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| pronounce =
| pronounce =
| tradename = Neulasta
| tradename = Neulasta
| biosimilars = pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Cegfila,<ref name="Cegfila EPAR">{{cite web | title=Cegfila EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila | url-status=live }}</ref> Filpegla,<ref name="Filpegla APMDS" /> Fulphila,<ref name="Fulphila EPAR">{{cite web | title=Fulphila EPAR | website=[[European Medicines Agency]] (EMA) | date=24 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0 | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0 | url-status=live }}</ref> Fylnetra,<ref name="Fylnetra FDA label">{{cite web | title=Fylnetra- pegfilgrastim injection | website=DailyMed | date=26 May 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03 | access-date=19 June 2022 | archive-date=3 July 2022 | archive-url=https://web.archive.org/web/20220703054042/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03 | url-status=live }}</ref> Grasustek,<ref name="Grasustek EPAR">{{cite web | title=Grasustek EPAR | website=[[European Medicines Agency]] (EMA) | date=24 April 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek | url-status=live }}</ref> Lapelga, Neutropeg, Nyvepria, Pelgraz, Pelmeg,<ref name="Pelmeg EPAR">{{cite web | title=Pelmeg EPAR | website=[[European Medicines Agency]] (EMA) | date=24 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210918/https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg | url-status=live }}</ref> Ristempa, Stimufend,<ref name="Stimufend FDA label">{{cite web | title=Stimufend- pegflilgrastim-fpgk injection, solution | website=DailyMed | date=15 September 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b44bcb82-7e60-4dab-a658-115bdf5c053c | access-date=21 January 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121063513/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b44bcb82-7e60-4dab-a658-115bdf5c053c | url-status=live }}</ref><ref name="Stimufend EPAR">{{cite web | title=Stimufend EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend | access-date=4 April 2022 | archive-date=21 April 2022 | archive-url=https://web.archive.org/web/20220421083742/https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend | url-status=live }}</ref> Tezmota,<ref name="Tezmota PI">{{cite web | title=Tezmota | website=NPS MedicineWise | date=15 July 2021 | url=https://www.nps.org.au/medicine-finder/tezmota#full-pi | access-date=19 February 2022 | archive-date=29 September 2022 | archive-url=https://web.archive.org/web/20220929024429/https://www.nps.org.au/medicine-finder/tezmota#full-pi | url-status=live }}</ref> Udenyca, Ziextenzo<ref name="Ziextenzo EPAR">{{cite web | title=Ziextenzo EPAR | website=[[European Medicines Agency]] (EMA) | date=24 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611223851/https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo | url-status=live }}</ref><ref name="Ziextenzo SBD">{{cite web | title=Summary Basis of Decision (SBD) for Ziextenzo | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00488&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530214535/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00488&lang=en | url-status=live }}</ref>
| biosimilars = pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Armlupeg,<ref>{{cite web | title=Regulatory Decision Summary for Armlupeg | website=Drug and Health Products Portal | date=16 August 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1724332454521 | access-date=27 December 2024}}</ref> Cegfila,<ref name="Cegfila EPAR">{{cite web | title=Cegfila EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/cegfila | url-status=live }}</ref> Filpegla,<ref name="Filpegla APMDS" /> Fulphila,<ref name="Fulphila EPAR">{{cite web | title=Fulphila EPAR | website=[[European Medicines Agency]] (EMA) | date=24 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0 | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/fulphila-0 | url-status=live }}</ref> Fylnetra,<ref name="Fylnetra FDA label">{{cite web | title=Fylnetra- pegfilgrastim injection | website=DailyMed | date=26 May 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03 | access-date=19 June 2022 | archive-date=3 July 2022 | archive-url=https://web.archive.org/web/20220703054042/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03 | url-status=live }}</ref> Grasustek,<ref name="Grasustek EPAR">{{cite web | title=Grasustek EPAR | website=[[European Medicines Agency]] (EMA) | date=24 April 2019 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210825/https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek | url-status=live }}</ref> Lapelga, Neutropeg, Niopeg,<ref name="Niopeg SBD" /> Nyvepria, Pelgraz, Pelmeg,<ref name="Pelmeg EPAR">{{cite web | title=Pelmeg EPAR | website=[[European Medicines Agency]] (EMA) | date=24 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210918/https://www.ema.europa.eu/en/medicines/human/EPAR/pelmeg | url-status=live }}</ref> Ristempa, Stimufend,<ref name="Stimufend FDA label">{{cite web | title=Stimufend- pegflilgrastim-fpgk injection, solution | website=DailyMed | date=15 September 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b44bcb82-7e60-4dab-a658-115bdf5c053c | access-date=21 January 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121063513/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b44bcb82-7e60-4dab-a658-115bdf5c053c | url-status=live }}</ref><ref name="Stimufend EPAR">{{cite web | title=Stimufend EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend | access-date=4 April 2022 | archive-date=21 April 2022 | archive-url=https://web.archive.org/web/20220421083742/https://www.ema.europa.eu/en/medicines/human/EPAR/stimufend | url-status=live }}</ref> Tezmota,<ref name="Tezmota PI">{{cite web | title=Tezmota | website=NPS MedicineWise | date=15 July 2021 | url=https://www.nps.org.au/medicine-finder/tezmota#full-pi | access-date=19 February 2022 | archive-date=29 September 2022 | archive-url=https://web.archive.org/web/20220929024429/https://www.nps.org.au/medicine-finder/tezmota#full-pi | url-status=live }}</ref> Udenyca, Ziextenzo<ref name="Ziextenzo EPAR">{{cite web | title=Ziextenzo EPAR | website=[[European Medicines Agency]] (EMA) | date=24 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611223851/https://www.ema.europa.eu/en/medicines/human/EPAR/ziextenzo | url-status=live }}</ref><ref name="Ziextenzo SBD">{{cite web | title=Summary Basis of Decision (SBD) for Ziextenzo | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00488&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530214535/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00488&lang=en | url-status=live }}</ref>
| Drugs.com = {{drugs.com|monograph|pegfilgrastim}}
| Drugs.com = {{drugs.com|monograph|pegfilgrastim}}
| MedlinePlus = a607058
| MedlinePlus = a607058
Line 31: Line 31:
| legal_BR_comment =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA = Rx-only
| legal_CA_comment = /&nbsp;Schedule D<ref>{{cite web | title=Summary Basis of Decision for Niopeg | website=Drug and Health Products Portal | date=1 September 2012 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730903762975 | access-date=17 December 2024}}</ref>
| legal_CA_comment = /&nbsp;Schedule D<ref name="Niopeg SBD">{{cite web | title=Summary Basis of Decision for Niopeg | website=Drug and Health Products Portal | date=1 September 2012 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1730903762975 | access-date=17 December 2024}}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_DE_comment =

