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LABELS · 9ee2fe09-ff4e-4bfb-9b38-f15ea77cf1d8

Ellence

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
2026-07-24
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m 2 , 1.6% at 700 mg/m 2 , and 3.3% at 900 mg/m 2 . The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with ELLENCE [see Warnings and Precautions (5.1) ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ] . • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m 2 , 1.6% at 700 mg/m 2 , and 3.3% at 900 mg/m 2 . The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with ELLENCE ( 5.1 ). • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE ( 5.2 ). • Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area ( 5.3 ). • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur ( 5.4 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).
Full extracted label fields
application numbers
  1. NDA050778
boxed warning exact
  1. WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m 2 , 1.6% at 700 mg/m 2 , and 3.3% at 900 mg/m 2 . The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with ELLENCE [see Warnings and Precautions (5.1) ] . • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE [see Warnings and Precautions (5.2) ] . • Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area [see Warnings and Precautions (5.3) ] . • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see Warnings and Precautions (5.4) ] . WARNING: CARDIAC TOXICITY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Cardiac Toxicity: Myocardial damage, including acute left ventricular failure, can occur with ELLENCE. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m 2 , 1.6% at 700 mg/m 2 , and 3.3% at 900 mg/m 2 . The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with ELLENCE ( 5.1 ). • Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including ELLENCE ( 5.2 ). • Extravasation and Tissue Necrosis: Extravasation of ELLENCE can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area ( 5.3 ). • Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur ( 5.4 ).
brand names
  1. Ellence
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a03c798-a652-4895-b29c-3b521a89ba42
generic names
  1. EPIRUBICIN HYDROCHLORIDE
id
9ee2fe09-ff4e-4bfb-9b38-f15ea77cf1d8
indications and usage exact
  1. 1 INDICATIONS AND USAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Pharmacia & Upjohn Company LLC
    matched search terms
    1. cancer
    2. tumor
    package ndcs
    1. 0009-5091-01
    2. 0009-5091-25
    3. 0009-5093-01
    4. 0009-5093-10
    product ndcs
    1. 0009-5091
    2. 0009-5093
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
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      3. 1732186
      4. 1732187
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      meta
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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. EPIRUBICIN HYDROCHLORIDE
      uniis
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      Drugs@FDA application source records
      1. application number
        NDA050778
        payload
        all indexed label documents
        1. Appl No
          050778
          Application Docs Date
          2013-02-21 00:00:00
          Application Docs ID
          18228
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          19
          Submission Type
          SUPPL
        2. Appl No
          050778
          Application Docs Date
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          Application Docs ID
          18229
          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
          21
          Submission Type
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        3. Appl No
          050778
          Application Docs Date
          1999-09-15 00:00:00
          Application Docs ID
          39313
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        4. Appl No
          050778
          Application Docs Date
          2005-03-10 00:00:00
          Application Docs ID
          39314
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          8
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        5. Appl No
          050778
          Application Docs Date
          2011-09-16 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          15
          Submission Type
          SUPPL
        6. Appl No
          050778
          Application Docs Date
          2011-09-16 00:00:00
          Application Docs ID
          39316
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          17
          Submission Type
          SUPPL
        7. Appl No
          050778
          Application Docs Date
          2011-09-16 00:00:00
          Application Docs ID
          39317
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          18
          Submission Type
          SUPPL
        8. Appl No
          050778
          Application Docs Date
          2019-07-29 00:00:00
          Application Docs ID
          59482
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          25
          Submission Type
          SUPPL
        9. Appl No
          050778
          Application Docs Date
          2019-10-15 00:00:00
          Application Docs ID
          59483
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          24
          Submission Type
          SUPPL
        10. Appl No
          050778
          Application Docs Date
          2025-01-21 00:00:00
          Application Docs ID
          80883
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          29
          Submission Type
          SUPPL
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        1. Appl No
          050778
          Review Priority
          N/A
          Submission Class Code ID
          4
          Submission No
          29
          Submission Status
          AP
          Submission Status Date
          2024-11-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          26
          Submission Status
          AP
          Submission Status Date
          2021-02-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
          AP
          Submission Status Date
          2019-07-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          24
          Submission Status
          AP
          Submission Status Date
          2019-07-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          21
          Submission Status
          AP
          Submission Status Date
          2014-12-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          19
          Submission Status
          AP
          Submission Status Date
          2013-02-19 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        7. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          18
          Submission Status
          AP
          Submission Status Date
          2011-09-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        8. Appl No
          050778
          Review Priority
          UNKNOWN
          Submission Class Code ID
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          Submission No
          17
          Submission Status
          AP
          Submission Status Date
          2011-09-14 00:00:00
          Submission Type
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          Submissions Public Notes
        9. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          15
          Submission Status
          AP
          Submission Status Date
          2011-09-14 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
          2
          Submission No
          8
          Submission Status
          AP
          Submission Status Date
          2005-03-02 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          050778
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          4
          Submission Status
          AP
          Submission Status Date
          2003-04-03 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          050778
          Review Priority
          PRIORITY
          Submission Class Code ID
          3
          Submission No
          3
          Submission Status
          AP
          Submission Status Date
          2003-04-03 00:00:00
          Submission Type
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          Submissions Public Notes
        application number
        NDA050778
        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
        2024-11-25
        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
          050778
          Application Docs Date
          2025-01-21 00:00:00
          Application Docs ID
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          Application Docs Title
          0
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          Submission No
          29
          Submission Type
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        official application record
        Appl No
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        Appl Public Notes
        Appl Type
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        Sponsor Name
        PFIZER INC
        openfda application present
        true
        products
        1. Active Ingredient
          EPIRUBICIN HYDROCHLORIDE
          Appl No
          050778
          Drug Name
          ELLENCE
          Form
          INJECTABLE;INJECTION
          Product No
          001
          Reference Drug
          1
          Reference Standard
          1
          Strength
          200MG/100ML (2MG/ML)
          marketing status
          1. Prescription
        2. Active Ingredient
          EPIRUBICIN HYDROCHLORIDE
          Appl No
          050778
          Drug Name
          ELLENCE
          Form
          INJECTABLE;INJECTION
          Product No
          002
          Reference Drug
          1
          Reference Standard
          0
          Strength
          50MG/25ML (2MG/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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      1 INDICATIONS AND USAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast can
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        NDICATIONS AND USAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of pr
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          1 INDICATIONS AND USAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] .
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          SAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1) ] . ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).
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              ELLENCE is an anthracycline topoisomerase inhibitor indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer ( 1 ).
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              indications_and_usage_exact
              source text sha256
              36e9fb940ddeecd4c5e4af03913604517b22e1d71cba98a94e532bbe07aef6b4
              start
              219
              source url
              https://api.fda.gov/drug/label.json?search=id%3A%229ee2fe09-ff4e-4bfb-9b38-f15ea77cf1d8%22
              spl effective date
              2026-07-24
              spl set id
              0a03c798-a652-4895-b29c-3b521a89ba42
              spl version
              26
              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
              tumor_directed_candidate

              Preserved source evidence · Not medical advice