Pegfilgrastim

Pegfilgrastim
Names
Trade namesNeulasta, Udenyca, Ristempa, others[1]
Other namespegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, pegfilgrastim-jmdb
IUPAC name
  • N-(3-Hydroxypropyl)Methionylcolony-stimulating Factor (human), 1-Ether with .Alpha.-Methyl-.Omega.-Hydroxypoly(Oxyethylene)
Clinical data
Drug classGranulocyte colony-stimulating factor (GCSF)[2]
Main usesLow neutrophils due to chemotherapy[3]
Side effectsBone pain, splenic rupture, adult respiratory distress syndrome (ADRS), anaphylaxis[4][3]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
    Routes of
    use    		Subcutaneous
    Typical dose6 mg[4]
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa607058
    Legal
    License data
    Legal status
    • AU: S4 (Prescription only) [5]
    • UK: POM (Prescription only) [7][8]
    • US: ℞-only [2]
    • EU: Rx-only [4]
    • In general: ℞ (Prescription only)
    Pharmacokinetics
    Elimination half-life15–80 hrs
    Chemical and physical data
    FormulaC845H1343N223O243S9
    Molar mass18802.90 g·mol−1

    Pegfilgrastim, sold under the brand name Neulasta among others, is a medication used treat low neutrophils in those on chemotherapy or with radiation sickness.[3][2] Its benefits are similar to filgrastim but does not need to be given as often.[3] It is given by injection under the skin.[4]

    Common side effects include bone pain.[4] Other side effects may include splenic rupture, adult respiratory distress syndrome (ADRS), and anaphylaxis.[3] It is a PEGylated form of filgrastim, a recombinant granulocyte colony-stimulating factor (GCSF).[2] It increases the production of white blood cells (leucocytes) by the bone marrow.[4]

    Pegfilgrastim was approved for medical use in the United States, Europe, and Australia in 2002.[3][4][9] It is on the World Health Organization's List of Essential Medicines.[10] In the United States it costs about 6,200 USD per dose as of 2021; though a biosimilar is available at 3,800 USD per dose.[11][12] In the United Kingdom this amount costs the NHS about £410.[13]

    Medical uses

    Pegfilgrastim is used 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).[2][14][15]

    Dosage

    It is given as a 6 mg injection.[4] Two doses one week apart may be used in those with radiation sickness.[2]

    Chemistry

    Pegfilgrastim has a human half-life of 15 to 80 hours, much longer than the parent filgrastim (3–4 hours).[16][3]

    Society and culture

    Pegfilgrastim was originally developed by Amgen.[17]

    Biosimilars

    See also: Biosimilars

    Ristempa was approved for medical use in Australia in January 2017.[18]

    Tezmota was approved for medical use in Australia in March 2018.[19]

    Pegfilgrastim-jmdb (Fulphila) was approved for medical use in the United States in June 2018.[20][21]

    Fulphila was approved for medical use in Australia in August 2018.[22]

    Pelgraz was approved for medical use in the European Union in September 2018.[23]

    Udenyca was approved for medical use in the European Union in September 2018.[24]

    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.[25][26]

    Pelmeg was approved for medical use in the European Union in November 2018.[27]

    Fulphila was approved for medical use in the European Union in November 2018.[28]

    Ziextenzo was approved for medical use in the European Union in November 2018.[29]

    Grasustek was approved for medical use in the European Union in June 2019.[30]

    Ziextenzo was approved for medical use in Australia in July 2019.[5]

    Pelgraz was approved for medical use in Australia in August 2019.[31]

    Neutropeg was approved for medical use in Australia in August 2019.[32]

    Pegfilgrastim-bmez (Ziextenzo) was approved for medical use in the United States in November 2019.[33][34]

    Cegfila was approved for medical use in the European Union in December 2019.[35]

    Pegfilgrastim-apgf (Nyvepria) was approved for medical use in the United States in June 2020.[36] 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.[37] The applicant for this medicinal product is Pfizer Europe MA EEIG.[37] Nyvepria was approved for medical use in the European Union in November 2020.[38]

