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Filgrastim
Biograstim, Granix, Neupogen, Nivestym, Releuko, Zarxio (filgrastim) is a protein pharmaceutical. Filgrastim was first approved as Neupogen on 1991-02-20. It is used to treat neutropenia in the USA. It has been approved in Europe to treat hematopoietic stem cell transplantation, neoplasms, and neutropenia. It is known to target macrophage colony-stimulating factor 1 receptor and granulocyte colony-stimulating factor receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
therapeuticsD013812
operative surgical proceduresD013514
Trade Name
FDA
EMA
Granix, Neupogen, Nivestym, Releuko, Zarxio
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Filgrastim
Tradename
Proper name
Company
Number
Date
Products
NeupogenfilgrastimAmgenN-103353 RX1991-02-20
4 products
Granixtbo-filgrastimUAB Teva BalticsN-125294 RX2012-08-29
4 products
Labels
FDA
EMA
Brand Name
Status
Last Update
granixBiologic Licensing Application2020-04-17
neupogenBiologic Licensing Application2021-02-04
nivestymBiologic Licensing Application2019-03-06
releukoBiologic Licensing Application2022-04-28
zarxioBiologic Licensing Application2019-08-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
neutropeniaD009503D70
Agency Specific
FDA
EMA
Expiration
Code
filgrastim, Neupogen, Amgen Inc.
2122-03-30Orphan excl.
filgrastim, Granix, UAB Teva Baltics
2024-08-29Reference product excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L03: Immunostimulants
L03A: Immunostimulants
L03AA: Colony stimulating factors
L03AA02: Filgrastim
HCPCS
Code
Description
J1442
Injection, filgrastim (g-csf), excludes biosimilars, 1 microgram
J1447
Injection, tbo-filgrastim, 1 microgram
J2506
Injection, pegfilgrastim, excludes biosimilar, 0.5 mg
Q5101
Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram
Q5108
Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
Q5110
Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram
Q5111
Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg
Q5120
Injection, pegfilgrastim-bmez, biosimilar, (ziextenzo), 0.5 mg
Q5122
Injection, pegfilgrastim-apgf, biosimilar, (nyvepria), 0.5 mg
Clinical
Clinical Trials
1001 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.93611224111168
LeukemiaD007938C9539811538127
Myelodysplastic syndromesD009190D463253141888
Breast neoplasmsD001943EFO_0003869C502547144683
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0122971546
NeoplasmsD009369C80281461146
Non-hodgkin lymphomaD008228C85.992651744
Plasma cell neoplasmsD054219112551443
NeutropeniaD009503D7061171126
Graft vs host diseaseD006086D89.814531516
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myeloid leukemia acuteD015470C92.033407269
Multiple myelomaD009101C90.020457669
SarcomaD01250913329151
NeuroblastomaD009447EFO_000062120209248
Central nervous system neoplasmsD01654316274144
Ovarian neoplasmsD010051EFO_0003893C5619263240
Hodgkin diseaseD006689C814177228
B-cell chronic lymphocytic leukemiaD015451C91.16131320
Large b-cell lymphoma diffuseD016403C83.37122320
Myeloproliferative disordersD009196D47.1881520
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mantle-cell lymphomaD020522C83.1612318
Myelodysplastic-myeloproliferative diseasesD05443758214
Hiv infectionsD015658EFO_0000764B2035311
Biphenotypic leukemia acuteD015456C95.0679
Fanconi anemiaD005199Orphanet_84D61.095619
Fallopian tube neoplasmsD0051855318
Pancreatic neoplasmsD010190EFO_0003860C254518
Waldenstrom macroglobulinemiaD008258C88.02427
Liver neoplasmsD008113EFO_1001513C22.0347
B-cell lymphoma marginal zoneD018442C88.42236
Show 95 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AstrocytomaD001254EFO_000027133
InfertilityD007246EFO_0000545123
Squamous cell carcinomaD00229422
GliomaD005910EFO_000052022
OligodendrogliomaD009837EFO_000063122
Primitive neuroectodermal tumorsD01824222
Coronary artery diseaseD003324I25.1112
Multiple sclerosisD009103EFO_0003885G3522
Salivary gland neoplasmsD012468EFO_0003826D1111
Basal cell carcinomaD00228011
Show 23 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hairy cell leukemiaD007943C91.433
Hematologic diseasesD006402EFO_0005803D75.922
Diamond-blackfan anemiaD029503D61.0111
Hemophagocytic lymphohistiocytosisD051359D76.111
Chediak-higashi syndromeD002609Orphanet_167D72.011
Iga vasculitisD011695EFO_1000965D69.011
Juvenile arthritisD001171EFO_0002609M0811
Rheumatoid arthritisD001172EFO_0000685M06.911
Giant cell arteritisD013700EFO_1001209M31.611
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.311
Show 17 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFILGRASTIM
INNfilgrastim
Description
Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause. It may also be used to increase white blood cells for gathering during leukapheresis. It is given either by injection into a vein or under the skin.
Classification
Protein
Drug classcolony-stimulating factors: granulocyte colony-stimulating factors (G-CSF)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID121181-53-1
RxCUI68442
ChEMBL IDCHEMBL1201567
ChEBI ID
PubChem CID
DrugBankDB00099
UNII IDPVI5M0M1GW (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CSF1R
CSF1R
CSF3R
CSF3R
Organism
Homo sapiens
Gene name
CSF1R
Gene synonyms
FMS
NCBI Gene ID
Protein name
macrophage colony-stimulating factor 1 receptor
Protein synonyms
CD115, CD115 antigen, CSF-1 receptor, CSF-1-R, CSF-1R, FMS proto-oncogene, M-CSF-R, macrophage colony stimulating factor I receptor, McDonough feline sarcoma viral (v-fms) oncogene homolog, Proto-oncogene c-Fms
Uniprot ID
Mouse ortholog
Csf1r (12978)
macrophage colony-stimulating factor 1 receptor (Q9DBH9)
Variants
Clinical Variant
No data
Financial
Neupogen - Amgen
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,230 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,420 adverse events reported
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