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Review

Hereditary Angioedema Agents

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

Hereditary Angioedema Agents

No authors listed.
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Excerpt

Multiple parenterally administered agents are available as prophylaxis or treatment of acute attacks of hereditary angioedema (HAE), including plasma derived and recombinant preparations of the C1-esterase Inhibitor as well as small protein and monoclonal antibody inhibitors of kallikrein and bradykinin activity. While several of these have been linked to transient serum aminotransferase elevations during therapy, the abnormalities are usually mild-to-moderate in severity, transient in duration, and sometimes due to the underlying condition rather than the treatment. None of the agents used to prevent or treat acute attacks of HAE have been convincingly implicated in cases of acute liver injury with symptoms or jaundice.

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References

    1. Skidgel RA. Histamine, bradykinin, and their antagonists. In, Brunton LL, Hilal-Dandan R, Knollmann BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 711-26.(Textbook of pharmacology and therapeutics).
    1. FDA. Integrated Review. 2009. Kalbitor (Ecallantide). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125277s000MedrR_...(FDA Summary of the data on the safety and efficacy of ecallantide submitted in support of the application for approval as treatment of acute attacks of HAE, discusses tolerance in 187 patients with HAE among whom 10 [4%] had anaphylactic reactions, often after repeated doses but none were fatal; no mention or discussion of ALT elevations or hepatic adverse events).
    1. FDA. Integrated Review. 2017. Takhzyro (Lanadelumab). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761090Orig1s000M...(FDA Summary of the data on the safety and efficacy of lanadelumab submitted in support of the application for its approval for prevention of attacks of HAE, mentions that ALT elevations above 3 times ULN arose in 5 of 84 [6%] subjects treated with lanadelumab, arising after 1 month of treatment with no clear pattern which were invariably transient and not associated with symptoms or jaundice, although leading to early discontinuation in one patient [peak ALT 142 U/L] with obesity and pre-existent minor ALT and AST elevations).
    1. FDA. Integrated Review. 2017. Firazyr (Icatibant). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022150Orig1s000M...(FDA Summary of the data on the safety and efficacy of icatibant submitted in support of the application for its approval for therapy of acute attacks of HAE, mentions that there were no clinically significant changes in laboratory values from baseline [pretreatment] to the end of the 14-day observation period; one subject had an ALT elevation to 246 U/L before receiving icatibant for a second attack of HAE, which ultimately resolved after therapy of the attack).
    1. FDA. Integrated Review. 2020. Orladeyo (Berotralstat). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214094Orig1s000M...(FDA Summary of the data on the safety and efficacy of berotralstat, submitted in support of the application for approval as means of prevention of acute attacks of hereditary angioedema [HAE], mentions that ALT elevations were more frequent with placebo [10%] than berotralstat [2.4% to 5.1%], although one patient on drug developed ALT elevations of above 5 times the upper limit of normal [ULN] and discontinued treatment with prompt resolution; no serious hepatic adverse events or liver injury with jaundice).

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