Indication 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.
Important Safety Information TNKase therapy in patients with acute myocardial infarction is
contraindicated in the following certain situations (eg, 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 (eg, 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.
Kushner FG, Hand M, Smith SC Jr, et al. 2009 Focused Updates: ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction (updating the 2004 Guideline and 2007 Focused Update) and ACC/AHA/SCAI Guidelines on Percutaneous Coronary Intervention (updating the 2005 Guideline and 2007 Focused Update): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2009;120(22):2271-2306.
