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Class: Thrombolytic Agents
- Tissue-type Plasminogen Activator (Recombinant)
Brands: TNKase

Medically reviewed by Last updated on Oct 23, 2017.


Thrombolytic agent; biosynthetic (recombinant DNA origin) form of human tissue-type plasminogen activator (t-PA).1 2 3 4 5 6 7

Uses for Tenecteplase

Acute MI

Used for reperfusion therapy in patients with acute MI, in conjunction with appropriate anticoagulant (e.g., heparin) and antiplatelet (e.g., aspirin and clopidogrel) therapies.1 5 7 527

Current standard of care in patients with ST-segment-elevation MI (STEMI) is timely reperfusion (with primary PCI or thrombolytic therapy).527 994 The American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guideline states that reperfusion therapy should be administered to all eligible patients with STEMI and onset of ischemic symptoms within the previous 12 hours.527 994 Select appropriate reperfusion method based on a risk-benefit analysis, considering the time from onset of MI symptoms, patient's clinical and hemodynamic status, comorbidities (e.g., severe heart failure), bleeding risk, contraindications, and availability (and timeliness) of PCI.527

Primary PCI is preferred when it can be performed in a timely manner.527 994 Thrombolytic therapy is recommended when it is anticipated that PCI cannot be performed within 120 minutes of first medical contact.527

Benefits of thrombolytic therapy in patients with STEMI are well established;527 30-day and 1-year mortality rates similar after tenecteplase 30–50 mg or an accelerated infusion of alteplase.1 5

Clinical benefit diminishes as the time period from symptom onset to initiation of therapy increases.527 Administer as soon as possible after onset of acute MI symptoms.1 ACCF and AHA recommend administration within 30 minutes of hospital arrival.527

Pulmonary Embolism

Has been used for the treatment of acute PE.16 17 20 1005

The American College of Chest Physicians (ACCP) generally recommends against the use of systemic thrombolytic therapy in most patients with acute PE; however, in patients with acute PE associated with hypotension (e.g., systolic BP <90 mm Hg), thrombolytic therapy may provide some benefit in terms of mortality reduction and is suggested as a possible treatment in patients without a high risk of bleeding.1005

Tenecteplase Dosage and Administration


  • Initiate therapy as soon as possible after acute MI.1 (See Acute MI under Uses.)


IV Administration

For solution compatibility information, see Solution Compatibility under Stability.

Administer IV.1


Consult the manufacturer's labeling for instructions for using the B-D 10-mL Syringe with TwinPak Dual Cannula Device for reconstitution and administration.1

Reconstitute with 10 mL of sterile water for injection without preservatives to provide a solution containing 5 mg/mL.1

If foaming (usually slight) occurs, leave vial undisturbed for several minutes to allow dissipation of any large bubbles.1 Gently swirl until contents are completely dissolved; avoid shaking.1

Rate of Administration

Administer over 5 seconds.1


Expressed in mg.1

Biologic potency is determined using an in vitro clot lysis assay and is expressed in tenecteplase-specific units.1 Each mg is equivalent to 200 tenecteplase-specific units.1

Dose based on patient weight.1


Acute MI

Patient Weight (kg)

Tenecteplase Dose (mg)



≥60 to <70


≥70 to <80


≥80 to <90




Prescribing Limits


Acute MI

Total dose should not exceed 50 mg.1

Cautions for Tenecteplase


  • Active internal bleeding.1

  • History of cerebrovascular accident.1

  • Recent (within 2 months) intracranial or intraspinal surgery or trauma.1

  • Intracranial neoplasm.1

  • Intracranial vascular disease (i.e., arteriovenous malformation, aneurysm).1

  • Known bleeding diathesis.1

  • Severe uncontrolled hypertension.1



Effects on Hemostasis

Possible bleeding involving internal bleeding at intracranial or retroperitoneal sites or bleeding from the GI, GU, or respiratory tract.1 Superficial or surface bleeding at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or sites of recent surgical intervention also may occur.1

