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Monoclonal antibody
Pegfilgrastim
Trade names Neulasta
Biosimilars pegfilgrastim-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.com
Monograph
MedlinePlus
a607058
License data
Pregnancy category
Routes of administration
Subcutaneous
Drug class Hematopoietic agents,
colony-stimulating factors ,
immunostimulants
ATC code
Legal status
Elimination half-life 15–80 hrs
N-(3-Hydroxypropyl)Methionylcolony-stimulating Factor (human), 1-Ether with .Alpha.-Methyl-.Omega.-Hydroxypoly(Oxyethylene)
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
ECHA InfoCard
100.169.155
Formula C 845 H 1343 N 223 O 243 S 9
Molar mass 18802 .90 g·mol−1 N Y
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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 .
[16] It serves to stimulate the production of white blood cells (
neutrophils ).
[16]
[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]
[17]
[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).
[16]
[26]
[27]
See also
Lipegfilgrastim (Lonquex) – another pegylated filgrastim biosimilar with even longer half-life
References
^
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 & 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 .
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