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LABELS · abb9eb38-c6a9-49e9-8e90-852f95773feb

CAPRELSA

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
2026-04-23
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval [see Warnings and Precautions (5.1) ] . WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH See full prescribing information for complete boxed warning. CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval ( 5.1 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. ( 1 ) Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. ( 1 )
Full extracted label fields
application numbers
  1. NDA022405
boxed warning exact
  1. WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval [see Warnings and Precautions (5.1) ] . WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH See full prescribing information for complete boxed warning. CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval ( 5.1 ).
brand names
  1. CAPRELSA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5721cb8-4185-47b9-bbb3-1c587e558a03
generic names
  1. VANDETANIB
id
abb9eb38-c6a9-49e9-8e90-852f95773feb
indications and usage exact
  1. 1 INDICATIONS AND USAGE CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. ( 1 ) Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Genzyme Corporation
    matched search terms
    1. cancer
    package ndcs
    1. 58468-7820-3
    2. 58468-7840-3
    product ndcs
    1. 58468-7820
    2. 58468-7840
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Warnings and Precautions ( 5.16 ) 05/2025
    record type
    complete_spl_indications_section_candidate
    routes
    1. ORAL
    rxcuis
    1. 1098416
    2. 1098418
    3. 1114074
    4. 1114096
    source batch
    file
    /private/tmp/cancer-full-research/indications/raw/labels-00500.json
    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
    results
    limit
    100
    skip
    500
    total
    830
    sha256
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    url
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%22abb9eb38-c6a9-49e9-8e90-852f95773feb%22
    spl effective date
    2026-04-23
    spl effective time
    20260423
    spl set id
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    spl version
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    substance names
    1. VANDETANIB
    uniis
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    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
      NDA022405
      payload
      all indexed label documents
      1. Appl No
        022405
        Application Docs Date
        2011-04-15 00:00:00
        Application Docs ID
        17325
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        022405
        Application Docs Date
        2013-07-05 00:00:00
        Application Docs ID
        17326
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      3. Appl No
        022405
        Application Docs Date
        2014-04-01 00:00:00
        Application Docs ID
        17327
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      4. Appl No
        022405
        Application Docs Date
        2011-06-29 00:00:00
        Application Docs ID
        38663
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      5. Appl No
        022405
        Application Docs Date
        2012-10-12 00:00:00
        Application Docs ID
        38664
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        3
        Submission Type
        SUPPL
      6. Appl No
        022405
        Application Docs Date
        2016-08-02 00:00:00
        Application Docs ID
        38665
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      7. Appl No
        022405
        Application Docs Date
        2018-10-15 00:00:00
        Application Docs ID
        55913
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        14
        Submission Type
        SUPPL
      8. Appl No
        022405
        Application Docs Date
        2020-06-05 00:00:00
        Application Docs ID
        63439
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      9. Appl No
        022405
        Application Docs Date
        2020-06-15 00:00:00
        Application Docs ID
        63579
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        17
        Submission Type
        SUPPL
      10. Appl No
        022405
        Application Docs Date
        2022-03-30 00:00:00
        Application Docs ID
        70656
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        19
        Submission Type
        SUPPL
      11. Appl No
        022405
        Application Docs Date
        2024-03-08 00:00:00
        Application Docs ID
        77767
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        22
        Submission Type
        SUPPL
      12. Appl No
        022405
        Application Docs Date
        2025-05-14 00:00:00
        Application Docs ID
        82244
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        23
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        26
        Submission Status
        AP
        Submission Status Date
        2026-01-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        022405
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        25
        Submission Status
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        Submission Status Date
        2025-09-23 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
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        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        24
        Submission Status
        AP
        Submission Status Date
        2025-06-26 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        23
        Submission Status
        AP
        Submission Status Date
        2025-05-14 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        22
        Submission Status
        AP
        Submission Status Date
        2024-03-07 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        022405
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        21
        Submission Status
        AP
        Submission Status Date
        2023-04-13 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        19
        Submission Status
        AP
        Submission Status Date
        2022-03-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        17
        Submission Status
        AP
        Submission Status Date
        2020-06-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2020-06-05 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2018-10-12 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2017-02-24 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        022405
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2016-07-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      NDA022405
      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
      2026-01-27
      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
        022405
        Application Docs Date
        2026-01-28 00:00:00
        Application Docs ID
        84866
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        26
        Submission Type
        SUPPL
      official application record
      Appl No
      022405
      Appl Public Notes
      Appl Type
      NDA
      Sponsor Name
      GENZYME CORP
      openfda application present
      true
      products
      1. Active Ingredient
        VANDETANIB
        Appl No
        022405
        Drug Name
        CAPRELSA
        Form
        TABLET;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        0
        Strength
        100MG
        marketing status
        1. Prescription
      2. Active Ingredient
        VANDETANIB
        Appl No
        022405
        Drug Name
        CAPRELSA
        Form
        TABLET;ORAL
        Product No
        002
        Reference Drug
        1
        Reference Standard
        1
        Strength
        300MG
        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. NDA022405
    brand names
    1. CAPRELSA
    classification reasons
    1. explicit_positive_indication_predicate
    2. tumor_or_malignant_hematology_words_in_positive_statement
    clinical review status
    pending
    content role
    positive_indication_candidate
    context span
    end
    388
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicate
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    duplicate text group
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    positive predicate support span
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    qualifier mentions
    1. context exact
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      kind
      biomarker
      polarity
      not_inferred
      span
      end
      187
      end exclusive
      true
      exact text
      metastatic disease
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      start
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    2. context exact
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      183
      end exclusive
      true
      exact text
      unresectable locally advanced or metastatic dis
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    regulatory links
      schema version
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      source defined aliases
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        188
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
        label id
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        start
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        source url
        https://api.fda.gov/drug/label.json?search=id%3A%22abb9eb38-c6a9-49e9-8e90-852f95773feb%22
        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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        Source null
        approval pathway
        Source null
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        Source null
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        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 · unclassified context
        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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        content role
        unclassified_context
        context span
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        548
        end exclusive
        true
        exact text
        1 INDICATIONS AND USAGE CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. ( 1 ) Use CAPRE
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        positive predicate support span
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        qualifier mentions
          regulatory links
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            source defined aliases
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              end exclusive
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              exact text
              Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
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              source url
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              spl effective date
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              spl set id
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              structured fields status
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              structured indication
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              Source null
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              Source null
              biomarker and test
              Source null
              disease stage
              Source null
              limitations
              Source null
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              Source null
              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              unclear
              Passage 3 · positive indication candidate
              application numbers
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              brand names
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              classification reasons
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              2. tumor_or_malignant_hematology_words_in_positive_statement
              clinical review status
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              exact text
              locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. ( 1 ) Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. ( 1 )
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              offset unit
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              current approval status
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              duplicate text group
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              generic names
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                        ( 1 ) Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
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                        exact text
                        y advanced or metastatic disease. ( 1 ) Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. ( 1 )
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                              Preserved source evidence · Not medical advice