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

contraindicated in the following clinical situations where bleeding could lead to significant morbidity or death:

  • 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

WARNINGS and PRECAUTIONS

Bleeding is the most common serious adverse effect associated with Xigris therapy. Each patient being considered for therapy with Xigris should be carefully evaluated and anticipated benefits weighed against potential risks associated with therapy.

Certain conditions, many of which led to exclusion from the Phase 3 clinical trial (PROWESS), are likely to increase the risk of bleeding with Xigris therapy. Therefore, for patients with severe sepsis who have one or more of the following conditions, the increased risk of bleeding should be carefully considered when deciding whether to use Xigris therapy:

  • Concurrent therapeutic dosing of heparin to treat an active thrombotic or embolic event
  • Platelet count <30,000 x 10,000,000/L, even if the platelet count is increased after transfusions
  • Prothrombin time-INR >3.0
  • Recent (within 6 weeks) gastrointestinal bleeding
  • Recent administration (within 3 days) of thrombolytic therapy
  • Recent administration (within 7 days) of oral anticoagulants or glycoprotein IIb/IIIa inhibitors
  • Recent administration (within 7 days) of aspirin >650 mg per day or other platelet inhibitors
  • Recent (within 3 months) ischemic stroke
  • Intracranial arteriovenous malformation or aneurysm
  • Known bleeding diathesis
  • Chronic severe hepatic disease '/>"/>

SOURCE Eli Lilly and Company
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