pegfilgrastim-apgf

FDA Drug Profile — NYVEPRIA

Drug Details

Generic Name
pegfilgrastim-apgf
Brand Names
NYVEPRIA
Application Number
BLA761111
Sponsor
Pfizer Laboratories Div Pfizer Inc
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
PEGFILGRASTIM

Indications and Usage

1 INDICATIONS AND USAGE NYVEPRIA 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) ] . NYVEPRIA 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 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 ) Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.