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Added info on delivery systems of PegFilgrastim from innovator's website
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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.<ref>{{cite web | title=Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031 | website=U.S. [[Food and Drug Administration]] (FDA) | date=25 October 2004 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125031_0000_NeulastaTOC.cfm | access-date=11 June 2020}}</ref><ref>{{cite web | title=Neulasta EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta | access-date=2 April 2020}}</ref><ref>{{cite web | url=http://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=C9C1C6DAE38ECA10CA258514003CB00F&agid=(PrintDetailsPublic)&actionid=1 | format=PDF | title=Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield | website=[[Therapeutic Goods Administration]] (TGA) }}</ref>
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.<ref>{{cite web | title=Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031 | website=U.S. [[Food and Drug Administration]] (FDA) | date=25 October 2004 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125031_0000_NeulastaTOC.cfm | access-date=11 June 2020}}</ref><ref>{{cite web | title=Neulasta EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta | access-date=2 April 2020}}</ref><ref>{{cite web | url=http://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=C9C1C6DAE38ECA10CA258514003CB00F&agid=(PrintDetailsPublic)&actionid=1 | format=PDF | title=Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield | website=[[Therapeutic Goods Administration]] (TGA) }}</ref>


Neulasta is administered by manual injection and is also available via the Neulasta'''<sup>®</sup>''' Onpro<sup>®</sup> kit, which includes a specially designed, single-use prefilled syringe co-packaged with an on-body injector.<ref>{{Cite web|title=Amgen Launches Neulasta® (pegfilgrastim) Onpro® NARRATIVES|url=https://www.amgen.com/newsroom/press-releases/2017/04/amgen-launches-neulasta-pegfilgrastim-onpro-narratives|url-status=live}}</ref>
Pegfilgrastim (brand name Neulasta) was developed by [[Amgen]]. Neulasta is administered by manual injection and is also available via the Neulasta'''<sup>®</sup>''' Onpro<sup>®</sup> kit, which includes a specially designed, single-use prefilled syringe co-packaged with an on-body injector.<ref>{{Cite web|title=Amgen Launches Neulasta® (pegfilgrastim) Onpro® NARRATIVES|url=https://www.amgen.com/newsroom/press-releases/2017/04/amgen-launches-neulasta-pegfilgrastim-onpro-narratives|url-status=live}}</ref>


== Medical uses ==
== Medical uses ==

Revision as of 04:32, 8 October 2021

Pegfilgrastim
Clinical data
Trade namesNeulasta, Udenyca, Ristempa, others[1]
Other namespegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-jmdb
AHFS/Drugs.comMonograph
MedlinePlusa607058
License data
Pregnancy
category
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)[2]
  • UK: POM (Prescription only)
  • US: ℞-only[4]
  • EU: Rx-only
  • In general: ℞ (Prescription only)
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 is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim. It serves to stimulate the production of white blood cells (neutrophils).[5]

Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.[6]

Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).[7][6]

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.[8][9][10]

Pegfilgrastim (brand name Neulasta) was developed by Amgen. Neulasta is administered by manual injection and is also available via the Neulasta® Onpro® kit, which includes a specially designed, single-use prefilled syringe co-packaged with an on-body injector.[11]

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).[4][12][13]

Biosimilars

See also: Biosimilars

Ristempa was approved for medical use in Australia in January 2017.[14]

Tezmota was approved for medical use in Australia in March 2018.[15]

Pegfilgrastim-jmdb (Fulphila) was approved for medical use in the United States in June 2018.[16][17]

Fulphila was approved for medical use in Australia in August 2018.[18]

Pelgraz was approved for medical use in the European Union in September 2018.[19]

Udenyca was approved for medical use in the European Union in September 2018.[20]

On November 2, 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.[21][22]

Pelmeg was approved for medical use in the European Union in November 2018.[23]

Fulphila was approved for medical use in the European Union in November 2018.[24]

Ziextenzo was approved for medical use in the European Union in November 2018.[25]

Grasustek was approved for medical use in the European Union in June 2019.[26]

Ziextenzo was approved for medical use in Australia in July 2019.[2]

Pelgraz was approved for medical use in Australia in August 2019.[27]

