Label: DOCETAXEL injection, solution, concentrate

  • NDC Code(s): 0143-9204-01, 0143-9205-01
  • Packager: Hikma Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 16, 2024

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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. DOCEDTAXEL 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 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 [see Warnings and Precautions (5.2)].

    Do not administer docetaxel 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 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 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, USP is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. Docetaxel Injection ...
  • 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    ONE-VIAL FORMULATION Docetaxel Injection, USP - Docetaxel Injection, USP 20 mg/1 mL - Docetaxel Injection, USP 20 mg/1 mL single-dose vial: 20 mg docetaxel in 1 mL in 50/50 (v/v) ratio ...
  • 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 or ...
  • 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 can cause fetal harm when administered to a pregnant woman [see ...
  • 10 OVERDOSAGE
    There is no known antidote for docetaxel 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 clastogenic in the in vitro chromosome aberration test in ...
  • 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 chemotherapy ...
  • 15 REFERENCES
    "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 a single-dose vial as a sterile, pyrogen-free, non-aqueous solution. Discard unused portion. Docetaxel Injection, USP 20 mg/1 mL ...
  • 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 ...
  • PATIENT INFORMATION
    This Patient Information has been approved by the U.S. Food and Drug Administration.  Patient Information - Docetaxel (doe-se-TAKS-el) Injection, USP - for intravenous use - What is the ...
  • PRINCIPAL DISPLAY PANEL - 1 mL Vial
    NDC 0143-9204-01   Rx only - ONE-VIAL FORMULATION - Docetaxel - Injection, USP - 20 mg/mL - Ready to add to infusion solution - For Intravenous Infusion ONLY - Caution: Cytotoxic Agent
  • PRINCIPAL DISPLAY PANEL - 4 mL Vial
    NDC 0143-9205-01   Rx only - ONE-VIAL FORMULATION - Docetaxel - Injection, USP - 80 mg per 4 mL - (20 mg/mL) Ready to add to infusion solution - For Intravenous Infusion ONLY - Caution: Cytotoxic ...
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