Pegfilgrastim

Last updated

Pegfilgrastim
Clinical data
Trade names Neulasta
Biosimilars pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Armlupeg, [1] Cegfila, [2] Filpegla, [3] Fulphila, [4] Fylnetra, [5] Grasustek, [6] Lapelga, Neutropeg, Niopeg, [7] Nyvepria, Pelgraz, Pelmeg, [8] Ristempa, Stimufend, [9] [10] Tezmota, [11] Udenyca, Ziextenzo [12] [13]
AHFS/Drugs.com Monograph
MedlinePlus a607058
License data
Pregnancy
category
Routes of
administration 		Subcutaneous
Drug class Hematopoietic agents, colony-stimulating factors, immunostimulants
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life 15–80 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 InfoCard 100.169.155 OOjs UI icon edit-ltr-progressive.svg
Chemical and physical data
Formula C845H1343N223O243S9
Molar mass 18802.90 g·mol−1
 X mark.svgNYes check.svgY  (what is this?)    (verify)

Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. [18] It serves to stimulate the production of white blood cells (neutrophils). [18] [20] Pegfilgrastim was developed by Amgen. [21]

Contents

Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. [22]

Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours). [23] [22]

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. [21] [19] [24] [25] [26] It is on the World Health Organization's List of Essential Medicines. [27]

Medical uses

Pegfilgrastim is indicated to 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). [18] [28] [29]

See also

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References

  1. ↑ "Regulatory Decision Summary for Armlupeg". Drug and Health Products Portal. 16 August 2024. Retrieved 27 December 2024.
  2. 1 2 "Cegfila EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  3. 1 2 3 "Filpegla | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  4. 1 2 "Fulphila EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  5. 1 2 "Fylnetra- pegfilgrastim injection". DailyMed. 26 May 2022. Archived from the original on 3 July 2022. Retrieved 19 June 2022.
  6. 1 2 "Grasustek EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  7. 1 2 "Summary Basis of Decision for Niopeg". Drug and Health Products Portal. 1 September 2012. Retrieved 17 December 2024.
  8. 1 2 "Pelmeg EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  9. 1 2 "Stimufend- pegflilgrastim-fpgk injection, solution". DailyMed. 15 September 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  10. 1 2 "Stimufend EPAR". European Medicines Agency (EMA). Archived from the original on 21 April 2022. Retrieved 4 April 2022.
  11. ↑ "Tezmota". NPS MedicineWise. 15 July 2021. Archived from the original on 29 September 2022. Retrieved 19 February 2022.
  12. 1 2 "Ziextenzo EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  13. ↑ "Summary Basis of Decision (SBD) for Ziextenzo". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  14. 1 2 "Ziextenzo". Therapeutic Goods Administration (TGA). 13 December 2019. Archived from the original on 20 October 2021. Retrieved 25 August 2020.
  15. ↑ "Pegfilgrastim Use During Pregnancy". Drugs.com. 9 December 2019. Archived from the original on 5 December 2020. Retrieved 13 July 2020.
  16. ↑ "Neulasta Pre-Filled Syringe - Summary of Product Characteristics (SmPC)". (emc). 1 June 2021. Archived from the original on 15 January 2021. Retrieved 11 October 2021.
  17. ↑ "Neulasta On Body Injector - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 17 January 2021. Retrieved 11 October 2021.
  18. 1 2 3 4 "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". DailyMed. Archived from the original on 15 July 2021. Retrieved 14 July 2021.
  19. 1 2 "Neulasta EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  20. ↑ Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
  21. 1 2 "Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031". U.S. Food and Drug Administration (FDA). 25 October 2004. Archived from the original on 30 March 2021. Retrieved 11 June 2020.
  22. 1 2 "Pegfilgrastim Monograph for Professionals". Drugs.com. 22 August 2019. Archived from the original on 7 March 2016. Retrieved 11 June 2020.
  23. ↑ Ho, Rodney J. Y.; Gibaldi, Milo, eds. (2004). "Pegfilgrastim". Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs. John Wiley & Sons. pp. 157–159. ISBN   978-0-471-45027-6. Archived from the original on 20 October 2021. Retrieved 10 November 2020.
  24. ↑ "Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield" (PDF). Therapeutic Goods Administration (TGA).[ dead link ]
  25. ↑ "NEULASTA pegfilgrastim (Rbe) 6mg/0.6mL injection syringe with automatic needle guard (166387) | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  26. ↑ "NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield (82873) | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  27. ↑ 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.
  28. ↑ 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. PMC   5082581 . PMID   27726031.
  29. ↑ Parker SD, King N, Jacobs TF (November 2020). "Pegfilgrastim". StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. PMID   30422488. Archived from the original on 20 October 2021. Retrieved 5 November 2020.
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