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doxorubicin hydrochloride Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

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

1 INDICATIONS AND USAGE

1.1 Adjuvant Breast Cancer

1.2 Other Cancers

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage for Adjuvant Breast Cancer

2.2 Recommended Dosage for Other Cancers

2.3 Dosage Modifications for Adverse Reactions

2.4 Dosage Modifications for Hepatic Impairment

2.5 Preparation and Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Cardiomyopathy and Arrhythmias

5.2 Secondary Malignancies

5.3 Extravasation and Tissue Necrosis

5.4 Severe Myelosuppression

5.5 Use in Patients with Hepatic Impairment

5.6 Tumor Lysis Syndrome

5.7 Potentiation of Radiation Toxicity and Radiation Recall

5.8 Embryo-Fetal Toxicity

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on Doxorubicin Hydrochloride Injection/for Injection

7.2 Concomitant Use of Trastuzumab

7.3 Concomitant Use of Dexrazoxane

7.4 Concomitant Use of 6-Mercaptopurine

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

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 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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