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LABELS · 45f7d427-0830-1612-e063-6294a90a04d2

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
2025-12-15
Captured
2026-09-09T23:37:44.904352+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).
  2. 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.
  3. 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.
  4. 1.3 Prostate Cancer BEIZRAY in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
  5. 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.
  6. 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=3538b979-8cac-49ed-b8dc-50f73ce38c72
generic names
  1. DOCETAXEL
id
45f7d427-0830-1612-e063-6294a90a04d2
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).
  2. 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.
  3. 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.
  4. 1.3 Prostate Cancer BEIZRAY in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
  5. 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.
  6. 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. Zhuhai Beihai Biotech Co., Ltd.
    matched search terms
    1. cancer
    2. carcinoma
    package ndcs
    1. 83513-009-01
    2. 83513-008-01
    product ndcs
    1. 83513-008
    2. 83513-009
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. INTRAVENOUS
      rxcuis
      1. 1860480
      2. 1860485
      3. 2697044
      4. 2728902
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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
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      url
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      source url
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      spl effective date
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      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
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      verification flags
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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
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission Type
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        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
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          Submission Status
          AP
          Submission Status Date
          2025-04-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
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        approval interpretation
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        current indication status
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        latest approved submission date
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        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
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          Application Docs Title
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          Application Docs Type ID
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          Submission No
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          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
      pending
      content role
      positive_indication_candidate
      context span
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      1088
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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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      1. DOCETAXEL
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      is a microtubule inhibitor indicated
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      qualifier mentions
      1. context exact
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        not_inferred
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      2. context exact
        l Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced
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        not_inferred
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      3. context exact
        e; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC ( 1.2 ) Castration-Resistant Prostate Cancer (CRPC): with predn
        kind
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      4. context exact
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      5. context exact
        hibitor indicated for: Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adju
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        not_inferred
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        adjuvant treatment of operable node-positiv
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      7. context exact
        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, local
        kind
        stage_or_setting
        polarity
        not_inferred
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      8. context exact
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        unresectable
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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 predn
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        not_inferred
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        exact text
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                                    Preserved source evidence · Not medical advice