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

Thymoglobulin and Cyclosporine in Patients With Aplastic Anemia or Myelodysplastic Syndrome

First Posted Date
2008-12-11
Last Posted Date
2013-03-12
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
53
Registration Number
NCT00806598
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Stem Cell Mobilization by G-CSF to Treat Severe Peripheral Artery Disease

First Posted Date
2008-11-25
Last Posted Date
2015-04-01
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
32
Registration Number
NCT00797056
Locations
🇺🇸

Washington University School of Medicine, St. Louis, Missouri, United States

Hematopoietic Stem Cell Transplant in Devic's Disease

First Posted Date
2008-11-07
Last Posted Date
2020-02-28
Lead Sponsor
Northwestern University
Target Recruit Count
13
Registration Number
NCT00787722
Locations
🇺🇸

Northwestern University, Feinberg School of Medicine, Chicago, Illinois, United States

Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Phase 3
Recruiting
Conditions
First Posted Date
2008-11-05
Last Posted Date
2023-07-25
Lead Sponsor
Center for International Blood and Marrow Transplant Research
Target Recruit Count
60000
Registration Number
NCT00785525
Locations
🇺🇸

DKMS Americas, New York, New York, United States

🇺🇸

Gift of Life Bone Marrow Foundation, Boca Raton, Florida, United States

🇺🇸

Be The Match, Minneapolis, Minnesota, United States

and more 1 locations

Use of G-CSF for the Treatment of Unexplained Recurrent Miscarriage

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-10-15
Last Posted Date
2008-10-15
Lead Sponsor
University of Florence
Target Recruit Count
68
Registration Number
NCT00772122
Locations
🇮🇹

CERM, Rome, Italy

The Effect of Granulocyte Colony Stimulating Factor (G-CSF) on Myocardial Function After Acute Anterior Myocardial Infarction, a Prospective Double Blind Randomized Placebo Controlled Study

First Posted Date
2008-09-22
Last Posted Date
2008-09-22
Lead Sponsor
Shiraz University of Medical Sciences
Target Recruit Count
20
Registration Number
NCT00756756
Locations
🇮🇷

Shiraz University of Medical Sciences/Cardiology Ward/Namazi and Shahid Faghihi Hospital, Shiraz, Fars, Iran, Islamic Republic of

Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies

First Posted Date
2008-08-26
Last Posted Date
2020-11-23
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Target Recruit Count
18
Registration Number
NCT00741455
Locations
🇺🇸

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

Intravenous AMD3100 for Collection of Autologous Peripheral Blood Stem Cells in Patients With Lymphoma

First Posted Date
2008-08-13
Last Posted Date
2017-03-09
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
61
Registration Number
NCT00733824
Locations
🇺🇸

Washington University School of Medicine, St. Louis, Missouri, United States

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