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ELLENCE®Index Section (epirubicin HCl)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 Recommended Dose

2.3 Dose Modifications

2.4 Preparation and Administration Precautions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Cardiac Toxicity

5.2 Secondary Malignancies

5.3 Extravasation and Tissue Necrosis

5.4 Severe Myelosuppression

5.5 Use in Patients with Hepatic Impairment

5.6 Use in Patients with Renal Impairment

5.7 Tumor-Lysis Syndrome

5.8 Immunosuppressant Effects/Increased Susceptibility to Infections

5.9 Thrombophlebitis and Thromboembolic Events

5.10 Potentiation of Radiation Toxicity and Radiation Recall

5.11 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

7.1 Cardiotoxic Agents

7.2 Cimetidine

7.3 Other Cytotoxic Drugs

7.4 Radiation Therapy

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 Hepatic Impairment

8.7 Renal Impairment

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

14 CLINICAL STUDIES

14.1 Adjuvant Treatment of Breast Cancer

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

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