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

Clinical Trials

T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

Phase 2

Terminated

Conditions: Relapsed Acute Myelogenous Leukemia

Interventions: Drug: Clofarabine
Drug: Etoposide
Drug: Cyclophosphamide
Drug: Filgrastim
Drug: Cytarabine

First Posted Date: 2009-07-15

Last Posted Date: 2020-02-19

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 6

Registration Number: NCT00939653

Locations: 🇺🇸
University of Miami Cancer Center, Miami, Florida, United States
🇺🇸
Childrens Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Memorial, Chicago, Illinois, United States

and more 1 locations

Study on the Incidence of Febrile Episodes During Stem Cells Collection After Chemotherapy in Patients With Multiple Myeloma

Phase 3

Conditions: G-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim

Interventions: Drug: filgrastim
Drug: lenograstim

First Posted Date: 2009-07-03

Last Posted Date: 2009-07-03

Lead Sponsor: University of Pisa

Target Recruit Count: 180

Registration Number: NCT00932217

A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia

Phase 1

Conditions: Diabetic Foot
Critical Limb Ischemia
Leg Ulcers

Interventions: Procedure: will receive G-CSF and peripheral blood derived mononuclear cells
Drug: G-CSF
Drug: Standard Therapy

First Posted Date: 2009-06-17

Last Posted Date: 2009-06-17

Lead Sponsor: Beike Biotech India Pvt.ltd

Target Recruit Count: 36

Registration Number: NCT00922389

Locations: 🇮🇳
Fortis FLT.LT.Rajan Dhall Hospital, New Delhi, Delhi, India

Chemosensitization With Plerixafor Plus G-CSF in Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: G-CSF
Drug: Plerixafor
Drug: Mitoxantrone
Drug: Etoposide
Drug: Cytarabine

First Posted Date: 2009-05-21

Last Posted Date: 2017-04-04

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 39

Registration Number: NCT00906945

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Washington University, St. Louis, Missouri, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States