ORBACTIV® (oritavancin) was studied in 2 large, identically designed, phase 3 trials1,2

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

SOLO I and SOLO II1,2

  • Two global, multicenter, randomized, double-blind studies [Corey 2014 NEJM/p2181 [PDF p2]/col1/par3/ln1-7; Corey 2015/p255 [PDF p2]/col1/par3/ln1-5]
  • Designed to compare the efficacy, safety, and noninferiority of single-dose intravenous ORBACTIV® (oritavancin) vs intravenous vancomycin for 7 to 10 days in adults with ABSSSIs (including cellulitis, abscesses, and wound infections) [Corey 2014 NEJM/p2181 [PDF p2]/col1/par3/ln1-7, p2183/col2/para3/all; Corey 2015/p255 [PDF p2]/col1/par3/ln1-5, col2/para7/Ln1-6]
  • 1,959 study participants (oritavancin, 978; vancomycin, 981) [Corey 2014 NEJM/p2182 [PDF p3]; Corey 2015/p256 [PDF p3]/ Fig1]
SOLO I: A global, randomized, double-blind study.1
SOLO II: A global, multicenter, randomized, double-blind, comparative efficacy and safety study2

Study Design for SOLO I and SOLO II


*The intent-to-treat (ITT) population included all patients randomized into the study.

*The modified intent-to-treat (mITT) population was the primary population for all the efficacy analyses and included all randomized patients who received any study drug.

Early clinical response defined as a composite of the cessation of spread or reduction in size of baseline lesion, absence of fever, and no rescue antibacterial drug at 48 to 72 hours.1 [Corey 2014 NEJM/p2183/col1/para2/Ln1-7]

§Patients achieving a ≥20% reduction in lesion area from baseline at 48 to 72 hours after initiation of therapy.1,2 [Corey 2014 NEJM/p2183 [PDF p4]/col1/par2/ln11; col2/par1/ln1-3; Corey 2015/p255 [PDF p2]/col2/par5/ln1-3]

SOLO I and SOLO II demographic baseline characteristics of the study participants (mITT population)1,2a

aThere were no significant between-group differences except for age (P=0.04, calculated with the use of the Kruskal–Wallis test) and a positive blood culture for S. aureus (P=0.002, calculated with the use of Fisher’s exact test). Percentages may not add up to 100 because of rounding.

bRace was self-reported.

cIncludes both infection site culture and blood culture.

Single-dose oritavancin achieved early clinical response rates at 48 to 72 hours in adults with ABSSSIs, including MRSA1

ABSSSI, acute bacterial skin and skin structure infection; max, maximum; min, minimum; MRSA, methicillin-resistant Staphylococcus aureus.

References: 1. Corey GR, Kabler H, Mehra P, et al. Single-dose oritavancin in the treatment of acute bacterial skin infections. N Engl J Med. 2014;370(23):2180-2190. doi:10.1056/NEJMoa1310422 2. Corey GR, Good S, Jiang H, et al. Single-dose oritavancin versus 7-10 days of vancomycin in the treatment of gram-positive acute bacterial skin and skin structure infections: the SOLO II noninferiority study. Clin Infect Dis. 2015;60(2):254-262. doi:10.1093/cid/ciu778

*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