Methoxy polyethylene glycol-epoetin beta

Methoxy polyethylene glycol-epoetin beta
Clinical data
Trade namesMircera
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • AU: B3
Routes of
administration		Intravenous, subcutaneous
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)[2]
  • UK: POM (Prescription only)[3]
  • US: WARNING[1]Rx-only[4]
  • EU: Rx-only[5]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
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Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease.[4] It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA).[citation needed]

It is on the World Health Organization's List of Essential Medicines.[6] It was approved for medical use in the European Union, [5] Switzerland,[citation needed] and the United States in 2007.[4]

Methoxy polyethylene glycol-epoetin beta is made from erythropoietin by chemically linking the N-terminal amino group or the ε-amino group of any lysine present in the protein with methoxy polyethylene glycol butanoic acid.[citation needed] The average molecular weight is approximately 60 kDa.[7] The drug stimulates erythropoiesis by interacting with the erythropoietin receptor on progenitor cells in the bone marrow.[7] It has a reduced receptor binding activity compared to other ESAs and but retains in vivo activity due to an extended serum half-life.[medical citation needed] It has an in vivo half-life of around 135 hours (5.6 days) as compared to darbepoetin alfa which has a half life of around 21 to 70 hours, the half life of which is three times that of the naturally occurring erthropoietin in the body.[medical citation needed]

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
  2. ^ https://www.guildlink.com.au/gc/ws/ro/pi.cfm?product=ropmirce10612 [bare URL]
  3. ^ "Mircera solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC)". (emc). 15 June 2021. Retrieved 9 January 2023.
  4. ^ a b c "Mircera- methoxy polyethylene glycol-epoetin beta injection, solution". DailyMed. 5 August 2019. Retrieved 9 January 2023.
  5. ^ a b "Mircera EPAR". European Medicines Agency. 17 September 2018. Retrieved 9 January 2023.
  6. ^ World Health Organization (2021). World Health Organization model list of essential medicines: 22nd list (2021). Geneva: World Health Organization. hdl:10665/345533. WHO/MHP/HPS/EML/2021.02.
  7. ^ a b Macdougall IC, Eckardt KU (September 2006). "Novel strategies for stimulating erythropoiesis and potential new treatments for anaemia". Lancet. 368 (9539): 947–53. doi:10.1016/S0140-6736(06)69120-4. PMID 16962885. S2CID 43889549.