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Pegfilgrastim information


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
  • EU EMA: by INN
  • US DailyMed: Pegfilgrastim
Pregnancy
category
  • AU: B3[12][2][13]
Routes of
administration
Subcutaneous
Drug classHematopoietic agents, colony-stimulating factors, immunostimulants
ATC code
  • L03AA13 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)[12][2]
  • CA: ℞-only / Schedule D
  • UK: POM (Prescription only)[14][15]
  • US: ℞-only[16][4][7]
  • EU: Rx-only[17][10][1][3][6][5][8]
  • In general: ℞ (Prescription only)
Pharmacokinetic data
Elimination half-life15–80 hrs
Identifiers
IUPAC name
  • N-(3-Hydroxypropyl)Methionylcolony-stimulating Factor (human), 1-Ether with .Alpha.-Methyl-.Omega.-Hydroxypoly(Oxyethylene)
CAS Number
  • 208265-92-3 checkY
IUPHAR/BPS
  • 6969
DrugBank
  • DB00019 checkY
ChemSpider
  • none
UNII
  • 3A58010674
KEGG
  • D06889 checkY
ChEMBL
  • ChEMBL1201568 ☒N
ECHA InfoCard100.169.155 Edit this at Wikidata
Chemical and physical data
FormulaC845H1343N223O243S9
Molar mass18802.90 g·mol−1
 ☒NcheckY (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.[16] It serves to stimulate the production of white blood cells (neutrophils).[16][18] Pegfilgrastim was developed by Amgen.[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 the World Health Organization's List of Essential Medicines.[25]

  1. ^ a b "Cegfila EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  2. ^ a b c "Filpegla | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  3. ^ a b "Fulphila EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  4. ^ a b "Fylnetra- pegfilgrastim injection". DailyMed. 26 May 2022. Archived from the original on 3 July 2022. Retrieved 19 June 2022.
  5. ^ a b "Grasustek EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  6. ^ a b "Pelmeg EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  7. ^ a b "Stimufend- pegflilgrastim-fpgk injection, solution". DailyMed. 15 September 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  8. ^ a b "Stimufend EPAR". European Medicines Agency (EMA). Archived from the original on 21 April 2022. Retrieved 4 April 2022.
  9. ^ "Tezmota". NPS MedicineWise. 15 July 2021. Archived from the original on 29 September 2022. Retrieved 19 February 2022.
  10. ^ a b "Ziextenzo EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  11. ^ "Summary Basis of Decision (SBD) for Ziextenzo". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  12. ^ a b "Ziextenzo". Therapeutic Goods Administration (TGA). 13 December 2019. Archived from the original on 20 October 2021. Retrieved 25 August 2020.
  13. ^ "Pegfilgrastim Use During Pregnancy". Drugs.com. 9 December 2019. Archived from the original on 5 December 2020. Retrieved 13 July 2020.
  14. ^ "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.
  15. ^ "Neulasta On Body Injector - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 17 January 2021. Retrieved 11 October 2021.
  16. ^ a b c "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". DailyMed. Archived from the original on 15 July 2021. Retrieved 14 July 2021.
  17. ^ a b "Neulasta EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  18. ^ Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
  19. ^ a b "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.
  20. ^ a b "Pegfilgrastim Monograph for Professionals". Drugs.com. 22 August 2019. Archived from the original on 7 March 2016. Retrieved 11 June 2020.
  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. ISBN 978-0-471-45027-6. Archived from the original on 20 October 2021. Retrieved 10 November 2020.
  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)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  24. ^ "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.
  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.

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