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docetaxel injection, USP 20 mg/ml VIAL
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docetaxel injection, USP 20 mg/ml VIAL Quick Finder
Highlights
Boxed Warning
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION
Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Breast Cancer
Docetaxel Injection is indicated for the treatment of patients with locally advanced or metastatic breast cancer after...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration (2.7)].
Administer in a facility equipped to...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Docetaxel Injection, USP is a pale-yellow to brownish yellow solution available as:
- •
- 20 mg/mL single-dose vial
- •
- 80 mg/4 mL (20 mg/mL) multiple-dose vial ...
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Contraindications
4 CONTRAINDICATIONS
Docetaxel Injection is contraindicated in patients with:
- •
- neutrophil counts of <1500 cells/mm3 [see Warnings and...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Toxic Deaths
Breast Cancer
...
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Adverse Reactions
6 ADVERSE REACTIONS
The most serious adverse reactions from docetaxel are:
- •
- Toxic Deaths [see Boxed Warning, Warnings and Precautions (5.1)...
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Drug Interactions
7 DRUG INTERACTIONS
Docetaxel is a CYP3A4 substrate. In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds that induce,...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
...
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Overdosage
10 OVERDOSAGE
There is no known antidote for Docetaxel Injection overdosage. In case of overdosage, the patient should be kept in a specialized unit where vital functions can be closely monitored. Anticipated complications...
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Description
11 DESCRIPTION
Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with docetaxel have not been...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Locally Advanced or Metastatic Breast Cancer
The efficacy and safety of docetaxel have been evaluated in locally advanced or metastatic...
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References
15 REFERENCES
- 1.
- "OSHA Hazardous Drugs." http://www.osha.gov/SLTC/hazardousdrugs/index.html
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Docetaxel Injection, USP is supplied in single-dose or multiple-dose vials as a sterile, pyrogen-free, non-...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Bone Marrow...
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