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Neulasta(pegfilgrastim)
Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo (pegfilgrastim) is a protein pharmaceutical. Pegfilgrastim was first approved as Neulasta on 2002-01-31. It is used to treat neutropenia in the USA. It has been approved in Europe to treat neoplasms and neutropenia. The pharmaceutical is active against granulocyte colony-stimulating factor receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Fulphila, Fylnetra, Neulasta, Neulasta onpro, Nyvepria, Stimufend, Udenyca, Ziextenzo
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)
Pegfilgrastim
Tradename
Proper name
Company
Number
Date
Products
Neulasta OnpropegfilgrastimAmgenN-125031 RX2014-12-23
1 products
NeulastapegfilgrastimAmgenN-125031 RX2002-01-31
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
fulphilaBiologic Licensing Application2020-06-16
fylnetraBiologic Licensing Application2022-05-26
neulastaBiologic Licensing Application2021-02-02
nyvepriaBiologic Licensing Application2020-12-10
stimufend Biologic Licensing Application2022-09-15
udenycaBiologic Licensing Application2020-12-22
ziextenzoBiologic Licensing Application2021-03-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
neutropenia—D009503D70
Agency Specific
FDA
EMA
Expiration
Code
pegfilgrastim, Neulasta, Amgen Inc.
2122-11-13Orphan excl.
pegfilgrastim, Neulasta Onpro, Amgen Inc.
2122-11-13Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L03: Immunostimulants
— L03A: Immunostimulants
— L03AA: Colony stimulating factors
— L03AA13: Pegfilgrastim
HCPCS
Code
Description
J2506
Injection, pegfilgrastim, excludes biosimilar, 0.5 mg
Q5108
Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg
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
266 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
Breast neoplasmsD001943EFO_0003869C50728154657
NeutropeniaD009503D70410102126
Non-hodgkin lymphomaD008228C85.936—2112
Non-small-cell lung carcinomaD00228928—1—11
Ovarian neoplasmsD010051EFO_0003893C5637—1—9
Lung neoplasmsD008175C34.90—41117
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.95193——24
Chemotherapy-induced febrile neutropeniaD064146—47—111
Large b-cell lymphoma diffuseD016403C83.3661——10
NeoplasmsD009369C80621——9
SarcomaD012509151—28
Multiple myelomaD009101C90.0241——6
Hodgkin diseaseD006689C81441——6
Triple negative breast neoplasmsD064726141——5
Colorectal neoplasmsD015179121——4
Myeloid leukemia acuteD015470C92.0131——3
Show 11 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C9528———8
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.016———6
Prostatic neoplasmsD011471C6134———5
Central nervous system neoplasmsD01654324———5
Follicular lymphomaD008224C8232———4
Urinary bladder neoplasmsD001749C67—4———4
Mantle-cell lymphomaD020522C83.122———3
Renal cell carcinomaD00229212———3
Male breast neoplasmsD01856713———3
TeratomaD013724D28—3———3
Show 40 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—14———115
Therapeutic equivalencyD0138103————3
NeuroblastomaD009447EFO_00006212————2
PharmacokineticsD0105992————2
Brain neoplasmsD001932EFO_0003833C711————1
T-cell lymphoma cutaneousD016410C84.A1————1
Small cell lung carcinomaD0557521————1
Aids-related lymphomaD016483EFO_10013651————1
Neuroendocrine tumorsD018358EFO_1001901D3A.81————1
AmyloidosisD000686EFO_1001875E851————1
Show 6 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coronary artery diseaseD003324I25.1————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePEGFILGRASTIM
INNpegfilgrastim
Description
Granulocyte colony-stimulating factor precursor (G-CSF) (Pluripoietin)
Classification
Protein
Drug classPEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer; colony-stimulating factors: granulocyte colony-stimulating factors (G-CSF)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID208265-92-3
RxCUI338036
ChEMBL IDCHEMBL1201568
ChEBI ID—
PubChem CID—
DrugBankDB00019
UNII ID3A58010674 (ChemIDplus, GSRS)
Target
Agency Approved
CSF3R
CSF3R
Organism
Homo sapiens
Gene name
CSF3R
Gene synonyms
GCSFR
NCBI Gene ID
1441
Protein name
granulocyte colony-stimulating factor receptor
Protein synonyms
CD114, CD114 antigen, colony stimulating factor 3 receptor (granulocyte), G-CSF receptor, G-CSF-R
Uniprot ID
Q99062
Mouse ortholog
Csf3r (12986)
granulocyte colony-stimulating factor receptor (P40223)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Neulasta - Amgen
$
€
£
₣
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Udenyca - Coherus BioSciences
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,599 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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24,671 adverse events reported
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