The FDA has approved room temperature stable, premixed vancomycin injections, which will be available in ready-to-use bags.
The US Food and Drug Administration (FDA) has approved premixed vancomycin injections in a ready-to-use bag, Xellia Pharmaceuticals announced today. The approval comes a year after the FDA issued a Qualified Infectious Disease Product designation for the injection.
The vancomycin injection is a glycopeptide antibacterial that is indicated for pediatric patients older than 1 month and adults for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory infections.
“Vancomycin is a critical World Health Organization designated essential medicine. With this approval, US health care professionals will now have access to multiple presentations of the first room temperature stable Vancomycin Injection Premix with 16 months of shelf life,” Craig Boyd, Xellia’s North American president, said in a statement. “In addition, this should move the product closer to the patients which may reduce time to delivery in urgent, emergency needs.”
According to the statement issues by Xellia, the approval was based on more than 60 non-clinical experiments and studies that verified that the new formulation does not have an adverse impact on the efficacy profile of vancomycin.
The new injectable formulation will be available as a premixed solution in single-dose flexible bags, stable at room temperature for 16 months.
The ready to use injection is provided as 100 mL, 200 mL, 300 mL, or 400 mL solution containing 500 mg, 1 g, 1.5 g, or 2 g vancomycin, respectively. Each 100 mL of solution contain 1.8 mL polyethylene glycol 400, 1.36 g N-acetyl-D-alanine, and 1.26 g L-lysine hydrochloride, with hydrochloric acid and sodium hydroxide used for pH adjustment.
The safety profile of the injection has been evaluated in both in vitro and in vivo studies, including 5 repeat dose toxicity studies in animal models with dosing up to 13 weeks. Additionally, the company reports full safety qualification of excipient N-acetyl-D-alanine (NADA) including safety pharmacology and repeat dose toxicity studies in 2 animal species with dosing up to 13 weeks, and animal reproduction studies of N-acetyl-D-alanine and polyethylene glycol 400.
Due to the presence of excipients polyethylene glycol (PEG 400) and NADA in the formulation, this product is not recommended for use during pregnancy. During animal reproduction studies, the product cause fetal malformations and therefore, there is a boxed warning of risk of embryo-fetal toxicity.
In the studies, the commonly reported adverse reactions were anaphylaxis, red man syndrome, acute kidney injury, hearing loss, neutropenia.
The company also notes that concomitant administration of vancomycin and anesthetic agents has been associated with erythema and histamine-like flushing. Additionally, increase incidence of acute kidney injury was noted in patients receiving concomitant piperacillin/tazobactam and vancomycin as compared to vancomycin alone. Therefore, kidney function should be monitored in these patients.