Preparation: 12 hour infusion bags: Actual Patient Weight (kg) x Dose (24 mcg/kg/hr) = Amount of Xigris needed per hour.Amount of Xigris needed/hr (µg/hr) x 12 hours ÷ 1000 = mg of Xigris needed per 12 hours – round to the nearest 5-mg increment. The solution of reconstituted Xigris is typically diluted into an infusion bag (0.9% Sodium Chloride) to a final concentration of between 100 mcg/mL - 200 mcg/mL. 

Vial dilution: Prior to administration, 5 mg vials must be reconstituted with 2.5 mL of Sterile Water for Injection, USP, and 20 mg vials of Xigris must be reconstituted with 10 mL of Sterile Water for Injection, USP. The resulting concentration of the solution isapproximately 2 mg/mL of Xigris. Slowly add the Sterile Water for Injection, USP tothe vial and avoid inverting or shaking the vial. Gently swirl each vial until the powder is completely dissolved. Because Xigris contains no antibacterial preservatives, the intravenous solution should be prepared immediately upon reconstitution of the Xigris in the vial(s). If the vial of reconstituted Xigris is not used immediately, it may be held at controlled room temperature 20° to 25°C (68° to 77°F), but must be used within 3 hours. Before further dilution or administration, the product should be inspectedvisually for particulate matter and discoloration. Do not use vials if particulate matter is visible or solution is discolored.

Stability: After preparation, the intravenous solution should be used at controlled roomtemperature 20° to 25°C within 14 hours. If the intravenous solution isnot administered immediately, the solution may be stored refrigerated 2° to 8°Cfor up to 12 hours. If the prepared solution is refrigerated prior to administration, the maximum time limit for use of the intravenous solution, including preparation, refrigeration, and administration, is 24 hours.

Instructions for a Syringe Pump: See package insert (The solution of reconstituted Xigris must be further diluted with 0.9% Sodium Chloride Injection, USP to a final concentration of between 100 µg/mL and 1000 µg/mL.)

Actions: Recombinant form of human Activated Protein C. Activated Protein C exerts an antithrombotic effect by inhibiting Factors Va and VIIIa. 

Indications: reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death. Efficacy has not been established in adult patients with severe sepsis and lower risk of death. 

Contraindications: Xigris increases the risk of bleeding. Xigris is contraindicated in patients with the following clinical situations in which bleeding could be associated with a high risk of death or significant morbidity: Active internal bleeding, Recent (within 3 months) hemorrhagic stroke, Recent (within 2 months) intracranial or intraspinal surgery, or severe head trauma; Trauma with an increased risk of life-threatening bleeding; Presence of an epidural catheter; Intracranial neoplasm or mass lesion or evidence of cerebral herniation; known hypersensitivity.