Overview
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/14 | Not Applicable | Recruiting | |||
2025/07/11 | Not Applicable | Not yet recruiting | |||
2025/07/04 | Not Applicable | Recruiting | |||
2025/07/01 | Not Applicable | Not yet recruiting | |||
2025/06/10 | Phase 1 | Not yet recruiting | |||
2025/06/04 | Not Applicable | Not yet recruiting | |||
2025/05/25 | Phase 4 | Not yet recruiting | |||
2025/04/24 | Early Phase 1 | Not yet recruiting | C17 Council | ||
2025/04/15 | Phase 1 | Recruiting | |||
2025/04/15 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-2522 | INTRAVENOUS | 300 ug in 1 mL | 12/2/2009 | |
| Amneal Pharmaceuticals LLC | 70121-1571 | INTRAVENOUS, SUBCUTANEOUS | 480 ug in 1.6 mL | 8/25/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0294 | SUBCUTANEOUS, INTRAVENOUS | 480 ug in 1.6 mL | 8/12/2025 | |
| Cephalon, LLC | 63459-912 | SUBCUTANEOUS | 480 ug in 0.8 mL | 11/30/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1570 | INTRAVENOUS, SUBCUTANEOUS | 480 ug in 0.8 mL | 8/25/2023 | |
| Physicians Total Care, Inc. | 54868-5020 | INTRAVENOUS | 300 ug in 0.5 mL | 12/2/2009 | |
| Amgen Inc | 55513-546 | INTRAVENOUS, SUBCUTANEOUS | 480 ug in 1.6 mL | 4/18/2023 | |
| Amgen, Inc | 55513-546 | INTRAVENOUS, SUBCUTANEOUS | 480 ug in 1.6 mL | 4/18/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0292 | SUBCUTANEOUS | 480 ug in 0.8 mL | 8/12/2025 | |
| Amneal Pharmaceuticals LLC | 70121-1569 | INTRAVENOUS, SUBCUTANEOUS | 300 ug in 1 mL | 8/25/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 6/7/2010 | ||
Authorised | 9/17/2014 | ||
Authorised | 9/17/2014 | ||
Authorised | 10/17/2013 | ||
Authorised | 2/12/2025 | ||
Authorised | 2/6/2009 | ||
Authorised | 2/6/2009 | ||
Authorised | 9/15/2008 | ||
Authorised | 2/6/2009 | ||
Authorised | 2/6/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ACCOFIL 30 SOLUTION FOR INJECTION OR INFUSION IN A PRE-FILLED SYRINGE 30 MU/0.5 ML | SIN16268P | INJECTION, SOLUTION | 300 mcg/0.5 mL | 7/8/2021 | |
| Nivestim 300mcg/0.5mL Solution for Injection/Infusion | SIN14196P | INFUSION, SOLUTION | 0.300 mg/0.5ml | 7/17/2012 | |
| ACCOFIL 48 SOLUTION FOR INJECTION OR INFUSION IN A PRE-FILLED SYRINGE 48 MU/0.5 ML | SIN16267P | INJECTION, SOLUTION | 480 mcg/0.5 mL | 7/8/2021 | |
| NEUPOGEN PRE-FILLED SYRINGE 30 mu/0.5 ml | SIN10780P | INJECTION | 30 mu/0.5 ml | 3/1/1999 | |
| ZARZIO SOLUTION FOR INJECTION/INFUSION IN A PREFILLED SYRINGE 30MU/0.5ML | SIN14764P | INJECTION, SOLUTION | 0.30mg/0.5ml | 3/24/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ACCOFIL SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE 30MU/0.5ML | N/A | N/A | N/A | 12/19/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ZARZIO filgrastim (rbe) 300 microgram/0.5 mL solution for injection pre-filled syringe | 195066 | Medicine | A | 5/7/2013 | |
| TEVAGRASTIM filgrastim 480 microgram/0.8mL injection | 163677 | Medicine | A | 8/29/2011 | |
| TEVAGRASTIM filgrastim 300 microgram/0.5mL injection | 163675 | Medicine | A | 8/29/2011 | |
| NIVESTIM filgrastim (rbe) 480microgram/0.5mL injection solution pre-filled syringe | 160107 | Medicine | A | 9/16/2010 | |