Neutropeg was approved for medical use in Australia in August 2019.[28]

Pegfilgrastim-bmez (Ziextenzo) was approved for medical use in the United States in November 2019.[29][30]

Cegfila was approved for medical use in the European Union in December 2019.[31]

Pegfilgrastim-apgf (Nyvepria) was approved for medical use in the United States in June 2020.[32] On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for Nyvepria.[33] The applicant for this medicinal product is Pfizer Europe MA EEIG.[33]

References

  1. ^ Drugs.com International brand names for pegfilgrastim Page accessed April 1, 2016
  2. ^ a b c "Ziextenzo". Therapeutic Goods Administration (TGA). 13 December 2019. Retrieved 25 August 2020.
  3. ^ "Pegfilgrastim Use During Pregnancy". Drugs.com. 9 December 2019. Retrieved 13 July 2020.
  4. ^ a b "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". DailyMed. Retrieved 14 July 2021.
  5. ^ Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
  6. ^ a b "Pegfilgrastim Monograph for Professionals". Drugs.com. 22 August 2019. Retrieved 11 June 2020.
  7. ^ 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.
  8. ^ "Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031". U.S. Food and Drug Administration (FDA). 25 October 2004. Retrieved 11 June 2020.
  9. ^ "Neulasta EPAR". European Medicines Agency (EMA). Retrieved 2 April 2020.
  10. ^ "Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield" (PDF). Therapeutic Goods Administration (TGA).
  11. ^ "Amgen Launches Neulasta® (pegfilgrastim) Onpro® NARRATIVES".{{cite web}}: CS1 maint: url-status (link)
  12. ^ 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.
  13. ^ Parker SD, King N, Jacobs TF (November 2020). "Pegfilgrastim". StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing.
  14. ^ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=DFB942E54351D3EDCA2585880030EB48&agid=(PrintDetailsPublic)&actionid=1
  15. ^ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=86E9A09F47791A95CA2585880030EB4A&agid=(PrintDetailsPublic)&actionid=1
  16. ^ "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. Retrieved 11 June 2020.
  17. ^ "Drug Approval Package: Fulphila". U.S. Food and Drug Administration (FDA). 26 October 2018. Retrieved 11 June 2020.
  18. ^ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=FB6888358ED3FA79CA25859D00425423&agid=(PrintDetailsPublic)&actionid=1
  19. ^ "Pelgraz EPAR". European Medicines Agency (EMA). Retrieved 2 April 2020.
  20. ^ "Udenyca EPAR". European Medicines Agency (EMA). Retrieved 2 April 2020.
  21. ^ "FDA Approves Coherus' Pegfilgrastim Biosimilar, Udenyca".
  22. ^ "Drug Approval Package: Udenyca". U.S. Food and Drug Administration (FDA). 5 March 2019. Retrieved 11 June 2020.
  23. ^ "Pelmeg EPAR". European Medicines Agency (EMA). Retrieved 2 April 2020.
  24. ^ "Fulphila EPAR". European Medicines Agency (EMA). Retrieved 2 April 2020.
  25. ^ "Ziextenzo EPAR". European Medicines Agency (EMA). Retrieved 2 April 2020.
  26. ^ "Grasustek EPAR". European Medicines Agency (EMA). Retrieved 2 April 2020.
  27. ^ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=D9374DDB59026212CA2585CE004233D0&agid=(PrintDetailsPublic)&actionid=1
  28. ^ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=C31CEBE1997897ABCA2585CE004233CE&agid=(PrintDetailsPublic)&actionid=1
  29. ^ "Ziextenzo". U.S. Food and Drug Administration (FDA). Retrieved 17 December 2019.
  30. ^ "Drug Approval Package: Ziextenzo". U.S. Food and Drug Administration (FDA). 27 December 2019. Retrieved 11 June 2020.
  31. ^ "Cegfila EPAR". European Medicines Agency (EMA). Retrieved 2 April 2020.
  32. ^ "Nyvepria". U.S. Food and Drug Administration (FDA). Retrieved 11 June 2020.
  33. ^ a b "Nyvepria: Pending EC decision". European Medicines Agency (EMA). 18 September 2020. Retrieved 21 September 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.


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