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University of Nebraska Medical Center

Dalbavancin

In Spring 2019, the Pharmacy and Therapeutics Committee voted to add Dalbavancin to the Nebraska Medicine formulary. Prescribing is currently restricted to use in outpatient infusion centers or Emergency Departments by Infectious Diseases (ID) services or via ID-approved institutional pathways.

Efficacy

Dalbavancin is a lipoglycopeptide antibiotic derived from teicoplanin, an analog of vancomycin. It possesses a similar spectrum of activity to vancomycin with potent activity against Gram-positive microorganisms, including Streptococcus spp., Enterococcus spp., and both methicillin-susceptible and -resistant Staphylococcus aureus (MSSA and MRSA). It also has activity against some vancomycin-intermediate S. aureus (VISA). However, it is not active against most vancomycin-resistant Enterococci (VRE) or any Gram-negative pathogens. It is currently indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). In two phase III trials that informed its approval, dalbavancin was shown to be non-inferior to intravenous (IV) vancomycin with optional switch to oral linezolid. Additionally, data has become available suggesting that it may also have a role in the treatment of other sources of infection, most notably osteomyelitis and endocarditis.

Safety

The pivotal clinical trials for the use of dalbavancin in ABSSSI showed that it was generally well tolerated, demonstrating that the majority of adverse effects were designated as mild or moderate. Our institutional experience has been consistent with this finding, even when given in a multi-dose regimen. The most common reported adverse effects in studies were rash, headache, nausea, vomiting, and diarrhea.

Dosing Regimen

ABSSSI: 1500mg IV infusion once (expected duration of effect = 10-14 days)

Complicated infections - Osteomyelitis, epidural abscess, endocarditis, bacteremia, etc. (expected duration of effect = 6-8 weeks)

  • For CrCL > 30 mL/min, or patients on intermittent hemodialysis:
    • 1500mg IV infusion on day 1, then 1500mg IV infusion on day 8
  • CrCL < 30 mL/min and not on hemodialysis:
    • 1125mg IV infusion on day 1, then 1125mg IV infusion on day 8

Uniqueness

In comparison to the other antibacterial agents that also have activity against resistant Gram-positive pathogens such as vancomycin, daptomycin, linezolid, tedizolid, telavancin, and oritavancin, positive characteristics of dalbavancin include:

  • Extended half-life 
    • Single-dose regimen for ABSSI
    • Two-dose, weekly regimen for infections requiring an extended duration of coverage
  • Short infusion time (30 minutes) 
  • Favorable adverse effect profile
    • Does not prolong prothrombin time (PT) or activated partial thromboplastin time (aPTT) 
  • No dosage-adjustment recommended for hemodialysis 
  • Therapeutic drug monitoring is not routinely indicated 

Updated December 2023

Formulary Review - February 2019