| ZARZIO filgrastim (rbe) 480 microgram/0.5 mL solution for injection pre-filled syringe | 195065 | Medicine | A | 5/7/2013 | |
| NIVESTIM filgrastim (rbe) 120microgram/0.2mL injection solution pre-filled syringe | 160106 | Medicine | A | 9/16/2010 | |
| NIVESTIM filgrastim (rbe) 300microgram/0.5mL injection solution pre-filled syringe | 160108 | Medicine | A | 9/16/2010 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| GRASTOFIL | 02454548 | Solution - Subcutaneous
,
Intravenous | 480 MCG / 0.8 ML | 11/28/2016 | |
| NEUPOGEN | Amgen Canada Inc | 02420112 | Solution - Subcutaneous
,
Intravenous | 600 MCG / ML | 2/2/2016 |
| NIVESTYM | 02485575 | Solution - Subcutaneous
,
Intravenous | 300 MCG / 0.5 ML | 5/11/2020 | |
| NYPOZI | 02521008 | Solution - Intravenous
,
Subcutaneous | 480 MCG / 0.8 ML | 1/24/2024 | |
| FILRA | 02556545 | Solution - Subcutaneous
,
Intravenous | 480 MCG / 0.8 ML | N/A | |
| NIVESTYM | 02485656 | Solution - Intravenous
,
Subcutaneous | 480 MCG / 1.6 ML | 6/10/2020 | |
| FILRA | 02556537 | Solution - Intravenous
,
Subcutaneous | 300 MCG / 0.5 ML | N/A | |
| NEUPOGEN | Amgen Canada Inc | 02420104 | Solution - Intravenous
,
Subcutaneous | 600 MCG / ML | 1/28/2016 |
| NEUPOGEN | Amgen Canada Inc | 01968017 | Solution - Intravenous
,
Subcutaneous | 300 MCG / ML | 12/31/1992 |
| GRASTOFIL | 02441489 | Solution - Subcutaneous
,
Intravenous | 300 MCG / 0.5 ML | 3/17/2016 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| NIVESTIM 12 MU/0,2 ml SOLUCION INYECTABLE O PARA PERFUSION | 110631002 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Commercialized | |
| ZARZIO 48 MU/0,5 ml SOLUCION INYECTABLE O PARA PERFUSION EN JERINGA PRECARGADA | 08495007IP | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Not Commercialized | |
| NEUPOGEN 30 MU (0,3 mg/ml) SOLUCION INYECTABLE | 59102 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| NIVESTIM 48 MU/0,5 ml SOLUCION INYECTABLE O PARA PERFUSION | 110631008 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Commercialized | |
| RATIOGRASTIM 48 MU/0,8 ml SOLUCION PARA INYECCION O PERFUSION | 08444005 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Not Commercialized | |
| ZARZIO 48 MU/0,5 ml SOL. INY. O PARA PERFUSION EN JERINGA PRECARGADA | 08495005 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Commercialized | |
| NIVESTIM 12 MU/0,2 ml SOLUCION INYECTABLE O PARA PERFUSION | 110631001 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| Accofil 48 MU/0,5 ml solucion inyectable y para perfusion en jeringa precargada | 114946011 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Commercialized | |
| TEVAGRASTIM 30 MU/0,5 ml SOLUCION PARA INYECCION O PERFUSION | 08445010 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Not Commercialized | |
| RATIOGRASTIM 30 MU/0,5 ml SOLUCION INYECTABLE O PARA PERFUSION | 08444010 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EN JERINGA PRECARGADA | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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