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DUAVEE®Index Section (conjugated estrogens/bazedoxifene)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA

1 INDICATIONS AND USAGE

1.3 Important Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

2.2 Prevention of Postmenopausal Osteoporosis

2.3 General Dosing Information

2.4 Recommendations for Calcium and Vitamin D Supplementation

2.5 Administration Instructions for Missed Doses

2.6 Use in Patients with Renal Impairment

2.7 Use in the Elderly

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Drugs Containing Progestins, Estrogens or Estrogen Agonist/Antagonists

5.2 Cardiovascular Disorders

5.3 Malignant Neoplasms

5.4 Probable Dementia

5.5 Gallbladder Disease

5.6 Visual Abnormalities

5.7 Elevated Blood Pressure

5.8 Hypertriglyceridemia

5.9 Hepatic Impairment and Past History of Cholestatic Jaundice

5.10 Hypothyroidism

5.11 Fluid Retention

5.12 Hypocalcemia

5.13 Hereditary Angioedema

5.14 Exacerbation of Other Conditions

5.15 Premenopausal Women

5.16 Laboratory Tests

5.17 Drug-Laboratory Test Interactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

7 DRUG INTERACTIONS

7.1 Cytochrome P450 (CYP)

7.2 Uridine Diphosphate Glucuronosyltransferase (UGT)

7.3 Atorvastatin

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Body Mass Index (BMI)

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause in Women with a Uterus

14.2 Prevention of Postmenopausal Osteoporosis in Women with a Uterus

14.3 Effects on the Endometrium

14.4 Effects on Uterine Bleeding and Spotting

14.5 Women's Health Initiative Studies

14.6 Women's Health Initiative Memory Study

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Instructions for Patients

17.2 Venous Thromboembolic Events

17.3 Abnormal Vaginal Bleeding

17.4 Possible Serious Adverse Reactions with Estrogen Therapy

17.5 Possible Less Serious Adverse Reactions with DUAVEE

17.6 Calcium and Vitamin D Intake

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