Weigh increased risks of therapy against anticipated benefits in patients with recent major surgery (e.g., CABG), obstetric delivery, organ biopsy, previous puncture of noncompressible vessels, cerebrovascular disease, hypertension (SBP ≥180 mm Hg and/or DBP ≥110 mm Hg), hemostatic defects (e.g., secondary to severe hepatic or renal disease), recent GI (active peptic ulcer) or GU bleeding, or recent trauma.1 527 Also, weigh risks against benefits of therapy in patients with diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions.1 Weigh risks against benefits in patients receiving concurrent oral anticoagulant therapy (e.g., warfarin) or recent therapy with platelet glycoprotein (GP IIb/IIIa) inhibitors.1 527 Weigh risks against benefits in patients with any condition in which bleeding constitutes a substantial hazard or would be particularly difficult to manage because of its location.1

Initiate therapy only after careful screening for contraindications.1

Minimize risk of bleeding by carefully selecting patients and monitoring all potential bleeding sites (e.g., venous punctures).1 Avoid IM injections for the first few hours following therapy.1 Perform invasive venous procedures carefully and as infrequently as possible.1 Minimize arterial punctures.1 Avoid arterial and venous invasive procedures in areas that are inaccessible to manual compression (e.g., internal jugular or subclavian punctures).1 Use of an artery in an upper extremity is preferred if an arterial puncture is essential.1 Apply pressure to the puncture site for ≥30 minutes followed by a pressure dressing and frequent inspection of the puncture site for bleeding.1

If serious bleeding occurs, immediately discontinue heparin and platelet-aggregation inhibitors.1 Can reverse heparin anticoagulation with protamine sulfate.1

Cardiovascular Effects

Weigh risks against anticipated benefits of therapy in patients with a high likelihood of left heart thrombus (e.g., mitral stenosis with atrial fibrillation), acute pericarditis, subacute bacterial endocarditis, septic thrombophlebitis, or an occluded arteriovenous cannula at a seriously infected site.1

Cholesterol Embolization

Possibly fatal cholesterol crystal embolization associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or thrombolytic agents.1 Clinical features of cholesterol embolism include livedo reticularis, “purple toe” syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, MI, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, and rhabdomyolysis.1


Possible reperfusion-related arrhythmias (e.g., sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, ventricular tachycardia).1

Manage with standard antiarrhythmic measures.1 Have appropriate antiarrhythmic therapy available during and after administration.1

Sensitivity Reactions

Hypersensitivity Reactions

Allergic-type reactions (e.g., angioedema, laryngeal edema, rash, urticaria) or anaphylactoid reactions reported rarely.1

Institute appropriate therapy if an anaphylactoid reaction occurs.1


Use with caution in patients with previous drug exposure.1 8 Repeat courses not systematically studied.1

Specific Populations


Category C.1

Increased risk of therapy in pregnant women; weigh risks against benefits of therapy in pregnant women.1


Not known whether tenecteplase is distributed into milk.1 Caution if used in nursing women.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 8

Geriatric Use

Intracranial hemorrhage, stroke, death, and major bleeding (i.e., bleeding requiring blood transfusions or leading to hemodynamic compromise) more frequent in patients ≥65 years of age than in younger adults.1 Weigh risks of drug against potential benefits.1

Hepatic Impairment

Weigh risks of therapy against potential benefits in patients with severe hepatic impairment.1

Common Adverse Effects


Interactions for Tenecteplase

Specific Drugs





Increased risk of hemorrhage1


Increased risk of hemorrhage1

Safety of concomitant therapy not established1

GP IIb/IIIa-receptor inhibitors

Increased risk of hemorrhage1

Safety of concomitant therapy not established1

Weigh risks against benefits1


Increased risk of hemorrhage1


Increased risk of hemorrhage1

Weigh risks against benefits1

Tenecteplase Pharmacokinetics



Not known whether tenecteplase is distributed into human milk.1



Cleared by the liver.1 21


Initial half-life is 20–24 minutes.1 21 22 Terminal half-life is 90–130 minutes.1 3 21




Powder for Injection

Controlled room temperature ≤30°C or under refrigeration at 2–8°C.1

Reconstituted solutions contain no preservative.1 Preferably use solution immediately after preparation; may be used up to 8 hours after reconstitution if refrigerated.1 Discard any unused solution after 8 hours.1


For information on systemic interactions resulting from concomitant use, see Interactions.


