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LABELS · 30ff13f0-1e77-43de-99c9-c309834f1e63

COPIKTRA

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
2025-12-18
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )] . Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected [see Warnings and Precautions ( 5.2 )]. Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA [see Warnings and Precautions ( 5.3 )] . Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA [see Warnings and Precautions ( 5.4 )] . Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA [see Warnings and Precautions ( 5.5 )]. WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patients. ( 5.1 ) Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected. ( 5.2 ) Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA. ( 5.3 ) Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA. ( 5.4 ) Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. ( 5.5 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines lines of systemic therapy. ( 1 ) Limitations of Use : COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. ( 1 )
Full extracted label fields
application numbers
  1. NDA211155
boxed warning exact
  1. WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, AND PNEUMONITIS Treatment-related mortality occurred in 15% of COPIKTRA-treated patients [see Warnings and Precautions ( 5.1 )] . Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected [see Warnings and Precautions ( 5.2 )]. Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA [see Warnings and Precautions ( 5.3 )] . Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA [see Warnings and Precautions ( 5.4 )] . Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA [see Warnings and Precautions ( 5.5 )]. WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS See full prescribing information for complete boxed warning Treatment-related mortality occurred in 15% of COPIKTRA-treated patients. ( 5.1 ) Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected. ( 5.2 ) Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA. ( 5.3 ) Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA. ( 5.4 ) Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA. ( 5.5 )
brand names
  1. COPIKTRA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e3c5ac56-e1f6-473a-bc73-687836534780
generic names
  1. DUVELISIB
id
30ff13f0-1e77-43de-99c9-c309834f1e63
indications and usage exact
  1. 1 INDICATIONS AND USAGE COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines lines of systemic therapy. ( 1 ) Limitations of Use : COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Secura Bio, Inc
    matched search terms
    1. lymphoma
    2. leukemia
    package ndcs
    1. 73116-225-28
    2. 73116-225-56
    3. 73116-215-28
    4. 73116-215-56
    product ndcs
    1. 73116-215
    2. 73116-225
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Boxed Warning, Treatment Related Mortality added Indications and Usage, Limitations of Use added ( 1 ) Warnings and Precautions, Treatment Related Mortality ( 5.1 ) 7/2024 7/2024 7/2024
    record type
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    2. 2058520
    3. 2058523
    4. 2058525
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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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    limit
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    spl effective date
    2025-12-18
    spl effective time
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    substance names
    1. DUVELISIB
    uniis
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    Drugs@FDA application source records
    1. application number
      NDA211155
      payload
      all indexed label documents
      1. Appl No
        211155
        Application Docs Date
        2018-09-24 00:00:00
        Application Docs ID
        55609
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
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        Submission Type
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      2. Appl No
        211155
        Application Docs Date
        2019-10-03 00:00:00
        Application Docs ID
        60213
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      3. Appl No
        211155
        Application Docs Date
        2021-09-30 00:00:00
        Application Docs ID
        68812
        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
        3
        Submission Type
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      4. Appl No
        211155
        Application Docs Date
        2021-12-19 00:00:00
        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        5
        Submission Type
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      5. Appl No
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        Application Docs Date
        2024-07-29 00:00:00
        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
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      all submission records
      1. Appl No
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        Review Priority
        PRIORITY
        Submission Class Code ID
        7
        Submission No
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        Submission Status
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        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      2. Appl No
        211155
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
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        Submission Status
        AP
        Submission Status Date
        2019-09-26 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        211155
        Review Priority
        PRIORITY
        Submission Class Code ID
        2
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2018-09-24 00:00:00
        Submission Type
        ORIG
        Submissions Public Notes
      4. Appl No
        211155
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2021-09-22 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        211155
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2021-12-17 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        211155
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        6
        Submission Status
        AP
        Submission Status Date
        2022-02-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        211155
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2024-07-26 00:00:00
        Submission Type
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        Submissions Public Notes
      8. Appl No
        211155
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        8
        Submission Status
        AP
        Submission Status Date
        2025-07-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        211155
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2025-10-24 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
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      approval interpretation
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      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
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      latest posted label documents
      1. Appl No
        211155
        Application Docs Date
        2024-07-29 00:00:00
        Application Docs ID
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        Application Docs Title
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        Submission No
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      Appl No
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      openfda application present
      true
      products
      1. Active Ingredient
        DUVELISIB
        Appl No
        211155
        Drug Name
        COPIKTRA
        Form
        CAPSULE;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        0
        Strength
        15MG
        marketing status
        1. Prescription
      2. Active Ingredient
        DUVELISIB
        Appl No
        211155
        Drug Name
        COPIKTRA
        Form
        CAPSULE;ORAL
        Product No
        002
        Reference Drug
        1
        Reference Standard
        0
        Strength
        25MG
        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. COPIKTRA
    classification reasons
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    true
    exact text
    1 INDICATIONS AND USAGE COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortal
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    qualifier mentions
    1. context exact
      ATIONS AND USAGE COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (C
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      IKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at
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        1 INDICATIONS AND USAGE COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy.
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        is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prio
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            Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.
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