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{{Short description|Monoclonal antibody}}
{{Short description|Monoclonal antibody}}
{{Use dmy dates|date=September 2022}}
{{Use dmy dates|date=March 2023}}
{{Drugbox
{{Drugbox
| Verifiedfields = changed
| Verifiedfields = changed
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| pronounce =
| pronounce =
| tradename = Neulasta
| tradename = Neulasta
| biosimilars = pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Armlupeg,<ref>{{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}}</ref> Cegfila,<ref name="Cegfila EPAR">{{cite web | title=Cegfila EPAR | website=[[European Medicines Agency]] (EMA) | 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 }}</ref> Filpegla,<ref name="Filpegla APMDS" /> Fulphila,<ref name="Fulphila EPAR">{{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 }}</ref> Fylnetra,<ref name="Fylnetra FDA label">{{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 }}</ref> Grasustek,<ref name="Grasustek EPAR">{{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 }}</ref> Lapelga, Neutropeg, Niopeg,<ref name="Niopeg SBD" /> Nyvepria, Pelgraz, Pelmeg,<ref name="Pelmeg EPAR">{{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 }}</ref> Ristempa, Stimufend,<ref name="Stimufend FDA label">{{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 }}</ref><ref name="Stimufend EPAR">{{cite web | title=Stimufend EPAR | website=[[European Medicines Agency]] (EMA) | 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 }}</ref> Tezmota,<ref name="Tezmota PI">{{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 }}</ref> Udenyca, Ziextenzo<ref name="Ziextenzo EPAR">{{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 }}</ref><ref name="Ziextenzo SBD">{{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 }}</ref>
| biosimilars = pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Cegfila,<ref name="Cegfila EPAR" /> Filpegla,<ref name="Filpegla APMDS" /> Fulphila,<ref name="Fulphila EPAR" /> Fylnetra,<ref name="Fylnetra FDA label" /> Grasustek,<ref name="Grasustek EPAR" /> Lapelga, Neutropeg, Nyvepria, Pelgraz, Pelmeg,<ref name="Pelmeg EPAR" /> Ristempa, Stimufend,<ref name="Stimufend FDA label" /><ref name="Stimufend EPAR" /> Tezmota,<ref name="Tezmota PI" /> Udenyca, Ziextenzo<ref name="Ziextenzo EPAR" /><ref name="Ziextenzo SBD" />
| Drugs.com = {{drugs.com|monograph|pegfilgrastim}}
| Drugs.com = {{drugs.com|monograph|pegfilgrastim}}
| MedlinePlus = a607058
| MedlinePlus = a607058
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| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
| pregnancy_AU = B3
| pregnancy_AU = B3
| pregnancy_AU_comment = <ref name="Ziextenzo APM summary" /><ref name="Filpegla APMDS" /><ref name="Drugs.com pregnancy">{{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 }}</ref>
| pregnancy_AU_comment = <ref name="Ziextenzo APM summary">{{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 }}</ref><ref name="Filpegla APMDS" /><ref name="Drugs.com pregnancy">{{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 }}</ref>
| pregnancy_category=
| pregnancy_category=
| routes_of_administration = [[Subcutaneous injection|Subcutaneous]]
| routes_of_administration = [[Subcutaneous injection|Subcutaneous]]
| class = Hematopoietic agents, [[colony-stimulating factor]]s, [[immunostimulant]]s
| class =
| ATC_prefix = L03
| ATC_prefix = L03
| ATC_suffix = AA13
| ATC_suffix = AA13
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| legal_BR_comment =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA = Rx-only
| legal_CA_comment = /&nbsp;Schedule D<ref name="Niopeg SBD">{{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}}</ref>
| legal_CA_comment = /&nbsp;Schedule D
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_DE_comment =
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Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.<ref name="Drugs.com" />
Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.<ref name="Drugs.com" />


Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).<ref>{{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=2020-11-10 |archive-date=2021-10-20 |archive-url=https://web.archive.org/web/20211020025437/https://books.google.com/books?id=NWeTRQejrRwC&pg=PA157 |url-status=live }}</ref><ref name="Drugs.com">{{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 }}</ref>
Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).<ref>{{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 }}</ref><ref name="Drugs.com">{{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 }}</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 name="Drug Approval Package: Neulasta">{{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 }}</ref><ref name="Neulasta EPAR">{{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 | 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 }}</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) }}{{dead link|date=December 2022}}</ref><ref>{{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) &#124; 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 }}</ref><ref>{{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) &#124; 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 }}</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 name="Drug Approval Package: Neulasta">{{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 }}</ref><ref name="Neulasta EPAR">{{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 }}</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) }}{{dead link|date=December 2022}}</ref><ref>{{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) &#124; 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 }}</ref><ref>{{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) &#124; 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 }}</ref> It is on the [[WHO Model List of Essential Medicines|World Health Organization's List of Essential Medicines]].<ref name="WHO23rd">{{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 }}</ref>


