Classes
DEA Class; Rx
Common Brand Names; TNK tPA, TNKase
- Thrombolytics
Description
Recombinant thrombolytic agent given as single IV bolus for AMI
Longer half-life, increased fibrin specificity, and increased resistance to PAI-1 compared to alteplase with similar clinical outcomes of 30-day mortality, intracranial bleeding, and minor bleeding
Major (non-cerebral) bleeding and blood transfusions were lower with tenecteplase (ASSENT 2 trial) compared to alteplase
Indications
Indicated for the treatment of acute myocardial infarction with ST-elevation (STEMI) due to coronary artery thrombosis.
Contraindications
Hypersensitivity
Active bleeding, history of CVA, recent (within 2 months) intracranial or intraspinal surgery or trauma, intracranial neoplasm, AVM, aneurysm, bleeding diathesis, severe uncontrolled HTN, recent (within 3 mth) facial trauma, suspected aortic dissection
Adverse Effects
Minor bleeding (22%)
Reperfusion arrhythmias
MI
Fever
Nausea
Vomiting
Cholesterol embolization
Allergic reaction
Warnings
Hypersensitivity, including urticarial/anaphylactic reactions, reported after administration of TNKase (eg, anaphylaxis, angioedema, laryngeal edema, rash, and urticaria); monitor patients treated with TNKase during and for several hours after infusion; if symptoms of hypersensitivity occur, initiate appropriate therapy
Standard management of myocardial infarction should be implemented concomitantly with TNKase treatment; arterial and venous punctures should be minimized; noncompressible arterial puncture must be avoided and internal jugular and subclavian venous punctures should be avoided to minimize bleeding from the non-compressible sites
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
Readministration of plasminogen activators, including TNKase, to patients who have received prior plasminogen activator therapy has not been systematically studied; although sustained antibody formation in patients receiving one dose of TNKase has not been documented,readministration should be undertaken with caution
Pregnancy and Lactation
There are no adequate and well-controlled studies in pregnant women; therapy should be given to pregnant women only if potential benefits justify potential risk to fetus
Not known if this drug is excreted in human milk; because many drugs are excreted in human milk, exercise caution when this drug is administered to a nursing woman
Maximum Dosage
50 mg/total dose IV.
50 mg/total dose IV.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tenecteplase
powder for injection
- 50mg