Filgrastim (Neupogen)

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, IV
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 are used for their adjuvant effect e.g. removing leukemia stem cells from their protective niches; they are not thought to have inherent anti-cancer activity.

• Acute myeloid leukemia
• B-cell acute lymphoblastic leukemia
• Neuroblastoma

Patient drug information

• Filgrastim (Neupogen) package insert
• Filgrastim (Neupogen) patient drug information (Chemocare)
• Filgrastim (Neupogen) patient drug information (UpToDate)

History of changes in FDA indication

• 1991-02-20: Initial approval.
• Uncertain date: Approved to 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.
• Uncertain date: Approved to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
• Uncertain date: Approved to 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).
• Uncertain date: Approved to mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.
• Uncertain date: Approved to 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 PMDA indication

• 2021-06-23: New indication and a new dosage for the enhancement of an antitumor effect of dinutuximab (genetical recombination) for neuroblastoma.
• 2022-06-20: New indication and a new dosage for use as an adjunctive therapy with antineoplastic agents for the treatment of relapsed or refractory acute myeloid leukemia.

Also known as

• Generic names: filgrastim, GCSF, G-CSF, granulocyte colony stimulating factor
• Brand names:

Synonyms
Biocilin	Biofigran	Biofilgran	Euprotin	Filatil	Filgen	Filgrastima	Gran
Granulokine	Grasalva	Grasin	Grastim	Leicita	Leubene	Leucin	Leucocim
Leucokain	Leucostim	Leukokine	Leumostin	Lioplim	Mielastra	Myelostim	Neipogen
Neitrostim	Neukine	Neupogen	Nevkine	Topneuter