TENECTELEX (TENECTEPLACE) 40MG VIAL

Tenecteplase is a genetically engineered variant of human tissue plasminogen activator (tPA) used as a thrombolytic (clot-dissolving) agent. It activates plasminogen to form plasmin, which then breaks down the fibrin network of blood clots.

Tenecteplase has greater fibrin specificity, higher resistance to plasminogen activator inhibitor-1 (PAI-1), and a longer half-life than alteplase, allowing single-bolus IV administration.

It is used for: thrombolytic therapy in adults with ST-elevation myocardial infarction (STEMI) — acute heart attack — to restore blood flow to blocked coronary arteries, ideally within 6 hours of symptom onset, when primary percutaneous coronary intervention (PCI) is not available within an acceptable time frame.

Tenecteplase is administered exclusively by trained medical or nursing staff in a hospital setting (usually emergency department, coronary care unit, or ambulance-based fibrinolysis services). It is given as a single IV bolus injection over 5–10 seconds, via an established peripheral or central IV line. The dose is weight-adjusted:

•       < 60 kg: 30 mg (6 mL)

•       60 to < 70 kg: 35 mg (7 mL)

•       70 to < 80 kg: 40 mg (8 mL) — this vial size

•       80 to < 90 kg: 45 mg (9 mL)

•       >= 90 kg: 50 mg (10 mL)

Reconstitute with the provided 8 mL sterile water for injection. Concomitant anticoagulation with unfractionated heparin or enoxaparin is given alongside tenecteplase as per STEMI fibrinolysis protocol.

TIA in last 6 months; oral anticoagulant therapy; pregnancy or within 1 week post-partum; refractory hypertension (SBP > 180 mmHg); advanced liver disease; infective endocarditis; active peptic ulcer; prolonged / traumatic resuscitation. All relative contraindications must be weighed against the benefit of fibrinolysis in life-threatening STEMI.

•       Anticoagulants (heparin, enoxaparin, warfarin, NOACs): given concurrently per STEMI protocol but increase bleeding risk — monitor closely.

•       Antiplatelet agents (aspirin, clopidogrel, ticagrelor): given concurrently; additive bleeding risk.

•       Nitroglycerin IV: can lower blood pressure significantly — monitor haemodynamics.

Store at 2–8°C (refrigerate). Do not freeze. Keep in original carton to protect from light. Reconstituted solution: use immediately or within 8 hours if refrigerated. The vial contains no preservative — single use only.

Tenecteplase has largely replaced alteplase for fibrinolytic therapy in STEMI, due to its single-bolus dosing, weight-based adjustment, and slightly improved fibrin specificity. Major guidelines (ESC, ACC/AHA) recommend primary PCI as the preferred reperfusion strategy. Fibrinolysis is indicated when primary PCI cannot be delivered within 120 minutes of first medical contact, and the expected PCI-related delay is > 60 minutes from when fibrinolysis could be administered.

Post-fibrinolysis, arrange transfer to a PCI-capable centre within 2–24 hours for routine coronary angiography ('pharmacoinvasive strategy').

The 40 mg vial dose corresponds to the 70–80 kg weight band — check weight before dispensing. Maximum dose: 50 mg. Do NOT overdose — higher doses do not improve outcomes and substantially increase bleeding risk.

Co-administer enoxaparin (30 mg IV bolus + 1 mg/kg SC 12-hourly for up to 8 days, or until PCI) or UFH per STEMI protocol (weight-adjusted, 60 IU/kg bolus max 4000 IU, then 12 IU/kg/hr max 1000 IU/hr). Aspirin 300 mg loading dose should also be given. Reconstitute by gently swirling — do not shake vigorously (foaming reduces deliverable volume). The reconstituted solution (5 mg/mL) should be clear and colourless to pale yellow.

How do I know if fibrinolysis has worked?

Signs of successful reperfusion include: >50% reduction in ST elevation at 60–90 minutes; resolution of chest pain; and reperfusion arrhythmias. A 12-lead ECG should be repeated at 60–90 minutes post-tenecteplase.

What if the patient has recently had surgery?

Major surgery or trauma within 3 weeks is an absolute contraindication to fibrinolysis. Weigh the risk of withholding thrombolysis against the risk of haemorrhage based on the type and timing of surgery.

What is the biggest risk of tenecteplase?

Intracranial haemorrhage (ICH) — occurring in approximately 1% of treated patients — is the most feared complication and can be fatal or cause permanent disability. Careful screening with the contraindication checklist before administration is essential.

Can tenecteplase be used in pulmonary embolism?

Tenecteplase is not licensed for pulmonary embolism (PE). Alteplase (100 mg over 2 hours) remains the standard thrombolytic for massive PE in most countries, though off-label tenecteplase use has been described.