Oritavancin 400mg powder for solution for infusion vials

Oritavancin (ORI) is a semisynthetic lipoglycopeptide approved as a single 1200 mg dose intravenous infusion for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by Gram-positive organisms in adults. The pharmacokinetic/pharmacodynamic (PK/PD) linear kinetic profile and long terminal half-life (~393 h) of ORI make it therapeutically attractive for the treatment of other Gram-positive infections for which prolonged therapy is needed. Multidose regimens are adopted in real-world clinical practice with promising results, but aggregated efficacy data are still lacking. A comprehensive search on PubMed/Medline, Scopus, Cochrane and Google Scholar databases was performed to include papers published up to the end of January 2023. All articles on ORI multiple doses usage, including case reports, with quantitative data and relevant clinical information were included. Two reviewers independently assessed papers against the inclusion/exclusion criteria and for methodological quality. Differences in opinion were adjudicated by a third party. From 1751 potentially relevant papers identified by this search, a total of 16 studies met the inclusion criteria and were processed further in the final data analysis. We extracted data concerning clinical response, bacteriologic response, mortality and adverse events (AEs). From the 16 included papers, 301 cases of treatment with multidose ORIs were identified. Multidose regimens comprised an initial ORI dose of 1200 mg followed by 1200 mg or 800 mg subsequent doses with a varying total number and frequency of reinfusions. The most often treated infections and isolates were osteomyelitis (148; 54.4%), ABSSSI (35; 12.9%) and cellulitis (14; 5.1%); and MRSA (121), MSSA (66), CoNS (17), E. faecalis (13) and E. faecium (12), respectively. Clinical cure and improvement by multidose ORI regimens were observed in 85% (231/272) and 8% (22/272) patients, respectively. Multidose ORI was safe and well tolerated; the most frequent AEs were infusion-related reactions and hypoglycemia. A multidose ORI regimen may be beneficial in treating other Gram-positive infections besides ABSSSIs, with a good safety profile. Further studies are warranted to ascertain the superiority of one multidose ORI scheme or posology over the other.

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Background: Dalbavancin and oritavancin are long-acting lipoglycopeptides increasingly used off-label for a variety of Gram-positive infections. While their efficacy has been described in osteomyelitis, bacteremia, and infective endocarditis, evidence specifically addressing cardiovascular prosthetic infections such as prosthetic valve endocarditis (PVE), cardiac implantable electronic device (CIED) infections, left ventricular assist device infections (LVAD), and prosthetic vascular graft infections (PVGI) remains limited. These conditions are particularly challenging due to biofilm formation, difficulties in achieving surgical source control, and the frequent need for prolonged or suppressive therapy. Objectives: This systematic review aimed to summarize the available literature on the use of dalbavancin and oritavancin in cardiovascular prosthetic infections, with a focus on therapeutic strategies, clinical outcomes, and safety. Methods: We performed a systematic search of PubMed, Embase, Scopus, and Cochrane Library up to 24 June 2025 in accordance with PRISMA guidelines. Eligible studies included adults treated with dalbavancin or oritavancin for cardiovascular prosthetic infections. Data on study characteristics, population demographics, causative pathogens, and microbiological profiles, antibiotic regimens, treatment duration, use of therapeutic drug monitoring (TDM), indication or non-indication for chronic suppressive therapy, adverse events, clinical outcomes, and clinical efficacy were extracted. Results: Twenty studies comprising 113 patients were identified, of whom 111 received dalbavancin and 2 oritavancin. The main infections were PVE, CIED, LVAD, and PVGI. Dalbavancin was most effective as consolidation therapy after surgery or device removal, with high cure rates. Prolonged regimens were used as bridging or in partially treated cases, sometimes supported by TDM or PET/CT. Chronic suppressive therapy, mainly for LVAD and PVGI infections, achieved variable outcomes with relapses in about one fifth of patients. Adverse events were infrequent and generally mild. Conclusions: The included studies were highly diverse, conducted in various settings and with different objectives. Eight of the twenty included studies were single case reports on dalbavancin and oritavancin, highlighting the predominance of individual case descriptions in the available literature. Long-acting lipoglycopeptides may represent a valuable option for cardiovascular prosthetic infections. Their role appears most favorable as consolidation after adequate source control, while chronic suppressive use showed heterogeneous outcomes. This systematic review was registered on Open Science Framework. This work was supported by grants from the Italian Ministry of Health through Ricerca Corrente, Linea 3, Progetto 3.

