The Food and Drug Administration (FDA) has approved a Supplemental Biologics License Application (sBLA) for Neupogen (filgrastim; Amgen) to increase survival in patients acutely exposed to myelosuppressive doses of radiation (hemopoietic syndrome of acute radiation syndrome).
Neupogen is a granulocyte colony stimulating factor (G-CSF) that is produced by monocytes‚ fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation‚ differentiation, and selected end-cell functions.
Neupogen is already approved to decrease incidence of infection in patients with nonmyeloid malignancies receiving certain myelosuppressive anti-cancer drugs; to reduce time to neutrophil recovery and fever duration after induction and consolidation chemotherapy treatment of adults with AML; to reduce duration of neutropenia and related sequelae in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone-marrow transplantation (BMT); to mobilize hematopoietic progenitor cells (PBPC) into peripheral blood for collection by leukapheresis; and to reduce the incidence and duration of neutropenia sequelae in severe chronic neutropenia (SCN).
Neupogen is available as 300mcg and 480mcg strength single-dose vials in 10-count packs and pre-filled syringes in 1- and 10-count packs.
For more information call (800) 272-9376 or visit Neupogen.com.