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Epoetin alfa information


Epoetin alfa
Clinical data
Pronunciation/ɛˈp.ɪtɪn/
Trade namesEpogen, Retacrit
Other namesepoetin alfa-epbx
AHFS/Drugs.comMonograph
MedlinePlusa692034
License data
  • EU EMA: by INN
  • US DailyMed: Epoetin_alfa
Routes of
administration
Intravenous, subcutaneous
ATC code
  • B03XA01 (WHO)
Legal status
Legal status
  • AU: S4 (Prescription only)
  • US: WARNING[1]Rx-only[2][3]
  • EU: Rx-only[4][5]
Identifiers
CAS Number
  • 11096-26-7 ☒N
DrugBank
  • DB00016 checkY
ChemSpider
  • none
UNII
  • 64FS3BFH5W
KEGG
  • D03231
ChEMBL
  • ChEMBL1201565 ☒N
Chemical and physical data
FormulaC815H1317N233O241S5
Molar mass18396.19 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology.[6] Authorised by the European Medicines Agency on 28 August 2007, it stimulates erythropoiesis (increasing red blood cell levels) and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy.

Epoetin is manufactured and marketed by Amgen under the brand name Epogen. Johnson & Johnson subsidiary Janssen Biotech (formerly Ortho Biotech Products, LP), sells the same drug under the name Procrit, pursuant to a product license agreement. The average cost per patient in the U.S. was $8,447 in 2009.[7] Darbepoetin alfa (rINN) /dɑːrbəˈpɔɪtɪn/ is a glycosylation analog of erythropoietin containing two additional N-linked carbohydrate chains,[8] also manufactured and marketed by Amgen, with a brand name of Aranesp. The Food and Drug Administration (FDA) warnings and safety precautions for Procrit, Epogen and Aranesp are identical.

For several years, epoetin alfa has accounted for the single greatest drug expenditure paid by the U.S. Medicare system; in 2010, the program paid $2 billion for the drug.[9][10] Raising hemoglobin levels has been found in some studies to be associated with higher risks of thrombotic events, strokes and death.[11]

It is on the World Health Organization's List of Essential Medicines.[12]

  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 October 2023.
  2. ^ "Epogen- epoetin alfa solution". DailyMed. 25 July 2018.
  3. ^ "Retacrit- epoetin alfa-epbx injection, solution". DailyMed. 29 January 2020.
  4. ^ Cite error: The named reference Abseamed EPAR was invoked but never defined (see the help page).
  5. ^ "Abseamed". Union Register of medicinal products. Retrieved 14 January 2021.
  6. ^ Walsh G, Spada S (2005). "Epogen/Procrit". Directory of approved biopharmaceutical products. Boca Raton: CRC Press. pp. 39–41. ISBN 978-0-415-26368-9.
  7. ^ Engelberg AB, Kesselheim AS, Avorn J (November 2009). "Balancing innovation, access, and profits--market exclusivity for biologics". The New England Journal of Medicine. 361 (20): 1917–9. doi:10.1056/NEJMp0908496. PMID 19828525.
  8. ^ Elliott S, Lorenzini T, Asher S, Aoki K, Brankow D, Buck L, et al. (April 2003). "Enhancement of therapeutic protein in vivo activities through glycoengineering". Nature Biotechnology. 21 (4): 414–21. doi:10.1038/nbt799. PMID 12612588. S2CID 7214868.
  9. ^ "Testimony Before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives.] Medicare. Information on Highest-Expenditure Part B Drugs." (PDF), United States Government Accountability Office (GAO), 28 June 2013, retrieved 29 June 2015
  10. ^ Mitka M (14 August 2013), "Capitol Health Call: High-Cost Drugs Account for Most of Medicare Part B Spending", JAMA, 310 (6): 572, doi:10.1001/jama.2013.192555
  11. ^ Anemia drugs made billions, but at what cost? By Peter Whoriskey, The Washington Post, 19 July 2012
  12. ^ 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.

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