pegfilgrastim-apgf
pegfilgrastim-apgf is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including NYVEPRIA. Available dosage form: injection, solution.
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 Patients with Cancer Receiving Myelosuppressive Chemotherapy NYVEPRIA 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 Dosage and Administration (2.1) and Clinical Studies (14) ] . NYVEPRIA is a leukocyte growth factor 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. ( 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.