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docetaxel injection, USP 10 mg/ml VIAL

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

docetaxel injection, USP 10 mg/ml VIAL Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION

Treatment-related mortality associated with docetaxel is increased in patients with abnormal liver...

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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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2 DOSAGE AND ADMINISTRATION

For all indications, toxicities may warrant dosage adjustments [see

2.1 Breast Cancer

  • For locally advanced or metastatic breast cancer after...

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3 DOSAGE FORMS AND STRENGTHS

Docetaxel Injection, USP is a colorless to pale yellow solution available as:

  • 20 mg/2 mL (10 mg/mL) single-dose vial
  • 80 mg/8 mL (10 mg/mL) multiple-dose vial
  • ...
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4 CONTRAINDICATIONS

Docetaxel Injection is contraindicated in patients with:

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5 WARNINGS AND PRECAUTIONS

5.1 Toxic Deaths

Breast Cancer

Docetaxel administered...

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6 ADVERSE REACTIONS

The most serious adverse reactions from docetaxel are:

  • Toxic Deaths [see

    6.1 Clinical Trials Experience

    ...
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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings in...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with docetaxel have not been performed.

...

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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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15 REFERENCES

  1. "OSHA Hazardous Drugs." http://www.osha.gov/SLTC/hazardousdrugs/index.html
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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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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Bone...

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