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

G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer

First Posted Date
2007-11-07
Last Posted Date
2019-05-29
Lead Sponsor
Radiation Therapy Oncology Group
Target Recruit Count
5
Registration Number
NCT00554463
Locations
🇺🇸

McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States

🇺🇸

Charles M. Barrett Cancer Center at University Hospital, Cincinnati, Ohio, United States

🇺🇸

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

and more 11 locations

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma

First Posted Date
2007-11-07
Last Posted Date
2024-10-22
Lead Sponsor
Children's Oncology Group
Target Recruit Count
60
Registration Number
NCT00554788
Locations
🇺🇸

Children's Healthcare of Atlanta - Arthur M Blank Hospital, Atlanta, Georgia, United States

🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

and more 70 locations

Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS

First Posted Date
2007-08-24
Last Posted Date
2012-08-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
15
Registration Number
NCT00520468
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients

First Posted Date
2007-07-19
Last Posted Date
2016-06-09
Lead Sponsor
University of Miami
Target Recruit Count
22
Registration Number
NCT00503984
Locations
🇺🇸

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Tissue Repair in Stem Cell Transplant Recipients

Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2007-07-16
Last Posted Date
2012-08-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
2
Registration Number
NCT00501228
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma

First Posted Date
2007-07-11
Last Posted Date
2021-07-06
Lead Sponsor
Children's Oncology Group
Target Recruit Count
464
Registration Number
NCT00499616
Locations
🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

🇺🇸

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

and more 186 locations

G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients

First Posted Date
2007-07-11
Last Posted Date
2013-08-02
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
84
Registration Number
NCT00499343
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Cord Blood Expansion on Mesenchymal Stem Cells

First Posted Date
2007-07-10
Last Posted Date
2020-02-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
98
Registration Number
NCT00498316
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL

First Posted Date
2007-06-22
Last Posted Date
2020-01-13
Lead Sponsor
Ronald Levy
Target Recruit Count
59
Registration Number
NCT00490529
Locations
🇺🇸

Stanford University Medical Center, Stanford, California, United States

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