Filgrastim

Generic Name
Filgrastim
Brand Names
Accofil, Granix, Grastofil, Neupogen, Nivestim, Nivestym, Ratiograstim, Releuko, Zarxio, Zarzio, Filgrastim Hexal, Tevagrastim
Drug Type
Biotech
Chemical Formula
-
CAS Number
121181-53-1
Unique Ingredient Identifier
PVI5M0M1GW
Background

Filgrastim is a short-acting recombinant, non-pegylated human granulocyte colony-stimulating factor (G-CSF) analog produced by recombinant DNA technology. It has an amino acid sequence identical to endogenous G-CSF, but it is non-glycosylated unlike the endogenous G-CSF and has an N-terminal methionine added in the sequence for expression in E. Coli. Human G-CSF is a glycoprotein that regulates the production and release of neutrophils from the bone marrow. Filgrastim mimics the biological actions of G-CSF to increase the levels of neutrophils in the blood. It has a number of therapeutic uses, including the management and prevention of infections and febrile neutropenia in patients receiving myelosuppressive chemotherapy or radiation therapy. It is also used to manage severe chronic neutropenia and mobilize hematopoietic progenitor cells to the peripheral blood for collection by leukapheresis in patients undergoing peripheral blood progenitor cell collection and therapy.

Filgrastim was approved in the US in 1991 and there are biosimilars available with similar therapeutic indications. Tbo-filgrastim was approved by the FDA on August 29, 2012. Filgrastim-sndz was approved on March 6, 2015 and filgrastim-ayow was approved on March 2, 2022. A long-acting, pegylated G-CSF, pegfilgrastim, was made available to increase the duration of action of the drug.

Indication

Filgrastim is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.

Filgrastim is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia.

Filgrastim is indicated 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.

Filgrastim is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.

Filgrastim is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

Filgrastim is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Associated Conditions
Congenital neutropenia, Cyclic neutropenia, Febrile Neutropenia, Hematopoietic Subsyndrome of Acute Radiation Syndrome, Idiopathic neutropenia, Infection, Neutropenia
Associated Therapies
Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis therapy

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First Posted Date
2014-04-11
Last Posted Date
2019-11-26
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
90
Registration Number
NCT02112045
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

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First Posted Date
2014-03-05
Last Posted Date
2021-02-21
Lead Sponsor
Sherif S. Farag
Target Recruit Count
38
Registration Number
NCT02078102
Locations
🇺🇸

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

Combination of G-CSF, Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Multiple Myeloma

First Posted Date
2014-01-06
Last Posted Date
2014-01-06
Lead Sponsor
Second Affiliated Hospital of Soochow University
Target Recruit Count
60
Registration Number
NCT02027220
Locations
🇨🇳

The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

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First Posted Date
2013-12-19
Last Posted Date
2024-12-19
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
40
Registration Number
NCT02015013
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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