| Drug Name |
Filgrastim |
| Drug ID |
BADD_D00897 |
| Description |
Chemotherapy-induced neutropenia (CIN) is a common and serious complication of myelosuppressive chemotherapy. It is associated with significant morbidity and mortality and can increase the cost of cancer therapy. In these cases, colony stimulating factor is necessary to restore important cells for immune function [A35591].
For over twenty years, granulocyte colony-stimulating factors (G-CSFs; filgrastims) have been a pillar of treatment and prevention of CIN, and have been found to reduce the risk of neutropenia across various patient settings, decrease the incidence of febrile neutropenia, reduce the incidence of infection, reduce the requirement for treatment with antibiotics, and accelerate neutrophil recovery [A35591].
Filgrastim is a recombinant, non-pegylated human granulocyte colony stimulating factor (G-CSF) analog. It is marketed as the brand name _Neupogen_ by Amgen (initially approved in 1998) and as _Nivestym_, a biosimilar agent by Pfizer. Nivestym was approved by the FDA on July 20th, 2018 [L3735]. Between 1998 and the present, Neupogen/filgrastim has been approved for various indications [L3744].
_Tbo-filgrastim_, which is marketed by Sicor Biotech and FDA approved on August 29, 2012, contains the same active ingredient as Neupogen and is biologically similar, but it is formulated to be short-acting [F719]. On March 6, 2015, the FDA approved the biosimilar Zarxio (filgrastim-sndz) and is indicated for use in the same conditions as Neupogen. Zarxio is marketed by Sandoz [L3742]. |
| Indications and Usage |
This drug is a leucocyte growth factor [FDA label] 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 [FDA label].
Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment in patients with acute myeloid leukemia (AML) [FDA label]
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 (BMT) [FDA label]
Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [FDA label]
Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [FDA label].
Neupogen is approved for treatment of patients with radiation-induced myelosuppression following a radiological/nuclear incident [L3739]. |
| Marketing Status |
approved |
| ATC Code |
L03AA02 |
| DrugBank ID |
DB00099
|
| KEGG ID |
D03235
|
| MeSH ID |
D000069585
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
D09WDK
|
| NDC Product Code |
70121-1568; 55513-209; 55513-530; 70121-1569; 70121-1571; 70121-1570; 71861-0001; 55513-924; 55513-546 |
| UNII |
PVI5M0M1GW
|
| Synonyms |
Filgrastim | Recombinant-Methionyl Human Granulocyte Colony-Stimulating Factor | Recombinant Methionyl Human Granulocyte Colony Stimulating Factor | G-CSF Recombinant, Human Methionyl | G CSF Recombinant, Human Methionyl | R-metHuG-CSF | R metHuG CSF | Zarxio | Filgrastim-sndz | Tbo-Filgrastim | Tbo Filgrastim | Granix | Topneuter | Neupogen |
