The U.S. Food and Drug Administration has approved Tyzavan (vancomycin injection, USP), a ready-to-infuse formulation for the treatment of serious infections in adults and pediatric patients aged 1 month and older, provided appropriate dosing can be achieved.

Tyzavan is the first FDA-approved vancomycin formulation that is stable at room temperature and requires no compounding, thawing, activation, or dilution prior to use. Indications include septicemia, infective endocarditis (including early-onset prosthetic valve endocarditis), skin and skin structure infections, bone infections, and lower respiratory tract infections. 

This product is positioned to address time-sensitive therapeutic needs, particularly in the management of sepsis. Independent research suggests a 15% reduction in sepsis survival occurring after 87 to 113 minutes. Tyzavan’s ready-to-infuse design may facilitate earlier administration in emergency and inpatient settings by reducing preparation time and pharmacy workload.

Tyzavan is contraindicated in patients with known hypersensitivity to vancomycin. Reported risks include infusion-related reactions, nephrotoxicity, ototoxicity, and severe dermatologic events such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Additional adverse effects include Clostridioides difficile–associated diarrhea, phlebitis, and neutropenia. Caution is advised with concomitant use of nephrotoxic or ototoxic agents, including piperacillin-tazobactam.

Additional product and safety information is available in the full prescribing information provided by Hikma Pharmaceuticals USA Inc.

Source: Hikma Pharmaceuticals USA Inc