Filgrastim-aafi (Nivestym)
General information
Class/mechanism: Recombinant human granulocyte colony-stimulating factor (G-CSF). Binds to cell surface receptors on hematopoietic cells and stimulates proliferation, differentiation, and some end-cell functional activation.
Route: SC
Extravasation: no known issues
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is used
Note that colony stimulating factors may be used for their adjuvant effect e.g. removing leukemia stem cells from their protective niches; but they are not thought to have inherent anti-cancer activity.
History of changes in FDA indication
- 2018-07-20: Approved as a biosimilar to US-licensed Neupogen for the five indications for which US-licensed Neupogen is approved:
- "Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever"
- "Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)"
- "Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT)"
- "Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis"
- "Reduce the incidence and duration of sequelae of severe neutropenia (e.g.,fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia"
History of changes in EMA indication
- 2010-06-07: Initial authorization as Nivestim
Also known as
- Brand name: Nivestim, Nivestym