{{Short description|Treatment of anemia associated with chronic kidney disease}} {{More medical citations needed|section|date=May 2025|reason=Section needs additional citations}} {{Drugbox | Verifiedfields = changed | Watchedfields = changed | verifiedrevid = 458433719 | image = | alt = | caption =
<!-- Clinical data --> | tradename = Mircera | Drugs.com = {{drugs.com|monograph|methoxy-polyethylene-glycol-epoetin-beta}} | licence_EU = yes | pregnancy_AU = B3 | pregnancy_category = | routes_of_administration = Intravenous, subcutaneous | ATCvet = | ATC_prefix = B03 | ATC_suffix = XA03
<!-- Legal status --> | legal_AU = S4 | legal_AU_comment = <ref name="Mircera PI">{{cite web|url=https://rss.medsinfo.com.au/ro/pi.cfm?product=ropmirce10612|title=Australian Product Information: Mircera (methoxy polyethylene glycol-epoetin beta)|date=3 November 2023|website=rss.medsinfo.com.au|archive-url=https://web.archive.org/web/20250120165649/https://rss.medsinfo.com.au/ro/pi.cfm?product=ropmirce10612|archive-date=20 January 2025|url-status=live}}</ref> | legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> | legal_BR_comment = | legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII --> | legal_CA_comment = | legal_DE = <!-- Anlage I, II, III or Unscheduled --> | legal_DE_comment = | legal_NZ = <!-- Class A, B, C --> | legal_NZ_comment = | legal_UK = POM | legal_UK_comment = <ref>{{cite web | title=Mircera solution for injection in pre-filled syringe - Summary of Product Characteristics (SmPC) | website=(emc) | date=15 June 2021 | url=https://www.medicines.org.uk/emc/product/360/smpc | access-date=9 January 2023}}</ref> | legal_US = Rx-only | legal_US_comment = <ref name="Mircera FDA label">{{cite web | title=Mircera- methoxy polyethylene glycol-epoetin beta injection, solution | website=DailyMed | date=5 August 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=22c56f2a-f73c-60e7-e054-00144ff88e88 | access-date=9 January 2023}}</ref> | legal_EU = Rx-only | legal_EU_comment = <ref name="Mircera EPAR">{{cite web | title=Mircera EPAR | website=European Medicines Agency | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/mircera | access-date=9 January 2023}}</ref> | legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> | legal_UN_comment = | legal_status = Rx-only
<!-- Pharmacokinetic data --> | bioavailability = | protein_bound = | metabolism = | metabolites = | onset = | elimination_half-life = | duration_of_action = | excretion =
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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.<ref name="Mircera FDA label" /> It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA).{{cn|date=January 2023}}
It is on the World Health Organization's List of Essential Medicines.<ref name="WHO22nd">{{cite book | title = World Health Organization model list of essential medicines: 22nd list (2021) | year = 2021 | hdl = 10665/345533 | publisher = World Health Organization | location = Geneva | id = WHO/MHP/HPS/EML/2021.02 | hdl-access=free }}</ref> It was approved for medical use in the European Union,<ref name="Mircera EPAR" /> Switzerland,{{cn|date=January 2023}} and the United States in 2007.<ref name="Mircera FDA label" />
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.{{cn|date=January 2023}} The average molecular weight is approximately 60 kDa.<ref name="MacdougallEckardt2006">{{cite journal | vauthors = Macdougall IC, Eckardt KU | s2cid = 43889549 | title = Novel strategies for stimulating erythropoiesis and potential new treatments for anaemia | journal = Lancet | volume = 368 | issue = 9539 | pages = 947–53 | date = September 2006 | pmid = 16962885 | doi = 10.1016/S0140-6736(06)69120-4 }}</ref> The drug stimulates erythropoiesis by interacting with the erythropoietin receptor on progenitor cells in the bone marrow.<ref name="MacdougallEckardt2006"/> It has a reduced receptor binding activity compared to other ESAs and but retains in vivo activity due to an extended serum half-life.{{medcn|date=January 2023}} 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.{{medcn|date=January 2023}}
