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LABELS · 5db62458-cb13-4a2a-b7ee-6ed3fca88a8c

Nipent

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
2026-07-01
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING NIPENT should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified (see DOSAGE AND ADMINISTRATION ) is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used NIPENT at higher doses (20-50 mg/m 2 in divided doses over 5 days) than recommended. In a clinical investigation in patients with refractory chronic lymphocytic leukemia using NIPENT at the recommended dose in combination with fludarabine phosphate, 4 of 6 patients entered in the study had severe or fatal pulmonary toxicity. The use of NIPENT in combination with fludarabine phosphate is not recommended.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
Full extracted label fields
application numbers
  1. NDA020122
boxed warning exact
  1. WARNING NIPENT should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified (see DOSAGE AND ADMINISTRATION ) is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used NIPENT at higher doses (20-50 mg/m 2 in divided doses over 5 days) than recommended. In a clinical investigation in patients with refractory chronic lymphocytic leukemia using NIPENT at the recommended dose in combination with fludarabine phosphate, 4 of 6 patients entered in the study had severe or fatal pulmonary toxicity. The use of NIPENT in combination with fludarabine phosphate is not recommended.
brand names
  1. Nipent
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=674e0e6d-46ed-4868-9196-04019d667716
generic names
  1. PENTOSTATIN
id
5db62458-cb13-4a2a-b7ee-6ed3fca88a8c
indications and usage exact
  1. INDICATIONS AND USAGE NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Hospira, Inc.
    matched search terms
    1. leukemia
    package ndcs
    1. 0409-0801-01
    product ndcs
    1. 0409-0801
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 105607
      2. 240573
      source batch
      file
      /private/tmp/cancer-full-research/indications/raw/labels-00400.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
      400
      total
      830
      sha256
      a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
      url
      https://api.fda.gov/drug/label.json?search=%28indications_and_usage%3Acancer+OR+indications_and_usage%3Acarcinoma+OR+indications_and_usage%3Acarcinomas+OR+indications_and_usage%3Alymphoma+OR+indications_and_usage%3Alymphomas+OR+indications_and_usage%3Aleukemia+OR+indications_and_usage%3Aleukaemia+OR+indications_and_usage%3Asarcoma+OR+indications_and_usage%3Asarcomas+OR+indications_and_usage%3Amelanoma+OR+indications_and_usage%3Amyeloma+OR+indications_and_usage%3Atumor+OR+indications_and_usage%3Atumors+OR+indications_and_usage%3Atumour+OR+indications_and_usage%3Atumours+OR+indications_and_usage%3Aneoplasm+OR+indications_and_usage%3Aneoplasms+OR+indications_and_usage%3Amalignant+OR+indications_and_usage%3Amalignancy+OR+indications_and_usage%3Amyelodysplastic+OR+indications_and_usage%3Amyelofibrosis+OR+indications_and_usage%3Amastocytosis+OR+indications_and_usage%3Aglioma+OR+indications_and_usage%3Aglioblastoma+OR+indications_and_usage%3Aneuroblastoma+OR+indications_and_usage%3Aretinoblastoma+OR+indications_and_usage%3Apheochromocytoma+OR+indications_and_usage%3Aparaganglioma+OR+indications_and_usage%3Amyeloproliferative+OR+indications_and_usage%3Awaldenstrom+OR+indications_and_usage%3Apolycythemia+OR+indications_and_usage%3Athrombocythemia+OR+indications_and_usage%3Adesmoid+OR+indications_and_usage%3Aneurofibromatosis+OR+indications_and_usage%3Ahistiocytosis%29+AND+%28openfda.application_number%3ANDA%2A+OR+openfda.application_number%3ABLA%2A%29&limit=100&skip=400&sort=id%3Aasc
      source url
      https://api.fda.gov/drug/label.json?search=id%3A%225db62458-cb13-4a2a-b7ee-6ed3fca88a8c%22
      spl effective date
      2026-07-01
      spl effective time
      20260701
      spl set id
      674e0e6d-46ed-4868-9196-04019d667716
      spl version
      28
      substance names
      1. PENTOSTATIN
      uniis
      1. 395575MZO7
      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
        NDA020122
        payload
        all indexed label documents
        1. Appl No
          020122
          Application Docs Date
          2019-10-29 00:00:00
          Application Docs ID
          60701
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        2. Appl No
          020122
          Application Docs Date
          2025-11-04 00:00:00
          Application Docs ID
          84047
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          020122
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2025-11-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          020122
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2019-10-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          020122
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          13
          Submission Status
          AP
          Submission Status Date
          2015-12-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          020122
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          12
          Submission Status
          AP
          Submission Status Date
          2013-06-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          020122
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          10
          Submission Status
          AP
          Submission Status Date
          2009-09-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          020122
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          7