== Medical uses ==
== Medical uses ==
Pegfilgrastim is [[Indication (medicine)|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).<ref name="Neulasta FDA label" /><ref>{{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 }}</ref><ref>{{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 = 2020-11-05 | archive-date = 2021-10-20 | archive-url = https://web.archive.org/web/20211020025514/https://www.ncbi.nlm.nih.gov/books/NBK532893/ | url-status = live }}</ref>
Pegfilgrastim is [[Indication (medicine)|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).<ref name="Neulasta FDA label" /><ref>{{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 }}</ref><ref>{{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 }}</ref>

==Biosimilars==
{{see also|Biosimilars}}

Ristempa was approved for medical use in Australia in January 2017.<ref>{{Cite web|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-01281-1|title=TGA eBS - Product and Consumer Medicine Information Licence|access-date=20 February 2022|archive-date=29 September 2022|archive-url=https://web.archive.org/web/20220929024429/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2017-PI-01281-1|url-status=live}}</ref><ref>{{cite web | title=Ristempa | website=NPS MedicineWise | date=15 July 2021 | url=https://www.nps.org.au/medicine-finder/ristempa-solution-for-injection#full-pi | access-date=19 February 2022 | archive-date=29 September 2022 | archive-url=https://web.archive.org/web/20220929024424/https://www.nps.org.au/medicine-finder/ristempa-solution-for-injection#full-pi | url-status=live }}</ref>

Tezmota was approved for medical use in Australia in March 2018.<ref name="Tezmota PI">{{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 }}</ref>

Pegfilgrastim-jmdb (Fulphila) was approved for medical use in the United States in June 2018.<ref>{{cite press release | title=FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment | website=U.S. Food and Drug Administration | date=4 June 2018 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-neulasta-help-reduce-risk-infection-during-cancer-treatment | access-date=11 June 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611202206/https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-neulasta-help-reduce-risk-infection-during-cancer-treatment | url-status=live }}</ref><ref>{{cite web | title=Drug Approval Package: Fulphila | website=U.S. [[Food and Drug Administration]] (FDA) | date=26 October 2018 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761075Orig1s000TOC.cfm | access-date=11 June 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611203416/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761075Orig1s000TOC.cfm | url-status=live }}</ref>

Fulphila was approved for medical use in Australia in August 2018.<ref>{{cite web | title=Fulphila | website=NPS MedicineWise | date=15 July 2021 | url=https://www.nps.org.au/medicine-finder/fulphila#full-pi | access-date=19 February 2022 | archive-date=29 September 2022 | archive-url=https://web.archive.org/web/20220929024425/https://www.nps.org.au/medicine-finder/fulphila#full-pi | url-status=live }}</ref><ref>{{cite web | title=Prescription medicines: registration of new generic medicines and biosimilar medicines, 2018 | website=Therapeutic Goods Administration (TGA) | date=28 February 2019 | url=https://www.tga.gov.au/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2018 | access-date=19 February 2022 | archive-date=20 February 2022 | archive-url=https://web.archive.org/web/20220220082435/https://www.tga.gov.au/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2018 | url-status=unfit }}</ref><ref>{{Cite web |url=https://www.tga.gov.au/resources/auspar/auspar-pegfilgrastim |title=AusPAR: Pegfilgrastim &#124; Therapeutic Goods Administration (TGA) |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218041603/https://www.tga.gov.au/resources/auspar/auspar-pegfilgrastim |url-status=live }}</ref>

Pelgraz was approved for medical use in the European Union in September 2018.<ref>{{cite web | title=Pelgraz EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz | access-date=2 April 2020 | archive-date=30 December 2019 | archive-url=https://web.archive.org/web/20191230160459/https://www.ema.europa.eu/en/medicines/human/EPAR/pelgraz | url-status=live }}</ref>

Udenyca was approved for medical use in the European Union in September 2018.<ref>{{cite web | title=Udenyca EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/udenyca | access-date=2 April 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611210836/https://www.ema.europa.eu/en/medicines/human/EPAR/udenyca | url-status=live }}</ref>

