Drug updated on 12/11/2024
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.
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Clinical Cure and Improvement with Oritavancin (ORI): In a systematic review of 301 cases treated with multidose ORI, clinical cure was achieved in 85% (231/272) of patients, and clinical improvement was noted in an additional 8% (22/272) of patients, with most cases involving infections such as osteomyelitis, acute bacterial skin and skin structure infections (ABSSSI), and cellulitis.
- Non-Inferiority in ABSSSI Treatment: Meta-analysis findings demonstrated that ORI was statistically non-inferior to control agents in efficacy outcomes for acute bacterial skin and skin structure infections (ABSSSIs), including investigator-assessed clinical cure and lesion size reduction, positioning it as a viable alternative to standard treatments.
- Adverse Events with Oritavancin: In a systematic review, the most common adverse events for patients treated with oritavancin included infusion-related reactions and hypoglycemia. Oritavancin was generally well-tolerated, showing a favorable safety profile across various infections.
- Comparison to Vancomycin: Oritavancin was associated with significantly fewer adverse events than vancomycin (relative risk (RR) = 0.72; P < 0.01) and showed similar all-cause mortality rates, highlighting a potential advantage in tolerability for treating Gram-positive infections.
- Population Types and Specific Infections Treated: The systematic review identified the most common infections treated with oritavancin as osteomyelitis (148 cases), ABSSSI (35 cases), and cellulitis (14 cases), primarily involving methicillin-resistant staphylococcus aureus (MRSA) (121 cases) and methicillin-susceptible staphylococcus aureus (MSSA) (66 cases), with additional isolates of coagulase-negative staphylococci (CoNS), E. faecalis, and E. faecium.
- Subgroup Findings in ABSSSI: In a meta-analysis of ABSSSI treatment, oritavancin significantly reduced the rate of 30-day emergency room visits in outpatient settings (RR = 0.34; P < 0.00001), indicating potential benefits for managing ABSSSI in outpatient care.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Orbactiv (oritavancin) Prescribing Information. | 2022 | Melinta Therapeutics LLC, Lincolnshire, IL |