Chemistry:Pegfilgrastim

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Short description: Monoclonal antibody
Pegfilgrastim
Clinical data
Trade namesNeulasta
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
Pharmacokinetic data
Elimination half-life15–80 hrs
Identifiers
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC845H1343N223O243S9
Molar mass18802.90 g·mol−1
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Pegfilgrastim, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim.[6] It serves to stimulate the production of white blood cells (neutrophils).[6][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][9][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).[6][26][27]

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.[16]

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.[13]

Fulphila was approved for medical use in the European Union in November 2018.[12]

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.[14]

Ziextenzo was approved for medical use in Australia in July 2019.[1][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.[11]

Ziextenzo was approved for medical use in Canada in April 2020.[17]

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.[15][54]

Pegfilgrastim-pbbk (Fylnetra) was approved for medical use in the United States in May 2022.[55][7]

Pegfilgrastim-fpgk (Stimufend) was approved for medical use in the United States in September 2022.[8]

See also

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

References

  1. ↑ 1.0 1.1 1.2 "Ziextenzo". 13 December 2019. https://www.tga.gov.au/apm-summary/ziextenzo. 
  2. ↑ 2.0 2.1 2.2 "Filpegla | Therapeutic Goods Administration (TGA)". https://www.tga.gov.au/resources/auspmd/filpegla. 
  3. ↑ "Pegfilgrastim Use During Pregnancy". 9 December 2019. https://www.drugs.com/pregnancy/pegfilgrastim.html. 
  4. ↑ "Neulasta Pre-Filled Syringe - Summary of Product Characteristics (SmPC)". 1 June 2021. https://www.medicines.org.uk/emc/product/10091/smpc. 
  5. ↑ "Neulasta On Body Injector - Summary of Product Characteristics (SmPC)". https://www.medicines.org.uk/emc/product/6770/smpc. 
  6. ↑ 6.0 6.1 6.2 6.3 "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce. 
  7. ↑ 7.0 7.1 7.2 "Fylnetra- pegfilgrastim injection". 26 May 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03. 
  8. ↑ 8.0 8.1 8.2 "Stimufend- pegflilgrastim-fpgk injection, solution". 15 September 2022. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b44bcb82-7e60-4dab-a658-115bdf5c053c. 
  9. ↑ 9.0 9.1 "Neulasta EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta. 
  10. ↑ 10.0 10.1 10.2 "Ziextenzo EPAR". 24 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo. 
  11. ↑ 11.0 11.1 11.2 "Cegfila EPAR". https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila. 
  12. ↑ 12.0 12.1 12.2 "Fulphila EPAR". 24 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0. 
  13. ↑ 13.0 13.1 13.2 "Pelmeg EPAR". 24 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg. 
  14. ↑ 14.0 14.1 14.2 "Grasustek EPAR". 24 April 2019. https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek. 
  15. ↑ 15.0 15.1 15.2 "Stimufend EPAR". https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend. 
  16. ↑ 16.0 16.1 "Tezmota". 15 July 2021. https://www.nps.org.au/medicine-finder/tezmota#full-pi. 
  17. ↑ 17.0 17.1 "Summary Basis of Decision (SBD) for Ziextenzo". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00488&lang=en. 
  18. ↑ Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
  19. ↑ 19.0 19.1 "Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031". 25 October 2004. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125031_0000_NeulastaTOC.cfm. 
  20. ↑ 20.0 20.1 "Pegfilgrastim Monograph for Professionals". 22 August 2019. https://www.drugs.com/monograph/pegfilgrastim.html. 
  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. https://books.google.com/books?id=NWeTRQejrRwC&pg=PA157. Retrieved 10 November 2020. 
  22. ↑ "Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield" (PDF). http://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=C9C1C6DAE38ECA10CA258514003CB00F&agid=(PrintDetailsPublic)&actionid=1. [|permanent dead link|dead link}}]
