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LABELS · b1aef238-5cd9-47cb-a83f-1f5eac49f013

Xospata

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
2022-01-01
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: DIFFERENTIATION SYNDROME Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. ( 5.1 , 6.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. ( 1.1 ) 1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
Full extracted label fields
application numbers
  1. NDA211349
boxed warning exact
  1. WARNING: DIFFERENTIATION SYNDROME Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal or life-threatening if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, or renal dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Patients treated with XOSPATA have experienced symptoms of differentiation syndrome, which can be fatal if not treated. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. ( 5.1 , 6.1 )
brand names
  1. Xospata
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b5ff59aa-9c0d-49a8-9053-1f179b482383
generic names
  1. GILTERITINIB
id
b1aef238-5cd9-47cb-a83f-1f5eac49f013
indications and usage exact
  1. 1 INDICATIONS AND USAGE XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. ( 1.1 ) 1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Astellas Pharma US, Inc.
    matched search terms
    1. leukemia
    package ndcs
    1. 0469-1425-90
    2. 0469-1425-21
    product ndcs
    1. 0469-1425
    product types
    1. HUMAN PRESCRIPTION DRUG
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      substance names
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      1. application number
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        payload
        all indexed label documents
        1. Appl No
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          Application Docs Date
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          Application Docs ID
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        2. Appl No
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          Application Docs Date
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          Application Docs ID
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        3. Appl No
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          Application Docs ID
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          Submission No
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          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        2. Appl No
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          Review Priority
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          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submissions Public Notes
        3. Appl No
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          Review Priority
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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
        application number
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        approval interpretation
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        has approved submission record
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        latest approved submission date
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        latest posted label documents
        1. Appl No
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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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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
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        Sponsor Name
        ASTELLAS
        openfda application present
        true
        products
        1. Active Ingredient
          GILTERITINIB FUMARATE
          Appl No
          211349
          Drug Name
          XOSPATA
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 40MG BASE
          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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      true
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      1 INDICATIONS AND USAGE XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. ( 1.1 ) 1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosin
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        OSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML
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      3. context exact
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          1 INDICATIONS AND USAGE XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
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          SAGE XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. ( 1.1 ) 1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase
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                PATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. ( 1.1 ) 1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
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                    1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.
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                    Source null
                    use intent
                    tumor_directed_candidate

                    Preserved source evidence · Not medical advice