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Names --> | pronounce = | tradename = Hemlibra | synonyms = ACE910, RG6013, emicizumab-kxwh | IUPAC_name = <!--..." 770268 wikitext text/x-wiki {{#unlinkedwikibase:id=Q27155409}} {{Short description|Monoclonal antibody}} {{Infobox drug | image = Emicizumab.png | alt = <!-- Monoclonal antibody data --> | type = mab | mab_type = mab | source = zu | target = Activated [[factor IX]], [[factor X]] <!-- Names --> | pronounce = | tradename = Hemlibra | synonyms = ACE910, RG6013, emicizumab-kxwh | IUPAC_name = <!-- Clinical data --> | class = | uses = <!-- primary uses --> | side_effects = <!-- common side effects and notable side effects --> | interactions = <!-- notable interactions --> | pregnancy_AU = B2 | pregnancy_AU_comment= <ref name="Hemlibra PI" /> | pregnancy_category= | breastfeeding = | routes_of_administration= [[Subcutaneous injection|Subcutaneous]] | onset = | duration_of_action= | defined_daily_dose= | typical_dose = <!-- External links --> | Drugs.com = {{drugs.com|monograph|emicizumab-kxwh}} | MedlinePlus = <!-- Legal data --> | legal_AU = S4 | legal_AU_comment = <ref name="Hemlibra PI">{{cite web |url=https://www.guildlink.com.au/gc/ws/ro/pi.cfm?product=rophemli10218 |title=AUSTRALIAN PRODUCT INFORMATION – Hemlibra (Emicizumab) |archive-url=https://web.archive.org/web/20230515185854/https://www.guildlink.com.au/gc/ws/ro/pi.cfm?product=rophemli10218 |archive-date=15 May 2023 |access-date=8 January 2023}}</ref> | legal_CA = Rx-only | legal_CA_comment = /&nbsp;Schedule D<ref>{{cite web | title=Summary Basis of Decision (SBD) for Hemlibra | website=[[Health Canada]] | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00411&lang=en | access-date=29 May 2022}}</ref> | legal_EU = Rx-only | legal_NZ = <!--Class A, B, C --> | legal_UN = <!-- N I, II, III, IV / P I, II, III, IV--> | legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM --> | legal_US = Rx-only | legal_status = Rx-only | DailyMedID = Emicizumab <!-- Pharmacokinetic data --> | bioavailability = | protein_bound = | metabolism = | metabolites = | elimination_half-life= | excretion = <!-- Chemical and physical data --> | C= 6434 | H= 9940 | N= 1724 | O= 2047 | S= 45 }} <!-- Definition and medical uses --> '''Emicizumab''', sold under the brand name '''Hemlibra''', is a medication used to treat [[haemophilia A]], including in those resistant to other treatments.<ref name=PI2025/> It is used in moderate to severe disease, and occationally mild disease.<ref name=Al2024>{{cite journal |last1=Alcedo Andrade |first1=PE |last2=Mannucci |first2=PM |last3=Kessler |first3=CM |title=Emicizumab: the hemophilia A game-changer. |journal=Haematologica |date=1 May 2024 |volume=109 |issue=5 |pages=1334-1347 |doi=10.3324/haematol.2022.282099 |pmid=37916312}}</ref><ref name=AHFS2025>{{cite web |title=Emicizumab-kxwh Monograph for Professionals |url=https://www.drugs.com/monograph/emicizumab-kxwh.html |website=Drugs.com |accessdate=3 October 2025 |language=en}}</ref> Benefits include that it is give subcutaneous and requires less frequent injections.<ref>{{cite journal | vauthors = Grabowska K, Grzelak M, Zhao LY, Płuciennik E, Pasieka Z, Kciuk M, Gielecińska A, Smakosz AK, Kałuzińska-Kołat Ż, Kołat D | title = Emicizumab as a Promising Form of Therapy for Type A Hemophilia - A Review of Current Knowledge from Clinical Trials | journal = Current Protein & Peptide Science | volume = 25 | pages = 719–737 | date = May 2024 | issue = 9 | pmid = 38797909 | doi = 10.2174/0113892037294674240509094418 }}</ref> <!