Drug updated on 12/11/2024
Dosage Form | Injection (intravenous: 500 mg) |
Drug Class | Lipoglycopeptide antibacterials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms.
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Summary
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Infective Endocarditis (IE): Dalbavancin achieved a clinical failure rate below 10% in five out of nine studies, with coagulase-negative Staphylococci as the most common pathogen (30.1%) and native valve endocarditis observed most frequently (48.7%).
- Osteoarticular (OA) Infections: An overall success rate of 79.3% was reported for dalbavancin in treating OA infections, with the highest success (92.3%) among patients receiving a three-dose regimen. Staphylococcus aureus was the most commonly isolated pathogen (67.5%).
- Gram-Positive Bacterial Infections and Catheter-Related Bloodstream Infections (CRBSIs): Dalbavancin demonstrated effectiveness comparable to vancomycin for osteomyelitis, with superior outcomes in bacteremia, and was effective in CRBSIs and osteomyelitis within the Gram-positive infection category.
- General Safety Across Infections: Dalbavancin exhibited a favorable safety profile in treating IE, OA infections, and multi-drug-resistant (MDR) infections in newborns, with no significant safety concerns documented across different age cohorts and infection types.
- Comparative Safety in Gram-Positive Infections: For gram-positive bacterial infections, dalbavancin and oritavancin had fewer adverse events compared to vancomycin, particularly with a dual-dose regimen showing reduced adverse events (AEs) and adverse drug reactions (ADRs) compared to a single-dose regimen.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Dalvance (dalbavancin) Prescribing Information. | 2024 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Expert opinion on dose regimen and therapeutic drug monitoring for long-term use of dalbavancin: Expert review panel. | 2023 | International Journal of Antimicrobial Agents |
Cellulitis and erysipelas: Antimicrobial prescribing guideline | 2019 | NICE |