Results observed in real-world settings with reduced hospitalizationsa

The efficacy of KIMYRSA has been established from adequate and well-controlled trials of another oritavancin product, ORBACTIV®, in patients with ABSSSI.

aDue to their nature, retrospective studies can contain material limitations and their results should be considered in light of the entire body of available evidence, including clinical trial data. This work was funded by Melinta Therapeutics.

Hospital avoidance in patients with ABSSSIsa

  • 97.3% of patients received oritavancin as outpatients in a retrospective observational study of 112 patients1†
  • 90% of patients received oritavancin as outpatients in a retrospective and concurrent chart review of 67 patients2‡

Study design: An ongoing retrospective observational registry was used to evaluate the use, outcomes, and AEs associated with oritavancin for the treatment of infections presumed or confirmed to be caused by gram-positive bacteria in clinical practice.

Study design: A retrospective and concurrent chart review was performed on all patients who had received oritavancin between June 2015 and December 2016.

Reduced LOS for admitted patients with ABSSSIa

  • Reduced LOS by 2.3 days (58.9%) in a retrospective descriptive cohort of 199 patients
  • Reduced LOS by 2.77 days (77.3%) in a retrospective cohort analysis of 122 patients4‡
Study design: An ongoing retrospective observational registry was used to evaluate the use, outcomes, and AEs associated with oritavancin for the treatment of infections presumed or confirmed to be caused by gram-positive bacteria in clinical practice.

Study design: A retrospective and concurrent chart review was performed on all patients who had received oritavancin between June 2015 and December 2016.

Reduced rates of readmissionsa

  • No patients admitted to or visited the ED within 30 days in a retrospective chart review of 118 patients5†
  • 2.6% infection-related admissions within 30 days in a retrospective study of 115 patients6‡
  • 2.6% 30-day infection-related readmissions in a retrospective study of 166 patients
  • 3.6% infection-related admissions 28 days post treatment in 2 separate multicenter observational chart reviews of 115 and 151 people1║
  • 83% reduction vs SoC in all-cause 30-day readmissions in a retrospective cohort study of 79 patients
Study design: An ongoing retrospective observational registry was used to evaluate the use, outcomes, and AEs associated with oritavancin for the treatment of infections presumed or confirmed to be caused by gram-positive bacteria in clinical practice.

Study design: A retrospective and concurrent chart review was performed on all patients who had received oritavancin between June 2015 and December 2016.

§Study design: A retrospective real-world study of readmission rates of patients treated in the outpatient setting with oritavancin for SSTI, including MRSA.

Study design: An ongoing retrospective observational registry to evaluate the use of, outcomes of, and AEs associated with oritavancin for the treatment of infections presumed or confirmed to be caused by gram-positive bacteria in clinical practice.

Study design: A retrospective chart review comparing the LOS, readmission rates, and economic impacts of treatment with oritavancin compared with other antibiotic agents effective for cellulitis and abscess.

Help patients get back to their days

ABSSSI, acute bacterial skin and skin structure infection; ED, emergency department; LOS, length of stay; MRSA, methicillin-resistant Staphylococcus aureus; SoC, standard of care.

References: 1. Redell M, Moeck G, Lucasti C, et al. A real-world patient registry for oritavancin demonstrates efficacy and safety consistent with the phase 3 SOLO program. Open Forum Infect Dis. 2018;5(6):ofy051. doi:10.1093/ofid/ofy051 2. Co D, Roebuck L, VanLandingham J. Evaluation of oritavancin use at a community hospital. Hosp Pharm. 2018;53(4):272-276. doi:10.1177/0018578717746415 3. Whittaker C, Lodise TP, Nhan E, Reilly J. Expediting discharge in hospitalized, adult patients with skin and soft tissue infections who received empiric vancomycin therapy with oritavancin: description of findings from an institutional pathway. Drugs Real World Outcomes. 2020;7(suppl 1):30-35. doi:10.1007/s40801-020-00196-6 4. Helton B, MacWhinnie A, Minor SB, Lodise TP, Rafferty KD, Allison SL. Early directed oritavancin therapy in the emergency department may lead to hospital avoidance compared to standard treatment for acute bacterial skin and skin structure infections: a real-world retrospective analysis. Drugs Real World Outcomes. 2020;7(suppl 1):20-29. doi:10.1007/s40801-020-00201-y 5. Anastasio PJ, Wolthoff P, Galli A, Fan W. Single-dose oritavancin compared to standard of care IV antibiotics for acute bacterial skin and skin structure infection in the outpatient setting: a retrospective real-world study. Infect Dis Ther. 2017;6(1):115-128. doi:10.1007/s40121-016-0145-7 6. Turner E, Estrada S, Galli A, Armstrong S, Delaportas D. Treatment of acute bacterial skin and skin structure infections (ABSSSI) in the outpatient setting: clinical and economic outcomes from a real-world multi-center study of oritavancin. Poster presented at: ASHP Conference for Pharmacy Leaders; October 17-18, 2016; Chicago, IL. 7. Estrada S, Lodise TP, Tillotson GS, Delaportas D. The real-world economic and clinical management of adult patients with skin and soft tissue infections (SSTIs) with oritavancin: data from two multicenter observational cohort studies. Drugs Real World Outcomes. 2020;7(suppl 1):6-12. doi:10.1007/s40801-020-00199-3 8. Saddler K, Zhang J, Sul J, et al. Improved economic and clinical outcomes with oritavancin versus a comparator group for treatment of acute bacterial skin and skin structure infections in a community hospital. PLoS One. 2021;16(3):e0248129. doi:10.1371/journal.pone.0248129

*INDICATION AND USAGE

  • Both KIMYRSA and ORBACTIV® are oritavancin products that are indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and methicillin-resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of oritavancin and other antibacterial drugs, oritavancin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
  • KIMYRSATM and ORBACTIV® are not approved for combination use and have differences in dose strength, duration of infusion, and preparation instructions, including reconstitution and dilution instructions and compatible diluents. Please see the full Prescribing Information for each product.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for approximately 120 hours (5 days) after oritavancin administration.
  • Oritavancin products are contraindicated in patients with known hypersensitivity to oritavancin.

Warnings and Precautions

  • Coagulation test interference: Oritavancin has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours and ACT for up to 24 hours. Oritavancin has also been shown to elevate D-dimer concentrations up to 72 hours. For patients who require aPTT monitoring within 120 hours of oritavancin dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT.
  • Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products. Discontinue infusion if signs of acute hypersensitivity occur. Closely monitor patients with known hypersensitivity to glycopeptides.
  • Infusion related reactions: Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of oritavancin products, including after the administration of more than one dose of oritavancin during a single course of therapy. Stopping or slowing the infusion may result in cessation of these reactions.
  • Clostridioides difficile-associated diarrhea: Evaluate patients if diarrhea occurs.
  • Concomitant warfarin use: Oritavancin has been shown to artificially prolong PT/INR for up to 12 hours. Patients should be monitored for bleeding if concomitantly receiving oritavancin products and warfarin.
  • Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.
  • Prescribing oritavancin products in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.

Adverse Reactions

  • The most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. The adverse reactions occurring in ≥2 patients receiving KIMYRSA were hypersensitivity, pruritus, chills and pyrexia.

Please see Full Prescribing Information for ORBACTIV®.

Please see Full Prescribing Information for KIMYRSA.

*INDICATION AND USAGE

Both KIMYRSA and ORBACTIV® are oritavancin products that are indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be

IMPORTANT SAFETY INFORMATION

ContraindicationsUse of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin