Expert Opinion on Dose Regimen and Therapeutic Drug Monitoring for Long-Term Use of Dalbavancin: Expert Review Panel

Background: Dalbavancin is a lipoglycopeptide with a long elimination half-life, currently licensed for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Dalbavancin's potential in treating off-label complex gram-positive infections is promising and real-world experience in treating such infections is growing. However, clear guidance on extended dosing regimens is lacking. Objectives: We aim to provide clear expert opinion based on recent pharmacokinetic literature and expert and real-world experience in infection areas that require >2 weeks of treatment. Methods: A single face-to-face meeting was held in September 2022 to collate expert opinion and present safety data of dalbavancin use in these clinical indications. A survey was completed by all authors on their individual experience with dalbavancin which highlighted the heterogeneity in the regimens used. Results: After review of the survey data and recent literature, we present expert panel proposals which accommodate different healthcare settings and resource availability, and centre around the length of treatment duration including up to, or exceeding, 6 weeks. To achieve adequate dalbavancin concentrations for up to 6 weeks, 3,000mg of dalbavancin should be given over 4 weeks for the agreed complex infections requiring >2 weeks treatment. Therapeutic drug monitoring (TDM) is advised for longer treatment durations and in case of renal failure. Specific dosing recommendations for other special populations require further investigation. Conclusions: These proposals based on expert opinion have been defined to encourage best practice with dalbavancin to optimise its administration beyond the current approved licenced dose across different healthcare settings.