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LABELS · f219a6c1-2e94-40a7-8b66-28520f7bb7f7

Elzonris

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
2024-12-09
Captured
2026-09-09T23:38:04.335995+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 )
Full extracted label fields
application numbers
  1. BLA761116
boxed warning exact
  1. WARNING: CAPILLARY LEAK SYNDROME Capillary Leak Syndrome (CLS) which may be life-threatening or fatal, can occur in patients receiving ELZONRIS. Monitor for signs and symptoms of CLS and take actions as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. Capillary Leak Syndrome (CLS), which may be life-threatening or fatal if not properly managed, can occur in patients receiving ELZONRIS. ( 5.1 )
brand names
  1. Elzonris
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80eb1080-fe20-4af0-b2a5-a67999923fa8
generic names
  1. TAGRAXOFUSP
id
f219a6c1-2e94-40a7-8b66-28520f7bb7f7
indications and usage exact
  1. 1 INDICATIONS AND USAGE ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Stemline Therapeutics, Inc.
    matched search terms
    1. neoplasm
    package ndcs
    1. 72187-0401-1
    product ndcs
    1. 72187-0401
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Dosage and Administration, Recommended Dosage (2.1) 7/2023 Warnings and Precautions, Capillary Leak Syndrome (5.1) 10/2022 Warnings and Precautions, Hepatotoxicity (5.3) 10/2022
    record type
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    routes
    1. INTRAVENOUS
    rxcuis
    1. 2109059
    2. 2109064
    source batch
    file
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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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    sha256
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    url
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    source url
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    spl effective date
    2024-12-09
    spl effective time
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    spl set id
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    spl version
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    substance names
    1. TAGRAXOFUSP
    uniis
    1. 8ZHS5657EH
    verification flags
    1. oncology_keyword_candidate_not_clinically_classified
    2. spl_text_not_verified_identical_to_latest_approved_label
    3. individual_indications_not_split_or_reconciled
    Drugs@FDA application source records
    1. application number
      BLA761116
      payload
      all indexed label documents
      1. Appl No
        761116
        Application Docs Date
        2018-12-21 00:00:00
        Application Docs ID
        56969
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761116
        Application Docs Date
        2022-10-28 00:00:00
        Application Docs ID
        72494
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
        SUPPL
      3. Appl No
        761116
        Application Docs Date
        2022-11-07 00:00:00
        Application Docs ID
        72570
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      4. Appl No
        761116
        Application Docs Date
        2023-07-27 00:00:00
        Application Docs ID
        74909
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761116
        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2018-12-21 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      2. Appl No
        761116
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2022-10-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761116
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2022-11-03 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        761116
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2023-07-26 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA761116
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2023-07-26
      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
      latest posted label documents
      1. Appl No
        761116
        Application Docs Date
        2023-07-27 00:00:00
        Application Docs ID
        74909
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      official application record
      Appl No
      761116
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      STEMLINE THERAPEUTICS INC
      openfda application present
      true
      products
      1. Active Ingredient
        TAGRAXOFUSP-ERZS
        Appl No
        761116
        Drug Name
        ELZONRIS
        Form
        SOLUTION;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
        1000MCG
        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. BLA761116
    brand names
    1. Elzonris
    classification reasons
    1. explicit_positive_indication_predicate
    2. tumor_or_malignant_hematology_words_in_positive_statement
    clinical review status
    pending
    content role
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    context span
    end
    357
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 )
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    duplicate text group
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    generic names
    1. TAGRAXOFUSP
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    qualifier mentions
    1. context exact
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      not_inferred
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      end exclusive
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      end exclusive
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    3. context exact
      c cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.
      kind
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      173
      end exclusive
      true
      exact text
      2 years and older
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    regulatory links
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      source defined aliases
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        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older.
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        source url
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        spl effective date
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        spl set id
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        spl version
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        structured fields status
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        structured indication
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        Source null
        approval pathway
        Source null
        biomarker and test
        Source null
        disease stage
        Source null
        limitations
        Source null
        line
        Source null
        prior therapy
        Source null
        regimen
        Source null
        tumor histology
        Source null
        use intent
        tumor_directed_candidate
        Passage 2 · positive indication candidate
        application numbers
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        brand names
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        classification reasons
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        clinical review status
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        357
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 )
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          source defined aliases
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            true
            exact text
            ELZONRIS is a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older ( 1 )
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            source url
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            structured fields status
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            Source null
            approval pathway
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            biomarker and test
            Source null
            disease stage
            Source null
            limitations
            Source null
            line
            Source null
            prior therapy
            Source null
            regimen
            Source null
            tumor histology
            Source null
            use intent
            tumor_directed_candidate

            Preserved source evidence · Not medical advice