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LABELS · 0fa10522-2034-c417-e063-6394a90a2cf5

Gleostine

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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
2024-01-23
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE DELAYED MYELOSUPPRESSION Gleostine causes myelosuppression including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative; occurring 4 to 6 weeks after drug administration and persisting for 1 to 2 weeks. Thrombocytopenia is generally more severe than leukopenia. Cumulative myelosuppression from Gleostine is manifested by greater severity and longer duration of cytopenias. Monitor blood counts for at least 6 weeks after each dose. Do not give Gleostine more frequently than every 6 weeks [see Warnings and Precautions ( 5.1 ), Dosage and Administration ( 2.2 , 2.3 )] . RISK OF OVERDOSAGE PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Gleostine. Both physician and pharmacist should emphasize to the patient that only one dose of Gleostine is taken every 6 weeks [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.2 ), Overdosage ( 10 )] . WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE See full prescribing information for complete boxed warning. Delayed Myelosuppression Gleostine causes myelosuppression including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative. Thrombocytopenia is generally more severe than leukopenia. Monitor blood counts and do not give Gleostine more frequently than every 6 weeks. ( 2.2 , 2.3 , 5.1 ) Risk of Overdosage PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Gleostine. Both physician and pharmacist should emphasize to patient that only one dose of Gleostine is taken every 6 weeks. ( 2.1 , 5.2 , 10 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Gleostine is an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1 ) Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1 ) 1.1 Brain Tumors Gleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.2 Hodgkin's Lymphoma Gleostine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.
Full extracted label fields
application numbers
  1. NDA017588
boxed warning exact
  1. WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE DELAYED MYELOSUPPRESSION Gleostine causes myelosuppression including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative; occurring 4 to 6 weeks after drug administration and persisting for 1 to 2 weeks. Thrombocytopenia is generally more severe than leukopenia. Cumulative myelosuppression from Gleostine is manifested by greater severity and longer duration of cytopenias. Monitor blood counts for at least 6 weeks after each dose. Do not give Gleostine more frequently than every 6 weeks [see Warnings and Precautions ( 5.1 ), Dosage and Administration ( 2.2 , 2.3 )] . RISK OF OVERDOSAGE PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Gleostine. Both physician and pharmacist should emphasize to the patient that only one dose of Gleostine is taken every 6 weeks [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.2 ), Overdosage ( 10 )] . WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE See full prescribing information for complete boxed warning. Delayed Myelosuppression Gleostine causes myelosuppression including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative. Thrombocytopenia is generally more severe than leukopenia. Monitor blood counts and do not give Gleostine more frequently than every 6 weeks. ( 2.2 , 2.3 , 5.1 ) Risk of Overdosage PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Gleostine. Both physician and pharmacist should emphasize to patient that only one dose of Gleostine is taken every 6 weeks. ( 2.1 , 5.2 , 10 )
brand names
  1. Gleostine
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7f77526b-4c40-409c-82ea-d0f934d89cc2
generic names
  1. LOMUSTINE
id
0fa10522-2034-c417-e063-6394a90a2cf5
indications and usage exact
  1. 1 INDICATIONS AND USAGE Gleostine is an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1 ) Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1 ) 1.1 Brain Tumors Gleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.2 Hodgkin's Lymphoma Gleostine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. NextSource Biotechnology, LLC
    matched search terms
    1. lymphoma
    2. tumors
    package ndcs
    1. 58181-3041-5
    2. 58181-3040-5
    3. 58181-3042-5
    product ndcs
    1. 58181-3040
    2. 58181-3041
    3. 58181-3042
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. ORAL
      rxcuis
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      2. 197895
      3. 197896
      4. 1545776
      5. 1545778
      6. 1545780
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      meta
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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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      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. LOMUSTINE
      uniis
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      verification flags
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      1. application number
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        payload
        all indexed label documents
        1. Appl No
          017588
          Application Docs Date
          2012-11-28 00:00:00
          Application Docs ID
          11040
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          36
          Submission Type
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        2. Appl No
          017588
          Application Docs Date
          2013-08-21 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          39
          Submission Type
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        3. Appl No
          017588
          Application Docs Date
          2016-01-07 00:00:00
          Application Docs ID
          11042
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          42
          Submission Type
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        4. Appl No
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          Application Docs Date
          2009-05-11 00:00:00
          Application Docs ID
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          0
          Application Docs Type ID
          2
          Submission No
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          Submission Type
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        5. Appl No
          017588
          Application Docs Date
          2011-05-16 00:00:00
          Application Docs ID
          33315
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          37
