FDA Approves Vancomycin Injection For Ready-to-Infuse Sepsis Therapy

The FDA has approved vancomycin injection, USP (Tyzavan; Hikma Pharmaceuticals PLC), for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections in adult and pediatric patients 1 month and older for whom appropriate dosing can be achieved.¹

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“[Vancomycin], available in ready-to-infuse aseptically filled bags, exemplifies our commitment to rethinking essential medicines by making them faster to administer, easier to manage, and available when patients need them most,” Bill Larkins, president of Hikma Injectables, said in a news release.¹

Vancomycin Treatment Indications

The injection received FDA approval to treat various infections, starting with septicemia—an infection that occurs when bacteria enter the bloodstream and spread—leading to sepsis.² An individual in the US is diagnosed with sepsis every 20 seconds, and a sepsis-related death occurs every 2 minutes, according to the Sepsis Alliance. The study authors noted that sepsis is also a leading cause of death and hospitalization that often requires antibiotic administration.¹

Infective endocarditis, caused by bacterial infection that inflames the lining of the heart valves and chambers, can also be treated with the injection.³ Other infections, such as skin and skin structure infections, bone infections, and lower respiratory tract infections that cause various complications among pediatrics and older adults, can also be treated with vancomycin.¹

Adverse Events

Individuals treated with vancomycin could experience adverse events (AEs), including infusion reactions caused by rapid administration that could lead to hypotension, shock, cardiac arrest, wheezing, dyspnea, urticaria, and muscular or chest pain, with pediatric patients experiencing more severe reactions. Nephrotoxicity can also occur, ranging from acute kidney injury to acute renal failure, primarily due to interstitial nephritis. Ototoxicity, presenting as tinnitus, hearing loss, dizziness, or vertigo, could occur and can be reversible or permanent. Other AEs include Clostridioides difficile-associated diarrhea, hemorrhagic occlusive retinal vasculitis, and neutropenia.¹

Benefits of Vancomycin in Health Care Setting

As a glycopeptide antibacterial, vancomycin delivers timely, simplified treatment by reducing the preparation steps to support faster treatment. The injection is available at room temperature and does not require compounding, thawing, activation, or dilution. The approval marks vancomycin as a first-of-its-kind, ready-to-infuse formulation of the injection.¹

Vancomycin offers hospitals a practical and scalable solution to enhance treatment efficiency and simplify preparation. Its ready-to-infuse formulation eliminates the need for on-site compounding, which ultimately reduces the burden on pharmacists and pharmacy staff, while also minimizing handling risks and lowering the chance of medication errors.¹

The injection is available in 7 different presentations that range from 0.5 to 2 g, which provides flexibility for both fixed and weight-based dosing. Additionally, its 16-month, room-temperature stability excludes the need for refrigeration, and its compatibility with automated dispensing cabinets ensures the injection can be integrated into existing hospital workflows.¹

REFERENCES

1. Hikma receives FDA approval for TYZAVANTM (Vancomycin Injection, USP) in the US. Hikma. News release. July 2, 2025. Accessed July 2, 2025. https://www.hikma.com/news/hikma-receives-fda-approval-for-tyzavantm-vancomycin-injection-usp-in-the-us/

2. Cleveland Clinic. Septicemia. News release. Updated May 17, 2021. Accessed July 2, 2025. https://my.clevelandclinic.org/health/diseases/21539-septicemia

3. Cleveland Clinic. Endocarditis. News release. Updated May 12, 2025. Accessed July 2, 2025. https://my.clevelandclinic.org/health/diseases/16957-endocarditis