  23. ↑ "NEULASTA pegfilgrastim (Rbe) 6mg/0.6mL injection syringe with automatic needle guard (166387) | Therapeutic Goods Administration (TGA)". https://www.tga.gov.au/resources/artg/166387. 
  24. ↑ "NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield (82873) | Therapeutic Goods Administration (TGA)". https://www.tga.gov.au/resources/artg/82873. 
  25. ↑ 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. 2023. WHO/MHP/HPS/EML/2023.02. 
  26. ↑ "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. December 2016. doi:10.1007/s00520-016-3430-9. PMID 27726031. 
  27. ↑ "Pegfilgrastim". StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. November 2020. https://www.ncbi.nlm.nih.gov/books/NBK532893/. Retrieved 5 November 2020. 
  28. ↑ "TGA eBS - Product and Consumer Medicine Information Licence". https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-01281-1. 
  29. ↑ "Ristempa". 15 July 2021. https://www.nps.org.au/medicine-finder/ristempa-solution-for-injection#full-pi. 
  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". 26 October 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761075Orig1s000TOC.cfm. 
  32. ↑ "Fulphila". 15 July 2021. https://www.nps.org.au/medicine-finder/fulphila#full-pi. 
  33. ↑ "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2018". 28 February 2019. https://www.tga.gov.au/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2018. 
  34. ↑ "AusPAR: Pegfilgrastim | Therapeutic Goods Administration (TGA)". https://www.tga.gov.au/resources/auspar/auspar-pegfilgrastim. 
  35. ↑ "Pelgraz EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz. 
  36. ↑ "Udenyca EPAR". 17 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/udenyca. 
  37. ↑ "FDA Approves Coherus' Pegfilgrastim Biosimilar, Udenyca". 2 November 2018. https://www.centerforbiosimilars.com/news/fda-approves-coherus-pegfilgrastim-biosimilar-udenyca. 
  38. ↑ "Drug Approval Package: Udenyca". 5 March 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm. 
  39. ↑ "Summary Basis of Decision (SBD) for Fulphila". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00432&lang=en. 
  40. ↑ 40.0 40.1 "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2019". 10 January 2020. https://www.tga.gov.au/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2019. 
  41. ↑ "Ziextenzo". 15 July 2021. https://www.nps.org.au/medicine-finder/ziextenzo#full-pi. 
  42. ↑ "Ziextenzo | Therapeutic Goods Administration (TGA)". https://www.tga.gov.au/resources/auspmd/ziextenzo. 
  43. ↑ "TGA eBS - Product and Consumer Medicine Information Licence". https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2019-PI-02071-1. 
  44. ↑ "Pelgraz". 15 July 2021. https://www.nps.org.au/medicine-finder/pelgraz#full-pi. 
  45. ↑ "PELGRAZ pegfilgrastim 6 mg/0.6 mL solution for injection pre-filled syringe (308177) | Therapeutic Goods Administration (TGA)". https://www.tga.gov.au/resources/artg/308177. 
  46. ↑ "Prescription medicines registrations | Therapeutic Goods Administration (TGA)". https://www.tga.gov.au/resources/prescription-medicines-registrations?f%5B0%5D=published%3A2019&f%5B1%5D=subtype%3ANew%20biosimilar%20medicine. 
  47. ↑ "LAPELGA, NEUTROPEG (Apotex Pty LTD) | Therapeutic Goods Administration (TGA)". https://www.tga.gov.au/resources/prescription-medicines-registrations/lapelga-neutropeg-apotex-pty-ltd. 
  48. ↑ "Ziextenzo". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761045. 
  49. ↑ "Drug Approval Package: Ziextenzo". 27 December 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761045Orig1s000TOC.cfm. 
  50. ↑ "Nyvepria". https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761111. 
  51. ↑ "Drug Approval Package: Nyvepria". 11 August 2020. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761111Orig1s000TOC.cfm. 
  52. ↑ "Nyvepria EPAR". https://www.ema.europa.eu/en/medicines/human/EPAR/nyvepria. 
  53. ↑ "Summary Basis of Decision (SBD) for Nyvepria". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00523&lang=en. 
  54. ↑ "Stimufend Product information". https://ec.europa.eu/health/documents/community-register/html/h1632.htm. 
  55. ↑ "Drug Approval Package: Fylnetra". 15 July 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000TOC.cfm. 




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