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Review

Avacopan

No authors listed
In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
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Review

Avacopan

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Excerpt

Avacopan is an orally available, complement factor 5a receptor antagonist that is used to treat adults with severe antineutrophil cytoplasmic autoantibody-associated vasculitis. Avacopan is associated with an appreciable rate of serum aminotransferase elevations during therapy and has been linked to rare instances of clinically apparent liver injury with jaundice.

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References

    1. Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.(Review of hepatotoxicity published in 1999 before the availability of complement receptor antagonists).
    1. Multidiscipline Review FDA.. 2021.
    1. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214487Orig1s000M... [(FDA website with product label and clinical review of data on avacopan provided by the sponsor in support of its approval as therapy of ANCA-associated vasculitis, mentions that in a pooled analysis of safety in 237 patients, hepatobiliary adverse events arose in 6% vs 1.8%, which were severe in 3.6% vs 0.6% and led to early discontinuation in 3% vs 0.6%. Of 9 hepatic severe adverse events analyzed in detail, 4 were considered drug induced liver injury, but none resulted in death or liver transplantation).]
    1. Jayne DRW, Bruchfeld AN, Harper L, Schaier M, Venning MC, Hamilton P, Burst V, Get al.; CLEAR Study Group. Randomized trial of C5a receptor inhibitor avacopan in ANCA-associated vasculitis. J Am Soc Nephrol. 2017;28:2756-2767.(Among 67 patients with newly diagnosed or relapsed ANCA-associated vasculitis treated with avacopan alone, avacopan with prednisone [20 mg], or placebo with prednisone [60 mg] daily for 12 weeks, clinical responses were higher with avacopan [81% and 86% vs 70%], while total adverse event rates were similar, and ALT elevations above 3 times ULN occurred in 5% of all three groups, one patient on avacopan alone developed marked liver and pancreatic enzyme elevations requiring discontinuation). - PMC - PubMed
    1. Merkel PA, Niles J, Jimenez R, Spiera RF, Rovin BH, Bomback A, Pagnoux C, et al.; CLASSIC Investigators. Adjunctive treatment with avacopan, an oral C5a receptor inhibitor, in patients with antineutrophil cytoplasmic antibody-associated vasculitis. ACR Open Rheumatol. 2020;2:662-671.(Among 42 patients with ANCA-associated vasculitis treated with standard of care [rituximab or cyclophosphamide] and avacopan [10 or 30 mg] or placebo twice daily for 12 weeks, response rates were high in all three groups [92% and 80% vs 85%], and adverse event rates were similar in the avacopan and placebo groups, including infections [24% vs 15%], severe adverse events [17% vs 15%], and discontinuations because of adverse events [14% vs 15%]; no mention of ALT elevations or hepatotoxicity). - PMC - PubMed

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