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LABELS · 427d10d2-c29d-4b71-a5fe-c97736d59aa6

Besponsa

Open original source → · Download preserved record

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
2026-02-06
Captured
2026-09-09T23:37:44.904352+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. ( 5.1 ) • A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA ( 5.2 ) HEPATOTOXICITY, INCLUDING VOD • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. • Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. • Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. INCREASED RISK OF POST-HSCT NON-RELAPSE MORTALITY • There was higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate [see Warnings and Precautions (5.2) ] .

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. ( 1 )
Full extracted label fields
application numbers
  1. BLA761040
boxed warning exact
  1. WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST-HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY WARNING: HEPATOTOXICITY, INCLUDING HEPATIC VENO-OCCLUSIVE DISEASE (VOD) (ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME) and INCREASED RISK OF POST- HEMATOPOIETIC STEM CELL TRANSPLANT (HSCT) NON-RELAPSE MORTALITY See full prescribing information for complete boxed warning. • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients who received BESPONSA. ( 5.1 ) • A higher post-HSCT non-relapse mortality rate occurred in patients receiving BESPONSA ( 5.2 ) HEPATOTOXICITY, INCLUDING VOD • Hepatotoxicity, including fatal and life-threatening VOD occurred in patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who received BESPONSA. The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level ≥ upper limit of normal (ULN) before HSCT were significantly associated with an increased risk of VOD. • Other risk factors for VOD in patients treated with BESPONSA included ongoing or prior liver disease, prior HSCT, increased age, later salvage lines, and a greater number of BESPONSA treatment cycles. • Elevation of liver tests may require dosing interruption, dose reduction, or permanent discontinuation of BESPONSA. Permanently discontinue treatment if VOD occurs. If severe VOD occurs, treat according to standard medical practice [see Dosage and Administration (2.3) and Warnings and Precautions (5.1) ]. INCREASED RISK OF POST-HSCT NON-RELAPSE MORTALITY • There was higher post-HSCT non-relapse mortality rate in patients receiving BESPONSA, resulting in a higher Day 100 post-HSCT mortality rate [see Warnings and Precautions (5.2) ] .
brand names
  1. Besponsa
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cc7014b1-c775-411d-b374-8113248b4077
generic names
  1. INOTUZUMAB OZOGAMICIN
id
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indications and usage exact
  1. 1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. ( 1 )
indications and usage tables exact
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    manufacturer names
    1. Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
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    1. leukemia
    package ndcs
    1. 0008-0100-01
    product ndcs
    1. 0008-0100
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage (1) 3/2024 Dosage and Administration, Instructions for Reconstitution, Dilution and Administration (2.4) 3/2024 Warnings and Precautions, Hepatotoxicity, Including Hepatic Veno-occlusive Disease (VOD) (also known as Sinusoidal Obstruction Syndrome) (5.1) 3/2024 Warnings and Precautions, Increased Risk of Post-Transplant Non-Relapse Mortality (5.2) 3/2024 Warnings and Precautions, Myelosuppression (5.3) 3/2024 Warnings and Precautions, Infusion Related Reactions (5.4) 3/2024 Warnings and Precautions, QT Interval Prolongation (5.5) 3/2024
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    1. INTRAVENOUS
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    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
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    substance names
    1. INOTUZUMAB OZOGAMICIN
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    Drugs@FDA application source records
    1. application number
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      payload
      all indexed label documents
      1. Appl No
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        Application Docs Date
        2017-08-17 00:00:00
        Application Docs ID
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        Application Docs Type ID
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        Application Docs Date
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        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 Class Code ID
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        Submission No
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        Submission Status Date
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        Submissions Public Notes
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        Submissions Public Notes
      application number
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      1. Appl No
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        Application Docs Date
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        Application Docs ID
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      official application record
      Appl No
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      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      WYETH PHARMS INC
      openfda application present
      true
      products
      1. Active Ingredient
        INOTUZUMAB OZOGAMICIN
        Appl No
        761040
        Drug Name
        BESPONSA
        Form
        POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER
        Product No
        001
        Reference Drug
        2
        Reference Standard
        0
        Strength
        0.9/MG/VIAL
        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 · unclassified context
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    brand names
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    1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and ol
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          Passage 2 · positive indication candidate
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          1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and
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            CD22-positive B-cell precursor acute lymphob
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            ATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and p
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              ATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older . BESPONSA is a CD22-directed antibody and cytotoxic drug conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older. ( 1 )
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                        Preserved source evidence · Not medical advice