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Lilly and Investor Group Form New Critical Care Company BioCritica, Sign Xigris License Agreement
Date:5/23/2011

ion to placeboplusXigris. This finding was based on prospectively defined exploratory subgroup analyses; however, the explanation for the finding is unclear. The safety of prophylactic heparin when concomitantly administered with Xigris in adult patients with severe sepsis was evaluated with low molecular weight heparin enoxaparin (40 mg every 24 hours) and unfractionated sodium heparin (5000 U every 12 hours), but was not evaluated with unfractionated sodium heparin 5000 U when dosed every 8 hours.

  • Invasive Procedures

Invasive procedures increase the risk for bleeding with Xigris. Such procedures, including arterial and central venous punctures, should be minimized during the Xigris infusion. Puncture of a noncompressible site should be avoided during the infusion. Xigris should be discontinued 2 hours prior to undergoing an invasive surgical procedure or procedures with an inherent risk of bleeding. Once adequate hemostasis has been achieved, Xigris may be restarted 12 hours after surgery and major invasive procedures or immediately after uncomplicated less invasive procedures.

ADVERSE REACTIONS

Bleeding is the most commonly reported adverse reaction in patients receiving Xigris therapy. Patients administered Xigris as treatment for severe sepsis experience many events which are potential sequelae of severe sepsis and may or may not be attributable to Xigris therapy. In severe sepsis clinical trials, there were no types of nonbleeding adverse events suggesting a causal association with Xigris.

In the PROWESS study, serious bleeding events were observed during the 28-day study period in 3.5% of Xigris-treated and 2.0% of placebo-treated patients. The difference in serious bleeding occurred primarily during infusion.

The incidence of intracranial hemorrhage (ICH) during the study period was 0.2% for Xigristreated patients and 0.1% for placebotre
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