679: Effect of Moderate Hepatic Impairment on the Safety and Pharmacokinetics of Rezafungin

Formulary Drug Review: Rezafungin

“…Investigators concluded that the observed difference in AUC was unlikely to be clinically relevant and identified no new safety concerns or indications for dose adjustment. 15,16 Age, sex, race, weight, hepatic impairment (Child Pugh class B or C), and renal impairment (creatinine clearance 9.3 ml/min to greater than 120 ml/min) had no clinically relevant effects on the pharmacokinetics of rezafungin. 1 A phase 1 study of a subcutaneous formulation of rezafungin was terminated early due to concerns of potential increased severity of injection-site reactions.…”

“…1 No dosage adjustments appear to be necessary in patients with hepatic impairment. 1,15,16 A validated ex vivo bovine blood continuous venovenous hemofiltration model was used to evaluate urea and rezafungin adsorption and transmembrane clearance at 3 different ultrafiltrate flow rates. Due to the observed sieving coefficient, the study authors concluded that rezafungin is unlikely to be adsorbed or cleared by any form of continuous renal replacement therapy; therefore, dosage adjustment is likely not required for patients receiving continuous renal replacement therapy.…”

“…Investigators concluded that the observed difference in AUC was unlikely to be clinically relevant and identified no new safety concerns or indications for dose adjustment. 15,16…”