#
Xigris
  • Professionals
  • FDA PI

Xigris

Generic name: drotrecogin alfa (activated)
Dosage form: injection, powder, lyophilized, for solution
Drug class:Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.

Indications and Usage for Xigris

Xigris® is indicated for the reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II score ≥25) [see Clinical Studies (14.1)].

Limitations of use:

Xigris is not indicated in adult patients with severe sepsis and a lower risk of death (e.g., APACHE II score <25) [see Clinical Studies (14.3)].

Xigris is not indicated in pediatric patients [see Clinical Studies (14.4)].

Xigris Dosage and Administration

Recommended Dosing and Administration Overview

Xigris should be administered intravenously at an infusion rate of 24 mcg/kg/hr (based on actual body weight) for a total duration of infusion of 96 hours. Dose adjustment based on clinical or laboratory measurements is not recommended [see Drug Interactions (7.3)]. Dose escalation or bolus doses of Xigris are not recommended.

If the infusion is interrupted, Xigris should be restarted at the 24 mcg/kg/hr infusion rate.

In the event of clinically important bleeding, immediately stop the infusion [see Warnings and Precautions (5.1)].

Xigris should be administered via a dedicated intravenous line or a dedicated lumen of a multilumen venous catheter. The ONLY other solutions that can be administered through the same line are 0.9% Sodium Chloride Injection, USP; Lactated Ringer's Injection, USP; Dextrose Injection, USP; and Dextrose and Sodium Chloride Injection, USP.

<...