pegfilgrastim

{{Drugbox

| Verifiedfields = changed

| Watchedfields = changed

| verifiedrevid = 462273886

| pronounce =

| tradename = Neulasta

| Drugs.com = {{drugs.com|monograph|pegfilgrastim}}

| MedlinePlus = a607058

| DailyMedID = Pegfilgrastim

| pregnancy_AU = B3

| pregnancy_AU_comment = {{cite web | title=Ziextenzo | website=Therapeutic Goods Administration (TGA) | date=13 December 2019 | url=https://www.tga.gov.au/resources/auspmd/ziextenzo | access-date=25 August 2020 | archive-date=20 October 2021 | archive-url=https://web.archive.org/web/20211020025442/https://www.tga.gov.au/apm-summary/ziextenzo | url-status=live }}{{cite web | title=Pegfilgrastim Use During Pregnancy | website=Drugs.com | date=9 December 2019 | url=https://www.drugs.com/pregnancy/pegfilgrastim.html | access-date=13 July 2020 | archive-date=5 December 2020 | archive-url=https://web.archive.org/web/20201205000651/https://www.drugs.com/pregnancy/pegfilgrastim.html | url-status=live }}

| pregnancy_category=

| routes_of_administration = Subcutaneous

| class = Hematopoietic agents, colony-stimulating factors, immunostimulants

| ATC_prefix = L03

| ATC_suffix = AA13

| ATC_supplemental =

| biosimilars = pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Armlupeg,{{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}}{{cite web | title=Summary Basis of Decision for Armlupeg | website=Drug and Health Products Portal | date=22 December 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1734963810994 | access-date=25 January 2025}} Cegfila,{{cite web | title=Cegfila EPAR | website=European Medicines Agency (EMA) | date=20 December 2019 | 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 }} Filpegla, Fulphila,{{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 }} Fylnetra,{{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 }} Grasustek,{{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 }} Lapelga, Neutropeg, Niopeg, Nyvepria, Pelgraz, Pelmeg,{{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 }} Ristempa, Stimufend,{{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 }}{{cite web | title=Stimufend EPAR | website=European Medicines Agency (EMA) | date=4 April 2022 | 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 }} Tezmota,{{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 }} Udenyca, Ziextenzo{{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 }}{{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 }}

| legal_AU = S4

| legal_AU_comment = {{Cite web |url=https://www.tga.gov.au/resources/auspmd/filpegla |title=Filpegla | Therapeutic Goods Administration (TGA) |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218041600/https://www.tga.gov.au/resources/auspmd/filpegla |url-status=live }}

| legal_BR =

| legal_BR_comment =

| legal_CA = Rx-only

| legal_CA_comment = / Schedule D{{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}}

| legal_DE =

| legal_DE_comment =

| legal_NZ =

| legal_NZ_comment =

| legal_UK = POM

| legal_UK_comment = {{cite web | title=Neulasta Pre-Filled Syringe - Summary of Product Characteristics (SmPC) | website=(emc) | date=1 June 2021 | url=https://www.medicines.org.uk/emc/product/10091/smpc | access-date=11 October 2021 | archive-date=15 January 2021 | archive-url=https://web.archive.org/web/20210115203526/https://www.medicines.org.uk/emc/product/10091/smpc | url-status=live }}{{cite web | title=Neulasta On Body Injector - Summary of Product Characteristics (SmPC) | website=(emc) | url=https://www.medicines.org.uk/emc/product/6770/smpc | access-date=11 October 2021 | archive-date=17 January 2021 | archive-url=https://web.archive.org/web/20210117224054/https://www.medicines.org.uk/emc/product/6770/smpc | url-status=live }}

| legal_US = Rx-only

| legal_US_comment = {{cite web | title=Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce | access-date=14 July 2021 | archive-date=15 July 2021 | archive-url=https://web.archive.org/web/20210715064016/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fdfe5d72-6b80-435a-afa4-c5d74dd852ce | url-status=live }}

| legal_EU = Rx-only

| legal_EU_comment =

| legal_UN =

| legal_UN_comment =

| legal_status = Rx-only

| elimination_half-life = 15–80 hrs

| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}

| ChemSpiderID = none

| CAS_number_Ref = {{cascite|correct|??}}

| CAS_number = 208265-92-3

| DrugBank_Ref = {{drugbankcite|correct|drugbank}}

| DrugBank = DB00019

| IUPHAR_ligand = 6969

| UNII_Ref = {{fdacite|correct|FDA}}

| UNII = 3A58010674

| KEGG_Ref = {{keggcite|correct|kegg}}

| KEGG = D06889

| ChEMBL_Ref = {{ebicite|changed|EBI}}

| ChEMBL = 1201568

| synonyms =

| IUPAC_name = N-(3-Hydroxypropyl)Methionylcolony-stimulating Factor (human), 1-Ether with .Alpha.-Methyl-.Omega.-Hydroxypoly(Oxyethylene)

