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LABELS · 73ced17e-8a58-44b6-b901-347f1561f238

Avopef

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
2026-06-25
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SEVERE MYELOSUPPRESSION AVOPEF can cause severe myelosuppression resulting in infection or bleeding [see Warnings and Precautions (5.1) ] . Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 [see Warnings and Precautions (5.1) ] . Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy [see Warnings and Precautions (5.1) ] . WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . AVOPEF can cause severe myelosuppression resulting in infection or bleeding. ( 5.1 ) Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 . ( 5.1 ) Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy. ( 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE AVOPEF is a topoisomerase inhibitor indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with: Refractory testicular cancer ( 1.1 ) Small cell lung cancer ( 1.2 ) 1.1 Refractory Testicular Cancer AVOPEF, in combination with chemotherapy, is indicated for the treatment of refractory testicular cancer in adult patients. 1.2 Small Cell Lung Cancer AVOPEF, in combination with chemotherapy and immunotherapy, is indicated for the first-line treatment of small cell lung cancer (SCLC) in adult patients.
Full extracted label fields
application numbers
  1. NDA220200
boxed warning exact
  1. WARNING: SEVERE MYELOSUPPRESSION AVOPEF can cause severe myelosuppression resulting in infection or bleeding [see Warnings and Precautions (5.1) ] . Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 [see Warnings and Precautions (5.1) ] . Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy [see Warnings and Precautions (5.1) ] . WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . AVOPEF can cause severe myelosuppression resulting in infection or bleeding. ( 5.1 ) Do not administer AVOPEF to patients with absolute neutrophil counts of less than 500 cells/mm 3 or platelets less than 50,000 cells/mm 3 . ( 5.1 ) Monitor complete blood cell counts, prior to the administration of AVOPEF and before each subsequent cycle, and at appropriate intervals during and after therapy. ( 5.1 )
brand names
  1. Avopef
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=acc1e443-ef7b-486f-a638-710a20e81059
generic names
  1. ETOPOSIDE
id
73ced17e-8a58-44b6-b901-347f1561f238
indications and usage exact
  1. 1 INDICATIONS AND USAGE AVOPEF is a topoisomerase inhibitor indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with: Refractory testicular cancer ( 1.1 ) Small cell lung cancer ( 1.2 ) 1.1 Refractory Testicular Cancer AVOPEF, in combination with chemotherapy, is indicated for the treatment of refractory testicular cancer in adult patients. 1.2 Small Cell Lung Cancer AVOPEF, in combination with chemotherapy and immunotherapy, is indicated for the first-line treatment of small cell lung cancer (SCLC) in adult patients.
indications and usage tables exact
    is original packager
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    manufacturer names
    1. Avyxa Pharma, LLC
    matched search terms
    1. cancer
    package ndcs
    1. 83831-144-05
    2. 83831-145-25
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    1. 83831-144
    2. 83831-145
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        1. Active Ingredient
          ETOPOSIDE
          Appl No
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          Drug Name
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          Product No
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          Reference Drug
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          Reference Standard
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          marketing status
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        2. Active Ingredient
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          Appl No
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          Drug Name
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          Product No
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          Reference Drug
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          Reference Standard
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          Strength
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          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 AVOPEF is a topoisomerase inhibitor indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with: Refractory testicular cancer ( 1.1 ) Small cell lung cancer ( 1.2 ) 1.1 Refractory Testicular Cancer AVOPEF, in combination with chemotherapy, is indicated for the treatment of refractory testicular cancer in adult patients. 1.2 Small Cell Lung Cancer AVOPEF, in comb
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        NS AND USAGE AVOPEF is a topoisomerase inhibitor indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with: Refractory testicular cancer ( 1.1 ) Small cell lung cancer ( 1.2 )
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          1 INDICATIONS AND USAGE AVOPEF is a topoisomerase inhibitor indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with: Refractory testicular cancer ( 1.1 ) Small cell lung cancer ( 1.2 )
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          omerase inhibitor indicated, in combination with other chemotherapy and/or immunotherapy, for the treatment of adult patients with: Refractory testicular cancer ( 1.1 ) Small cell lung cancer ( 1.2 ) 1.1 Refractory Testicular Cancer AVOPEF, in combination with chemotherapy, is indicated for the treatment of refractory testicular cancer in adult patients. 1.2 Small Cell Lung Cancer AVOPEF, in combination with chemotherapy and immunotherapy, is indicated for the first-line treatment of small cell lung cancer (SCLC) in adult patients.
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              cer ( 1.1 ) Small cell lung cancer ( 1.2 ) 1.1 Refractory Testicular Cancer AVOPEF, in combination with chemotherapy, is indicated for the treatment of refractory testicular cancer in adult patients. 1.2 Small Cell Lung Cancer AVOPEF, in combination with chemotherapy and immunotherapy, is indicated for the first-line treatment of small cell lung cancer (SCLC) in adult patients.
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                  1.2 Small Cell Lung Cancer AVOPEF, in combination with chemotherapy and immunotherapy, is indicated for the first-line treatment of small cell lung cancer (SCLC) in adult patients.
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                  biomarker and test
                  Source null
                  disease stage
                  Source null
                  limitations
                  Source null
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                  Source null
                  prior therapy
                  Source null
                  regimen
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                  tumor histology
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                  Preserved source evidence · Not medical advice