Tacrolimus pharmacokinetics are not affected by concomitant anidulafungin

Dowell, J.A., J. Schranz, M. Buckwalter, M. Stogniew, D. Krause

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Background: Fungal infections in transplant recipients are a major cause of morbidity and mortality. Antifungal drugs have been shown to be effective in the prevention and treatment of serious fungal infections, but may interact with immunosuppressive agents. Anidulafungin is a novel echinocandin in late-stage development for the treatment of serious fungal infections. Tacrolimus is a potent macrolide immunosuppressant for prophylaxis of organ rejection in patients receiving allogeneic liver or kidney transplants. Drug interactions with tacrolimus have been observed for caspofungin, another echinocandin. A study was done to assess a possible pharmacokinetic interaction following co-administration of tacrolimus and anidulafungin. Methods: An open-label, single sequence pharmacokinetic interaction study was conducted in healthy male subjects, ages 18 to 55 years. Subjects received a single oral 5 mg dose of tacrolimus on Days 1 and 13. Anidulafungin was given intravenously as 200 mg on Day 4 followed by 100 mg/day (Days 513). Pharmacokinetic parameters were assessed fortacrolimus alone and in combination with anidulafungin. Maximum plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) were determined and compared. Results: Thirty-six healthy males were enrolled in the study. Thirty-five of these subjects completed all treatments. No dose-limiting toxicities occurred in the study. No differences were observed in the pharmacokinetic parameters when tacrolimus was administered alone, compared to concomitant administra-tion.Mean (standard deviation) tacrolimus pharmacokinetic parameters are shown in the table. Conclusions: Anidulafungin and tacrolimus can be administered together. The combination was well-tolerated. Pharmaco-kinetic parameters are not affected when tacrolimus and anidulafungin are administered concomitantly.

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    • ECCMID 15th (2005)