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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
neutropeniaD009503D70
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 lymphomaD008228C85.9362112
Non-small-cell lung carcinomaD00228928111
Ovarian neoplasmsD010051EFO_0003893C563719
Lung neoplasmsD008175C34.9041117
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.9519324
Chemotherapy-induced febrile neutropeniaD06414647111
Large b-cell lymphoma diffuseD016403C83.366110
NeoplasmsD009369C806219
SarcomaD01250915128
Multiple myelomaD009101C90.02416
Hodgkin diseaseD006689C814416
Triple negative breast neoplasmsD0647261415
Colorectal neoplasmsD0151791214
Myeloid leukemia acuteD015470C92.01313
Show 11 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95288
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.0166
Prostatic neoplasmsD011471C61345
Central nervous system neoplasmsD016543245
Follicular lymphomaD008224C82324
Urinary bladder neoplasmsD001749C6744
Mantle-cell lymphomaD020522C83.1223
Renal cell carcinomaD002292123
Male breast neoplasmsD018567133
TeratomaD013724D2833
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients14115
Therapeutic equivalencyD01381033
NeuroblastomaD009447EFO_000062122
PharmacokineticsD01059922
Brain neoplasmsD001932EFO_0003833C7111
T-cell lymphoma cutaneousD016410C84.A11
Small cell lung carcinomaD05575211
Aids-related lymphomaD016483EFO_100136511
Neuroendocrine tumorsD018358EFO_1001901D3A.811
AmyloidosisD000686EFO_1001875E8511
Show 6 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Coronary artery diseaseD003324I25.111
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
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
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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