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LABELS · 4efe8f3a-a176-4b69-90c8-5ba5891dccfd

BEIZRAY

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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
2025-12-17
Captured
2026-09-09T23:37:47.659725+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 BEIZRAY 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 BEIZRAY as a single agent at a dose of 100 mg/m 2 [see Warnings and Precautions ( 5.1 )] . Avoid the use of BEIZRAY 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 BEIZRAY [see Warnings and Precautions ( 5.2 )] . Do not administer BEIZRAY 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 BEIZRAY to patients who have a history of severe hypersensitivity reactions to docetaxel [see Contraindications ( 4 )] . Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the BEIZRAY 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 BEIZRAY at 100 mg/m 2 ( 5.1 ) Avoid use of BEIZRAY 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 BEIZRAY 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 BEIZRAY and administration of appropriate therapy ( 5.5 ) Contraindicated if history of severe hypersensitivity reactions to docetaxel ( 4 ) Severe fluid retention may occur despite dexamethasone ( 5.6 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE BEIZRAY 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 BEIZRAY is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. BEIZRAY 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 BEIZRAY 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. BEIZRAY 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 BEIZRAY in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. 1.4 Gastric Adenocarcinoma BEIZRAY 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 BEIZRAY 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. NDA218711
boxed warning exact
  1. WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA, HYPERSENSITIVITY REACTIONS, and FLUID RETENTION Treatment-related mortality associated with BEIZRAY 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 BEIZRAY as a single agent at a dose of 100 mg/m 2 [see Warnings and Precautions ( 5.1 )] . Avoid the use of BEIZRAY 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 BEIZRAY [see Warnings and Precautions ( 5.2 )] . Do not administer BEIZRAY 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 BEIZRAY to patients who have a history of severe hypersensitivity reactions to docetaxel [see Contraindications ( 4 )] . Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the BEIZRAY 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 BEIZRAY at 100 mg/m 2 ( 5.1 ) Avoid use of BEIZRAY 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 BEIZRAY 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 BEIZRAY and administration of appropriate therapy ( 5.5 ) Contraindicated if history of severe hypersensitivity reactions to docetaxel ( 4 ) Severe fluid retention may occur despite dexamethasone ( 5.6 )
brand names
  1. BEIZRAY
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8fb7d980-d6c7-468b-a9f0-adff16101a4b
generic names
  1. DOCETAXEL
id
4efe8f3a-a176-4b69-90c8-5ba5891dccfd
indications and usage exact
  1. 1 INDICATIONS AND USAGE BEIZRAY 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 BEIZRAY is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. BEIZRAY 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 BEIZRAY 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. BEIZRAY 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 BEIZRAY in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer. 1.4 Gastric Adenocarcinoma BEIZRAY 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 BEIZRAY 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. Zydus Pharmaceuticals USA Inc.
    matched search terms
    1. cancer
    2. carcinoma
    package ndcs
    1. 70710-2091-3
    2. 70710-2090-1
    3. 64208-2512-4
    4. 70710-2093-4
    5. 70710-2152-1
    6. 70710-2092-8
    product ndcs
    1. 70710-2091
    2. 70710-2093
    3. 70710-2152
    4. 70710-2092
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 1860480
      2. 1860485
      3. 2054168
      4. 2054170
      5. 2697044
      6. 2723663
      7. 2723664
      8. 2723665
      9. 2723666
      10. 2728902
      source batch
      file
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      meta
      disclaimer
      Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
      last updated
      2026-09-09
      results
      limit
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      skip
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      830
      sha256
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      url
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      source url
      https://api.fda.gov/drug/label.json?search=id%3A%224efe8f3a-a176-4b69-90c8-5ba5891dccfd%22
      spl effective date
      2025-12-17
      spl effective time
      20251217
      spl set id
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      spl version
      4
      substance names
      1. DOCETAXEL ANHYDROUS
      uniis
      1. 699121PHCA
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA218711
        payload
        all indexed label documents
        1. Appl No
          218711
          Application Docs Date
          2024-10-25 00:00:00
          Application Docs ID
          79979
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        all submission records
        1. Appl No
          218711
          Review Priority
          STANDARD
          Submission Class Code ID
          15
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2024-10-23 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          218711
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2025-04-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA218711
        approval interpretation
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        current indication status
        not_reconciled
        has approved submission record
        true
        latest approved submission date
        2025-04-22
        latest label selection rule
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        latest posted label documents
        1. Appl No
          218711
          Application Docs Date
          2024-10-25 00:00:00
          Application Docs ID
          79979
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        official application record
        Appl No
        218711
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        ZHUHAI
        openfda application present
        true
        products
        1. Active Ingredient
          DOCETAXEL
          Appl No
          218711
          Drug Name
          BEIZRAY
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          80MG/4ML (20MG/ML)
          marketing status
          1. Prescription
        2. Active Ingredient
          DOCETAXEL
          Appl No
          218711
          Drug Name
          BEIZRAY
          Form
          SOLUTION;INTRAVENOUS
          Product No
          002
          Reference Drug
          1
          Reference Standard
          1
          Strength
          20MG/ML (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
      1. NDA218711
      brand names
      1. BEIZRAY
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
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      content role
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      true
      exact text
      1 INDICATIONS AND USAGE BEIZRAY 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 BEIZRAY is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. BEIZRAY in combination with doxorubicin and
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      qualifier mentions
      1. context exact
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        not_inferred
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      2. context exact
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      3. context exact
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      4. context exact
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      6. context exact
        erapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC) : single age
        kind
        stage_or_setting
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        not_inferred
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        adjuvant treatment of operable node-positiv
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      7. context exact
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        not_inferred
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      8. context exact
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      9. context exact
        tinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration-Resistant Prostate Cancer (CRPC) : with pred
        kind
        stage_or_setting
        polarity
        not_inferred
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        locally advanced or metastatic untreated NSCLC ( 1
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      10. context exact
        ation-Resistant Prostate Cancer (CRPC) : with prednisone in metastatic castration-resistant prostate cancer ( 1.3 ) Gastric Adenocarcinoma (GC) : with cisplatin and
        kind
        stage_or_setting
        polarity
        not_inferred
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