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docetaxel injection, USP 20 mg/ml VIAL Index Section

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

1 INDICATIONS AND USAGE

1.1 Breast Cancer

1.2 Non-small Cell Lung Cancer

1.3 Prostate Cancer

1.4 Gastric Adenocarcinoma

1.5 Head and Neck Cancer

2 DOSAGE AND ADMINISTRATION

2.1 Breast Cancer

2.2 Non-small Cell Lung Cancer

2.3 Prostate Cancer

2.4 Gastric Adenocarcinoma

2.5 Head and Neck Cancer

2.6 Premedication Regimen

2.7 Dosage Adjustments during Treatment

2.8 Administration Precautions

2.9 Preparation and Administration

2.10 Stability

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Toxic Deaths

5.2 Hepatic Impairment

5.3 Hematologic Effects

5.4 Enterocolitis and Neutropenic Colitis

5.5 Hypersensitivity Reactions

5.6 Fluid Retention

5.7 Second Primary Malignancies

5.8 Cutaneous Reactions

5.9 Neurologic Reactions

5.10 Eye Disorders

5.11 Asthenia

5.12 Embryo-Fetal Toxicity

5.13 Alcohol Content

5.14 Tumor Lysis Syndrome

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

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 Locally Advanced or Metastatic Breast Cancer

14.2 Adjuvant Treatment of Breast Cancer

14.3 Non-small Cell Lung Cancer (NSCLC)

14.4 Castration-Resistant Prostate Cancer

14.5 Gastric Adenocarcinoma

14.6 Head and Neck Cancer

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage

16.3 Handling and Disposal

17 PATIENT COUNSELING INFORMATION

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