Pegfilgrastim

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

Clinical data
Trade names	Neulasta
Biosimilars	pegfilgrastim-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.com	Monograph
MedlinePlus	a607058
License data	EU EMA: by INN US DailyMed: Pegfilgrastim
Pregnancy category	AU: B3[12][2][13]
Routes of administration	Subcutaneous
Drug class	Hematopoietic 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-life	15–80 hrs
Identifiers
IUPAC name N-(3-Hydroxypropyl)Methionylcolony-stimulating Factor (human), 1-Ether with .Alpha.-Methyl-.Omega.-Hydroxypoly(Oxyethylene)
CAS Number	208265-92-3 Y
IUPHAR/BPS	6969
DrugBank	DB00019 Y
ChemSpider	none
UNII	3A58010674
KEGG	D06889 Y
ChEMBL	ChEMBL1201568 N
ECHA InfoCard	100.169.155
Chemical and physical data
Formula	C845H1343N223O243S9
Molar mass	18802.90 g·mol−1
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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]

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).^[16][26][27]

See also

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

References

1. "Cegfila EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
2. "Filpegla | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
3. "Fulphila EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
4. "Fylnetra- pegfilgrastim injection". DailyMed. 26 May 2022. Archived from the original on 3 July 2022. Retrieved 19 June 2022.
5. "Grasustek EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
6. "Pelmeg EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
7. "Stimufend- pegflilgrastim-fpgk injection, solution". DailyMed. 15 September 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
8. "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. "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. "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. "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". DailyMed. Archived from the original on 15 July 2021. Retrieved 14 July 2021.
17. "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. "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. "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.
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. PMC 5082581. PMID 27726031.
27. 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.