My organization has recently been approached by Hikma representatives regarding Tyzavan. Some of you may recall the Vanco Ready or "Xellia" premix bags of vancomycin (NDC 70594-041-01, among others), which were acquired by Hikma a while back. These products have an advantage as room temperature premixes of vancomycin, which is fairly unique.

Vanco Ready is notable for having a boxed warning for teratogenicity due to the presence of PEG 400 and NADA. While we have implemented Vanco Ready, we have numerous precautions in place to ensure it is not given to patients of childbearing potential.

This newly marketed Tyzavan is notable in that it lacks the PEG 400. FDA approved a label revision last June to remove the boxed warning because of this. The removal of the boxed warning has been shared as a selling point for Tyzavan.

However, the product contains the exact same concentration of NADA as Vanco Ready. I concluded that, because Tyzavan contains the exact same concentration of NADA as Vanco Ready and no new literature has been published regarding the teratogenicity of NADA, the original conclusion of the Xellia review must continue to apply to Tyzavan regardless of whether the black boxed warning is present.

I am surprised by FDA's decision to remove this boxed warning, and I think this is possibly an opportunity for ISMP to alert clinicians of the continued teratogenic risk of NADA and Tyzavan.

Has anyone else evaluated Tyzavan? Are you considering it contraindicated in pregnancy similar to Vanco Ready?