What is the recommended dosing regimen for Dalvance (Orbactiv) in a patient with a positive bone culture and potentially impaired renal function?

Dalvance Dosing for Positive Bone Culture

For patients with positive bone culture, the recommended dosing regimen for Dalvance (dalbavancin) is 1,500 mg administered as a two-dose regimen: 1,000 mg initially followed by 500 mg one week later, with dosage adjustment required for patients with renal impairment whose creatinine clearance is less than 30 mL/min. 1

Standard Dosing Regimen

For adult patients with normal renal function (CrCl ≥30 mL/min):

• 1,500 mg total dose, administered as either:
  • Single dose regimen: 1,500 mg as a one-time dose, OR
  • Two-dose regimen: 1,000 mg initially, followed by 500 mg one week later
• Administer via intravenous infusion over 30 minutes 1

Dosing in Renal Impairment

For adult patients with impaired renal function (CrCl <30 mL/min) who are not on regularly scheduled hemodialysis:

• 1,125 mg total dose, administered as either:
  • Single dose regimen: 1,125 mg as a one-time dose, OR
  • Two-dose regimen: 750 mg initially, followed by 375 mg one week later 1

For patients on regularly scheduled hemodialysis:

• No dosage adjustment is required
• Dalvance can be administered without regard to the timing of hemodialysis 1

Bone Penetration and Efficacy

Dalvance demonstrates excellent bone penetration, making it particularly suitable for bone infections:

• Concentrations in cortical bone 12 hours after a single 1,000 mg infusion reach 6.3 μg/g
• Concentrations remain at 4.1 μg/g even two weeks later 2
• This sustained concentration exceeds the MIC90 for Staphylococcus aureus (0.06 μg/mL), the most common pathogen in bone infections 3

Clinical Evidence for Bone Infections

A randomized clinical trial specifically evaluating dalbavancin for osteomyelitis showed:

• Two-dose regimen (1,500 mg on days 1 and 8) achieved 97% clinical cure rate at day 42
• Efficacy was maintained at 6 months and 1 year (96% clinical response)
• Treatment was well-tolerated with no discontinuations due to adverse events 4

Administration Considerations

When preparing and administering Dalvance:

1. Reconstitute with either Sterile Water for Injection or 5% Dextrose Injection
2. Dilute only with 5% Dextrose Injection to a final concentration of 1-5 mg/mL
3. Administer over 30 minutes
4. Do not use saline-based solutions as they may cause precipitation
5. Do not co-infuse with other medications 1

Important Monitoring Considerations

• Baseline renal function assessment is essential to determine appropriate dosing
• No routine monitoring of drug levels is required due to the predictable pharmacokinetics with minimal intra- and inter-individual variability 5
• Monitor for potential adverse effects, though these are generally mild and comparable to other antibiotics 4

Clinical Pearls

• The extended half-life of Dalvance (>300 hours) allows for the convenient weekly dosing schedule 5
• This makes it particularly valuable for osteomyelitis treatment, which traditionally requires 4-6 weeks of daily intravenous antibiotics 4
• The two-dose regimen provides tissue exposure above the MIC for Staphylococcus aureus for approximately 8 weeks 2
• Dalvance is effective against methicillin-resistant Staphylococcus aureus (MRSA), which is commonly implicated in bone infections 3

Dalvance's unique pharmacokinetic profile, excellent bone penetration, and proven efficacy in osteomyelitis make it an excellent choice for treating bone infections while minimizing the burden of prolonged daily intravenous therapy.