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LABELS · ca3e7112-6dfe-403f-af6f-a0051e77d125

Zydelig

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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
2025-02-20
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION Fatal and/or serious hepatotoxicity occurred in 16% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig as recommended [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) ] . Fatal and/or serious and severe diarrhea or colitis occurred in 20% of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig as recommended [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ] . Fatal and/or serious pneumonitis occurred in 4% of Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig as recommended [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . Fatal and/or serious infections occurred in 48% of Zydelig-treated patients. Monitor for signs and symptoms of infection. Interrupt Zydelig if infection is suspected [see Dosage and Administration (2.2) , Warnings and Precautions (5.4) ]. Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig for intestinal perforation [see Warnings and Precautions (5.5) ] . WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION See full prescribing information for complete boxed warning. Fatal and/or serious hepatotoxicity occurred in 16% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig. ( 5.1 ) Fatal and/or serious and severe diarrhea or colitis occurred in 20% of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig. ( 5.2 ) Fatal and/or serious pneumonitis occurred in 4% of Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig. ( 5.3 ) Fatal and/or serious infections occurred in 48% of Zydelig-treated patients. Monitor for signs and symptoms of infection. Interrupt Zydelig if infection is suspected. ( 5.4 ) Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig if intestinal perforation is suspected. ( 5.5 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. ( 1 ) Limitations of use: Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. ( 1 , 6.1 ) Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas. ( 6.1 ) Limitations of Use Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.
Full extracted label fields
application numbers
  1. NDA205858
boxed warning exact
  1. WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION Fatal and/or serious hepatotoxicity occurred in 16% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig as recommended [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) ] . Fatal and/or serious and severe diarrhea or colitis occurred in 20% of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig as recommended [see Dosage and Administration (2.2) , Warnings and Precautions (5.2) ] . Fatal and/or serious pneumonitis occurred in 4% of Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig as recommended [see Dosage and Administration (2.2) , Warnings and Precautions (5.3) ] . Fatal and/or serious infections occurred in 48% of Zydelig-treated patients. Monitor for signs and symptoms of infection. Interrupt Zydelig if infection is suspected [see Dosage and Administration (2.2) , Warnings and Precautions (5.4) ]. Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig for intestinal perforation [see Warnings and Precautions (5.5) ] . WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION See full prescribing information for complete boxed warning. Fatal and/or serious hepatotoxicity occurred in 16% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig. ( 5.1 ) Fatal and/or serious and severe diarrhea or colitis occurred in 20% of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig. ( 5.2 ) Fatal and/or serious pneumonitis occurred in 4% of Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig. ( 5.3 ) Fatal and/or serious infections occurred in 48% of Zydelig-treated patients. Monitor for signs and symptoms of infection. Interrupt Zydelig if infection is suspected. ( 5.4 ) Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig if intestinal perforation is suspected. ( 5.5 )
brand names
  1. Zydelig
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=efbdafa9-d18c-4e85-b4a2-1e620fc74e50
generic names
  1. IDELALISIB
id
ca3e7112-6dfe-403f-af6f-a0051e77d125
indications and usage exact
  1. 1 INDICATIONS AND USAGE Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. ( 1 ) Limitations of use: Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. ( 1 , 6.1 ) Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas. ( 6.1 ) Limitations of Use Zydelig is not indicated and is not recommended for first-line treatment of any patient, including patients with CLL, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), and other indolent non-Hodgkin lymphomas. Zydelig is not indicated and is not recommended in combination with bendamustine and rituximab, or in combination with rituximab for the treatment of patients with FL, SLL, and other indolent non-Hodgkin lymphomas.
indications and usage tables exact
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    manufacturer names
    1. Gilead Sciences, Inc.
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    2. 61958-1702
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    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage, Relapsed Follicular B-cell non-Hodgkin Lymphoma – Accelerated Approval Indication Removed ( 1 ) 2/2022 Indications and Usage, Relapsed Small Lymphocytic Lymphoma – Accelerated Approval Indication Removed ( 1 ) 2/2022
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    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.
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    spl effective date
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    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
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      payload
      all indexed label documents
      1. Appl No
        205858
        Application Docs Date
        2014-07-23 00:00:00
        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
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      2. Appl No
        205858
        Application Docs Date
        2016-09-29 00:00:00
        Application Docs ID
        45411
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        4
        Submission Type
        SUPPL
      3. Appl No
        205858
        Application Docs Date
        2017-11-30 00:00:00
        Application Docs ID
        50529
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        7
        Submission Type
        SUPPL
      4. Appl No
        205858
        Application Docs Date
        2018-01-30 00:00:00
        Application Docs ID
        52083
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
        SUPPL
      5. Appl No
        205858
        Application Docs Date
        2018-02-05 00:00:00
        Application Docs ID
        52399
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      6. Appl No
        205858
        Application Docs Date
        2018-10-11 00:00:00
        Application Docs ID
        55897
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        13
        Submission Type
        SUPPL
      7. Appl No
        205858
        Application Docs Date
        2020-10-21 00:00:00
        Application Docs ID
        64954
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        14
        Submission Type
        SUPPL
      8. Appl No
        205858
        Application Docs Date
        2022-02-22 00:00:00
        Application Docs ID
        70197
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
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      1. Appl No
        205858
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        18
        Submission Status
        AP
        Submission Status Date
        2022-07-06 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        205858
        Review Priority
        N/A
        Submission Class Code ID
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        Submission No
        17
        Submission Status
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        Submission Status Date
        2022-03-10 00:00:00
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        Submissions Public Notes
      3. Appl No
        205858
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2022-02-18 00:00:00
        Submission Type
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        Submissions Public Notes
      4. Appl No
        205858
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2020-10-19 00:00:00
        Submission Type
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        Submissions Public Notes
      5. Appl No
        205858
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        13
        Submission Status
        AP
        Submission Status Date
        2018-10-10 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        205858
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2018-03-22 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        205858
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2018-02-02 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        205858
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2018-02-06 00:00:00
        Submission Type
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        Submissions Public Notes
      9. Appl No
        205858
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2018-01-26 00:00:00
        Submission Type
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        Submissions Public Notes
      10. Appl No
        205858
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        7
        Submission Status
        AP
        Submission Status Date
        2017-11-29 00:00:00
        Submission Type
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        Submissions Public Notes
      11. Appl No
        205858
        Review Priority
        N/A
        Submission Class Code ID
        21
        Submission No
        5
        Submission Status
        AP
        Submission Status Date
        2017-01-04 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        205858
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2016-09-21 00:00:00
        Submission Type
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        Submissions Public Notes
      application number
      NDA205858
      approval interpretation
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      current indication status
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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
        205858
        Application Docs Date
        2022-02-22 00:00:00
        Application Docs ID
        70197
        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
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      official application record
      Appl No
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      Appl Public Notes
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      Sponsor Name
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      openfda application present
      true
      products
      1. Active Ingredient
        IDELALISIB
        Appl No
        205858
        Drug Name
        ZYDELIG
        Form
        TABLET;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        0
        Strength
        100MG
        marketing status
        1. Prescription
      2. Active Ingredient
        IDELALISIB
        Appl No
        205858
        Drug Name
        ZYDELIG
        Form
        TABLET;ORAL
        Product No
        002
        Reference Drug
        1
        Reference Standard
        1
        Strength
        150MG
        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 Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be c
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      1 INDICATIONS AND USAGE Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
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      1 INDICATIONS AND USAGE Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
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