Dalbavancin Intravenous and Renal dysfunction

Dalbavancin is primarily eliminated by the kidney. In a study of patients with varying degrees of renal impairment, the mean plasma clearance of dalbavancin following a single 500 mg or 1000 mg dose was reduced by 11%, 35%, and 47% in subjects with mild (CrCl 50 to 79 mL/min), moderate (CrCl 30 to 49 mL/min), and severe (CrCl less than 30 mL/min) renal impairment, respectively, compared to subjects with normal renal function. The clinical significance of these decreases and the associated increase in systemic exposure (AUC) noted in subjects with severe renal impairment has not been established. No dosage adjustment is necessary for patients with CrCl greater than 30 mL/min or for patients receiving hemodialysis. The recommended two-dose regimen in patients with severe renal impairment who are not receiving regularly scheduled hemodialysis is 750 mg once, followed by 375 mg one week later. Dalbavancin pharmacokinetic parameters in subjects with end-stage renal disease receiving hemodialysis three times per week were similar to those observed in subjects with mild to moderate renal impairment, and less than 6% of an administered dose was removed after three hours of hemodialysis. Therefore, no dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and dalbavancin may be administered without regard to the timing of hemodialysis.