          Submission Type
          SUPPL
        6. Appl No
          017588
          Application Docs Date
          2014-05-28 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          40
          Submission Type
          SUPPL
        7. Appl No
          017588
          Application Docs Date
          2016-02-02 00:00:00
          Application Docs ID
          33317
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          43
          Submission Type
          SUPPL
        8. Appl No
          017588
          Application Docs Date
          2020-10-06 00:00:00
          Application Docs ID
          64854
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          46
          Submission Type
          SUPPL
        all submission records
        1. Appl No
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          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          46
          Submission Status
          AP
          Submission Status Date
          2020-06-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          017588
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          43
          Submission Status
          AP
          Submission Status Date
          2016-01-29 00:00:00
          Submission Type
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          Submissions Public Notes
        3. Appl No
          017588
          Review Priority
          STANDARD
          Submission Class Code ID
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          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
        4. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submissions Public Notes
        5. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          40
          Submission Status
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          Submission Status Date
          2014-05-20 00:00:00
          Submission Type
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          Submissions Public Notes
        6. Appl No
          017588
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          39
          Submission Status
          AP
          Submission Status Date
          2013-08-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          017588
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          38
          Submission Status
          AP
          Submission Status Date
          2013-08-14 00:00:00
          Submission Type
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          Submissions Public Notes
        8. Appl No
          017588
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          37
          Submission Status
          AP
          Submission Status Date
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          Submissions Public Notes
        9. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          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
        10. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          34
          Submission Status
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          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        11. Appl No
          017588
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          33
          Submission Status
          AP
          Submission Status Date
          2003-02-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          017588
          Review Priority
          STANDARD
          Submission Class Code ID
          4
          Submission No
          32
          Submission Status
          AP
          Submission Status Date
          1999-06-01 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
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        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
        2020-06-04
        latest label selection rule
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        latest posted label documents
        1. Appl No
          017588
          Application Docs Date
          2020-10-06 00:00:00
          Application Docs ID
          64854
          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
        AZURITY
        openfda application present
        true
        products
        1. Active Ingredient
          LOMUSTINE
          Appl No
          017588
          Drug Name
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          Form
          CAPSULE;ORAL
          Product No
          001
          Reference Drug
          1
          Reference Standard
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          Appl No
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          Drug Name
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          CAPSULE;ORAL
          Product No
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          Reference Drug
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          Reference Standard
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        3. Active Ingredient
          LOMUSTINE
          Appl No
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          Drug Name
          GLEOSTINE
          Form
          CAPSULE;ORAL
          Product No
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          Reference Drug
          1
          Reference Standard
          0
          Strength
          100MG
          marketing status
          1. Prescription
        4. Active Ingredient
          LOMUSTINE
          Appl No
          017588
          Drug Name
          GLEOSTINE
          Form
          CAPSULE;ORAL
          Product No
          004
          Reference Drug
          1
          Reference Standard
          0
          Strength
          5MG
          marketing status
          1. Discontinued

      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. Gleostine
      classification reasons
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      exact text
      1 INDICATIONS AND USAGE Gleostine is an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1 ) Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1 ) 1.1 Brain Tumors Gleostine is indicated for the treatment of patients
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          1 INDICATIONS AND USAGE Gleostine is an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures.
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          ATIONS AND USAGE Gleostine is an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ( 1 ) Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1 ) 1.1 Brain Tumors Gleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.2 Hodgkin's L
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