TNKase Reconstitution and Administration

Deliver the 5-Second Single Bolus

Follow the instructions to properly reconstitute and administer TNKase for AMI.

Reconstitution Instructions for TNKase

Syringe

See TNKase Package Insert for instructions on the use of the dual cannula device.

Step 1

Remove the shield assembly from the supplied B-D 10 mL syringe with TwinPak™  Dual Cannula Device.

Step 1

Step 2

Aseptically WITHDRAW 10 mL of Sterile Water for Injection, USP, using the B-D 10 mL syringe with TwinPak™ Dual Cannula Device included in the kit. Do not use Bacteriostatic Water for Injection, USP.

Step 2

Step 3

INJECT entire contents (10 mL) into the TNKase vial, directing the diluent into the powder. Slight foaming upon reconstitution is not unusual; any large bubbles will dissipate if the product is allowed to stand undisturbed for several minutes.

Step 3

Step 4

GENTLY SWIRL until contents are completely dissolved. DO NOT SHAKE. Solution should be colorless or pale yellow and transparent. Once the appropriate dose of TNKase is drawn into the syringe, stand the shield vertically and recap the red tab cannula.

Step 4

Step 5

USE UPON RECONSTITUTION. If not used immediately, refrigerate solution (which does not contain bacterial preservative) at 2–8°C (36–46°F) and use within 8 hours. DO NOT FREEZE. Final concentration of TNKase is 5 mg/mL.

Administration Instructions for TNKase

Step 1

Determine the correct dose of TNKase based on patient weight. TNKase is for IV administration only.

Step 1

Step 2

WITHDRAW the appropriate volume of solution based on patient weight. The recommended total dose should not exceed 50 mg. Discard solution remaining in the vial.

Step 2

Step 3

FLUSH a dextrose-containing line with a saline-containing solution prior to and following administration (precipitation may occur when TNKase is administered in an IV line containing dextrose). ADMINISTER as an IV BOLUS over 5 seconds.

Step 3
Bottle

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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.

    • TNKase [prescribing information]. South San Francisco, CA. Genentech, Inc: 2018.

      TNKase [prescribing information]. South San Francisco, CA. Genentech, Inc: 2018.

    • O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:e362-e425.

      O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;127:e362-e425.

    • Bennett WF, Paoni NF, Keyt BA, et al. High resolution analysis of functional determinants on human tissue-type plasminogen activator. J Biol Chem. 1991;266:5191-5201.

      Bennett WF, Paoni NF, Keyt BA, et al. High resolution analysis of functional determinants on human tissue-type plasminogen activator. J Biol Chem. 1991;266:5191-5201.

    • 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.

      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.

    • Cannon CP, Gibson CM, McCabe CH, et al. TNK-tissue plasminogen activator compared with front-loaded alteplase in acute myocardial infarction. Results of the TIMI 10B trial. Circulation. 1998;98:2805-2814.

      Cannon CP, Gibson CM, McCabe CH, et al. TNK-tissue plasminogen activator compared with front-loaded alteplase in acute myocardial infarction. Results of the TIMI 10B trial. Circulation. 1998;98:2805-2814.

    • Cannon CP, McCabe CH, Gibson CM, et al. TNK-tissue plasminogen activator in acute myocardial infarction: results of the Thrombolysis Myocardial Infarction (TIMI) 10A dose-ranging trial. Circulation. 1997;95:351-356.

      Cannon CP, McCabe CH, Gibson CM, et al. TNK-tissue plasminogen activator in acute myocardial infarction: results of the Thrombolysis Myocardial Infarction (TIMI) 10A dose-ranging trial. Circulation. 1997;95:351-356.