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.
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Indication
TNKase® (Tenecteplase) is indicated for use in the reduction of mortality associated with acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after the onset of AMI symptoms
Important Safety Information
TNKase therapy in patients with acute myocardial infarction is contraindicated in the following certain situations (e.g. active internal bleeding, history of cerebrovascular accident, known bleeding diathesis, severe uncontrolled hypertension) because of an increased risk of bleeding [See Contraindications in full prescribing information].
The most common complication encountered during TNKase therapy is bleeding. Should serious bleeding (not controlled by local pressure) occur, any concomitant heparin or antiplatelet agents should be discontinued immediately.
In certain conditions (e.g. recent major surgery, cerebrovascular disease, hypertension) the risk of TNKase therapy may be increased and should be weighed against the anticipated benefits. [See WARNINGS in full prescribing information].
Cholesterol embolism has been reported rarely in patients treated with all types of thrombolytic agents; the true incidence is unknown.
Coronary thrombolysis may result in arrhythmias associated with reperfusion. It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered.
Please see full Prescribing Information at www.tnkase.com for additional important safety information.