Tenecteplase

Class
Fibrinolytics
Subclass
Recombinant tissue plasminogen activators
Substance name
Tenecteplase
Brand names
Tnkase®
Common formulations
Kit for injection after reconstitution
Dosage and administration
Adults patients
AIS
Weight < 60 kg
•
15 mg IV bolus over 5 seconds, as soon as possible within 3 hours of symptom onset
Weight 80-90 kg
•
22.5 mg IV bolus over 5 seconds, as soon as possible within 3 hours of symptom onset
Weight 70-80 kg
•
20 mg IV bolus over 5 seconds, as soon as possible within 3 hours of symptom onset
Weight 60-70 kg
•
17.5 mg IV bolus over 5 seconds, as soon as possible within 3 hours of symptom onset
Weight ≥ 90 kg
•
25 mg IV bolus over 5 seconds, as soon as possible within 3 hours of symptom onset
STEMI
Weight < 60 kg
•
30 mg IV bolus over 5 seconds, as soon as possible within 12-24 hours of symptom onset, ideally within 30 minutes of hospital arrival
Administered in combination with antiplatelet and/or anticoagulant therapy.
Weight 60-70 kg
•
35 mg IV bolus over 5 seconds, as soon as possible within 12-24 hours of symptom onset, ideally within 30 minutes of hospital arrival
Administered in combination with antiplatelet and/or anticoagulant therapy.
Weight 70-80 kg
•
40 mg IV bolus over 5 seconds, as soon as possible within 12-24 hours of symptom onset, ideally within 30 minutes of hospital arrival
Administered in combination with antiplatelet and/or anticoagulant therapy.
Weight 80-90 kg
•
45 mg IV bolus over 5 seconds, as soon as possible within 12-24 hours of symptom onset, ideally within 30 minutes of hospital arrival
Administered in combination with antiplatelet and/or anticoagulant therapy.
Weight ≥ 90 kg
•
50 mg IV bolus over 5 seconds, as soon as possible within 12-24 hours of symptom onset, ideally within 30 minutes of hospital arrival
Administered in combination with antiplatelet and/or anticoagulant therapy.
Cardiac arrest in patients with PE • Off-label
Weight < 60 kg
•
30 mg IV bolus over 5 seconds
Weight 60-70 kg
•
35 mg IV bolus over 5 seconds
Weight 70-80 kg
•
40 mg IV bolus over 5 seconds
Weight 80-90 kg
•
45 mg IV bolus over 5 seconds
Weight ≥ 90 kg
•
50 mg IV bolus over 5 seconds
Central venous catheter occlusion • Off-label
•
2 mg intracatheter bolus into the occluded catheter, repeated after 2 hours if needed
Hemodialysis catheter dysfunction • Off-label
•
2 mg intracatheter bolus into each catheter lumen 1 hour before dialysis session, repeated up to 72 hours after session if needed
PE • Off-label
Weight < 60 kg
•
30 mg IV bolus over 5 seconds
Administered in combination with or followed by systemic anticoagulant therapy.
Weight 60-70 kg
•
35 mg IV bolus over 5 seconds
Administered in combination with or followed by systemic anticoagulant therapy.
Weight 70-80 kg
•
40 mg IV bolus over 5 seconds
Administered in combination with or followed by systemic anticoagulant therapy.
Weight 80-90 kg
•
45 mg IV bolus over 5 seconds
Administered in combination with or followed by systemic anticoagulant therapy.
Weight ≥ 90 kg
•
50 mg IV bolus over 5 seconds
Administered in combination with or followed by systemic anticoagulant therapy.
Indications for use
Labeled indications
Adults
•
Treatment of STEMI
•
Treatment of AIS
Off-label indications
Adults
•
Treatment of cardiac arrest in patients with PE
•
Treatment of central venous catheter occlusion
•
Treatment of hemodialysis catheter dysfunction
•
Treatment of PE
Safety risks
Contraindications
Hypersensitivity to tenecteplase or its components
Active internal bleeding
Bleeding diathesis
History of cerebrovascular accident
Severe uncontrolled hypertension
Warnings and precautions
Bleeding
•
Maintain a high level of suspicion, as tenecteplase is associated with an increased risk of bleeding. Avoid administering intramuscular injections for the first few hours following treatment with tenecreplase. Perform arterial and venous punctures carefully and only as required. Avoid performing internal jugular and subclavian venous punctures to minimize bleeding from noncompressible sites. Use an upper extremity vessel accessible to manual compression if an arterial puncture is required, and apply pressure for at least 30 minutes. Discontinue concomitant heparin and antiplatelet therapy immediately if serious bleeding occurs not controlled by local pressure, and manage the bleeding accordingly.
Cardiac arrhythmias
•
Maintain a high level of suspicion, as tenecteplase has been associated with an increased risk of reperfusion arrhythmias, including sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, and VT. Ensure antiarrhythmic therapy for bradycardia and/or ventricular irritability is readily available when administering tenectaplase.
Cholesterol embolization syndrome
•
Maintain a high level of suspicion, as teneceteplase has been associated with an increased risk of cholesterol emobolization.
HF, recurrent myocardial ischemia
•
Maintain a high level of suspicion, as tenectaplase has been associated with an increased risk of mortality, cardiogenic shock, congestive HF, recurrent myocardial infarction, and repeat target vessel revascularization in patients undergoing planned PCI for STEMI after fibrinolytic therapy.
Thromboembolism
•
Use caution in patients at high risk of left heart thrombus, such as with MS or AF.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
No guidance available. Use caution in patients with hemostatic defects due to hepatic disease.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Use only if no alternatives are available.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Congestive heart failure
Common 1-10%
•
Cardiogenic shock, cerebrovascular accident, recurrent myocardial ischemia
Uncommon < 1%
•
Serum anti-tenecteplase antibodies, intracranial hemorrhage
Unknown frequency
•
Cholesterol embolization syndrome, thromboembolism, anaphylaxis, bleeding, angioedema, urticaria, skin rash, laryngeal edema, cardiac arrhythmias
Interactions
Drug(s)
Check Interactions
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