Emicizumab
 | |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | Activated factor IX, factor X |
| Names | |
| Trade names | Hemlibra |
| Other names | ACE910, RG6013, emicizumab-kxwh |
| Clinical data | |
| Main uses | Haemophilia A[1] |
| Side effects | Reactions at the side of injection, headache, joint pain[1] |
| Interactions | Activated prothrombin complex concentrate[1] |
| Pregnancy category |
|
| Routes of use | Subcutaneous |
| Typical dose | 6mg/kg q 4 weeks[1] |
| External links | |
| AHFS/Drugs.com | Monograph |
| Legal | |
| License data |
|
| Legal status | |
| Chemical and physical data | |
| Formula | C6434H9940N1724O2047S45 |
| Molar mass | 145639.02 g·mol−1 |
Emicizumab, sold under the brand name Hemlibra, is a medication used to treat haemophilia A, including in those resistant to other treatments.[1] It is used in moderate to severe disease, and occationally mild disease.[4][5] Benefits include that it is give subcutaneous and requires less frequent injections.[6]
Common side effects include reactions at the side of injection, headache, and joint pain.[1] Less commonly antibodies develop against the medication, or blood clots may form.[1][7] It may react with activated prothrombin complex concentrate.[1] It is a bispecific monoclonal antibody that helps the blood clot by bringing factor IXa and factor X together.[1][7]
Emicizumab was approved for medical use in the United States in 2017 and Europe in 2018.[1][7] In 2019 the cost for a typical adult in Canada was 670,000 CAD per year.[8] In the United States this amount is about 480,000 USD per year as of 2025.[9]
Medical uses
It is used to treat haemophilia A including in those with factor VIII inhibitors.[1] It is used preventatively to prevent bleeding.[5]
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.[1] It is taken long term.[7]
Side effects
The most common side effects are (incidence ≥10%) injection site reactions, headache, and arthralgia.[10]
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.[11][12]
History
It was developed by Genentech and Chugai (both organizations are subsidiaries of Hoffmann-La Roche).[11] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[13]
References
- ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 "DailyMed - HEMLIBRA- emicizumab injection, solution". dailymed.nlm.nih.gov. Archived from the original on 14 April 2025. Retrieved 3 October 2025.
- ↑ 2.0 2.1 "AUSTRALIAN PRODUCT INFORMATION – Hemlibra (Emicizumab)". Archived from the original on 15 May 2023. Retrieved 8 January 2023.
- ↑ "Summary Basis of Decision (SBD) for Hemlibra". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
- ↑ Alcedo Andrade, PE; Mannucci, PM; Kessler, CM (1 May 2024). "Emicizumab: the hemophilia A game-changer". Haematologica. 109 (5): 1334–1347. doi:10.3324/haematol.2022.282099. PMID 37916312.
- ↑ 5.0 5.1 "Emicizumab-kxwh Monograph for Professionals". Drugs.com. Archived from the original on 19 July 2025. Retrieved 3 October 2025.
- ↑ Grabowska K, Grzelak M, Zhao LY, Płuciennik E, Pasieka Z, Kciuk M, Gielecińska A, Smakosz AK, Kałuzińska-Kołat Ż, Kołat D (May 2024). "Emicizumab as a Promising Form of Therapy for Type A Hemophilia - A Review of Current Knowledge from Clinical Trials". Current Protein & Peptide Science. 25 (9): 719–737. doi:10.2174/0113892037294674240509094418. PMID 38797909.
- ↑ 7.0 7.1 7.2 7.3 "Hemlibra". www.ema.europa.eu. European Medicines Agency (EMA). 23 August 2018. Archived from the original on 2 October 2018. Retrieved 3 October 2025.
- ↑ "Why one Nova Scotia boy is being treated with drugs that cost $6-million a year despite a better, cheaper alternative". The Globe and Mail. 5 May 2019. Retrieved 3 October 2025.
- ↑ "Hemlibra Prices, Coupons, Copay Cards & Patient Assistance". Drugs.com. Retrieved 3 October 2025.
- ↑ FDA Professional Drug Information
- ↑ 11.0 11.1 Spreitzer H (4 July 2016). "Neue Wirkstoffe - Emicizumab". Österreichische Apothekerzeitung (in German) (14/2016).
{{cite journal}}: CS1 maint: unrecognized language (link) - ↑ Shima M, Hanabusa H, Taki M, Matsushita T, Sato T, Fukutake K, Fukazawa N, Yoneyama K, Yoshida H, Nogami K (May 2016). "Factor VIII-Mimetic Function of Humanized Bispecific Antibody in Hemophilia A". The New England Journal of Medicine. 374 (21): 2044–53. doi:10.1056/NEJMoa1511769. PMID 27223146.
- ↑ New Drug Therapy Approvals 2017. U.S. Food and Drug Administration (FDA) (Report). January 2018. Archived from the original (PDF) on 14 September 2019. Retrieved 16 September 2020.
External links
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