Full Prescribing Information
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TNKase® (Tenecteplase) is a single-bolus thrombolytic agent, that has been approved by the U.S. Food and Drug Administration for the treatment of acute myocardial infarction (AMI). TNKase is the first thrombolytic that can be administered over five seconds in a single dose, offering physicians the fastest administration of a thrombolytic to date in the treatment of heart attack. TNKase is a bioengineered variant of Activase® (Alteplase, recombinant), which is a recombinant DNA-derived version of naturally occurring tissue plasminogen activator (t-PA). It is constructed with amino acid substitutions at three sites (the letters T, N and K represent the three regions changed from the natural t-PA protein).

Status TNKase was approved for the treatment of acute myocardial infarction (AMI) in June 2000.

Proposed Mechanism of Action TNKase works by stimulating the body's own clot-dissolving mechanism by activating plasminogen, a naturally occurring substance secreted by endothelial cells in response to injury to the artery walls that contributes to clot formation. When TNKase activates plasminogen, it converts into plasmin, which breaks down the fibrin mesh that binds the clot together. The clot is then dissolved, restoring blood flow to the heart.

Acute Myocardial Infarction Heart attack, or acute myocardial infarction, is caused when a blood clot obstructs a coronary artery supplying blood to the heart. This causes an inadequate flow of oxygenated and nutrient-enriched blood and results in the death of a portion of the heart muscle. Symptoms of a heart attack may include: uncomfortable pressure, fullness, squeezing or pain in the center of the chest that lasts for more than a few minutes; pain spreading to the shoulders, neck or arms; and chest discomfort with lightheadedness, fainting, sweating, nausea or shortness of breath. As many as 1.1 million Americans suffer heart attacks each year. Of these, about one-third will die, making heart attack the number one killer of men and women in the U.S. About 650,000 of these cases are first attacks while 450,000 are recurrent attacks.

Safety Information All thrombolytic agents increase the risk of bleeding, including intracranial bleeding, and should be used only in eligible patients. In addition, thrombolytic therapy increases the risk of stroke, including hemorrhagic stroke, in elderly patients.