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LABELS · 1fbda3cb-1ba1-490d-e063-6294a90a6777

DOCETAXEL

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2024-08-15
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with Docetaxel Injection 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 Injection as a single agent at a dose of 100 mg/m 2 [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/mm 3 . 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 Injection 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) ]. WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION See full prescribing information for complete boxed warning. Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving Docetaxel Injection at 100 mg/m 2 ( 5.1 ) Avoid use of Docetaxel Injection if bilirubin > ULN, or if AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle ( 5.2 ) Do not administer Docetaxel Injection to patients with neutrophil counts <1500 cells/mm 3 . Obtain frequent blood counts to monitor for neutropenia ( 4 , 5.3 ) Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of Docetaxel Injection and administration of appropriate therapy ( 5.5 ) Contraindicated if history of severe hypersensitivity reactions to Docetaxel Injection or to drugs formulated with polysorbate 80 ( 4 ) Severe fluid retention may occur despite dexamethasone ( 5.6 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE 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. Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. 1.2 Non-small Cell Lung Cancer Docetaxel Injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Docetaxel Injection in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. 1.3 Prostate Cancer Docetaxel Injection in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. 1.4 Gastric Adenocarcinoma Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease. 1.5 Head and Neck Cancer Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
Full extracted label fields
application numbers
  1. NDA201195
boxed warning exact
  1. WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with Docetaxel Injection 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 Injection as a single agent at a dose of 100 mg/m 2 [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/mm 3 . 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 Injection 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) ]. WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION See full prescribing information for complete boxed warning. Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with NSCLC and prior platinum-based therapy receiving Docetaxel Injection at 100 mg/m 2 ( 5.1 ) Avoid use of Docetaxel Injection if bilirubin > ULN, or if AST and/or ALT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle ( 5.2 ) Do not administer Docetaxel Injection to patients with neutrophil counts <1500 cells/mm 3 . Obtain frequent blood counts to monitor for neutropenia ( 4 , 5.3 ) Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of Docetaxel Injection and administration of appropriate therapy ( 5.5 ) Contraindicated if history of severe hypersensitivity reactions to Docetaxel Injection or to drugs formulated with polysorbate 80 ( 4 ) Severe fluid retention may occur despite dexamethasone ( 5.6 )
brand names
  1. DOCETAXEL
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59f7811-70b7-4c44-99f7-4f4fdce3ed22
generic names
  1. DOCETAXEL
id
1fbda3cb-1ba1-490d-e063-6294a90a6777
indications and usage exact
  1. 1 INDICATIONS AND USAGE 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. Docetaxel Injection in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. 1.2 Non-small Cell Lung Cancer Docetaxel Injection as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy. Docetaxel Injection in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. 1.3 Prostate Cancer Docetaxel Injection in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. 1.4 Gastric Adenocarcinoma Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease. 1.5 Head and Neck Cancer Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Accord Healthcare Inc.
    matched search terms
    1. cancer
    2. carcinoma
    package ndcs
    1. 16729-231-65
    2. 16729-231-64
    3. 16729-231-63
    4. 16729-267-63
    5. 16729-267-64
    6. 16729-267-65
    product ndcs
    1. 16729-267
    2. 16729-231
    product types
    1. HUMAN PRESCRIPTION DRUG
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      last updated
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      source url
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      spl effective date
      2024-08-15
      spl effective time
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      spl set id
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      spl version
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      substance names
      1. DOCETAXEL ANHYDROUS
      uniis
      1. 699121PHCA
      verification flags
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      Drugs@FDA application source records
      1. application number
        NDA201195
        payload
        all indexed label documents
        1. Appl No
          201195
          Application Docs Date
          2011-06-10 00:00:00
          Application Docs ID
          18995
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
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        2. Appl No
          201195
          Application Docs Date
          2013-04-09 00:00:00
          Application Docs ID
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          Application Docs Title
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          Application Docs Type ID
          2
          Submission No
          4
          Submission Type
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        3. Appl No
          201195
          Application Docs Date
          2014-07-08 00:00:00
          Application Docs ID
          40052
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          6
          Submission Type
          SUPPL
        4. Appl No
          201195
          Application Docs Date
          2016-07-27 00:00:00
          Application Docs ID
          40053
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          9
          Submission Type
          SUPPL
        5. Appl No
          201195
          Application Docs Date
          2019-06-27 00:00:00
          Application Docs ID
          59176
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          13
          Submission Type
          SUPPL
        6. Appl No
          201195
          Application Docs Date
          2020-07-22 00:00:00
          Application Docs ID
          64007
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        7. Appl No
          201195
          Application Docs Date
          2023-09-21 00:00:00
          Application Docs ID
          75529
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
          15
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2011-06-08 00:00:00
          Submission Type
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        2. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
          AP
          Submission Status Date
          2013-04-05 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          5
          Submission Status
          AP
          Submission Status Date
          2013-11-06 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2014-07-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2016-05-27 00:00:00
          Submission Type
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          Submissions Public Notes
        6. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2015-10-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          9
          Submission Status
          AP
          Submission Status Date
          2016-07-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2019-06-21 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2020-07-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          201195
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          19
          Submission Status
          AP
          Submission Status Date
          2023-09-20 00:00:00
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          Submissions Public Notes
        application number
        NDA201195
        approval interpretation
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        current indication status
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        latest posted label documents
        1. Appl No
          201195
          Application Docs Date
          2023-09-21 00:00:00
          Application Docs ID
          75529
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          19
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        official application record
        Appl No
        201195
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ACCORD HLTHCARE
        openfda application present
        true
        products
        1. Active Ingredient
          DOCETAXEL
          Appl No
          201195
          Drug Name
          DOCETAXEL
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          20MG/0.5ML (40MG/ML)
          marketing status
          1. Discontinued
        2. Active Ingredient
          DOCETAXEL
          Appl No
          201195
          Drug Name
          DOCETAXEL
          Form
          INJECTABLE;INJECTION
          Product No
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          Reference Drug
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          Reference Standard
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          Strength
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        3. Active Ingredient
          DOCETAXEL
          Appl No
          201195
          Drug Name
          DOCETAXEL
          Form
          INJECTABLE;INJECTION
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        4. Active Ingredient
          DOCETAXEL
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          Drug Name
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          Form
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          Product No
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          Reference Drug
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          Reference Standard
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          Strength
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        5. Active Ingredient
          DOCETAXEL
          Appl No
          201195
          Drug Name
          DOCETAXEL
          Form
          INJECTABLE;INJECTION
          Product No
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          Reference Drug
          1
          Reference Standard
          1
          Strength
          160MG/8ML (20MG/ML)
          marketing status
          1. Prescription

      Source passages and status connections

      Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

      Passage 1 · positive indication candidate
      application numbers
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      1. DOCETAXEL
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      exact text
      1 INDICATIONS AND USAGE 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. Docetaxel Injection in combinat
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        ation-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) Gastric Adenocarcinoma (GC) : with cisplatin an
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                      1.5 Head and Neck Cancer Docetaxel Injection in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
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                      Preserved source evidence · Not medical advice