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emicizumab-kxwh (Hemlibra, ACE910)

Indications: - treatment of hemophilia A - prophylaxis in hemophilia A due to inhibitors [3] Dosage: - 3 mg/kg SC weekly for the first 4 weeks, then 1.5 mg/kg SC weekly thereafter. [2,4] Mechanism of action: - bispecific antibody that binds to activated factor IX & factor X, substituting for factor VIII

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

Related

coagulation cascade

General

pharmaceutical monoclonal antibody hematologic agent bispecific antibody; bispecific monoclonal antibody

References

  1. Uchida N, Sambe T, Yoneyama K et al A first-in-human phase 1 study of ACE910, a novel factor VIII- mimetic bispecific antibody, in healthy subjects. Blood. 2016 Mar 31;127(13):1633-41. PMID: 26626991 Free PMC Article
  2. Shima M et al. Factor VIII-mimetic function of humanized bispecific antibody in hemophilia A. N Engl J Med 2016 May 26; 374:2044. PMID: 27223146 http://www.nejm.org/doi/10.1056/NEJMoa1511769 - DiMichele DM. Hemophilia therapy - navigating speed bumps on the innovation highway. N Engl J Med 2016 May 26; 374:2087 PMID: 27223151 http://www.nejm.org/doi/10.1056/NEJMoa1511769
  3. Oldenburg J, Mahlangu JN, Kim B et al Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med 2017; 377:809-818. August 31, 2017 PMID: 28691557 Free Article http://www.nejm.org/doi/full/10.1056/NEJMoa1703068
  4. Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm