Pegfilgrastim Explained
Pegfilgrastim, sold under the brand name Neulasta among others, 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).[1] Pegfilgrastim was developed by Amgen.
Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.
Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).[2] [3]
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.[4] [5] [6] [7] [8] It is on the World Health Organization's List of Essential Medicines.[9]
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).[10] [11]
See also
- Lipegfilgrastim (Lonquex) another pegylated filgrastim biosimilar with even longer half-life
Notes and References
- Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
- Book: Ho . Rodney J. Y. . Gibaldi . Milo . 2004 . Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs . John Wiley & Sons . 978-0-471-45027-6 . Pegfilgrastim . 157–159 . https://books.google.com/books?id=NWeTRQejrRwC&pg=PA157 . 10 November 2020 . 20 October 2021 . https://web.archive.org/web/20211020025437/https://books.google.com/books?id=NWeTRQejrRwC&pg=PA157 . live .
- Web site: Pegfilgrastim Monograph for Professionals . Drugs.com . 22 August 2019 . 11 June 2020 . 7 March 2016 . https://web.archive.org/web/20160307105515/http://www.drugs.com/monograph/pegfilgrastim.html . live .
- Web site: Drug Approval Package: Neulasta (Pegfilgrastim) NDA #125031 . U.S. Food and Drug Administration (FDA) . 25 October 2004 . 11 June 2020 . 30 March 2021 . https://web.archive.org/web/20210330161656/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125031_0000_NeulastaTOC.cfm . live .
- Web site: Neulasta EPAR . European Medicines Agency (EMA) . 17 September 2018 . 2 April 2020 . 11 June 2020 . https://web.archive.org/web/20200611210847/https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta . live .
- Web site: Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield . PDF . Therapeutic Goods Administration (TGA) .
- Web site: NEULASTA pegfilgrastim (Rbe) 6mg/0.6mL injection syringe with automatic needle guard (166387) | Therapeutic Goods Administration (TGA) . 18 December 2022 . 18 December 2022 . https://web.archive.org/web/20221218041606/https://www.tga.gov.au/resources/artg/166387 . live .
- Web site: NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield (82873) | Therapeutic Goods Administration (TGA) . 18 December 2022 . 18 December 2022 . https://web.archive.org/web/20221218041606/https://www.tga.gov.au/resources/artg/82873 . live .
- Book: ((World Health Organization)) . The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) . 2023 . 10665/371090 . World Health Organization . World Health Organization . Geneva . WHO/MHP/HPS/EML/2023.02 . free .
- Cerchione C, Catalano L, Peluso I, Nappi D, Di Perna M, Salvatore D, Migliaccio I, Picardi M, Pane F . 6 . 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 . 27726031 . 5082581 . 10.1007/s00520-016-3430-9 .
- Book: Parker SD, King N, Jacobs TF . Pegfilgrastim . November 2020 . StatPearls [Internet] . Treasure Island (FL) . StatPearls Publishing . 30422488 . https://www.ncbi.nlm.nih.gov/books/NBK532893/ . 5 November 2020 . 20 October 2021 . https://web.archive.org/web/20211020025514/https://www.ncbi.nlm.nih.gov/books/NBK532893/ . live .