Magazine article Drug Topics

Letters

Magazine article Drug Topics

Letters

Article excerpt

Beware of these Xigris dosing concerns

As a physician at Eli Lilly & Co., the manufacturer of Xigris (drotrecogin alfa [activated]), I am responding to an article that appeared in your Aug. 21 issue, referencing a pharmacy technician who created a "Xigris calculator."

While the dosing calculator is capable of producing results that are within recommended dosing guidelines with respect to concentration and infusion rate, it may lead to a potential deviation of the infusion duration, shortening the duration by as much as four hours.

Consequently, the dosing calculator leads to recommendations inconsistent with how the drug has been studied and approved, which is at a 24 mcg/kg/hr continuous infusion for 96 hours in adult severe sepsis patients at high risk of death. The pivotal phase III study, upon which FDA approval was granted, did not include dosing guidelines based on variable dosing duration dependent upon patient weight. Additionally, the dosing calculator produces a recommendation to vary the infusion rate during the administration period (due to variable concentrations), which could lead to dosing errors. …

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