Vanco Ready, a ready-to-use (RTU) vancomycin injection, has been made available by Xellia Pharmaceuticals.
The new 100mL premixed bag contains 500mg of vancomycin and is stable at room temperature (up to 25 °C) with a 16-month shelf life in overwrap and 28-day shelf life outside of overwrap. The product can also be stored in automated dispensing cabinets. In addition, the RTU formulation is available in 200mL, 300mL, and 400mL premixed bags containing 1g, 1.5g, and 2g of vancomycin, respectively.
The approval was based on more than 60 non-clinical studies to confirm that the new formulation does not negatively affect the efficacy of vancomycin. Regarding safety, the RTU formulation carries a Boxed Warning for embryo-fetal toxicity. It is not recommended for use during pregnancy due to the excipients polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), which have caused fetal malformations in animal reproduction studies. If use of vancomycin is needed during pregnancy, alternative formulations of vancomycin should be used.
“Our room temperature stable Vanco Ready premix has been critical in providing a truly ready vancomycin injection product,” said Craig Boyd, Xellia’s North American President. “It aligns with recommendations from US agencies – such as the American Society of Hospital Pharmacists (ASHP), Institute for Safe Medication Practices (ISMP) and Joint Commission – to use manufacturer-prepared products as part of safe medication practice.”
Vancomycin is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections.
For more information visit xellia.com.
This article originally appeared on MPR