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Outline
What is the generic name?
FILGRASTIM
What is the Trade Name for FILGRASTIM?
NEUPOGEN
What are the Indications for FILGRASTIM?
- 1 INDICATIONS AND USAGE NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection‚Äö as manifested by febrile neutropenia‚Äö in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚Äö e.g.‚Äö febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) ( 1.3 ) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis ( 1.4 ) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚Äö fever‚Äö infections‚Äö oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚Äö cyclic neutropenia‚Äö or idiopathic neutropenia ( 1.5 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) ( 1.6 ) 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy NEUPOGEN is indicated to decrease the incidence of infection‚Äö as manifested by febrile neutropenia‚Äö in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1) ] . 1.2 Patients with Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy NEUPOGEN is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2) ] . 1.3 Patients with Cancer Undergoing Bone Marrow Transplantation NEUPOGEN is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚Äö e.g.‚Äö febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3) ] . 1.4 Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy NEUPOGEN is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4) ] . 1.5 Patients with Severe Chronic Neutropenia NEUPOGEN is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚Äö fever‚Äö infections‚Äö oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚Äö cyclic neutropenia‚Äö or idiopathic neutropenia [see Clinical Studies (14.5) ] . 1.6 Patients Acutely Exposed to Myelosuppressive Doses of Radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) NEUPOGEN is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.6) ] .
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References: https://open.fda.gov/
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