dalbavancin
Regulatory sources consulted
Approved indications
- Acute bacterial skin and skin-structure infections caused by susceptible gram-positive organisms.
Contraindications
Absolute
- Hypersensitivity to dalbavancin.
Clinical warnings
- It may cause severe hypersensitivity; discontinue dalbavancin and treat immediately if it occurs. — DailyMed, set_id f4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c1
- Major warning · Rapid infusion may cause flushing, urticaria, pruritus, or rash; stop or slow the infusion. — DailyMed, set_id f4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c1
- Major warning · ALT elevations have been observed; monitor liver function in hepatic disease or if injury signs develop. — DailyMed, set_id f4c0bd0f-03c2-4ce5-bcc2-b58f21ce75c1
Adverse events
Common (≥1%)
Nausea, headache, and diarrhea
Rare but serious
Anaphylaxis, severe infusion reaction, and C. difficile colitis
Pregnancy and lactation
Use during pregnancy only if benefit outweighs risk. Decide whether to discontinue breastfeeding or treatment according to maternal benefit.
Recent literature (PubMed)
Dalbavancin is a long-acting antimicrobial agent with an excellent in vitro activity against Gram-positive pathogens, including staphylococcal biofilms. The unusually long terminal half-life ranging from 149 to 250 hours in human subjects, allows a weekly dose. Currently is indicated in acute bacterial skin and skin structure infections (ABSSSIs), but in real-life clinical practice it has already been used successfully and safely in other infections, especially as consolidation therapy.
Dalbavancin is a synthetic lipoglycopeptide that exerts its antimicrobial activity through two distinct modes of action, inhibition of cell wall synthesis and an anchoring mechanism. Compared with previous glycopeptide antibiotics, dalbavancin demonstrates improved antibacterial potency against Gram-positive organisms and a long half-life of approximately 1 week, which is longer in tissues (e.g., skin, bone) than plasma. These factors facilitated the development of single-dose or once-weekly dosing regimens to treat acute bacterial skin and skin structure infections (ABSSSI). Dalbavancin exhibits dose-proportional pharmacokinetics and is highly protein bound (93%). Despite being highly protein bound, it has a steady-state volume of distribution >10 L and distributes widely into the skin, bone, peritoneal space, and epithelial lining fluid, but not cerebrospinal fluid. Dalbavancin elimination occurs via a combination of renal (approximately 45%) and non-renal clearance, with dose adjustments recommended only in patients with a creatinine clearance <30 mL/min not receiving any form of dialysis. The established pharmacokinetic/pharmacodynamic index associated with bacterial kill is free area under the concentration-time curve over the minimum inhibitory concentration (fAUC/MIC), with a goal 24-h fAUC/MIC of at least 27.1 for Staphylococcus aureus infections. Recent data suggest usefulness in the treatment of infections beyond ABSSSI, with convenient dosing and redosing strategies for complicated infections requiring extended treatment durations. Additional studies are needed to confirm these preliminary findings. No information is available on the use of dalbavancin during breastfeeding. Dalbavancin is 93% plasma protein bound and is poorly absorbed orally, so it is not likely to reach the bloodstream of the infant or cause any adverse effects in breastfed infants. If dalbavancin is required by the mother, it is not a reason to discontinue breastfeeding. Monitor the in
Today, Enterococcus faecalis is one of the main causes of infective endocarditis in the world, generally affecting an elderly and fragile population, with a high mortality rate. Enterococci are partially resistant to many commonly used antimicrobial agents such as penicillin and ampicillin, as well as high-level resistance to most cephalosporins and sometimes carbapenems, because of low-affinity penicillin-binding proteins, that lead to an unacceptable number of therapeutic failures with monotherapy. For many years, the synergistic combination of penicillins and aminoglycosides has been the cornerstone of treatment, but the emergence of strains with high resistance to aminoglycosides led to the search for new alternatives, like dual beta-lactam therapy. The development of multi-drug resistant strains of Enterococcus faecium is a matter of considerable concern due to its probable spread to E. faecalis and have necessitated the search of new guidelines with the combination of daptomycin, fosfomycin or tigecycline. Some of them have scarce clinical experience and others are still under investigation and will be analyzed in this review. In addition, the need for prolonged treatment (6-8 weeks) to avoid relapses has forced to the consideration of other viable options as outpatient parenteral strategies, long-acting administrations with the new lipoglycopeptides (dalbavancin or oritavancin), and sequential oral treatments, which will also be discussed.
Dalbavancin is a parenteral lipoglycopeptide antibiotic derived from teicoplanin, an analogue of vancomycin. It is mainly used for skin and soft tissue infections. The sustained half-life of approximately 14 days makes dalbavancin a novel option for potential use as sequential treatment in infections such as infective endocarditis, which require prolonged antibiotic courses. However, only a few studies have been reported in the literature, and the use of dalbavancin remains limited. This article is a review of the currently available literature using dalbavancin for the treatment of infective endocarditis due to Gram-positive organisms. Almost all patients received dalbavancin as sequential therapy following standard-of-care antibiotics. The overall clinical efficacy of dalbavancin was approximately 90%, and it appeared to be well tolerated.