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EVISTA(raloxifene hydrochloride) tablet

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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use EVISTA safely and effectively. See full prescribing information for EVISTA. EVISTA (raloxifene hydrochloride) Tablet for Oral use Initial U.S. Approval: 1997
WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE See full prescribing information for complete boxed warning. Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA (5.1). Women with active or past history of venous thromboembolism should not take EVISTA (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).
RECENT MAJOR CHANGES

INDICATIONS AND USAGE
EVISTA® 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: EVISTA 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)
DOSAGE AND ADMINISTRATION
60 mg tablet orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets (not scored): 60 mg (3)
CONTRAINDICATIONS
Active or past history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. (4.1) Pregnancy, women who may become pregnant, and nursing mothers. (4.2, 8.1, 8.3)
WARNINGS AND PRECAUTIONS
Venous Thromboembolism: Increased risk of deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. Discontinue use 72 hours prior to and during prolonged immobilization. (5.1, 6.1) Death Due to Stroke: 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. No increased risk of stroke was seen in this trial. Consider risk-benefit balance in women at risk for stroke. (5.2, 14.5) Cardiovascular Disease: EVISTA should not be used for the primary or secondary prevention of cardiovascular disease. (5.3, 14.5) Premenopausal Women: Use is not recommended. (5.4) Hepatic Impairment: Use with caution. (5.5) Concomitant Use with Systemic Estrogens: Not recommended. (5.6) Hypertriglyceridemia: If previous treatment with estrogen resulted in hypertriglyceridemia, monitor serum triglycerides. (5.7)
ADVERSE REACTIONS
Adverse reactions (>2% and more common than with placebo) include: hot flashes, leg cramps, peripheral edema, flu syndrome, arthralgia, sweating. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-545-5979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
Cholestyramine: Use with EVISTA is not recommended. Reduces the absorption and enterohepatic cycling of raloxifene. (7.1, 12.3) Warfarin: Monitor prothrombin time when starting or stopping EVISTA. (7.2, 12.3) Highly Protein-Bound Drugs: Use with EVISTA with caution. Highly protein-bound drugs include diazepam, diazoxide, and lidocaine. EVISTA is more than 95% bound to plasma proteins. (7.3, 12.3)
USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety and effectiveness not established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide
Revised: 05/2010

Back to Highlights and Tabs

FULL PRESCRIBING INFORMATION: CONTENTS*

*Sections or subsections omitted from the full prescribing information are not listed

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE

1INDICATIONS AND USAGE

1.1Treatment and Prevention of Osteoporosis in Postmenopausal Women

1.2Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis

1.3Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer

2DOSAGE AND ADMINISTRATION

2.1Recommended Dosing

2.2Recommendations for Calcium and Vitamin D Supplementation

3DOSAGE FORMS AND STRENGTHS

4CONTRAINDICATIONS

4.1Venous Thromboembolism

4.2Pregnancy, Women Who May Become Pregnant, and Nursing Mothers

5WARNINGS AND PRECAUTIONS

5.1Venous Thromboembolism

5.2Death Due to Stroke

5.3Cardiovascular Disease

5.4Premenopausal Use

5.5Hepatic Impairment

5.6Concomitant Estrogen Therapy

5.7History of Hypertriglyceridemia when Treated with Estrogens

5.8Renal Impairment

5.9History of Breast Cancer

5.10Use in Men

5.11Unexplained Uterine Bleeding

5.12Breast Abnormalities

6ADVERSE REACTIONS

6.1Clinical Trials Experience

6.2Postmarketing Experience

7DRUG INTERACTIONS

7.1Cholestyramine

7.2Warfarin

7.3Other Highly Protein-Bound Drugs

7.4Systemic Estrogens

7.5Other Concomitant Medications

8USE IN SPECIFIC POPULATIONS

8.1Pregnancy

8.3Nursing Mothers

8.4Pediatric Use

8.5Geriatric Use

8.6Renal Impairment

8.7Hepatic Impairment

10OVERDOSAGE

11DESCRIPTION

12CLINICAL PHARMACOLOGY

12.1Mechanism of Action

12.2Pharmacodynamics

12.3Pharmacokinetics

13NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2Animal Toxicology and/or Pharmacology

14CLINICAL STUDIES

14.1Treatment of Postmenopausal Osteoporosis

14.2Prevention of Postmenopausal Osteoporosis

14.3Reduction in Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis

14.4Reduction in Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer

14.5Effects on Cardiovascular Disease

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2Storage and Handling

17PATIENT COUNSELING INFORMATION

17.1Osteoporosis Recommendations, Including Calcium and Vitamin D Supplementation

17.2Patient Immobilization

17.3Hot Flashes or Flushes

17.4Reduction in Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis or at High Risk of Invasive Breast Cancer

FULL PRESCRIBING INFORMATION

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE

Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA [see Warnings and Precautions (5.1)]. Women with active or past history of venous thromboembolism should not take EVISTA [see Contraindications (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 [see Warnings and Precautions (5.2) and Clinical Studies (14.5)].

1INDICATIONS AND USAGE

1.1Treatment and Prevention of Osteoporosis in Postmenopausal Women

EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.1, 14.2)].

1.2Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis

EVISTA is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see Clinical Studies (14.3)].

1.3Reduction in the Risk of Invasive Breast Cancer in Postmenopausal Women at High Risk of Invasive Breast Cancer

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

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

Important Limitations of Use for Breast Cancer Risk Reduction

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

2DOSAGE AND ADMINISTRATION

2.1Recommended Dosing

The recommended dosage is one 60 mg EVISTA (raloxifene hydrochloride tablets) tablet 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)].

2.2Recommendations 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.

3DOSAGE FORMS AND STRENGTHS

60 mg, white, elliptical, film-coated tablets (not scored). They are imprinted on one side with LILLY and the tablet code 4165 in edible blue ink.

4CONTRAINDICATIONS

4.1Venous Thromboembolism

EVISTA 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)].