Description TNKase® (Tenecteplase), a single-bolus thrombolytic, or clot-busting agent, works by stimulating the body's own clot-dissolving mechanism by activating plasminogen. TNKase activates plasminogen, converting it into plasmin, which then breaks down the fibrin mesh that binds the clot together. The clot is then dissolved.

Development Status Phase III clinical trials evaluating TNKase for restoration of function in dysfunctional central venous access catheters and dysfunctional hemodialysis catheters are ongoing.

Approved Uses

• In June 2000, the U.S. Food and Drug Administration (FDA) approved TNKase, a thrombolytic, or clot-busting agent, for the reduction of mortality associated with acute myocardial infarction (AMI), or heart attack.

Important Safety Information TNKase therapy should not be used in the following conditions due to an increased risk of bleeding: active internal bleeding, history of stroke, brain or spinal surgery or a serious head injury within 2 months, brain tumor, an abnormal connection between veins and arteries, or abnormal bulge in the wall of an artery, problems with blood clotting, and severe uncontrolled high blood pressure.

All thrombolytic agents increase the risk of bleeding, including bleeding in the brain, and should be used only in eligible patients. In addition, drug therapy that dissolves blood clots increases the risk of stroke, including stroke caused by bleeding into the brain, particularly in elderly patients. In serious heart attack patients, physicians should choose either drug therapy that dissolves blood clots or a mechanical means to remove the clot as the main treatment strategy.

For TNKase full prescribing information, including additional important safety information, please visit http://www.tnkase.com.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

August 2009