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Anidulafungin Does Not Require Dosage Adjustment in Subjects With Varying Degrees of Hepatic or Renal Impairment

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

Two open-label studies assessed the effects of hepatic and renal impairment on anidulafungin pharmacokinetics. A single 50-mg dose was administered intravenously to subjects with varying degrees of hepatic or renal insufficiency or with end-stage renal disease; all were matched to normal healthy controls. Anidulafungin was well tolerated. AUC, CL, C_max, t_max, t_1/2, and V_ss between renally impaired subjects and controls were not significantly different (P > .05), and no measurable amounts of drug were found in dialysate. The same pharmacokinetic parameters were also not affected (P > .05) by mild or moderate hepatic insufficiency, with respective mean AUCs of 50.6 ± 11.7 µg·h/mL and 68.6 ± 14.5 µg·h/mL, compared to 70.0 ± 13.4 µg·h/mL in controls. Statistically significant decreases (P < 05) of AUC (33% change) and C_max (36% change) in severely hepatically impaired subjects compared to controls—most likely secondary to ascites and edema—were not clinically relevant. Anidulafungin can be safely administered to patients with any degree of hepatic or renal impairment without dosage adjustment and without regard to hemodialysis schedules.

Key Words: Anidulafungin • pharmacokinetics • hepatic impairment • renal impairment

Address for reprints: 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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