Extended stability of bivalirudin in intravenous solutions

Background

Bivalirudin is the preferred anticoagulant for pediatric ventricular assist device (VAD) patients. The manufacturer only permits the diluted drug to be used for 24 h once mixed with the sterile solutions. Most infants on VAD require much less than a single infusion bag in 24 h and any remaining infusion at 24 h must be discarded, resulting in increased medication waste and health care costs. The objective of this study was to examine the effect of storage containers and temperature on the stability and activity of intravenous (IV) bivalirudin solutions.

Results

Diluted bivalirudin (AngioMax®) IV solutions (1 and 5 mg/mL in dextrose 5% in water) were prepared in bags and syringes and stored at room temperature and at 2–8 °C. Bivalirudin concentrations were determined at different time points. Bivalirudin activity was determined by assessing its anticoagulating effect on human plasma via partial thromboplastin time (PTT) prolongation. Results suggest that a compounded bivalirudin infusion solution maintains its therapeutic activity and stability at room temperature for up to 48 h.

Conclusions

Data suggest that bivalirudin solutions in dextrose 5% in water and protected from light are potentially stable at room temperature for up to 48 h. Further studies are needed to confirm our study findings.