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
Important Safety Information
TNKase therapy in patients with AMI is contraindicated in
the following situations because of an increased risk of bleeding: active
internal bleeding; history of cerebrovascular accident; intracranial or
intraspinal surgery, or trauma within 2 months; intracranial neoplasm,
arteriovenous malformation, or aneurysm; known bleeding diathesis; and
severe uncontrolled hypertension.
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 and treated appropriately.
In clinical studies of TNKase, patients were treated with
both aspirin and heparin. Heparin may contribute to the bleeding risks
associated with TNKase. The safety of the use of TNKase with other
antiplatelet agents has not been adequately studied. Intramuscular injections
and nonessential handling of the patient should be avoided for the first few
hours following treatment with TNKase.
The risk of bleeding may be increased in the following
conditions and should be weighed against the anticipated benefits: recent
major surgery, cerebrovascular disease, recent gastrointestinal or
genitourinary bleeding, recent trauma, hypertension, acute pericarditis, subacute
bacterial endocarditis, hemostatic defects, severe hepatic dysfunction, pregnancy,
diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions, septic
thrombophlebitis or occluded AV cannula at seriously infected site, advanced
age, patients currently receiving oral anticoagulants, recent administration
of GP IIb/IIIa inhibitors, and any other condition in which bleeding
constitutes a significant hazard or would be particularly difficult to manage
because of its location.
The use of thrombolytics can increase the risk of thrombo-embolic events in patients
with high likelihood of left heart thrombus, such as patients with mitral stenosis or
Cholesterol embolism has been reported rarely in patients
treated with all types of thrombolytic agents; the true incidence is unknown.
This serious condition, which can be lethal, is also associated with invasive
vascular procedures (e.g., cardiac catheterization, angiography, vascular
surgery) and/or anticoagulant therapy.
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
Use with Percutaneous Coronary Intervention (PCI)
In patients with large ST-segment elevation myocardial
infarction, physicians should choose either thrombolysis or PCI as the primary
treatment strategy for reperfusion.
Standard management of myocardial infarction should be
implemented concomitantly with TNKase treatment. In the event of serious bleeding,
heparin and antiplatelet agents should be discontinued immediately.
Anaphylactoid reactions associated with the administration
of TNKase are rare and can be caused by hypersensitivity to the active substance
tenecteplase or to any of the excipients. If symptoms of hypersensitivity occur,
appropriate therapy should be initiated.
Drug and Drug/Laboratory Test Interactions
Formal interaction studies of TNKase with other drugs have
not been performed. Patients studied in clinical trials of TNKase were routinely
treated with heparin and aspirin.
During TNKase therapy, results of coagulation tests and/or
measures of fibrinolytic activity may be unreliable unless specific precautions are
taken to prevent in vitro artifacts. Tenecteplase is an enzyme that, when present in
blood in pharmacologic concentrations, remains active under in vitro conditions. This
can lead to degradation of fibrinogen in blood samples removed for analysis.
The most frequent adverse reaction associated with TNKase
Should serious bleeding occur, concomitant heparin and
antiplatelet therapy should be discontinued. Death or permanent disability
can occur in patients who experience stroke or serious bleeding episodes. For
TNKase-treated patients in ASSENT-2, the incidence of intracranial hemorrhage was 0.9%
and incidence of any stroke was 1.8%. The incidence of all strokes, including intracranial
bleeding, increases with advancing age.
Please see full Prescribing Information for additional
Important Safety Information.