pegfilgrastim-jmdb
Drug Details
- Generic Name
- pegfilgrastim-jmdb
- Brand Names
- Fulphila
- Application Number
- BLA761075
- Sponsor
- Biocon Biologics Inc.
- NDC Codes
- 1
- Dosage Forms
- INJECTION
- Routes
- SUBCUTANEOUS
- Active Ingredients
- PEGFILGRASTIM
Indications and Usage
1 INDICATIONS AND USAGE Fulphila 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 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Fulphila 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 Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.