Drug updated on 9/4/2024
Dosage Form | Injection (intravenous: 400 mg) |
Drug Class | Lipoglycopeptide antibacterials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms.
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Summary
- Orbactiv (oritavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms.
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Clinical Cure and Improvement: Multidose oritavancin (ORI) demonstrated a clinical cure rate of 85% (231/272) and clinical improvement in 8% (22/272) of patients with ABSSSIs. ORI was statistically non-inferior to control agents for clinical cure and lesion size reduction ≥20%. Oritavancin's efficacy was similar to vancomycin for treating SSTIs and other gram-positive bacterial infections.
- In Vitro Antibacterial Activity: Oritavancin exhibited potent in vitro activity against MRSA isolates, with an MIC50 of 0.045 µg/mL and an MIC90 of 0.120 µg/mL, comparable to telavancin and dalbavancin.
- Specific Infections and Outcomes: Oritavancin showed a median success rate of 73% (IQR 58-85%) for osteoarticular infections, and it significantly reduced 30-day readmission rates (RR=0.42) and ER visits (RR=0.34) in outpatient settings compared to comparators for ABSSSIs.
- Multidose oritavancin was reported as safe and well-tolerated, with the most frequent adverse events being infusion-related reactions and hypoglycemia.
- Oritavancin was associated with fewer drug-related adverse events (RR=0.78) compared to comparators for ABSSSIs and demonstrated a safety profile non-inferior to these comparators.
- Oritavancin was used to treat osteomyelitis (54.4%), ABSSSI (12.9%), and cellulitis (5.1%) in specific subgroups, with a focus on its potent in vitro activity against MRSA isolates, showing similar efficacy to telavancin and dalbavancin in these populations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Orbactiv (oritavancin) prescribing information. | 2022 | Melinta Therapeutics LLC, Lincolnshire, IL |