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Oritavancin is a long-acting lipoglycopeptide with in vitro activity against Gram-positive pathogens, as well as good bactericidal activity and sterilisation ability in biofilm. It has been approved for acute bacterial skin and skin structure infections (ABSSSI), but recent reports have demonstrated possible off-label uses, such as for vancomycin resistant enterococci (VRE), deep-seated infections including those involving prosthetic material and invasive infections. The aim of this work is to review the uses of oritavancin outside of ABSSSI, focusing on its real-life applications on infective endocarditis, catheter- or device-related infections, bloodstream infections, and bone and prosthetic joint infections in humans, as well as possible future applications. We performed a narrative review, collecting the literature published between 1 December 2002 and 1 November 2022 on PubMed and the Cochrane Library using the term ‘oritavancin’. Available studies have shown how effective it is in different settings, suggesting an opportunity for step-down strategies or outpatient management of infections requiring a long duration of antibiotic treatment. So far, evidence is still scarce, and limited to a few studies and case reports, mostly focusing on Staphylococcus aureus as the major isolate. Concerns about fluid intake for dilution and interaction with coagulation markers also need to be taken into account. Further studies are required in order to assess the safety and effectiveness of Oritavancin in vascular, prosthetic, or device-related infections, as well as in resistant Gram-positive bacteria or enterococcal infections.

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Background: Periprosthetic joint infections (PJIs) remain among the most challenging complications in orthopedic surgery, often requiring prolonged antibiotic therapy and complex surgical interventions. Oritavancin, a long-acting semisynthetic lipoglycopeptide approved for acute bacterial skin and skin structure infections, has emerged as a potential off-label agent in PJI treatment due to its favorable pharmacokinetic properties, potent Gram-positive coverage, and documented antibiofilm activity. Objectives: This comprehensive review aims to assess the current clinical and preclinical data regarding the potential use of oritavancin in the management of PJIs. Methods: A comprehensive literature search was conducted in three major databases. Results: Six studies were included. In vitro data demonstrated strong activity of oritavancin against methicillin-resistant Staphylococcus aureus and S. epidermidis biofilms, particularly in synergy with rifampin. Clinical reports described successful outcomes in both acute and chronic PJI cases, including those with limited surgical options. Weekly or monthly dosing regimens were well-tolerated and effective in suppressive and curative contexts. Adverse events were infrequent but included infusion-related reactions. Conclusions: Oritavancin represents a promising adjunct or alternative to conventional antimicrobial regimens in PJIs, particularly for outpatient management or in patients with multidrug-resistant Gram-positive infections. Further prospective studies are needed to define its role, optimal dosing, and long-term efficacy in this complex clinical setting.

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The clinical landscape of Gram-positive infections has been reshaped with the introduction of long-acting lipoglycopeptides, particularly dalbavancin and oritavancin. Both agents share broad-spectrum activity against multidrug-resistant pathogens, including methicillin-resistant Staphylococcus aureus and vancomycin-resistant strains, yet differ markedly in pharmacokinetics, pharmacodynamics, resistance profiles, and clinical adoption. This review presents a comprehensive comparative analysis of their structural innovations, distinct pharmacokinetic and pharmacodynamic characteristics, and dual mechanisms of action, supported by minimum inhibitory concentration data across key pathogens. Despite belonging to the same antimicrobial class, these agents exhibit important differences in real-world applications and clinical integration. We highlight real-world evidence supporting off-label use in osteomyelitis, endocarditis, and bloodstream infections, where traditional therapies fall short. Furthermore, we explore resistance development, drug-drug interaction profiles, and outpatient utility, providing actionable insights for optimizing treatment strategies. These findings underscore the need for tailored clinical integration of dalbavancin and oritavancin and spotlight their potential roles in future antimicrobial stewardship frameworks.

