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LABELS · 293334d4-88f2-4ec2-9eed-20975ff65c0a

Topotecan

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
2021-02-01
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: MYELOSUPPRESSION Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5.1) ] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm 3 and platelet count greater than or equal to 100,000/mm 3 . Monitor blood cell counts. ( 2.2 , 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Topotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy. ( 1 )
Full extracted label fields
application numbers
  1. NDA200582
boxed warning exact
  1. WARNING: MYELOSUPPRESSION Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts of greater than or equal to 1,500/mm 3 and platelet counts greater than or equal to 100,000/mm 3 . Monitor blood cell counts [see Warnings and Precautions (5.1) ] . WARNING: MYELOSUPPRESSION See full prescribing information for complete boxed warning. Topotecan can cause severe myelosuppression. Administer first cycle only to patients with baseline neutrophil counts greater than or equal to 1,500/mm 3 and platelet count greater than or equal to 100,000/mm 3 . Monitor blood cell counts. ( 2.2 , 5.1 )
brand names
  1. Topotecan
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d4e1cce-c57e-4a8b-be96-f95a2778e221
generic names
  1. TOPOTECAN
id
293334d4-88f2-4ec2-9eed-20975ff65c0a
indications and usage exact
  1. 1 INDICATIONS AND USAGE Topotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy. ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Hospira, Inc.
    matched search terms
    1. cancer
    package ndcs
    1. 0409-0302-01
    product ndcs
    1. 0409-0302
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      1. INTRAVENOUS
      rxcuis
      1. 1799424
      source batch
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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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      url
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      source url
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      spl effective date
      2021-02-01
      spl effective time
      20210201
      spl set id
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      spl version
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      substance names
      1. TOPOTECAN HYDROCHLORIDE
      uniis
      1. 956S425ZCY
      verification flags
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      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        NDA200582
        payload
        all indexed label documents
        1. Appl No
          200582
          Application Docs Date
          2011-02-04 00:00:00
          Application Docs ID
          18965
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          200582
          Application Docs Date
          2016-02-25 00:00:00
          Application Docs ID
          18966
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          2
          Submission Type
          SUPPL
        3. Appl No
          200582
          Application Docs Date
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          Application Docs ID
          40028
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          SUPPL
        4. Appl No
          200582
          Application Docs Date
          2019-12-17 00:00:00
          Application Docs ID
          61325
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          200582
          Review Priority
          STANDARD
          Submission Class Code ID
          15
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2011-02-02 00:00:00
          Submission Type
          ORIG
          Submissions Public Notes
        2. Appl No
          200582
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          1
          Submission Status
          AP
          Submission Status Date
          2014-02-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          200582
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          2
          Submission Status
          AP
          Submission Status Date
          2016-01-29 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          200582
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2019-12-16 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        NDA200582
        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
        2019-12-16
        latest label selection rule
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        latest posted label documents
        1. Appl No
          200582
          Application Docs Date
          2019-12-17 00:00:00
          Application Docs ID
          61325
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          3
          Submission Type
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        official application record
        Appl No
        200582
        Appl Public Notes
        Appl Type
        NDA
        Sponsor Name
        HOSPIRA INC
        openfda application present
        true
        products
        1. Active Ingredient
          TOPOTECAN HYDROCHLORIDE
          Appl No
          200582
          Drug Name
          TOPOTECAN HYDROCHLORIDE
          Form
          SOLUTION;INTRAVENOUS
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
          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. Topotecan
      classification reasons
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      clinical review status
      pending
      content role
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      430
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      true
      exact text
      1 INDICATIONS AND USAGE Topotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of fi
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      qualifier mentions
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          1 INDICATIONS AND USAGE Topotecan Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy.
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          Passage 2 · positive indication candidate
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          an Injection is indicated for the treatment of patients with small cell lung cancer (SCLC) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy. ( 1 )
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          is a topoisomerase inhibitor indicated
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              Topotecan Injection is a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy.
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              a topoisomerase inhibitor indicated for treatment of small cell lung cancer (SCLC) platinum-sensitive disease in patients who progressed at least 60 days after initiation of first-line chemotherapy. ( 1 )
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                    Preserved source evidence · Not medical advice