| Clinical data | |
|---|---|
| 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 | |
| Legal status | |
| Pharmacokinetic data | |
| Elimination half-life | 15–80 hrs |
| Identifiers | |
| |
| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| ChEMBL | |
| ECHA InfoCard | 100.169.155 |
| Chemical and physical data | |
| Formula | C845H1343N223O243S9 |
| Molar mass | 18802.90 g·mol−1 |
  (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.[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]
YouTube Encyclopedic
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Advantages of pegfilgrastim over filgrastim in managing chemotherapy-induced febrile neutropenia
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Phase III study of plinabulin and pegfilgrastim for chemotherapy-induced neutropenia
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Hematinics | Drugs | Darbepoetin alfa, Pegfilgrastim, Sargramostim, Oprelvekin and Avatrombopag
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NCLEX Prep (Pharmacology): Filgrastim (Neupogen)
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How to Identify a Neulasta On Body Injector Malfunction
Transcription
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.
This page was last edited on 21 March 2024, at 18:08