Anidulafungin does not require dosage adjustment in subjects with varying degrees of hepatic or renal impairment.
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 microg x h/mL and 68.6 +/- 14.5 microg x h/mL, compared to 70.0 +/- 13.4 microg x 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.
Dowell
James A
JA
Vicuron Pharmaceuticals, Inc, New York, NY, USA.
Stogniew
Martin
M
Krause
David
D
Damle
Bharat
B
D000328:Adult; D000368:Aged; D000077612:Anidulafungin; D000935:Antifungal Agents / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D054714:Echinocandins; D005260:Female; D006207:Half-Life; D048550:Hepatic Insufficiency / Q000378:metabolism*; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D010456:Peptides, Cyclic / Q000009:adverse effects / Q000493:pharmacokinetics*; D051437:Renal Insufficiency / Q000378:metabolism*
D000935:Antifungal Agents; D054714:Echinocandins; D010456:Peptides, Cyclic; D000077612:Anidulafungin