Solution Compatibility

Incompatible with dextrose.1

If administered via an IV administration set that is used for infusing a dextrose-containing solution, flush line with 0.9% sodium chloride-containing solution prior to and following drug administration.1

Do not use bacteriostatic water for injection as diluent.1


  • Binds to fibrin and converts plasminogen to plasmin.1

  • A relatively fibrin-selective plasminogen activator.1 Exhibits higher fibrin selectivity and greater resistance to plasminogen-activator inhibitors (e.g., PAI-1) than alteplase.2 3 4 5 6 7

Advice to Patients

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or recent surgery.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.



Dosage Forms


Brand Names



For IV use only

50 mg (with sterile water for injection)



AHFS DI Essentials™. © Copyright 2019, Selected Revisions October 23, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.


1. Genentech. TNKase (tenecteplase) injection prescribing information. South San Francisco, CA; 2006 Apr.

2. Van de Werf F. What do new lytics add to t-PA?Am Heart J. 1999; 138:S115- 20.

3. Verstraete M. Third-generation thrombolytic drugs. Am J Med. 2000; 109:52-8.

4. Van de Werf F, Cannon CP, Luyten A et al for the ASSENT-1 investigators. Safety assessment of single-bolus administration of TNK tissue-plasminogen activator in acute myocardial infarction: the ASSENT-1 trial. Am Heart J. 1999; 137:786-91.

5. 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 randomised trial. Lancet. 1999; 354:716-22.

6. Cannon CP, McCabe CH, Gibson CM et al and the TIMI 10A Investigators TNK-tissue plasminogen activator in acute myocardial infarction: results of the Thrombolysis in Myocardial Infraction (TIMI) 10A Dose-Ranging Trial. Circulation. 1997; 95:351-6.

7. Cannon CP, Gibson CM, McCabe CH et al for the Thrombolysis in Myocardial Infarction (TIMI) 10B Investigators. TNK-tissue plasminogen activator compared with front-loaded alteplase in acute myocardial infarction: results of the TIMI 10B Trial. Circulation. 1998; 98:2805-14.

8. Genentech, Inc., South San Francisco, CA: Personal communication.

10. Antman EM, Anbe DT, Armstrong PW et al. ACC/AHA guidelines for the management of patients with ST-elevation acute myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction). 2004. From website.

16. Becattini C, Agnelli G, Salvi A et al. Bolus tenecteplase for right ventricle dysfunction in hemodynamically stable patients with pulmonary embolism. Thromb Res. 2010; 125:e82-6.

17. Steering Committee. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J. 2012; 163:33-38.e1.

20. Konstantinides S. Clinical practice. Acute pulmonary embolism. N Engl J Med. 2008; 359:2804-13.

21. Tanswell P, Modi N, Combs D et al. Pharmacokinetics and pharmacodynamics of tenecteplase in fibrinolytic therapy of acute myocardial infarction. Clin Pharmacokinet. 2002; 41:1229-45.

22. Modi NB, Fox NL, Clow FW et al. Pharmacokinetics and pharmacodynamics of tenecteplase: results from a phase II study in patients with acute myocardial infarction. J Clin Pharmacol. 2000; 40:508-15.

527. 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:e362-425.

803. Lamas GA, Escolar E, Faxon DP. Examining treatment of ST-elevation myocardial infarction: the importance of early intervention. J Cardiovasc Pharmacol Ther. 2010; 15:6-16.

805. Reed GW, Rossi JE, Cannon CP. Acute myocardial infarction. Lancet. 2017; 389:197-210.

807. Smith JN, Negrelli JM, Manek MB et al. Diagnosis and management of acute coronary syndrome: an evidence-based update. J Am Board Fam Med. 2015 Mar-Apr; 28:283-93.

994. Levine GN, Bates ER, Blankenship JC et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011; 58:e44-122.

1005. Kearon C, Akl EA, Comerota AJ et al. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141(2 Suppl):e419S-94S.

1013. Monagle P, Chan AK, Goldenberg NA et al. Antithrombotic therapy in neonates and children: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141(2 Suppl):e737S-801S.

1016. Eikelboom JW, Hirsh J, Spencer FA et al. Antiplatelet drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012; 141(2 Suppl):e89S-119S.