Population Pharmacokinetic Analysis of Dalbavancin, a Novel Lipoglycopeptide

  title={Population Pharmacokinetic Analysis of Dalbavancin, a Novel Lipoglycopeptide},
  author={Mary Buckwalter and James A. Dowell},
  journal={The Journal of Clinical Pharmacology},
Dalbavancin is a lipoglycopeptide antibiotic in clinical development as a once‐weekly treatment for serious infections. A total of 532 patients, consisting of 502 patients with skin and soft tissue infections requiring parenteral therapy and 30 patients with catheter‐related bloodstream infections, was available for population pharmacokinetic analysis. The majority of patients (78.4%) received dalbavancin intravenously as a 1000‐mg dose on day 1 and a single 500‐mg dose on day 8. A 2… 

Clinical Pharmacokinetics and Pharmacodynamics of Dalbavancin

Recent data suggest usefulness in the treatment of infections beyond ABSSSI, with convenient dosing and redosing strategies for complicated infections requiring extended treatment durations suggested.

Review of the pharmacokinetics of dalbavancin, a recently approved lipoglycopeptide antibiotic

It is concluded that dalbavancin, despite high protein binding offers pharmacokinetic benefits such as good tissue penetration and long half-life, may be a drug of choice and replace more resource demanding intravenous drugs to treat serious infections in a hospital setting.

In Vivo Pharmacodynamic Activity of the Glycopeptide Dalbavancin

The dose-dependent efficacy and prolonged elimination half-life of dalbavancin support the widely spaced regimens used in clinical trials and the free-drug 24-h AUC/MIC targets identified in these studies should be helpful for discerning rational susceptibility breakpoints.

Pharmacokinetic‐Pharmacodynamic Modeling of Dalbavancin, a Novel Glycopeptide Antibiotic

The analysis supports the use of once‐weekly dosing regimens of dalbavancin in the treatment of complicated skin and skin structure infections.

Dalbavancin Population Pharmacokinetic Modeling and Target Attainment Analysis

This analysis represents the update of the population pharmacokinetics modeling and target attainment simulations performed with data from the single‐dose safety and efficacy study and an unrelated but substantial revision of the preclinical pharmacokinetic/pharmacodynamic target (fAUC/MIC).

Population Pharmacokinetics of Dalbavancin and Dosing Consideration for Optimal Treatment of Adult Patients with Staphylococcal Osteoarticular Infections

Giving a regimen of two 1,500-mg doses of dalbavancin 1 week apart may ensure efficacy against both MSSA and MRSA up to 5 weeks in patients with OA infections.

Dalbavancin: a new lipoglycopeptide antibiotic.

  • J. BaileyK. Summers
  • Biology, Medicine
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
  • 2008
Dalbavancin has enhanced activity against gram-positive bacteria and unique pharmacokinetics compared with existing drugs in its class and appears to be safe and efficacious for use against common infections, including complicated skin infections and catheter-related bloodstream infections.

Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients

Dalbavancin at 1,500 mg administered intravenously can be utilized without dose adjustment in peritoneal dialysis patients and will likely achieve the necessary peritoneAL fluid concentrations to treat peritonitis caused by typical Gram-positive pathogens.

Population Pharmacokinetic and Pharmacodynamic Analysis of Dalbavancin for Long-Term Treatment of Subacute and/or Chronic Infectious Diseases: The Major Role of Therapeutic Drug Monitoring

Therapeutic drug monitoring should be considered mandatory for managing inter-individual variability and for supporting clinicians in long-term treatments of subacute and chronic infections.

Dalbavancin: a novel once-weekly lipoglycopeptide antibiotic.

Dalbavancin, a new lipoglycopeptide, has the desirable characteristics of increased in vitro activity, compared with vancomycin, for most gram-positive pathogenic bacteria, as well as an extremely long half-life, permitting once-weekly intravenous dosing.



Human pharmacokinetics and rationale for once-weekly dosing of dalbavancin, a semi-synthetic glycopeptide.

The efficacy study showed that a two-dose weekly dalbavancin dosage regimen was well tolerated and associated with a higher clinical response rate than the comparator regimens.

Tolerability, Pharmacokinetics, and Serum Bactericidal Activity of Intravenous Dalbavancin in Healthy Volunteers

The long half-life and maintenance of SBA against MRSA for 1 week suggest that weekly dosing may be feasible and the long tolerated dose, characterize the pharmacokinetics, and obtain serum bactericidal activity (SBA) data for intravenous dalbavancin are suggested.

Pharmacokinetics and excretion of dalbavancin in the rat.

Dalbavancin is not selectively retained in any single organ, tissue or blood component and is completely eliminated by both renal and non-renal routes in rats, useful in designing and interpreting animal infection model studies used to select the dose for human studies.

Once-weekly dalbavancin versus standard-of-care antimicrobial regimens for treatment of skin and soft-tissue infections.

It is suggested that a regimen of 2 doses of dalbavancin administered 1 week apart is effective in the treatment of complicated, gram-positive bacterial SSTIs and warrants further study.

Worldwide assessment of dalbavancin activity and spectrum against over 6,000 clinical isolates.

In-vitro and in-vivo antibacterial activity of BI 397, a new semi-synthetic glycopeptide antibiotic.

The data from these studies show that BI 397 combines an excellent in-vitro antibacterial activity with favourable pharmacokinetic behaviour resulting in potent in- vivo activity.

Xpose--an S-PLUS based population pharmacokinetic/pharmacodynamic model building aid for NONMEM.

The pharmacokinetics and renal excretion of dalbavancin in healthy subjects

Dalbavancin: phase 1 single and multiple-dose placebo controlled intravenous safety pharmacokinetic study in healthy volunteers

  • Poster presented at: 41st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); December
  • 2001