Kimyrsa™ (oritavancin) is now available for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms.
Kimyrsa is a single-dose, long-acting lipoglycopeptide antibiotic indicated for the treatment of ABSSSI caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -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).
The efficacy and safety of Kimyrsa was supported by data from the phase 3 SOLO I (ClinicalTrials.gov Identifier: NCT01252719) and II (ClinialTrials.gov Identifier: NCT01252732) trials, which compared a single dose of oritavancin 1200mg intravenously to vancomycin (1g or 15mg/kg twice daily intravenously for 7 to 10 days).
Findings from both studies showed that oritavancin was as effective as vancomycin for the primary and secondary endpoints. Approval was also based on data from a pharmacokinetics (PK) study that compared Kimyrsa (n=50) administered over 1 hour to Orbactiv (oritavancin) (n=52) administered over 3 hours for the treatment of adults with ABSSSI.
The most common adverse reactions reported with oritavancin products include headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. In the PK study, hypersensitivity, pruritus, chills and pyrexia occurred in 2 or more patients receiving Kimyrsa.
Kimyrsa is supplied as a lyophilized powder in a single-dose vial containing 1200mg of oritavancin. As there are 2 oritavancin products available (Kimyrsa and Orbactiv), the recommended dosage and dose preparation instructions for Kimyrsa should be carefully followed.
- Melinta Therapeutics announces commercial availability of Kimyrsa™ (oritavancin). [press release]. Morristown, NJ: July 7, 2021.
- Kimyrsa [package insert]. Lincolnshire, IL: Melinta Therapeutics, LLC; 2021.