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LABELS · ecf24bac-28f2-4093-986b-b62bc807b6e0

ARMLUPEG

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
2026-07-23
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE Armlupeg is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Armlupeg is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)]. Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Armlupeg is indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)] .
Full extracted label fields
application numbers
  1. BLA761212
boxed warning exact
    brand names
    1. ARMLUPEG
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c48fe1a7-63d7-4dce-bb53-a913cb0ade83
    generic names
    1. PEGFILGRASTIM-UNNE
    id
    ecf24bac-28f2-4093-986b-b62bc807b6e0
    indications and usage exact
    1. 1 INDICATIONS AND USAGE Armlupeg is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Armlupeg is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)]. Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Armlupeg is indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)] .
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Lupin Pharmaceuticals, Inc.
      matched search terms
      1. cancer
      package ndcs
      1. 70748-273-01
      product ndcs
      1. 70748-273
      product types
      1. HUMAN PRESCRIPTION DRUG
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        1. SUBCUTANEOUS
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        last updated
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        spl effective time
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        Drugs@FDA application source records
        1. application number
          BLA761212
          payload
          all indexed label documents
            all submission records
            1. Appl No
              761212
              Review Priority
              STANDARD
              Submission Class Code ID
              19
              Submission No
              1
              Submission Status
              AP
              Submission Status Date
              2025-11-28 00:00:00
              Submission Type
              ORIG
              Submissions Public Notes
            application number
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            approval interpretation
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            latest posted label documents
              official application record
              Appl No
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              Appl Public Notes
              Appl Type
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              Sponsor Name
              LUPIN LTD
              openfda application present
              true
              products
              1. Active Ingredient
                PEGFILGRASTIM-UNNE
                Appl No
                761212
                Drug Name
                ARMLUPEG
                Form
                INJECTION;SOLUTION
                Product No
                001
                Reference Drug
                0
                Reference Standard
                0
                Strength
                6MG/0.6ML
                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 Armlupeg is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use Armlupeg is not indicated
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            is a leukocyte growth factor indicated
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                  1 INDICATIONS AND USAGE Armlupeg is a leukocyte growth factor indicated to Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
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                  as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppr
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                        (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
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                        cally significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Armlupeg is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by
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                              (1.2) Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                              tic Subsyndrome of Acute Radiation Syndrome). (1.2) Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Armlupeg is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)]. Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acut
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                                  1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Armlupeg is indicated in adults and pediatric patients aged newborn and older to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)].
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                                  openia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)]. Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Armlupeg is indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosupp
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                                        Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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                                        febrile neutropenia [see Clinical Studies (14.1)]. Limitations of Use Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Armlupeg is indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)] .
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                                            1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrome Armlupeg is indicated to increase survival in adults and pediatric patients aged newborn and older acutely exposed to myelosuppressive doses of radiation [see Dosage and Administration (2.2) and Clinical Studies (14.2)] .
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