-- Side effects and mechanism --> Common side effects include reactions at the side of injection, headache, and joint pain.<ref name=PI2025/> Less commonly [[antibodies]] may develop against the medication, or blood clots may form.<ref name=PI2025/><ref name=EMA2025/> It may react with [[activated prothrombin complex concentrate]].<ref name=PI2025/> It is a [[bispecific monoclonal antibody]] that helps the [[blood clot]] by bringing [[factor IXa]] and [[factor X]] together.<ref name=PI2025/><ref name=EMA2025>{{cite web |title=Hemlibra |url=https://www.ema.europa.eu/en/medicines/human/EPAR/hemlibra |website=www.ema.europa.eu |publisher=European Medicines Agency (EMA) |accessdate=3 October 2025 |language=en |date=23 August 2018}}</ref> <!-- History and culture --> Emicizumab was approved for medical use in the United States in 2017 and Europe in 2018.<ref name=PI2025>{{cite web |title=DailyMed - HEMLIBRA- emicizumab injection, solution |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2483adba-fab6-4d1b-96c5-c195577ed071 |website=dailymed.nlm.nih.gov |accessdate=3 October 2025}}</ref><ref name=EMA2025/> In 2019 the cost for a typical adult in Canada was 670,000 CAD per year.<ref>{{cite news |title=Why one Nova Scotia boy is being treated with drugs that cost $6-million a year despite a better, cheaper alternative |url=https://www.theglobeandmail.com/canada/article-why-one-nova-scotia-boy-is-being-treated-with-6-million-a-year-drugs/ |accessdate=3 October 2025 |work=The Globe and Mail |date=5 May 2019 |language=en-CA}}</ref> In the United States this amount is about 480,000 USD per year as of 2025.<ref>{{cite web |title=Hemlibra Prices, Coupons, Copay Cards & Patient Assistance |url=https://www.drugs.com/price-guide/hemlibra |website=Drugs.com |accessdate=3 October 2025 |language=en}}</ref> ==Medical uses== It is used to treat [[haemophilia A]] including in those with [[factor VIII]] inhibitors.<ref name=PI2025/> It is used preventatively to prevent bleeding.<ref name=AHFS2025/> ===Dosage=== It is started at a dose of 3 mg/kg once a week for four weeks followed by further doses every one to four weeks.<ref name=PI2025/> It is taken long term.<ref name=EMA2025/> ==Side effects== The most common side effects are (incidence ≥10%) [[injection site reaction]]s, [[headache]], and [[arthralgia]].<ref>{{Drugs.com|pro|hemlibra}}</ref> ==Mechanism of action== Emicizumab binds to both the activated [[coagulation factor IX]] and to [[factor X]], mediating the activation of the latter. This is normally the function of [[coagulation factor VIII]], which is missing in haemophilia A patients.<ref name="Spreitzer" /><ref>{{cite journal | vauthors = Shima M, Hanabusa H, Taki M, Matsushita T, Sato T, Fukutake K, Fukazawa N, Yoneyama K, Yoshida H, Nogami K | title = Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A | journal = The New England Journal of Medicine | volume = 374 | issue = 21 | pages = 2044–53 | date = May 2016 | pmid = 27223146 | doi = 10.1056/NEJMoa1511769 | doi-access =free }}</ref> ==History== It was developed by [[Genentech]] and [[Chugai]] (both organizations are subsidiaries of [[Hoffmann-La Roche]]).<ref name="Spreitzer">{{cite journal | vauthors = Spreitzer H | date = 4 July 2016 | title = Neue Wirkstoffe - Emicizumab | journal = Österreichische Apothekerzeitung | issue = 14/2016 | language = German }}</ref> The U.S. [[Food and Drug Administration]] (FDA) considers it to be a [[first-in-class medication]].<ref>{{cite report 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