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence.

RALISTA is not indicated for the reduction in the risk of noninvasive breast cancer.

 

DOSAGE AND ADMINISTRATION

Recommended Dosing 

The recommended dosage is one 60 mg RALISTA tablet daily, which may be administered any time of day without regard to meals.

 

For the indications in risk of invasive breast cancer the optimum duration of treatment is not known.

 

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.

 

 

CONTRAINDICATIONS

Venous Thromboembolism 

RALISTA is contraindicated in women with active or past history of venous thromboembolism (VTE), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

 

Pregnancy, women who may become pregnant and nursing mothers 

RALISTA is contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers. Raloxifene may cause foetal 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 foetus.

 

 

 

 

 

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