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Lack of Pharmacokinetic Interaction Between Anidulafungin and Tacrolimus

From Vicuron Pharmaceuticals, a subsidiary of Pfizer, Inc, New York, (Dr Dowell, Dr Stogniew, Dr Krause, Dr Henkel) and Pfizer Global Research and Development, Pfizer, Inc, New York, (Dr Damle).

The safety and pharmacokinetics of anidulafungin coadministered with tacrolimus were investigated using a single-sequence, open-label design. Healthy volunteers received 5 mg tacrolimus orally on days 1 and 13 of the study. Anidulafungin (200 mg) was administered intravenously on day 4, followed by 100-mg doses on days 5 through 13. Key pharmacokinetic parameters, including C_max, AUC, t, CL, and V_ss, were derived from concentration-time data. The 90% confidence intervals (CIs) of the ratios of mean pharmacokinetic parameters of anidulafungin plus tacrolimus to each drug alone were well within the 80% to 125% bioequivalence range, indicating no pharmacokinetic interaction. This ratio was 101.6 (90% CI: 92.77-111.22) for tacrolimus AUC_0- and 107.2 (90% CI: 105.1-109.4) for anidulafungin AUC_ss. The 2 drugs were well tolerated, and no drug-related serious adverse events were reported. Because of its lack of pharmacokinetic interaction with key immunosuppressive agents, anidulafungin is an important option for the prevention and treatment of invasive fungal infections in transplant recipients.

Key Words: anidulafungin • tacrolimus • drug interaction • pharmacokinetics • tolerability

Address for reprints: Address for correspondence: Bharat Damle, PhD, Associate Director, Clinical Pharmacology, Pfizer Global Research & Development, 685 3rd Avenue, New York, NY 10017; e-mail: bharat.damle{at}pfizer.com.

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				B. D. Damle, J. A. Dowell, R. L. Walsky, G. L. Weber, M. Stogniew, and P. B. Inskeep In Vitro and In Vivo Studies To Characterize the Clearance Mechanism and Potential Cytochrome P450 Interactions of Anidulafungin Antimicrob. Agents Chemother., March 1, 2009; 53(3): 1149 - 1156. [Abstract] [Full Text] [PDF]