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LABELS · c328016b-fc3e-4d6f-99b3-8d2c13b362f3

Inrebic

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
2026-07-20
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: ENCEPHALOPATHY INCLUDING WERNICKE'S Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: ENCEPHALOPATHY INCLUDING WERNICKE'S See full prescribing information for complete boxed warning. Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize. ( 2.6 , 5.1 , 6.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ).
Full extracted label fields
application numbers
  1. NDA212327
boxed warning exact
  1. WARNING: ENCEPHALOPATHY INCLUDING WERNICKE'S Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize [see Dosage and Administration (2.6) , Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] . WARNING: ENCEPHALOPATHY INCLUDING WERNICKE'S See full prescribing information for complete boxed warning. Serious and fatal encephalopathy, including Wernicke's, has occurred in patients treated with INREBIC. Wernicke's encephalopathy is a neurologic emergency. Assess thiamine levels in all patients prior to starting INREBIC. Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation. While on treatment all patients should receive prophylaxis with daily oral thiamine and should have thiamine levels assessed as clinically indicated. If encephalopathy is suspected, immediately discontinue INREBIC and initiate parenteral thiamine. Monitor until symptoms resolve or improve and thiamine levels normalize. ( 2.6 , 5.1 , 6.1 ).
brand names
  1. Inrebic
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f0f55a2a-4e0c-4cba-8571-03e1424486d7
generic names
  1. FEDRATINIB HYDROCHLORIDE
id
c328016b-fc3e-4d6f-99b3-8d2c13b362f3
indications and usage exact
  1. 1 INDICATIONS AND USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Celgene Corporation
    matched search terms
    1. myelofibrosis
    2. polycythemia
    3. thrombocythemia
    package ndcs
    1. 59572-720-12
    product ndcs
    1. 59572-720
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Warnings and Precautions ( 5.10 ) 03/2026
    record type
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    1. 2197495
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    meta
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    spl effective date
    2026-07-20
    spl effective time
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    substance names
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    uniis
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    Drugs@FDA application source records
    1. application number
      NDA212327
      payload
      all indexed label documents
      1. Appl No
        212327
        Application Docs Date
        2019-08-16 00:00:00
        Application Docs ID
        59727
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
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      2. Appl No
        212327
        Application Docs Date
        2021-11-24 00:00:00
        Application Docs ID
        69415
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      3. Appl No
        212327
        Application Docs Date
        2021-12-07 00:00:00
        Application Docs ID
        69486
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        3
        Submission Type
        SUPPL
      4. Appl No
        212327
        Application Docs Date
        2023-05-16 00:00:00
        Application Docs ID
        74258
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
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      5. Appl No
        212327
        Application Docs Date
        2024-08-02 00:00:00
        Application Docs ID
        79263
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        6
        Submission Type
        SUPPL
      6. Appl No
        212327
        Application Docs Date
        2025-05-21 00:00:00
        Application Docs ID
        82208
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      7. Appl No
        212327
        Application Docs Date
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        Application Docs ID
        85485
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      8. Appl No
        212327
        Application Docs Date
        2026-07-27 00:00:00
        Application Docs ID
        86710
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      all submission records
      1. Appl No
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        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2019-08-16 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
        212327
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2021-12-03 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        212327
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2021-11-23 00:00:00
        Submission Type
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        Submissions Public Notes
      4. Appl No
        212327
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2023-05-15 00:00:00
        Submission Type
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        Submissions Public Notes
      5. Appl No
        212327
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2024-07-30 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        212327
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2025-05-12 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        212327
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2026-03-18 00:00:00
        Submission Type
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        Submissions Public Notes
      8. Appl No
        212327
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        11
        Submission Status
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        Submission Status Date
        2026-07-20 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
      NDA212327
      approval interpretation
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      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
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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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        Application Docs Title
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      Appl No
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      Appl Public Notes
      Appl Type
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      Sponsor Name
      BRISTOL-MYERS
      openfda application present
      true
      products
      1. Active Ingredient
        FEDRATINIB HYDROCHLORIDE
        Appl No
        212327
        Drug Name
        INREBIC
        Form
        CAPSULE;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        EQ 100MG 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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    brand names
    1. Inrebic
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    1 INDICATIONS AND USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibro
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    qualifier mentions
    1. context exact
      TIONS AND USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post
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        1 INDICATIONS AND USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF).
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        limitations
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        D USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ).
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            INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ).
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            limitations
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            prior therapy
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            regimen
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            tumor histology
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            Preserved source evidence · Not medical advice