          Submission Status
          AP
          Submission Status Date
          2002-05-23 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          020122
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          6
          Submission Status
          AP
          Submission Status Date
          2001-08-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          020122
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          1998-10-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        9. Appl No
          020122
          Review Priority
          PRIORITY
          Submission Class Code ID
          4
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          1997-12-24 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          020122
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          1994-07-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          020122
          Review Priority
          UNKNOWN
          Submission Class Code ID
          2
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1993-09-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          020122
          Review Priority
          PRIORITY
          Submission Class Code ID
          7
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          1991-10-11 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        application number
        NDA020122
        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
        2025-11-03
        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
          020122
          Application Docs Date
          2025-11-04 00:00:00
          Application Docs ID
          84047
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          21
          Submission Type
          SUPPL
        official application record
        Appl No
        020122
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        HOSPIRA INC
        openfda application present
        true
        products
        1. Active Ingredient
          PENTOSTATIN
          Appl No
          020122
          Drug Name
          NIPENT
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          10MG/VIAL
          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. NDA020122
      brand names
      1. Nipent
      classification reasons
      1. explicit_positive_indication_predicate
      2. supportive_or_complication_use_words
      clinical review status
      pending
      content role
      positive_indication_candidate
      context span
      end
      272
      end exclusive
      true
      exact text
      INDICATIONS AND USAGE NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
      label id
      5db62458-cb13-4a2a-b7ee-6ed3fca88a8c
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      487651d5308eb1121470496f237024b4fbc6ed7e97122066d6ddd78c5eeb5d5d
      start
      0
      current approval status
      not_reconciled
      duplicate text group
      dup-f4f4e7e3d7bb5bd68948
      extraction review status
      automated_candidate_pending_source_review
      generic names
      1. PENTOSTATIN
      id
      ind-span-3085a743bd7fd43c4071
      label id
      5db62458-cb13-4a2a-b7ee-6ed3fca88a8c
      positive predicate support span
      end
      41
      end exclusive
      true
      exact text
      is indicated
      label id
      5db62458-cb13-4a2a-b7ee-6ed3fca88a8c
      offset unit
      unicode_code_points
      source array index
      0
      source field
      indications_and_usage_exact
      source text sha256
      487651d5308eb1121470496f237024b4fbc6ed7e97122066d6ddd78c5eeb5d5d
      start
      29
      qualifier mentions
      1. context exact
        gle-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia,
        kind
        stage_or_setting
        polarity
        not_inferred
        span
        end
        153
        end exclusive
        true
        exact text
        refractory hairy cell leukemia patients with
        label id
        5db62458-cb13-4a2a-b7ee-6ed3fca88a8c
        offset unit
        unicode_code_points
        source array index
        0
        source field
        indications_and_usage_exact
        source text sha256
        487651d5308eb1121470496f237024b4fbc6ed7e97122066d6ddd78c5eeb5d5d
        start
        108
      regulatory links
        schema version
        0.1.0
        source batch sha256
        a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
        source defined aliases
          source span
          end
          272
          end exclusive
          true
          exact text
          INDICATIONS AND USAGE NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients with active disease as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms.
          label id
          5db62458-cb13-4a2a-b7ee-6ed3fca88a8c
          offset unit
          unicode_code_points
          source array index
          0
          source field
          indications_and_usage_exact
          source text sha256
          487651d5308eb1121470496f237024b4fbc6ed7e97122066d6ddd78c5eeb5d5d
          start
          0
          source url
          https://api.fda.gov/drug/label.json?search=id%3A%225db62458-cb13-4a2a-b7ee-6ed3fca88a8c%22
          spl effective date
          2026-07-01
          spl set id
          674e0e6d-46ed-4868-9196-04019d667716
          spl version
          28
          structured fields status
          not_extracted_no_values_inferred_from_mentions
          structured indication
          age
          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
          supportive_care_candidate

          Preserved source evidence · Not medical advice