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LABELS · 76183831-b710-4be2-a6a7-9349dd501830

Revuforj

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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
2026-02-04
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION and TORSADES DE POINTES Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. [see Dosage and Administration (2.3 ) , Warnings and Precautions (5.1) , and Adverse Reactions (6.1) ] . QTc prolongation and Torsades de Pointes have occurred in patients receiving REVUFORJ. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate REVUFORJ in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue REVUFORJ. [see Dosage and Administration (2.3) , Warnings and Precautions (5.2) , and Adverse Reactions (6.1) ] WARNING: DIFFERENTIATION SYNDROME, and QTc PROLONGATION and TORSADES DE POINTES See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 2.3 , 5.1 ) QTc prolongation and Torsades de Pointes have occurred in patients receiving REVUFORJ. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate REVUFORJ in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue REVUFORJ. ( 2.3 , 5.2 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. ( 1 ) Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. REVUFORJ is indicated for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 ( NPM1 ) mutation [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) , and Clinical Studies (14.1) ] in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
Full extracted label fields
application numbers
  1. NDA218944
boxed warning exact
  1. WARNING: DIFFERENTIATION SYNDROME, QTc PROLONGATION and TORSADES DE POINTES Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. Signs and symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and renal dysfunction. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. [see Dosage and Administration (2.3 ) , Warnings and Precautions (5.1) , and Adverse Reactions (6.1) ] . QTc prolongation and Torsades de Pointes have occurred in patients receiving REVUFORJ. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate REVUFORJ in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue REVUFORJ. [see Dosage and Administration (2.3) , Warnings and Precautions (5.2) , and Adverse Reactions (6.1) ] WARNING: DIFFERENTIATION SYNDROME, and QTc PROLONGATION and TORSADES DE POINTES See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, has occurred with REVUFORJ. If differentiation syndrome is suspected, immediately initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution ( 2.3 , 5.1 ) QTc prolongation and Torsades de Pointes have occurred in patients receiving REVUFORJ. Correct hypokalemia and hypomagnesemia prior to and during treatment. Do not initiate REVUFORJ in patients with QTcF > 450 msec. If QTc interval prolongation occurs, interrupt, reduce, or permanently discontinue REVUFORJ. ( 2.3 , 5.2 ).
brand names
  1. Revuforj
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6eb3cdbc-0e74-477d-82d6-3bb172d3f63f
generic names
  1. REVUMENIB
id
76183831-b710-4be2-a6a7-9349dd501830
indications and usage exact
  1. 1 INDICATIONS AND USAGE REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. ( 1 ) Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. REVUFORJ is indicated for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 ( NPM1 ) mutation [see Dosage and Administration (2.1) , Clinical Pharmacology (12.1) , and Clinical Studies (14.1) ] in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Syndax Pharmaceuticals, Inc.
    matched search terms
    1. leukemia
    package ndcs
    1. 73555-500-00
    2. 73555-501-00
    3. 73555-502-00
    product ndcs
    1. 73555-500
    2. 73555-501
    3. 73555-502
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. ORAL
      rxcuis
      1. 2698331
      2. 2698337
      3. 2698339
      4. 2698341
      5. 2698343
      6. 2698345
      source batch
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      meta
      disclaimer
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      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 version
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      substance names
      1. REVUMENIB CITRATE
      uniis
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      Drugs@FDA application source records
      1. application number
        NDA218944
        payload
        all indexed label documents
        1. Appl No
          218944
          Application Docs Date
          2024-11-18 00:00:00
          Application Docs ID
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          Application Docs Type 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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          Submission No
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        all submission records
        1. 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
          AP
          Submission Status Date
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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 Date
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          Submissions Public Notes
        application number
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        approval interpretation
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        current indication status
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        has approved submission record
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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
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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
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        Sponsor Name
        SYNDAX
        openfda application present
        true
        products
        1. Active Ingredient
          REVUMENIB CITRATE
          Appl No
          218944
          Drug Name
          REVUFORJ
          Form
          TABLET;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 25MG BASE
          marketing status
          1. Prescription
        2. Active Ingredient
          REVUMENIB CITRATE
          Appl No
          218944
          Drug Name
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          Form
          TABLET;ORAL
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          EQ 110MG BASE
          marketing status
          1. Prescription
        3. Active Ingredient
          REVUMENIB CITRATE
          Appl No
          218944
          Drug Name
          REVUFORJ
          Form
          TABLET;ORAL
          Product No
          003
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 160MG 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
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      1 INDICATIONS AND USAGE REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfacto
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      4. context exact
        VUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation a
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          1 INDICATIONS AND USAGE REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older.
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          structured fields status
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          Source null
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          Source null
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          Source null
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          Source null
          tumor histology
          Source null
          use intent
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          Passage 2 · positive indication candidate
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          ment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options. ( 1 ) Relapsed or Refractory Acute Leukemia REVUFORJ is indicated for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determi
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              ( 1 ) the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation in adult and pediatric patients 1 year and older who have no satisfactory alternative treatment options.
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                      Preserved source evidence · Not medical advice