Label: DOCETAXEL- docetaxel anhydrous injection, solution

  • NDC Code(s): 0409-0016-01, 0409-2026-01
  • Packager: Hospira, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 20, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL injection, for ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    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 higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m2 [see Warnings and Precautions (5.1)].

    Avoid the use of Docetaxel Injection in patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 × ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of Docetaxel Injection [see Warnings and Precautions (5.2)].

    Do not administer Docetaxel Injection to patients with neutrophil counts of <1500 cells/mm3. Monitor blood counts frequently as neutropenia may be severe and result in infection [see Warnings and Precautions (5.3)].

    Do not administer Docetaxel Injection to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80 [see Contraindications (4)]. Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the Docetaxel Injection infusion and administration of appropriate therapy [see Warnings and Precautions (5.5)].

    Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [see Warnings and Precautions (5.6)].

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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 failure of prior chemotherapy. Docetaxel Injection in ...
  • 2 DOSAGE AND ADMINISTRATION
    For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration (2.7)]. Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). 2.1 ...
  • 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 - • 160 mg/16 mL (10 mg/mL) multiple-dose vial
  • 4 CONTRAINDICATIONS
    Docetaxel Injection is contraindicated in patients with: • neutrophil counts of <1500 cells/mm3 [see Warnings and Precautions (5.3)]. • a history of severe hypersensitivity reactions to docetaxel ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Toxic Deaths - Breast Cancer - Docetaxel administered at 100 mg/m2 was associated with deaths considered possibly or probably related to treatment in 2.0% (19/965) of metastatic breast ...
  • 6 ADVERSE REACTIONS
    The most serious adverse reactions from docetaxel are: • Toxic Deaths [see Boxed Warning, Warnings and Precautions (5.1)] • Hepatic Impairment [see Boxed Warning, Warnings and Precautions ...
  • 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, inhibit, or are ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy -    Risk Summary - Based on findings in animal reproduction studies and its mechanism of action, Docetaxel Injection can cause fetal harm when administered to a pregnant ...
  • 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 ...
  • 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 ...
  • 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 mitotic and interphase cellular functions ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenicity studies with docetaxel have not been performed. Docetaxel was genotoxic by an aneugenic mechanism in the in vitro ...
  • 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 breast cancer after failure of previous ...
  • 15 REFERENCES
    1. "OSHA Hazardous Drugs." http://www.osha.gov/SLTC/hazardousdrugs/index.html
  • 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-aqueous colorless to pale yellow solution. Discard unused portion of ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Bone Marrow Suppression - Advise patients that periodic assessment of their blood count will be performed to ...
  • SPL UNCLASSIFIED SECTION
    Distributed by Hospira, Inc., Lake Forest, IL 60045 USA - Novaplus is a registered trademark of Vizient, Inc. LAB-1495-2.0
  • PATIENT PACKAGE INSERT
    This Patient Information has been approved by the U.S. Food and Drug Administration.     Revised: May 2023 - Patient Information - Docetaxel (doe-se-TAKS-el) Injection - for intravenous ...
  • PRINCIPAL DISPLAY PANEL - 2 mL Vial Label
    2 mL Single-dose vial. Docetaxel - Injection, USP - 20 mg/2 mL - (10 mg/mL) For Intravenous Use only
  • PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton
    20 mg/2 mL (10 mg/mL) NDC 0409-2026-01 - 1 x 2 mL - Single-dose vial - Discard unused portion. Docetaxel - Injection, USP - 20 mg/2 mL - (10 mg/mL) For Intravenous Use only - Ready to add to - infusion ...
  • PRINCIPAL DISPLAY PANEL - 16 mL Vial Label
    16 mL - Multiple-dose Vial - NDC 0409-0016-01 - Rx only - Sterile - Docetaxel - Injection, USP - 160 mg/16 mL - (10 mg/mL) For Intravenous Use only - Ready to add to infusion solution. Check - concentration prior to ...
  • PRINCIPAL DISPLAY PANEL - 16 mL Vial Carton
    160 mg/16 mL (10 mg/mL) NDC 0409-0016-01 - 1 x 16 mL - Multiple-dose vial - Docetaxel - Injection, USP - 160 mg/16 mL - (10 mg/mL) For Intravenous Use only - Ready to add to - infusion solution - Caution: Hazardous ...
  • INGREDIENTS AND APPEARANCE
    Product Information