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

Phase II Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-08-15
Last Posted Date
2014-10-01
Lead Sponsor
Dong-A ST Co., Ltd.
Target Recruit Count
61
Registration Number
NCT01923545
Locations
🇰🇷

Korea University GURO hospital, Seoul, Korea, Republic of

Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma

First Posted Date
2013-08-12
Last Posted Date
2024-11-21
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
77
Registration Number
NCT01920932
Locations
🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

🇺🇸

Maine Children's Cancer Program (MCCP), Scarborough, Maine, United States

🇺🇸

Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States

and more 3 locations

A Trial to Study the Influence of Growth Factors on Bone Marrow and Hepatic Regeneration in Patients With Decompensated Cirrhosis.

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2013-07-18
Last Posted Date
2016-11-22
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Target Recruit Count
60
Registration Number
NCT01902511
Locations
🇮🇳

Institute of Liver & Biliary Sciences, New Delhi, Delhi, India

Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

First Posted Date
2013-05-29
Last Posted Date
2024-11-12
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
83
Registration Number
NCT01864109
Locations
🇺🇸

Memorial Sloan Kettering Commack, Commack, New York, United States

🇺🇸

Memorial Sloan Kettering Cancer Center Basking Ridge, Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States

and more 4 locations

MIBG for Refractory Neuroblastoma and Pheochromocytoma

First Posted Date
2013-05-10
Last Posted Date
2024-01-26
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
100
Registration Number
NCT01850888
Locations
🇺🇸

University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States

The Effect of GCSF in the Treatment of ALS Patients

First Posted Date
2013-04-05
Last Posted Date
2013-11-13
Lead Sponsor
Tehran University of Medical Sciences
Target Recruit Count
40
Registration Number
NCT01825551
Locations
🇮🇷

Iranian Neurology Research Center of Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of

An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors

First Posted Date
2013-04-02
Last Posted Date
2018-02-12
Lead Sponsor
Incyte Corporation
Target Recruit Count
42
Registration Number
NCT01822756
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