pegfilgrastim
pegfilgrastim is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand names including Neulasta, FYLNETRA. Available dosage forms: liquid, solution, kit, injection.
Drug Details
- Generic Name
- pegfilgrastim
- Brand Names
- Neulasta, FYLNETRA
- Application Number
- BLA125031
- Sponsor
- Novartis Pharmaceuticals Corporation
- NDC Codes
- 5
- Dosage Forms
- LIQUID, SOLUTION, KIT, INJECTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- PEGFILGRASTIM
Indications and Usage
1 INDICATIONS AND USAGE UDENYCA 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 UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy UDENYCA 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 UDENYCA 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 UDENYCA 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 )] .