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Wikipedia

Pegfilgrastim

January 01, 1970

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
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
  • 208265-92-3 Y
IUPHAR/BPS
  • 6969
DrugBank
  • DB00019 Y
ChemSpider
  • none
UNII
  • 3A58010674
KEGG
  • D06889 Y
ChEMBL
  • ChEMBL1201568 N
ECHA InfoCard100.169.155
Chemical and physical data
FormulaC845H1343N223O243S9
Molar mass18802.90 g·mol−1
 NY (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 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).[16][26][27]

See also edit

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

References edit

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

January 01, 1970
pegfilgrastim, sold, under, brand, name, neulasta, among, others, pegylated, form, recombinant, human, granulocyte, colony, stimulating, factor, gcsf, analog, filgrastim, serves, stimulate, production, white, blood, cells, neutrophils, developed, amgen, clinic. 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 PegfilgrastimClinical dataTrade namesNeulastaBiosimilarspegfilgrastim 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 comMonographMedlinePlusa607058License dataEU EMA by INN US DailyMed PegfilgrastimPregnancycategoryAU B3 12 2 13 Routes ofadministrationSubcutaneousDrug classHematopoietic agents colony stimulating factors immunostimulantsATC codeL03AA13 WHO Legal statusLegal statusAU 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 dataElimination half life15 80 hrsIdentifiersIUPAC name N 3 Hydroxypropyl Methionylcolony stimulating Factor human 1 Ether with Alpha Methyl Omega Hydroxypoly Oxyethylene CAS Number208265 92 3 YIUPHAR BPS6969DrugBankDB00019 YChemSpidernoneUNII3A58010674KEGGD06889 YChEMBLChEMBL1201568 NECHA InfoCard100 169 155Chemical and physical dataFormulaC 845H 1343N 223O 243S 9Molar mass18802 90 g mol 1 N Y 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 editPegfilgrastim 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 editLipegfilgrastim Lonquex another pegylated filgrastim biosimilar with even longer half lifeReferences edit a b Cegfila EPAR European Medicines Agency EMA Archived from the original on 11 June 2020 Retrieved 2 April 2020 a b c Filpegla Therapeutic Goods Administration TGA Archived from the original on 18 December 2022 Retrieved 18 December 2022 a b Fulphila EPAR European Medicines Agency EMA 24 September 2018 Archived from the original on 11 June 2020 Retrieved 2 April 2020 a b Fylnetra pegfilgrastim injection DailyMed 26 May 2022 Archived from the original on 3 July 2022 Retrieved 19 June 2022 a b Grasustek EPAR European Medicines Agency EMA 24 April 2019 Archived from the original on 11 June 2020 Retrieved 2 April 2020 a b Pelmeg EPAR European Medicines Agency EMA 24 September 2018 Archived from the original on 11 June 2020 Retrieved 2 April 2020 a b Stimufend pegflilgrastim fpgk injection solution DailyMed 15 September 2022 Archived from the original on 21 January 2023 Retrieved 21 January 2023 a b Stimufend EPAR European Medicines Agency EMA Archived from the original on 21 April 2022 Retrieved 4 April 2022 Tezmota NPS MedicineWise 15 July 2021 Archived from the original on 29 September 2022 Retrieved 19 February 2022 a b Ziextenzo EPAR European Medicines Agency EMA 24 September 2018 Archived from the original on 11 June 2020 Retrieved 2 April 2020 Summary Basis of Decision SBD for Ziextenzo Health Canada 23 October 2014 Archived from the original on 30 May 2022 Retrieved 29 May 2022 a b Ziextenzo Therapeutic Goods Administration TGA 13 December 2019 Archived from the original on 20 October 2021 Retrieved 25 August 2020 Pegfilgrastim Use During Pregnancy Drugs com 9 December 2019 Archived from the original on 5 December 2020 Retrieved 13 July 2020 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 Neulasta On Body Injector Summary of Product Characteristics SmPC emc Archived from the original on 17 January 2021 Retrieved 11 October 2021 a b c d Neulasta pegfilgrastim kit Neulasta pegfilgrastim injection DailyMed Archived from the original on 15 July 2021 Retrieved 14 July 2021 a b Neulasta EPAR European Medicines Agency EMA 17 September 2018 Archived from the original on 11 June 2020 Retrieved 2 April 2020 Walsh G Spada S Epogen Procrit in Directory of approved biopharmaceutical products CRC Press 2005 pp 136 37 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 a b Pegfilgrastim Monograph for Professionals Drugs com 22 August 2019 Archived from the original on 7 March 2016 Retrieved 11 June 2020 Ho Rodney J Y Gibaldi Milo eds 2004 Pegfilgrastim Biotechnology and Biopharmaceuticals Transforming Proteins and Genes into Drugs John Wiley amp Sons pp 157 159 ISBN 978 0 471 45027 6 Archived from the original on 20 October 2021 Retrieved 10 November 2020 Summary for ARTG Entry 82873 Neulasta pegfilgrastim rbe 6mg 0 6mL injection syringe with stelmi needle shield PDF Therapeutic Goods Administration TGA dead link 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 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 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 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 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 Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Pegfilgrastim amp oldid 1214868961, wikipedia, wiki, book, books, library,

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