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Found 1 result for Related Articles by Review for PMID: 39899770
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Review

Ibrexafungerp

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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

Ibrexafungerp

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Excerpt

Ibrexafungerp is a triterpenoid antifungal agent used to treat as well as prevent recurrent episodes of vulvovaginal candidiasis. Ibrexafungerp therapy has not been associated with elevations in serum enzyme elevations or with instances of jaundice or clinically apparent liver injury.

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References

    1. Zimmerman HJ. Antifungal agents. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999, pp. 609-11.(Expert review of hepatotoxicity of antifungal agents published in 1999 before the availability of ibrexafungerp).
    1. Moseley RH. Antifungal agents. Antibacterial and antifungal agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 470-3.(Review of hepatotoxicity of antifungal agents before the availability of ibrexafungerp or other inhibitors of β-1,3,-D glucan).
    1. Rogers PD, Krysan DJ. Antifungal agents. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1987-1104.(Textbook of pharmacology and therapeutics discusses the echinocandins (-fungins) which inhibit β-1,3-D glucan synthesis, but not ibrexafungerp).
    1. Multi-Discipline Review FDA.. 2021. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214900Orig1s000M...(FDA website with product label and multidiscipline review of ibrexafungerp based upon data submitted by the sponsor in support of its approval for use in vulvovaginal candidiasis, mentions that 2 healthy subjects in phase 1 trials of a single dose of ibrexafungerp developed ALT elevations [peak 575 and 275 U/L] with mild symptoms, that resolved spontaneously, and that the rate of ALT elevations in phase 3 trials of therapy of acute vulvovaginal candidiasis was 0.7% [4/575] on ibrexafungerp vs 0.4% [1/275] on placebo, and none of the elevations was associated with symptoms or jaundice).
    1. Lee A. Ibrexafungerp: first approval. Drugs. 2021;81:1445-1450.(Review of the mechanism of action, history of development, pharmacology, clinical efficacy, and safety of ibrexafungerp shortly after its approval for use in the US, mentions common adverse events of diarrhea [17%], nausea [12%], abdominal pain [11%], dizziness [3%], and vomiting [2%] and the lack of serious adverse events in registration trials; no mention of ALT elevations or hepatotoxicity). - PubMed

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