Latest revision as of 08:35, 27 December 2024

Pegfilgrastim
Clinical data
Trade namesNeulasta
Biosimilarspegfilgrastim-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.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
  • 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 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.[18] It serves to stimulate the production of white blood cells (neutrophils).[18][20] Pegfilgrastim was developed by Amgen.[21]

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

[edit]

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]

References

[edit]
  1. ^ "Regulatory Decision Summary for Armlupeg". Drug and Health Products Portal. 16 August 2024. Retrieved 27 December 2024.
  2. ^ a b "Cegfila EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  3. ^ a b c "Filpegla | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  4. ^ a b "Fulphila EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  5. ^ a b "Fylnetra- pegfilgrastim injection". DailyMed. 26 May 2022. Archived from the original on 3 July 2022. Retrieved 19 June 2022.
  6. ^ a b "Grasustek EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  7. ^ a b "Summary Basis of Decision for Niopeg". Drug and Health Products Portal. 1 September 2012. Retrieved 17 December 2024.
  8. ^ a b "Pelmeg EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  9. ^ a b "Stimufend- pegflilgrastim-fpgk injection, solution". DailyMed. 15 September 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  10. ^ a b "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. ^ a b "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. ^ a b "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. ^ a b c d "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". DailyMed. Archived from the original on 15 July 2021. Retrieved 14 July 2021.
  19. ^ a b "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. ^ 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.
  22. ^ a b "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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