What is the recommended dosing regimen for Dalvance (Orbactiv), an intravenous (IV) antibiotic, for the treatment of acute bacterial skin and skin structure infections?

Dalvance (Dalbavancin) IV Dosing for Acute Bacterial Skin and Skin Structure Infections

The recommended dosing regimen for Dalvance (dalbavancin) IV for the treatment of acute bacterial skin and skin structure infections (ABSSSI) is 1000 mg administered intravenously on day 1, followed by 500 mg intravenously on day 8. 1, 2

Standard Dosing Regimens

• The FDA-approved two-dose regimen consists of 1000 mg IV on day 1, followed by 500 mg IV on day 8 1
• An alternative single-dose regimen of 1500 mg IV has been shown to be non-inferior to the two-dose regimen in clinical trials 3
• For patients with severe renal impairment (creatinine clearance less than 30 mL/min) not on regular dialysis, the dose should be reduced to 750 mg IV on day 1, followed by 375 mg IV on day 8 1

Clinical Evidence Supporting Efficacy

• In the DISCOVER 1 and 2 trials, dalbavancin demonstrated non-inferiority to vancomycin (with option to switch to oral linezolid) for treatment of ABSSSI 4
• Early clinical success rates (48-72 hours after initiation of treatment) were similar between dalbavancin and vancomycin/linezolid treatment groups 1
• Clinical response rates at end of treatment (day 14-15) were also similar between treatment groups regardless of infection type, diabetes status, or causative pathogen 4

Safety Considerations

• Dalbavancin is generally well-tolerated with adverse events typically being mild to moderate in intensity and transient 4
• Nephrotoxicity rates are lower with dalbavancin compared to vancomycin (3.7% vs 9.3%, p=0.039) 5
• No therapeutic drug monitoring is required for dalbavancin, unlike vancomycin 4

Advantages of Dalbavancin

• Long half-life allows for convenient once-weekly dosing 6
• Excellent skin and soft tissue penetration 6
• Bactericidal activity against Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA) 6
• May reduce need for hospitalization or facilitate early discharge due to convenient dosing schedule 4

Single-Dose vs Two-Dose Regimen

• A randomized clinical trial demonstrated that a single 1500 mg infusion of dalbavancin was non-inferior to the two-dose regimen (81.4% vs 84.2% clinical success; difference -2.9%, 95% CI -8.5% to 2.8%) 3
• The single-dose regimen had a similar safety profile to the two-dose regimen 3
• Single-dose administration may improve convenience and remove logistical constraints related to delivering the second dose 3

Spectrum of Activity

• Dalbavancin is active against clinically relevant Gram-positive pathogens including 1:
  • Staphylococcus aureus (including methicillin-resistant isolates)
  • Streptococcus pyogenes
  • Streptococcus agalactiae
  • Streptococcus dysgalactiae
  • Streptococcus anginosus group
  • Enterococcus faecalis (vancomycin-susceptible isolates only)

Clinical Pearls

• Dalbavancin should be administered as an intravenous infusion over 30 minutes 7
• No dose adjustment is needed for patients with mild to moderate renal impairment or mild hepatic impairment 1
• Consider dalbavancin for patients who may benefit from outpatient therapy or early discharge from hospital 4
• The convenient dosing schedule may improve patient adherence compared to daily antibiotic regimens 6