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.<ref>{{cite web |title=FDA Approves Coherus' Pegfilgrastim Biosimilar, Udenyca |url=https://www.centerforbiosimilars.com/news/fda-approves-coherus-pegfilgrastim-biosimilar-udenyca |access-date=2019-02-26 |archive-date=2020-03-14 |archive-url=https://web.archive.org/web/20200314050304/https://www.centerforbiosimilars.com/news/fda-approves-coherus-pegfilgrastim-biosimilar-udenyca |url-status=live }}</ref><ref>{{cite web | title=Drug Approval Package: Udenyca | website=U.S. [[Food and Drug Administration]] (FDA) | date=5 March 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm | access-date=11 June 2020 | archive-date=18 December 2019 | archive-url=https://web.archive.org/web/20191218045004/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761039Orig1s000TOC.cfm | url-status=live }}</ref>

Pelmeg was approved for medical use in the European Union in November 2018.<ref name="Pelmeg EPAR">{{cite web | title=Pelmeg EPAR | website=[[European Medicines Agency]] (EMA) | 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 }}</ref>

Fulphila was approved for medical use in the European Union in November 2018.<ref name="Fulphila EPAR">{{cite web | title=Fulphila EPAR | website=[[European Medicines Agency]] (EMA) | 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 }}</ref>

Ziextenzo was approved for medical use in the European Union in November 2018.<ref name="Ziextenzo EPAR">{{cite web | title=Ziextenzo EPAR | website=[[European Medicines Agency]] (EMA) | 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 }}</ref>

Fulphila was approved for medical use in Canada in December 2018.<ref>{{cite web | title=Summary Basis of Decision (SBD) for Fulphila | website=[[Health Canada]] | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00432&lang=en | access-date=29 May 2022 | archive-date=31 May 2022 | archive-url=https://web.archive.org/web/20220531063700/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00432&lang=en | url-status=live }}</ref>

Grasustek was approved for medical use in the European Union in June 2019.<ref name="Grasustek EPAR">{{cite web | title=Grasustek EPAR | website=[[European Medicines Agency]] (EMA) | 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 }}</ref>

Ziextenzo was approved for medical use in Australia in July 2019.<ref name="Ziextenzo APM summary">{{cite web | title=Ziextenzo | website=Therapeutic Goods Administration (TGA) | date=13 December 2019 | url=https://www.tga.gov.au/apm-summary/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 }}</ref><ref name="AU biosimilar 2019" /><ref>{{cite web | title=Ziextenzo | website=NPS MedicineWise | date=15 July 2021 | url=https://www.nps.org.au/medicine-finder/ziextenzo#full-pi | access-date=19 February 2022 | archive-date=20 February 2022 | archive-url=https://web.archive.org/web/20220220085423/https://www.nps.org.au/medicine-finder/ziextenzo#full-pi | url-status=live }}</ref><ref>{{Cite web |url=https://www.tga.gov.au/resources/auspmd/ziextenzo |title=Ziextenzo &#124; Therapeutic Goods Administration (TGA) |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218041605/https://www.tga.gov.au/resources/auspmd/ziextenzo |url-status=live }}</ref>

Pelgraz was approved for medical use in Australia in August 2019.<ref>{{Cite web|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2019-PI-02071-1|title=TGA eBS - Product and Consumer Medicine Information Licence|access-date=2022-02-20|archive-date=2022-02-20|archive-url=https://web.archive.org/web/20220220082423/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2019-PI-02071-1|url-status=live}}</ref><ref>{{cite web | title=Pelgraz | website=NPS MedicineWise | date=15 July 2021 | url=https://www.nps.org.au/medicine-finder/pelgraz#full-pi | access-date=19 February 2022 | archive-date=20 February 2022 | archive-url=https://web.archive.org/web/20220220100937/https://www.nps.org.au/medicine-finder/pelgraz#full-pi | url-status=live }}</ref><ref>{{Cite web |url=https://www.tga.gov.au/resources/artg/308177 |title=PELGRAZ pegfilgrastim 6 mg/0.6 mL solution for injection pre-filled syringe (308177) &#124; Therapeutic Goods Administration (TGA) |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218041611/https://www.tga.gov.au/resources/artg/308177 |url-status=live }}</ref>