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Background: Bone and joint infections (BJIs), including osteomyelitis, septic arthritis, and periprosthetic joint infections, typically require prolonged antimicrobial therapy and often involve complex outpatient management. Oritavancin, a long-acting lipoglycopeptide approved for the treatment of acute bacterial skin and skin structure infections caused by Gram-positive bacteria, has emerged as a potential off-label option for BJIs owing to its favourable pharmacokinetic and pharmacodynamic properties. Objectives: To provide a comprehensive overview of the pharmacological rationale, microbiological activity, and available clinical evidence supporting the use of oritavancin in BJIs. Methods: A comprehensive narrative review of the literature was performed using MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL), focusing on publications from 2011 to 2025. Observational studies, case series, and case reports describing the off-label use of oritavancin in BJIs were considered. Results: The available literature primarily consists of observational studies and real-world experiences. Eighteen studies met the inclusion criteria. Oritavancin was most frequently evaluated for osteomyelitis (n = 14 studies), prosthetic joint infections (n = 10) and septic arthritis (n = 5). Multi-dose regimens, typically including a 1200 mg loading dose followed by weekly doses of 800–1200 mg, were the most commonly described strategies. Reported clinical success rates generally ranged from approximately 70% to over 90%. Oritavancin was overall well tolerated, with adverse events being mostly mild and self-limiting. Conclusions: Current evidence suggests that oritavancin may represent an effective and well-tolerated off-label option for selected patients with Gram-positive BJIs. Its use may offer practical advantages, including reduced hospitalization and avoidance of prolonged intravenous antimicrobial therapy, particularly in patients for whom standard treatment approaches are challenging.

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BACKGROUND: Oritavancin, a long-acting lipoglycopeptide approved for use in acute bacterial skin and skin structure infections, has limited data evaluating use in serious infections due to Gram-positive organisms. We aimed to assess the effectiveness and safety of oritavancin for consolidative treatment of Gram-positive bloodstream infections (BSI), including infective endocarditis (IE). METHODS: We conducted a retrospective cohort study evaluating adult patients admitted to University of Colorado Hospital from March 2016 to January 2022 who received ≥ 1 oritavancin dose for treatment of Gram-positive BSI. Patients were excluded if the index culture was drawn at an outside facility or were > 89 years of age. The primary outcome was a 90-day composite failure (clinical or microbiological failure) in those with 90-day follow-up. Secondary outcomes included individual components of the primary outcome, acute kidney injury (AKI), infusion-related reactions (IRR), and institutional cost avoidance. RESULTS: Overall, 72 patients were included. Mean ± SD age was 54 ± 16 years, 61% were male, and 10% had IE. Organisms most commonly causing BSI were Staphylococcus aureus (68%, 17% methicillin-resistant), followed by Streptococcus spp. (26%), and Enterococcus spp. (10%). Patients received standard-of-care antibiotics before oritavancin for a median (IQR) of 11 (5-17) days. Composite failure in the clinically evaluable population (n = 64) at 90-days occurred in 14% and was composed of clinical and microbiological failure, which occurred in 14% and 5% of patients, respectively. Three patients (4%) experienced AKI after oritavancin, and two (3%) experienced an IRR. Oritavancin utilization resulted in earlier discharge for 94% of patients corresponding to an institutional cost-avoidance of $3,055,804 (mean $44,938/patient) from 1,102 hospital days saved (mean 16 days/patient). CONCLUSIONS: The use of oritavancin may be an effective sequential therapy for Gram-positive BSI to facilitate early discharge resulting in institutional cost avoidance.

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INTRODUCTION: Weekly intravenous (IV) oritavancin and daily daptomycin were compared in an outpatient setting following extensive surgical debridement for treating patients with osteomyelitis. METHODS: This was a retrospective, observational study of patients diagnosed with acute osteomyelitis. Exclusion criteria were the use of Gram-negative antibiotic therapy, use of antibiotics for more than 48 h prior to oritavancin or daptomycin or prior use of > 2 doses of oritavancin or more than 4 weeks of daptomycin. Clinical success was resolution or improvement of symptoms and no further treatment. Data were analyzed with Chi-square test or Fisher's exact test. RESULTS: Consecutive outpatients (n = 150) with acute osteomyelitis who were treated with oritavancin or daptomycin (1:1) following extensive surgical debridement were identified. Staphylococcus aureus was the most common pathogen (n = 117). No patient in either group received prior antibiotic therapy (previous 30 days) or was hospitalized within 90 days prior to surgical debridement. Twenty-one (28%) patients prescribed oritavancin had chronic kidney disease, seven of whom were receiving hemodialysis or peritoneal dialysis. Compared to oritavancin, patients prescribed daptomycin had higher rates of all-cause readmission [odds ratio (OR) 2.89; p < 0.001], more infection-related readmission (OR 3.19; p < 0.001), and greater likelihood of receiving antibiotics post-discontinuation of initial therapy (OR 2.13; p < 0.001). Repeat surgical debridement was required for 68.0% with daptomycin vs. 23.1% with oritavancin (p < 0.001). CONCLUSIONS: Oritavancin demonstrated a significantly higher rate of clinical success compared to daptomycin, with lower all-cause and infection-related readmissions, reduced need for repeat surgical debridement, and fewer additional antibiotic requirements.

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