oritavancin
Regulatory sources consulted
Approved indications
- Acute bacterial skin and skin-structure infections caused by susceptible gram-positive organisms.
Contraindications
Absolute
- Hypersensitivity to oritavancin; use of IV unfractionated heparin during the following 120 hours.
Clinical warnings
- Major warning · It interferes with aPTT up to 120 h, PT/INR up to 12 h, and ACT up to 24 h; use unaffected tests. — CIMA/AEMPS, ficha técnica 115989001
- Major warning · It may cause hypersensitivity and infusion reaction. An osteomyelitis signal was observed; assess persistent bone pain. — CIMA/AEMPS, ficha técnica 115989001
Drug interactions
- ModerateIV unfractionated heparin
Mechanism: Prolonged aPTT interference prevents reliable monitoring.
Recommendation: Do not administer for 120 hours after oritavancin.
CIMA/AEMPS, ficha técnica 115989001
- HighWarfarin
Mechanism: INR is unreliable during the first 12 hours and bleeding risk may increase.
Recommendation: Clinically monitor bleeding and use an alternative test during interference.
CIMA/AEMPS, ficha técnica 115989001
- ModerateNarrow-therapeutic-index CYP2C9, CYP2C19, CYP3A4, or CYP2D6 substrates
Mechanism: Oritavancin weakly inhibits CYP2C9/2C19 and weakly induces CYP3A4/2D6.
Recommendation: Monitor substrate efficacy, concentrations, or toxicity and adjust if needed.
CIMA/AEMPS, ficha técnica 115989001
Adverse events
Common (≥1%)
Nausea, hypersensitivity, infusion-site reaction, and headache
Rare but serious
Anaphylaxis, severe infusion reaction, and osteomyelitis
Pregnancy and lactation
Avoid during pregnancy unless benefit outweighs risk. Decide whether to discontinue breastfeeding or treatment.
Recent literature (PubMed)
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.
Infections caused by methicillin-resistant Staphylococcus aureus (MRSA) are associated with high mortality rates. Optimal antibiotic dosage plays a crucial role in reducing MRSA burden; thus, the use of therapeutic drug monitoring (TDM) in the clinical practice, especially of new drugs such as ceftobiprole, ceftaroline, dalbavancin, and oritavancin, should be implemented. We aim to examine and summarize the available evidence about TDM of anti-MRSA molecules, with a focus on pneumonia, endocarditis and vascular infections, and bone and joint infections. We applied 'therapeutic drug monitoring' and 'Staphylococcus aureus' as search terms in PubMed, considering a time frame of 24 years (2001-2024). Articles in English language, non-duplicated, evaluating antibiotic therapeutic target, and role of TDM were included in the study. In this review, available data for therapeutic target and TDM were critically analysed and summarized and suggestions about the use of old and new anti-MRSA antibiotics were provided, focusing on optimal dosages, tissue penetration according to infection types, and toxicity. Limitations to the widespread use of TDM in clinical practice were discussed. The use of TDM may play an important role for the optimal management of patients with MRSA infections and may impact on patient outcomes by increasing efficacy and reducing the risk of adverse events. TDM may be implemented in clinical practice; however, several limitations such as the wide variability in the methodology and the need for skilled personnel need to be considered.
Oritavancin is emerging as a potential alternative to standard antibiotic regimens in the treatment of infective endocarditis caused by gram-positive bacteria, though evidence remains limited. We hereby report 7 cases of enterococcal endocarditis treated with oritavancin as consolidation therapy, resulting in 6 cures and 1 relapse.
This review discusses small molecule antibiotics approved for clinical use in the time frame 2010-2022. This time span saw the approval of four synthetic antibiotics (bedaquiline, pretomanid, delafloxacin, tedizolid), nine natural product derivatives (ceftaroline fosamil, cefiderocol, plazomicin, omadacycline, eravacycline, sarecycline, lefamulin, dalbavancin, oritavancin), and one natural product (fidaxomicin).