| C=845 | H=1343 | N=223 | O=243 | S=9

}}

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).Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37. 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).{{cite book |editor1-last=Ho |editor1-first=Rodney J. Y. |editor2-last=Gibaldi |editor2-first=Milo |year=2004 |title=Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs |publisher=John Wiley & Sons |isbn=978-0-471-45027-6 |chapter=Pegfilgrastim |pages=157–159 |chapter-url=https://books.google.com/books?id=NWeTRQejrRwC&pg=PA157 |access-date=10 November 2020 |archive-date=20 October 2021 |archive-url=https://web.archive.org/web/20211020025437/https://books.google.com/books?id=NWeTRQejrRwC&pg=PA157 |url-status=live }}{{cite web | title=Pegfilgrastim Monograph for Professionals | website=Drugs.com | date=22 August 2019 | url=https://www.drugs.com/monograph/pegfilgrastim.html | access-date=11 June 2020 | archive-date=7 March 2016 | archive-url=https://web.archive.org/web/20160307105515/http://www.drugs.com/monograph/pegfilgrastim.html | url-status=live }}

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.{{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 | archive-date=30 March 2021 | archive-url=https://web.archive.org/web/20210330161656/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125031_0000_NeulastaTOC.cfm | url-status=live }}{{cite web | title=Neulasta EPAR | website=European Medicines Agency (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210847/https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta | url-status=live }}{{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) }}{{dead link|date=December 2022}}{{Cite web |url=https://www.tga.gov.au/resources/artg/166387 |title=NEULASTA pegfilgrastim (Rbe) 6mg/0.6mL injection syringe with automatic needle guard (166387) | Therapeutic Goods Administration (TGA) |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218041606/https://www.tga.gov.au/resources/artg/166387 |url-status=live }}{{Cite web |url=https://www.tga.gov.au/resources/artg/82873 |title=NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield (82873) | Therapeutic Goods Administration (TGA) |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218041606/https://www.tga.gov.au/resources/artg/82873 |url-status=live }} It is on the World Health Organization's List of Essential Medicines.{{cite book | vauthors = ((World Health Organization)) | title = The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) | year = 2023 | hdl = 10665/371090 | author-link = World Health Organization | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2023.02 | hdl-access=free }}

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).{{cite journal | vauthors = Cerchione C, Catalano L, Peluso I, Nappi D, Di Perna M, Salvatore D, Migliaccio I, Picardi M, Pane F | display-authors = 6 | title = Managing neutropenia by pegfilgrastim in patients affected by relapsed/refractory multiple myeloma treated with bendamustine-bortezomib-dexamethasone | journal = Supportive Care in Cancer | volume = 24 | issue = 12 | pages = 4835–4837 | date = December 2016 | pmid = 27726031 | pmc = 5082581 | doi = 10.1007/s00520-016-3430-9 }}{{cite book | vauthors = Parker SD, King N, Jacobs TF | chapter = Pegfilgrastim | date = November 2020 | title = StatPearls [Internet] | location = Treasure Island (FL) | publisher = StatPearls Publishing | pmid = 30422488 | chapter-url = https://www.ncbi.nlm.nih.gov/books/NBK532893/ | access-date = 5 November 2020 | archive-date = 20 October 2021 | archive-url = https://web.archive.org/web/20211020025514/https://www.ncbi.nlm.nih.gov/books/NBK532893/ | url-status = live }}

Society and culture

= Legal status =

In January 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Dyrupeg, intended to shorten the duration of neutropenia and help prevent febrile neutropenia after cytotoxic chemotherapy. The applicant for this medicinal product is CuraTeQ Biologics s.r.o.{{cite web | title=Dyrupeg EPAR | website=European Medicines Agency (EMA) | date=30 January 2025 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/dyrupeg | access-date=16 February 2025}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Dyrupeg is a biosimilar medicinal product. It is highly similar to the reference product Neulasta (pegfilgrastim), which was authorized in the EU in August 2002.

References

Category:Amgen

Category:Drugs developed by Hoffmann-La Roche

Category:Immunostimulants

Category:Recombinant proteins

Category:World Health Organization essential medicines