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Pegfilgrastim

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Pegfilgrastim
Clinical data
Trade namesNeulasta
Biosimilarspegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Cegfila,[1]Filpegla,[2]Fulphila,[3]Fylnetra,[4]Grasustek,[5]Lapelga, Neutropeg, Nyvepria, Pelgraz, Pelmeg,[6]Ristempa, Stimufend,[7][8]Tezmota,[9]Udenyca, Ziextenzo[10][11]
AHFS/Drugs.comMonograph
MedlinePlusa607058
License data
Pregnancy
category
Routes of
administration		Subcutaneous
Drug classHematopoietic agents,colony-stimulating factors,immunostimulants
ATC code
Legal status
Legal status
Pharmacokineticdata
Eliminationhalf-life15–80 hrs
Identifiers
  • N-(3-Hydroxypropyl)Methionylcolony-stimulating Factor (human), 1-Ether with.Alpha.-Methyl-.Omega.-Hydroxypoly(Oxyethylene)
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard100.169.155Edit this at Wikidata
Chemical and physical data
FormulaC845H1343N223O243S9
Molar mass18802.90g·mol−1
☒NcheckY(what is this?)(verify)

Pegfilgrastim,sold under the brand nameNeulastaamong others, is aPEGylatedform of the recombinant humangranulocyte colony-stimulating factor(GCSF) analogfilgrastim.[16]It serves to stimulate the production of white blood cells (neutrophils).[16][18]Pegfilgrastim was developed byAmgen.[19]

Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.[20]

Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).[21][20]

Pegfilgrastim was approved for medical use in the United States in January 2002, in the European Union in August 2002, and in Australia in September 2002.[19][17][22][23][24]It is on theWorld Health Organization's List of Essential Medicines.[25]

Medical uses

[edit]

Pegfilgrastim isindicatedto decrease the incidence of infection, as manifested by febrile neutropenia, in people with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and to increase survival in people acutely exposed to myelosuppressive doses of radiation (hematopoietic subsyndrome of acute radiation syndrome).[16][26][27]

See also

[edit]
  • Lipegfilgrastim(Lonquex) – another pegylated filgrastim biosimilar with even longer half-life

References

[edit]
  1. ^ab"Cegfila EPAR".European Medicines Agency(EMA).Archivedfrom the original on 11 June 2020.Retrieved2 April2020.
  2. ^abc"Filpegla | Therapeutic Goods Administration (TGA)".Archivedfrom the original on 18 December 2022.Retrieved18 December2022.
  3. ^ab"Fulphila EPAR".European Medicines Agency(EMA).24 September 2018.Archivedfrom the original on 11 June 2020.Retrieved2 April2020.
  4. ^ab"Fylnetra- pegfilgrastim injection".DailyMed.26 May 2022.Archivedfrom the original on 3 July 2022.Retrieved19 June2022.
  5. ^ab"Grasustek EPAR".European Medicines Agency(EMA).24 April 2019.Archivedfrom the original on 11 June 2020.Retrieved2 April2020.
  6. ^ab"Pelmeg EPAR".European Medicines Agency(EMA).24 September 2018.Archivedfrom the original on 11 June 2020.Retrieved2 April2020.
  7. ^ab"Stimufend- pegflilgrastim-fpgk injection, solution".DailyMed.15 September 2022.Archivedfrom the original on 21 January 2023.Retrieved21 January2023.
  8. ^ab"Stimufend EPAR".European Medicines Agency(EMA).Archivedfrom the original on 21 April 2022.Retrieved4 April2022.
  9. ^"Tezmota".NPS MedicineWise.15 July 2021.Archivedfrom the original on 29 September 2022.Retrieved19 February2022.
  10. ^ab"Ziextenzo EPAR".European Medicines Agency(EMA).24 September 2018.Archivedfrom the original on 11 June 2020.Retrieved2 April2020.
  11. ^"Summary Basis of Decision (SBD) for Ziextenzo".Health Canada.23 October 2014.Archivedfrom the original on 30 May 2022.Retrieved29 May2022.
  12. ^ab"Ziextenzo".Therapeutic Goods Administration (TGA).13 December 2019.Archivedfrom the original on 20 October 2021.Retrieved25 August2020.
  13. ^"Pegfilgrastim Use During Pregnancy".Drugs.com.9 December 2019.Archivedfrom the original on 5 December 2020.Retrieved13 July2020.
  14. ^"Neulasta Pre-Filled Syringe - Summary of Product Characteristics (SmPC)".(emc).1 June 2021.Archivedfrom the original on 15 January 2021.Retrieved11 October2021.
  15. ^"Neulasta On Body Injector - Summary of Product Characteristics (SmPC)".(emc).Archivedfrom the original on 17 January 2021.Retrieved11 October2021.
  16. ^abcd"Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection".DailyMed.Archivedfrom the original on 15 July 2021.Retrieved14 July2021.
  17. ^ab"Neulasta EPAR".European Medicines Agency(EMA).17 September 2018.Archivedfrom the original on 11 June 2020.Retrieved2 April2020.
  18. ^Walsh, G, Spada, S. "Epogen/Procrit" in:Directory of approved biopharmaceutical products.CRC Press, 2005, pp. 136–37.
  19. ^ab"Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031".U.S.Food and Drug Administration(FDA).25 October 2004.Archivedfrom the original on 30 March 2021.Retrieved11 June2020.
  20. ^ab"Pegfilgrastim Monograph for Professionals".Drugs.com.22 August 2019.Archivedfrom the original on 7 March 2016.Retrieved11 June2020.
  21. ^Ho, Rodney J. Y.; Gibaldi, Milo, eds. (2004)."Pegfilgrastim".Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs.John Wiley & Sons. pp. 157–159.ISBN978-0-471-45027-6.Archivedfrom the original on 20 October 2021.Retrieved10 November2020.
  22. ^"Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield"(PDF).Therapeutic Goods Administration(TGA).[dead link]
  23. ^"NEULASTA pegfilgrastim (Rbe) 6mg/0.6mL injection syringe with automatic needle guard (166387) | Therapeutic Goods Administration (TGA)".Archivedfrom the original on 18 December 2022.Retrieved18 December2022.
  24. ^"NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield (82873) | Therapeutic Goods Administration (TGA)".Archivedfrom the original on 18 December 2022.Retrieved18 December2022.
  25. ^World Health Organization(2023).The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023).Geneva: World Health Organization.hdl:10665/371090.WHO/MHP/HPS/EML/2023.02.
  26. ^Cerchione C, Catalano L, Peluso I, Nappi D, Di Perna M, Salvatore D, et al. (December 2016)."Managing neutropenia by pegfilgrastim in patients affected by relapsed/refractory multiple myeloma treated with bendamustine-bortezomib-dexamethasone".Supportive Care in Cancer.24(12): 4835–4837.doi:10.1007/s00520-016-3430-9.PMC5082581.PMID27726031.
  27. ^Parker SD, King N, Jacobs TF (November 2020)."Pegfilgrastim".StatPearls [Internet].Treasure Island (FL): StatPearls Publishing.PMID30422488.Archivedfrom the original on 20 October 2021.Retrieved5 November2020.
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