Lapelga and Neutropeg were approved for medical use in Australia in August 2019.<ref name="AU biosimilar 2019">{{cite web | title=Prescription medicines: registration of new generic medicines and biosimilar medicines, 2019 | website=Therapeutic Goods Administration (TGA) | date=10 January 2020 | url=https://www.tga.gov.au/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2019 | access-date=19 February 2022 | archive-date=20 February 2022 | archive-url=https://web.archive.org/web/20220220082420/https://www.tga.gov.au/prescription-medicines-registration-new-generic-medicines-and-biosimilar-medicines-2019 | url-status=unfit }}</ref><ref>{{Cite web |url=https://www.tga.gov.au/resources/prescription-medicines-registrations?f%5B0%5D=published%3A2019&f%5B1%5D=subtype%3ANew%20biosimilar%20medicine |title=Prescription medicines registrations &#124; Therapeutic Goods Administration (TGA) |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218041603/https://www.tga.gov.au/resources/prescription-medicines-registrations?f%5B0%5D=published:2019&f%5B1%5D=subtype:New%20biosimilar%20medicine |url-status=live }}</ref><ref>{{Cite web |url=https://www.tga.gov.au/resources/prescription-medicines-registrations/lapelga-neutropeg-apotex-pty-ltd |title=LAPELGA, NEUTROPEG (Apotex Pty LTD) &#124; Therapeutic Goods Administration (TGA) |access-date=18 December 2022 |archive-date=18 December 2022 |archive-url=https://web.archive.org/web/20221218041609/https://www.tga.gov.au/resources/prescription-medicines-registrations/lapelga-neutropeg-apotex-pty-ltd |url-status=live }}</ref>

Pegfilgrastim-bmez (Ziextenzo) was approved for medical use in the United States in November 2019.<ref>{{cite web | title=Ziextenzo | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761045 | access-date=17 December 2019 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611203422/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761045 | url-status=live }}</ref><ref>{{cite web | title=Drug Approval Package: Ziextenzo | website=U.S. [[Food and Drug Administration]] (FDA) | date=27 December 2019 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761045Orig1s000TOC.cfm | access-date=11 June 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611203414/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761045Orig1s000TOC.cfm | url-status=live }}</ref>

Cegfila was approved for medical use in the European Union in December 2019.<ref name="Cegfila EPAR">{{cite web | title=Cegfila EPAR | website=[[European Medicines Agency]] (EMA) | 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 }}</ref>

Ziextenzo was approved for medical use in Canada in April 2020.<ref name="Ziextenzo SBD">{{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 }}</ref>

Pegfilgrastim-apgf (Nyvepria) was approved for medical use in the United States in June 2020.<ref>{{cite web | title=Nyvepria | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761111 | access-date=11 June 2020 | archive-date=11 June 2020 | archive-url=https://web.archive.org/web/20200611201725/https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761111 | url-status=live }}</ref><ref>{{cite web | title=Drug Approval Package: Nyvepria | website=U.S. [[Food and Drug Administration]] (FDA) | date=11 August 2020 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761111Orig1s000TOC.cfm | access-date=26 May 2022 | archive-date=25 January 2021 | archive-url=https://web.archive.org/web/20210125043237/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761111Orig1s000TOC.cfm | url-status=live }}</ref> Nyvepria was approved for medical use in the European Union in November 2020.<ref>{{cite web | title=Nyvepria EPAR | website=[[European Medicines Agency]] (EMA) | url=https://www.ema.europa.eu/en/medicines/human/EPAR/nyvepria | access-date=11 October 2021 | archive-date=24 July 2021 | archive-url=https://web.archive.org/web/20210724171315/https://www.ema.europa.eu/en/medicines/human/EPAR/nyvepria | url-status=live }}</ref>

Nyvepria was approved for medical use in Canada in October 2020.<ref>{{cite web | title=Summary Basis of Decision (SBD) for Nyvepria | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00523&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530045250/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00523&lang=en | url-status=live }}</ref>

Stimufend was approved for medical use in the European Union in March 2022.<ref name="Stimufend EPAR">{{cite web | title=Stimufend EPAR | website=[[European Medicines Agency]] (EMA) | 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 }}</ref><ref>{{cite web | title=Stimufend Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1632.htm | access-date=3 March 2023}}</ref>

Pegfilgrastim-pbbk (Fylnetra) was approved for medical use in the United States in May 2022.<ref>{{cite web | title=Drug Approval Package: Fylnetra | website=U.S. [[Food and Drug Administration]] (FDA) | date=15 July 2022 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000TOC.cfm | access-date=2 September 2022 | archive-date=3 September 2022 | archive-url=https://web.archive.org/web/20220903040614/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000TOC.cfm | url-status=live }}</ref><ref name="Fylnetra FDA label">{{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 }}</ref>

Pegfilgrastim-fpgk (Stimufend) was approved for medical use in the United States in September 2022.<ref name="Stimufend FDA label">{{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 }}</ref>


