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 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
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-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 InfoCard100.169.155
Chemical and physical data
FormulaC845H1343N223O243S9
Molar mass18802.90 g·mol−1
 ☒NcheckY (what is this?)  (verify)

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]

Biosimilars
See also: Biosimilars

Ristempa was approved for medical use in Australia in January 2017.[28][29]

Tezmota was approved for medical use in Australia in March 2018.[9]

Pegfilgrastim-jmdb (Fulphila) was approved for medical use in the United States in June 2018.[30][31]

Fulphila was approved for medical use in Australia in August 2018.[32][33][34]

Pelgraz was approved for medical use in the European Union in September 2018.[35]

Udenyca was approved for medical use in the European Union in September 2018.[36]

On 2 November 2018, Coherus Biosciences received FDA approval for its biosimilar, pegfilgrastim-cbqv (Udenyca). The push to receive approval and begin production of Udenyca was due in large part to the quickly increasing cost of Neulasta, which has nearly tripled since its release in 2002.[37][38]

Pelmeg was approved for medical use in the European Union in November 2018.[6]

Fulphila was approved for medical use in the European Union in November 2018.[3]

Ziextenzo was approved for medical use in the European Union in November 2018.[10]

Fulphila was approved for medical use in Canada in December 2018.[39]

Grasustek was approved for medical use in the European Union in June 2019.[5]

Ziextenzo was approved for medical use in Australia in July 2019.[12][40][41][42]

Pelgraz was approved for medical use in Australia in August 2019.[43][44][45]

Lapelga and Neutropeg were approved for medical use in Australia in August 2019.[40][46][47]

Pegfilgrastim-bmez (Ziextenzo) was approved for medical use in the United States in November 2019.[48][49]

Cegfila was approved for medical use in the European Union in December 2019.[1]

Ziextenzo was approved for medical use in Canada in April 2020.[11]

Pegfilgrastim-apgf (Nyvepria) was approved for medical use in the United States in June 2020.[50][51] Nyvepria was approved for medical use in the European Union in November 2020.[52]

Nyvepria was approved for medical use in Canada in October 2020.[53]

Stimufend was approved for medical use in the European Union in March 2022.[8][54]

Pegfilgrastim-pbbk (Fylnetra) was approved for medical use in the United States in May 2022.[55][4]

Pegfilgrastim-fpgk (Stimufend) was approved for medical use in the United States in September 2022.[7]

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).
  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.
  28. "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 29 September 2022. Retrieved 20 February 2022.
  29. "Ristempa". NPS MedicineWise. 15 July 2021. Archived from the original on 29 September 2022. Retrieved 19 February 2022.
  30. "FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment". U.S. Food and Drug Administration (Press release). 4 June 2018. Archived from the original on 11 June 2020. Retrieved 11 June 2020.
  31. "Drug Approval Package: Fulphila". U.S. Food and Drug Administration (FDA). 26 October 2018. Archived from the original on 11 June 2020. Retrieved 11 June 2020.
  32. "Fulphila". NPS MedicineWise. 15 July 2021. Archived from the original on 29 September 2022. Retrieved 19 February 2022.
  33. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2018". Therapeutic Goods Administration (TGA). 28 February 2019. Archived from the original on 20 February 2022. Retrieved 19 February 2022.{{cite web}}: CS1 maint: unfit URL (link)
  34. "AusPAR: Pegfilgrastim | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  35. "Pelgraz EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 30 December 2019. Retrieved 2 April 2020.
  36. "Udenyca EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  37. "FDA Approves Coherus' Pegfilgrastim Biosimilar, Udenyca". 2 November 2018. Archived from the original on 14 March 2020. Retrieved 26 February 2019.
  38. "Drug Approval Package: Udenyca". U.S. Food and Drug Administration (FDA). 5 March 2019. Archived from the original on 18 December 2019. Retrieved 11 June 2020.
  39. "Summary Basis of Decision (SBD) for Fulphila". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
  40. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2019". Therapeutic Goods Administration (TGA). 10 January 2020. Archived from the original on 20 February 2022. Retrieved 19 February 2022.{{cite web}}: CS1 maint: unfit URL (link)
  41. "Ziextenzo". NPS MedicineWise. 15 July 2021. Archived from the original on 20 February 2022. Retrieved 19 February 2022.
  42. "Ziextenzo | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  43. "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 20 February 2022. Retrieved 20 February 2022.
  44. "Pelgraz". NPS MedicineWise. 15 July 2021. Archived from the original on 20 February 2022. Retrieved 19 February 2022.
  45. "PELGRAZ pegfilgrastim 6 mg/0.6 mL solution for injection pre-filled syringe (308177) | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  46. "Prescription medicines registrations | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  47. "LAPELGA, NEUTROPEG (Apotex Pty LTD) | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  48. "Ziextenzo". U.S. Food and Drug Administration (FDA). Archived from the original on 11 June 2020. Retrieved 17 December 2019.
  49. "Drug Approval Package: Ziextenzo". U.S. Food and Drug Administration (FDA). 27 December 2019. Archived from the original on 11 June 2020. Retrieved 11 June 2020.
  50. "Nyvepria". U.S. Food and Drug Administration (FDA). Archived from the original on 11 June 2020. Retrieved 11 June 2020.
  51. "Drug Approval Package: Nyvepria". U.S. Food and Drug Administration (FDA). 11 August 2020. Archived from the original on 25 January 2021. Retrieved 26 May 2022.
  52. "Nyvepria EPAR". European Medicines Agency (EMA). Archived from the original on 24 July 2021. Retrieved 11 October 2021.
  53. "Summary Basis of Decision (SBD) for Nyvepria". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  54. "Stimufend Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  55. "Drug Approval Package: Fylnetra". U.S. Food and Drug Administration (FDA). 15 July 2022. Archived from the original on 3 September 2022. Retrieved 2 September 2022.
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