    References

    1. ↑ Drugs.com International brand names for pegfilgrastim Archived 2016-04-22 at the Wayback Machine Page accessed April 1, 2016
    2. 1 2 3 4 5 6 "Neulasta- pegfilgrastim kit Neulasta- pegfilgrastim injection". DailyMed. Archived from the original on 15 July 2021. Retrieved 14 July 2021.
    3. 1 2 3 4 5 6 7 "Pegfilgrastim Monograph for Professionals". Drugs.com. 22 August 2019. Archived from the original on 7 March 2016. Retrieved 11 June 2020.
    4. 1 2 3 4 5 6 7 8 "Neulasta EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
    5. 1 2 3 "Ziextenzo". Therapeutic Goods Administration (TGA). 13 December 2019. Archived from the original on 20 October 2021. Retrieved 25 August 2020.
    6. ↑ "Pegfilgrastim Use During Pregnancy". Drugs.com. 9 December 2019. Archived from the original on 5 December 2020. Retrieved 13 July 2020.
    7. ↑ "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.
    8. ↑ "Neulasta On Body Injector - Summary of Product Characteristics (SmPC)". (emc). Archived from the original on 17 January 2021. Retrieved 11 October 2021.
    9. ↑ "NEULASTA pegfilgrastim rbe 6mg/0.6mL injection syringe with stelmi needle shield". Retrieved 27 October 2021.{{cite web}}: CS1 maint: url-status (link)
    10. ↑ 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.
    11. ↑ "Pegfilgrastim Prices, Coupons & Savings Tips - GoodRx". GoodRx.
    12. ↑ "Pegfilgrastim-Bmez Prices, Coupons & Savings Tips - GoodRx". GoodRx. Retrieved 27 October 2021.
    13. ↑ BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 1078. ISBN 978-0857114105.
    14. ↑ 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.
    15. ↑ Parker SD, King N, Jacobs TF (November 2020). "Pegfilgrastim". StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Archived from the original on 2021-10-20. Retrieved 2021-10-12.
    16. ↑ 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 2021-10-20. Retrieved 2021-10-12.
    17. ↑ "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.
    18. ↑ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=DFB942E54351D3EDCA2585880030EB48&agid=(PrintDetailsPublic)&actionid=1%5B%5D
    19. ↑ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=86E9A09F47791A95CA2585880030EB4A&agid=(PrintDetailsPublic)&actionid=1%5B%5D
    20. ↑ "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. Archived from the original on 11 June 2020. Retrieved 11 June 2020.
    21. ↑ "Drug Approval Package: Fulphila". U.S. Food and Drug Administration (FDA). 26 October 2018. Archived from the original on 11 June 2020. Retrieved 11 June 2020.
    22. ↑ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=FB6888358ED3FA79CA25859D00425423&agid=(PrintDetailsPublic)&actionid=1%5B%5D
    23. ↑ "Pelgraz EPAR". European Medicines Agency (EMA). Archived from the original on 30 December 2019. Retrieved 2 April 2020.
    24. ↑ "Udenyca EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
    25. ↑ "FDA Approves Coherus' Pegfilgrastim Biosimilar, Udenyca". Archived from the original on 2020-03-14. Retrieved 2021-10-12.
    26. ↑ "Drug Approval Package: Udenyca". U.S. Food and Drug Administration (FDA). 5 March 2019. Archived from the original on 18 December 2019. Retrieved 11 June 2020.
    27. ↑ "Pelmeg EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
    28. ↑ "Fulphila EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
    29. ↑ "Ziextenzo EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
    30. ↑ "Grasustek EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
    31. ↑ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=D9374DDB59026212CA2585CE004233D0&agid=(PrintDetailsPublic)&actionid=1%5B%5D
    32. ↑ https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=C31CEBE1997897ABCA2585CE004233CE&agid=(PrintDetailsPublic)&actionid=1%5B%5D
    33. ↑ "Ziextenzo". U.S. Food and Drug Administration (FDA). Archived from the original on 11 June 2020. Retrieved 17 December 2019.
    34. ↑ "Drug Approval Package: Ziextenzo". U.S. Food and Drug Administration (FDA). 27 December 2019. Archived from the original on 11 June 2020. Retrieved 11 June 2020.
    35. ↑ "Cegfila EPAR". European Medicines Agency (EMA). Archived from the original on 11 June 2020. Retrieved 2 April 2020.
    36. ↑ "Nyvepria". U.S. Food and Drug Administration (FDA). Archived from the original on 11 June 2020. Retrieved 11 June 2020.
    37. 1 2 "Nyvepria: Pending EC decision". European Medicines Agency (EMA). 18 September 2020. Archived from the original on 23 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.
    38. ↑ "Nyvepria EPAR". European Medicines Agency (EMA). Archived from the original on 24 July 2021. Retrieved 11 October 2021.
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