Neulasta

Product manufactured by Amgen Inc

Application Nr Approved Date Route Status External Links
BLA125031 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Neulasta 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 Neulasta Is Not Indicated For The Mobilization Of Peripheral Blood Progenitor Cells For Hematopoietic Stem Cell Transplantation. 1.1 Patients With Cancer Receiving Myelosuppressive Chemotherapy Neulasta Is 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 [ See Clinical Studies ( 14.1 ) ] . Limitations Of Use Neulasta 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 Neulasta Is Indicated To Increase Survival In Patients Acutely Exposed To Myelosuppressive Doses Of Radiation [See Dosage And Administration ( 2.2 ) And Clinical Studies ( 14.2 )] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pegfilgrastim

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