== Society and culture ==
=== Legal status === ==== Patent infringement claims ==== A U.S. Federal Appeals Court ruled in September 2009, that Mircera infringed a patent held by Amgen Inc. The court refused to lift an injunction entered in the fall of 2008 which barred Roche from selling Mircera in the United States.<ref>{{cite web | url = https://online.wsj.com/article/BT-CO-20090915-713911.html | title = Update: US Court Won't Disturb Injunction Against Roche Anemia Drug | first = Brent | last = Kendall | name-list-style = vanc | work = Dow Jones Newswires Tuesday | date = 15 September 2009 }}</ref> The injunction has since expired and Mircera has been available on the U.S. market since 2015.<ref>{{Cite news|url=https://www.reuters.com/article/us-fresenius-medi-results-mircera-idUSKCN0VX11F|title=FMC aims for 110,000 U.S. patients to be on Mircera in first-quarter|date= 24 April 2017 |work=Reuters |access-date= 23 May 2017 }}</ref>
=== Controversies === ==== Use in sports ==== Mircera can reportedly replace traditional erythropoietin drugs as a blood doping agent in endurance sports. The drug appears to fall under section S2 of the list of substances officially prohibited - in competition and out of competition - in France and by the World Anti-Doping Agency.<ref>{{cite web | url = http://www.afld.fr/docs/20080112.pdf | title = Substances et méthodes interdites en permanence (en et hors compétition) | language = fr | archive-url = https://web.archive.org/web/20081112032253/http://www.afld.fr/docs/20080112.pdf | archive-date=12 November 2008 }} (''Décret no 2008-35 du 10 janvier 2008 portant publication de l'amendement à l'annexe de la convention contre le dopage, adopté par le groupe de suivi lors de sa 26e réunion le 12 novembre 2007 à Madrid.'')</ref>
In July 2008, Italian bicycle racer Riccardo Riccò was disqualified from the Tour de France after reports that a urine sample tested positive for Mircera.<ref>{{cite web | first = Charles | last = Pelkey | name-list-style = vanc | date = 17 July 2008 | url = http://tour-de-france.velonews.com/article/80269/riccardo-ricco-tests-positive-saunier-duval-team-withdraws | work = VeloNews | title = Riccardo Riccò tests positive; Saunier Duval team withdraws from Tour de France | archive-url = https://web.archive.org/web/20090805033933/http://tour-de-france.velonews.com/article/80269/riccardo-ricco-tests-positive-saunier-duval-team-withdraws | archive-date= 5 August 2009 }}</ref><ref>{{Cite news | last = Wyatt | first = Edward | name-list-style = vanc | title = Tour de France team out after test | newspaper = The New York Times | date = 18 July 2008 | url = https://www.nytimes.com/2008/07/18/sports/sportsspecial1/18tour.html?ref=sports }}</ref> There had not previously been any public acknowledgment that a test for the new drug was being administered, or had even been developed yet. The Tour de France testing was done under the auspices of the French Cycling Federation and the French Anti-Doping Agency, not the Union Cycliste Internationale.<ref>{{cite web | title = The 2008 Tour de France under the control of the French Cycling Federation | publisher = Amaury Sport Organisation | date = 6 March 2008 | url = http://www.letour.fr/2008/TDF/COURSE/us/actus.html#zone14 | access-date = 17 July 2008 | archive-url = https://web.archive.org/web/20080316063229/http://www.letour.fr/2008/TDF/COURSE/us/actus.html#zone14 | archive-date = 16 March 2008 }}</ref><ref>{{cite web | url = http://www.afld.fr/ | title = L'Agence française de lutte contre le dopage | language = fr | access-date = 17 July 2008 }}</ref>
== References == {{Reflist}}
{{Antianemic preparations}} {{Cytokine receptor modulators}} {{Portal bar | Medicine}}
Category:Antianemic preparations Category:Erythropoiesis-stimulating agents Category:World Anti-Doping Agency prohibited substances Category:Drugs developed by Hoffmann-La Roche