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.


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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. 

References

  1. Melinta Therapeutics announces commercial availability of Kimyrsa™ (oritavancin). [press release]. Morristown, NJ: July 7, 2021. 
  2. Kimyrsa [package insert]. Lincolnshire, IL: Melinta Therapeutics, LLC; 2021.