pharmacopeia
GET
/api/v1/drug/docetaxel

Boxed warning

TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION The incidence of treatment-related mortality associated with docetaxel therapy 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/m 2 [ see Warnings and Precautions ( 5.1 ) ] . Docetaxel injection should not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT >1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 x ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death. Bilirubin, AST or ALT, and alkaline phosphatase values should be obtained prior to each cycle of docetaxel injection therapy [ see Warnings and Precautions ( 5.2 ) ].

Mechanism of action

Sourced from openFDA

Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly.

Protein Synthesis

Indications

Sourced from openFDA
  • Docetaxel injection is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4 ) Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5 ) 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.ICD-10: C34.90, C50.919, C61

Contraindications

Sourced from openFDA
  • Hypersensitivity to docetaxel or polysorbate 80 ( 4 ) Neutrophil counts of <1500 cells/mm 3 ( 4 ) Docetaxel is contraindicated in patients with: neutrophil counts of <1500 cells/mm 3 [ see Warnings and Precautions ( 5.3 ) ]. a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80.contraindicated

Dosage & administration

Sourced from openFDA

Administer in a facility equipped to manage possible complications (e.g., anaphylaxis). Administer intravenously (IV) over 1 hr. every 3 weeks. PVC equipment is not recommended. Use only a 21 gauge needle to withdraw docetaxel injection from the vial. BC locally advanced or metastatic: 60 mg/m 2 to 100 mg/m 2 single agent ( 2.1 ) BC adjuvant: 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 cycles ( 2.1 ) NSCLC: after platinum therapy failure: 75 mg/m 2 single agent ( 2.2 ) NSCLC: chemotherapy-naive: 75 mg/m 2 followed by cisplatin 75 mg/m 2 ( 2.2 ) HRPC: 75 mg/m 2 with 5 mg prednisone twice a day continuously ( 2.3 ) GC: 75 mg/m 2 followed by cisplatin 75 mg/m 2 (both on day 1 only) followed by fluorouracil 750 mg/m 2 per day as a 24 hr IV (days 1-5), starting at end of cisplatin infusion ( 2.4 ) SCCHN: 75 mg/m 2 followed by cisplatin 75 mg/m 2 IV (day 1), followed by fluorouracil 750 mg/m 2 per day as a 24-hr IV (days 1-5), starting at end of cisplatin infusion; for 4 cycles ( 2.5 ) SCCHN: 75 mg/m 2 followed by cisplatin 100 mg/m 2 IV (day 1), followed by fluorouracil 1000 mg/m 2 per day as a 24-hr IV (days 1-4); for 3 cycles ( 2.5 ) For all patients: Premedicate with oral corticosteroids ( 2.6 ) Adjust dose as needed ( 2.7 ) 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).

Warnings & precautions

Sourced from openFDA

Second primary malignancies: In patients treated with docetaxel-containing regimens, monitor for delayed AML, MDS, NHL, and renal cancer. ( 5.7 ) Cutaneous reactions: Reactions including erythema of the extremities with edema followed by desquamation may occur. Severe skin toxicity may require dose adjustment ( 5.8 ) Neurologic reactions: Reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent ( 5.9 ) Eye disorders: Cystoid macular edema (CME) has been reported and requires treatment discontinuation ( 5.10 ) Asthenia: Severe asthenia may occur and may require treatment discontinuation ( 5.11 ) Embryo-fetal toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.12 , 8.1 , 8.3 ) Alcohol content: The alcohol content in a dose of docetaxel injection may affect the central nervous system. This may include impairment of a patient's ability to drive or use machines immediately after infusion ( 5.12 ) 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 cancer patients, both previously treated and untreated, with normal baseline liver function and in 11.5% (7/61) of patients with various tumor types who had abnormal baseline liver function (AST and/or ALT >1.5 times ULN together with AP >2.5 times ULN).

Adverse reactions

Sourced from openFDA

Most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia ( 6 ) "To report SUSPECTED ADVERSE REACTIONS, contact at 1-888-557-1212 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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 ( 5.2 ) ] Hematologic Effects [ see Boxed Warning , Warnings and Precautions ( 5.3 ) ] Enterocolitis and Neutropenic Colitis [ see Warnings and Precautions ( 5.4 ) ] Hypersensitivity Reactions [ see Boxed Warning, Warnings and Precautions ( 5.5 ) ] Fluid Retention [ see Boxed Warning , Warnings and Precautions ( 5.6 ) ] Second Primary Malignancies [ see Warnings and Precautions ( 5.7 ) ] Cutaneous Reactions [ see Warnings and Precautions ( 5.8 ) ] Neurologic Reactions [ see Warnings and Precautions ( 5.9 ) ] Eye Disorders [ see Warnings and Precautions ( 5.10 ) ] Asthenia [ see Warnings and Precautions ( 5.11 ) ] Alcohol Content [ see Warnings and Precautions ( 5.13 ) ] The most common adverse reactions across all docetaxel indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nause…

