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Pharmacokinetics of Dalbavancin in Patients With Renal or Hepatic Impairment

From the Orlando Clinical Research Center, Orlando, Florida (Dr Marbury) and Vicuron, a wholly owned subsidiary of Pfizer Inc, New York (Dr Dowell, Dr Seltzer, Ms Buckwalter).

Three open-label studies assessed the safety, tolerability, and pharmacokinetics of intravenous dalbavancin in patients with hepatic or renal impairment, including patients with end-stage renal disease (ESRD) receiving dialysis. In each study, 4 to 10 patients with mild, moderate, or severe impairment and age-, sex-, and weight-matched controls were administered either a single dose (500 or 1000 mg) or 2 doses (1000 mg followed by 500 mg 1 week apart) of dalbavancin. Dalbavancin exposures were not increased due to mild renal impairment. The mean area under the concentration-time curve from time 0 to infinity (AUC_0-) values were approximately 50% higher in patients with moderate renal impairment or ESRD and 100% higher in patients with severe renal impairment. Dose adjustment is not considered necessary in patients with mild or moderate renal impairment or for patients with ESRD receiving hemodialysis; however, a lower dose of dalbavancin (750 mg followed 1 week later by 375 mg) may be considered for patients with severe renal impairment (creatinine clearance <30 mL/min). AUC_0- values were similar in patients with mild hepatic impairment and were about 27% to 36% lower in patients with moderate to severe hepatic impairment compared with controls. No dosage adjustment is recommended in patients with any degree of hepatic impairment. Dalbavancin was well tolerated in all impairment groups.

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

Address for reprints: James A. Dowell, PhD, Senior Director, Preclinical Development and Clinical Pharmacology, Ception Therapeutics, 101 Lindenwood Drive, Suite 400, Valleybrooke III, Malvern, PA 19355; e-mail: jdowell{at}ceptiontx.com.

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