Side Effect Reporting
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.
What it Treats
TNKase® (Tenecteplase) is a single-bolus thrombolytic, or clot-busting agent, approved by the U.S. Food and Drug Administration for use in mortality reduction associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms.
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).
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.
- The most common side effect with TNKase therapy is bleeding. It can be internal bleeding, bleeding in the brain, bleeding from the digestive system, the urinary system, or the reproductive system, or the lungs. Bleeding can also happen from parts of the body where needles have been injected or parts of the body that have had recent surgery. Blood thinners may increase the risk of bleeding if taken before, during, or after TNKase therapy. Patients should inform their doctor of all prescription and over-the-counter drugs they are currently taking.
- A plug of cholesterol that blocks an artery (cholesterol embolism) has been reported rarely in patients treated with all types of clot dissolving agents. This is a serious condition which can be lethal, and is also associated with invasive medical procedures involving the arteries and veins.
- Irregular heart beats can also occur with TNKase therapy. In serious heart attack patients, doctors should choose either drug therapy that dissolves blood clots or a mechanical means to remove the clot as the main treatment strategy.
Please visit www.tnkase.com for the TNKase full prescribing information for additional important safety information.