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TNKase Survival Probability Curves




Probability of survival observed in ASSENT-2 (N=16 949)1

Kaplan-Meier curves shown are for all-cause mortality in TNKase-treated patients and Activase® (alteplase)-treated patients through 30 days post-enrollment


30-day mortality observed in ASSENT-2 (N=16 949)2

6.2% for TNKase (n=8461), 6.2% for Activase (n=8488) (relative risk 1.00; 95% CI=0.89-1.12; absolute difference=0.0%)

Indication

Activase® (alteplase) is indicated for use in acute myocardial infarction (AMI) for the reduction of mortality and reduction of the incidence of heart failure.

Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose AMI puts them at low risk for death or heart failure.

Important Safety Information

Contraindications

Do not administer Activase to treat acute myocardial infarction in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding; history of recent stroke; recent (within 3 months) intracranial or intraspinal surgery or serious head trauma; presence of intracranial conditions that may increase the risk of bleeding (e.g. some neoplasms, arteriovenous malformations, or aneurysms); bleeding diathesis; and current severe uncontrolled hypertension.

Warnings and Precautions

Bleeding

Activase can cause significant, sometimes fatal internal or external bleeding, especially at arterial and venous puncture sites. Avoid intramuscular injections and trauma to the patient. Perform venipunctures carefully and only as required. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Aspirin and heparin have been administered concomitantly with and following infusions of Activase in the management of AMI. Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. If serious bleeding occurs, terminate the Activase infusion, and treat properly.

In the following conditions, the risks of bleeding with Activase are increased and should be weighed against the anticipated benefits: recent major surgery or procedure; cerebrovascular disease; recent intracranial hemorrhage; recent gastrointestinal or genitourinary bleeding; recent trauma; hypertension; acute pericarditis; subacute bacterial endocarditis; hemostatic defects including those secondary to severe hepatic or renal disease; significant hepatic dysfunction; pregnancy; diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions; septic thrombophlebitis or occluded AV cannula at seriously infected site; advanced age; and patients currently receiving oral anticoagulants, or any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location.

Hypersensitivity

Hypersensitivity, including urticarial/anaphylactic reactions, have been reported. Rare fatal outcome for hypersensitivity was reported. Angioedema has been observed during and up to 2 hours after infusion in patients treated for acute ischemic stroke and acute myocardial infarction. In many cases, patients received concomitant angiotensin converting enzyme inhibitors. Monitor patients during and for several hours after infusion for hypersensitivity. If signs of hypersensitivity occur, e.g. anaphylactoid reaction or angioedema develops, discontinue Activase and promptly institute appropriate therapy (e.g., antihistamines, intravenous corticosteroids, epinephrine).

Thromboembolism

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 atrial fibrillation. Activase has not been shown to treat adequately underlying deep vein thrombosis in patients with PE. Consider the possible risk of re-embolization due to the lysis of underlying deep venous thrombi in this setting.

Cholesterol Embolization

Cholesterol embolism, sometimes fatal, has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown. It is associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy.

Coagulation Tests May be Unreliable during Activase Therapy

Coagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy unless specific precautions are taken to prevent in vitro artifacts. When present in blood at pharmacologic concentrations, Activase remains active under in vitro conditions, which can result in degradation of fibrinogen in blood samples removed for analysis.

Adverse Reactions

The most frequent adverse reaction associated with Activase AMI therapy is bleeding

Please see full Prescribing Information for additional Important Safety Information.


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

Contraindications

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.

Warnings

Bleeding

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.

Thromboembolism

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 atrial fibrillation.

Cholesterol Embolization

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.

Arrhythmias

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.

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.

Precautions

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.

Hypersensitivity

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.

Adverse Reactions

The most frequent adverse reaction associated with TNKase is bleeding.

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.


References:
1.  Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomized trial. Lancet. 1999;354:716-722.
2.  TNKase [prescribing information]. South San Francisco, CA. Genentech, Inc: 2018.





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Please see TNKase full Prescribing Information. TNKase® (Tenecteplase). Activase® (alteplase).

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