Use in specific populations

Sourced from openFDA

Lactation: Advise women not to breastfeed. ( 8.2 ) Females and Males of Reproductive Potential: Verify pregnancy status of females prior to initiation of docetaxel injection. ( 8.3 ) 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 woman [ see Clinical Pharmacology ( 12.1 ) ]. Available data from case reports in the literature and pharmacovigilance with docetaxel use in pregnant women are not sufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Docetaxel injection contains alcohol which can interfere with neurobehavioral development ( see Clinical Considerations ). In animal reproductive studies, administration of docetaxel to pregnant rats and rabbits during the period of organogenesis caused an increased incidence of embryo-fetal toxicities, including intrauterine mortality, at doses as low as 0.02 and 0.003 times the recommended human dose based on body surface area, respectively [ see Data ]. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20 mg/m² to 115 mg/m² in phase 1 studies. The area under the curve (AUC) was dose proportional following doses of 70 mg/m² to 115 mg/m² with infusion times of 1 to 2 hours.

Overdosage

Sourced from openFDA

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 complications of overdosage include: bone marrow suppression, peripheral neurotoxicity, and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed. In two reports of overdose, one patient received 150 mg/m² and the other received 200 mg/m² as 1-hour infusions. Both patients experienced severe neutropenia, mild asthenia, cutaneous reactions, and mild paresthesia, and recovered without incident. In mice, lethality was observed following single intravenous doses that were ≥154 mg/kg (about 4.5 times the human dose of 100 mg/m² on a mg/m² basis); neurotoxicity associated with paralysis, non-extension of hind limbs, and myelin degeneration was observed in mice at 48 mg/kg (about 1.5 times the human dose of 100 mg/m² basis).

Approval history

Sourced from openFDA
  • May 14, 1996NDANDA020449Sanofi Aventis Us
  • Mar 8, 2011NDANDA022234Hospira Inc
  • May 3, 2011NDANDA022534Sun Pharm
  • Jun 8, 2011NDANDA201195Accord Hlthcare
  • Jun 29, 2011NDANDA201525Sandoz
  • Apr 12, 2013NDANDA203551Actavis
  • Nov 22, 2022NDANDA215813Avyxa Holdings
  • Oct 23, 2024NDANDA218711Zhuhai

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Docetaxel, Injection, 10 mg/1 mL (NDC 50742-431-08)To be discontinued
    Sponsor: Ingenus Pharmaceuticals LLC
    Updated
  • Docetaxel, Injection, 10 mg/1 mL (NDC 50742-463-16)To be discontinued
    Sponsor: Ingenus Pharmaceuticals LLC
    Updated
  • Docetaxel, Injection, 160 mg/16 mL (10 mg/mL) Multiple Dose ONCO-TAIN™ Glass Fliptop Vial Novaplus® (NDC 0409-0016-01)To be discontinued
    Sponsor: Pfizer Inc.
    Updated
  • Docetaxel, Injection, 20 mg/2 mL (10 mg/mL) Single Dose ONCO-TAIN™ Glass Fliptop Vial Novaplus® (NDC 0409-2026-01)To be discontinued
    Sponsor: Pfizer Inc.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
66,045 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Alopecia16,95126%
  2. 2Madarosis6,71310%
  3. 3Hair Texture Abnormal5,9939.1%
  4. 4Hair Colour Changes5,8748.9%
  5. 5Hair Disorder5,6258.5%
  6. 6Diarrhoea5,1797.8%
  7. 7Nausea3,7625.7%
  8. 8Emotional Distress3,6155.5%
  9. 9Anxiety3,4565.2%
  10. 10Neutropenia3,2995.0%
  11. 11Fatigue3,1914.8%
  12. 12Febrile Neutropenia3,0314.6%
  13. 13Malignant Neoplasm Progression2,7204.1%
  14. 14Vomiting2,7194.1%
  15. 15Disease Progression2,5963.9%

Literature

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Recent PubMed references pinned to Docetaxel as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 3,118 ClinicalTrials.gov registrations naming Docetaxel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Docetaxel work?
Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly.
What is Docetaxel used for?
According to FDA labeling, Docetaxel carries indications including: Docetaxel injection is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) Gastric Adenocarcinoma (GC) : with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction ( 1.4 ) Squamous Cell Carcinoma of the Head and Neck (SCCHN) : with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN ( 1.5 ) 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Docetaxel?
Docetaxel is classified as Taxanes, Protein Synthesis Inhibitors, Tubulin Interactions, Decreased DNA Integrity, Decreased Meiosis, Decreased Mitosis, Decreased Protein Synthesis, Decreased RNA Integrity, Microtubule Inhibition.
What are the brand names for Docetaxel?
Docetaxel is marketed under brand names including Beizray, Docivyx.
What are the contraindications for Docetaxel?
Docetaxel labeling lists contraindications including: Hypersensitivity to docetaxel or polysorbate 80 ( 4 ) Neutrophil counts of <1500 cells/mm 3 ( 4 ) Docetaxel is contraindicated in patients with: neutrophil counts of <1500 cells/mm 3 [ see Warnings and Precautions ( 5.3 ) ]. a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80.. Always consult the full prescribing information and a clinician.
Note. Data for docetaxel is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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