== References ==
== References ==
{{Reflist}}
{{Reflist}}

== External links ==
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/pegfilgrastim | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Pegfilgrastim }}
* {{cite web | title=FDA notifies Amgen of misbranding of its biological product Neulasta | website=U.S. [[Food and Drug Administration]] (FDA) | date=14 July 2021 | url=https://www.fda.gov/drugs/drug-safety-and-availability/fda-notifies-amgen-misbranding-its-biological-product-neulasta-due-false-or-misleading-promotional }}


{{Immunostimulants}}
{{Immunostimulants}}
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[[Category:Recombinant proteins]]
[[Category:Recombinant proteins]]
[[Category:Amgen]]
[[Category:Amgen]]
[[Category:Hoffmann-La Roche brands]]
[[Category:Drugs developed by Hoffmann-La Roche]]
[[Category:World Health Organization essential medicines]]

Latest revision as of 08:35, 27 December 2024

Pegfilgrastim
Clinical data
Trade namesNeulasta
Biosimilarspegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-fpgk, pegfilgrastim-jmdb, pegfilgrastim-pbbk, Armlupeg,[1] Cegfila,[2] Filpegla,[3] Fulphila,[4] Fylnetra,[5] Grasustek,[6] Lapelga, Neutropeg, Niopeg,[7] Nyvepria, Pelgraz, Pelmeg,[8] Ristempa, Stimufend,[9][10] Tezmota,[11] Udenyca, Ziextenzo[12][13]
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
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, sold under the brand name Neulasta among others, is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (GCSF) analog filgrastim.[18] It serves to stimulate the production of white blood cells (neutrophils).[18][20] Pegfilgrastim was developed by Amgen.[21]

Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy.[22]

Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).[23][22]

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.[21][19][24][25][26] It is on the World Health Organization's List of Essential Medicines.[27]

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).[18][28][29]

References

[edit]
  1. ^ "Regulatory Decision Summary for Armlupeg". Drug and Health Products Portal. 16 August 2024. Retrieved 27 December 2024.
  2. ^ a b "Cegfila EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  3. ^ a b c "Filpegla | Therapeutic Goods Administration (TGA)". Archived from the original on 18 December 2022. Retrieved 18 December 2022.
  4. ^ a b "Fulphila EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  5. ^ a b "Fylnetra- pegfilgrastim injection". DailyMed. 26 May 2022. Archived from the original on 3 July 2022. Retrieved 19 June 2022.
  6. ^ a b "Grasustek EPAR". European Medicines Agency (EMA). 24 April 2019. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  7. ^ a b "Summary Basis of Decision for Niopeg". Drug and Health Products Portal. 1 September 2012. Retrieved 17 December 2024.
  8. ^ a b "Pelmeg EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  9. ^ a b "Stimufend- pegflilgrastim-fpgk injection, solution". DailyMed. 15 September 2022. Archived from the original on 21 January 2023. Retrieved 21 January 2023.
  10. ^ a b "Stimufend EPAR". European Medicines Agency (EMA). Archived from the original on 21 April 2022. Retrieved 4 April 2022.
  11. ^ "Tezmota". NPS MedicineWise. 15 July 2021. Archived from the original on 29 September 2022. Retrieved 19 February 2022.
  12. ^ a b "Ziextenzo EPAR". European Medicines Agency (EMA). 24 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  13. ^ "Summary Basis of Decision (SBD) for Ziextenzo". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  14. ^ a b "Ziextenzo". Therapeutic Goods Administration (TGA). 13 December 2019. Archived from the original on 20 October 2021. Retrieved 25 August 2020.
  15. ^ "Pegfilgrastim Use During Pregnancy". Drugs.com. 9 December 2019. Archived from the original on 5 December 2020. Retrieved 13 July 2020.
  16. ^ "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.
  17. ^ "Neulasta On Body Injector - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 17 January 2021. Retrieved 11 October 2021.
  18. ^ a b c d "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". DailyMed. Archived from the original on 15 July 2021. Retrieved 14 July 2021.
  19. ^ a b "Neulasta EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 11 June 2020. Retrieved 2 April 2020.
  20. ^ Walsh, G, Spada, S. "Epogen/Procrit" in: Directory of approved biopharmaceutical products. CRC Press, 2005, pp. 136–37.
  21. ^ 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.
  22. ^ a b "Pegfilgrastim Monograph for Professionals". Drugs.com. 22 August 2019. Archived from the original on 7 March 2016. Retrieved 11 June 2020.
  23. ^ 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.
  24. ^ "Summary for ARTG Entry: 82873 Neulasta pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield" (PDF). Therapeutic Goods Administration (TGA).[dead link‍]
  25. ^ "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.
  26. ^ "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.
  27. ^ 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.
  28. ^ 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.
  29. ^ 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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