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Cardiovascular Emergency Pregnancy: Limited data from use in pregnant women. Nonclinical data showed bleeding with secondary maternal mortality and, in a few cases, abortion and foetal resorption (with repeated dosing only); tenecteplase is not considered teratogenic. The benefit of treatment must be evaluated against the potential risks in case of myocardial infarction during pregnancy. Breast-feeding: it is unknown whether tenecteplase is excreted in human milk — caution should be exercised and a decision made whether to discontinue breast-feeding within the first 24 hours after administration.

Tenecteplase

Brand names: Metalyse

Used in: Stroke & TIA

Tenecteplase is a genetically engineered fibrinolytic (tissue plasminogen activator) given as a single intravenous bolus, used for thrombolysis in acute ST-elevation myocardial infarction.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Body-weight banded single dose: <60 kg = 6,000 units (30 mg, 6 mL); >=60 to <70 kg = 7,000 units (35 mg, 7 mL); >=70 to <80 kg = 8,000 units (40 mg, 8 mL); >=80 to <90 kg = 9,000 units (45 mg, 9 mL); >=90 kg = 10,000 units (50 mg, 10 mL) of reconstituted solution
Route: Intravenous — single bolus over approximately 10 seconds; the reconstituted solution is for immediate use
Frequency: Single dose; treatment should be initiated as early as possible after onset of symptoms
Max: 10,000 units (50 mg tenecteplase)
INDICATION LIMIT OF THIS SOURCE: the fetched SPC is Metalyse 10,000 units (50 mg), and §4.2 states 'The 40 mg and 50 mg presentations are only intended for use in acute myocardial infarction.' Dosing for any other indication (including acute ischaemic stroke, which uses a different presentation) is NOT covered by this label and must be sourced separately — do not extrapolate. Should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use. ELDERLY (>=75 years): administer with caution due to a higher bleeding risk. ADJUNCTIVE THERAPY: antithrombotic adjunctive therapy with platelet inhibitors and anticoagulants should be given according to current STEMI treatment guidelines; unfractionated heparin and enoxaparin were used in clinical studies; acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued lifelong unless contraindicated. CORONARY INTERVENTION: if primary PCI is scheduled according to current guidelines, tenecteplase should not be given; patients who cannot undergo primary PCI within one hour and receive tenecteplase should be transferred without delay for angiography and timely adjunctive coronary intervention within 6-24 hours or earlier if medically indicated. PAEDIATRIC: safety and efficacy in children below 18 years have not been established; no data are available. US TNKase labelling gives the same weight bands in mg administered as a single intravenous bolus over 5 seconds, and notes TNKase is incompatible with dextrose-containing solutions (flush dextrose lines with saline before and after). NOTE ON SOURCES: eMC §4.5 was not captured in the fetched bundle — the interactions listed are drawn from §4.3/§4.4 and from the US label §7; clinician to check the full §4.5.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to tenecteplase, to any of the excipients, or to gentamicin (a trace residue from the manufacturing process)
  • Significant bleeding disorder either at present or within the past 6 months; known haemorrhagic diathesis
  • Patients receiving effective oral anticoagulant treatment (e.g. vitamin K antagonists with INR > 1.3)
  • Any history of central nervous system damage (neoplasm, aneurysm, intracranial or spinal surgery); recent trauma to the head or cranium
  • Any known history of haemorrhagic stroke or stroke of unknown origin; known history of ischaemic stroke or TIA in the preceding 6 months; dementia
  • Severe uncontrolled hypertension
  • Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (including trauma associated with the current AMI)
  • Bacterial endocarditis, pericarditis; acute pancreatitis
  • Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
  • Active ulcerative gastro-intestinal disease; known arterial aneurysm and/or arterial-venous malformation; neoplasm with increased bleeding risk

Side effects

  • Very common: haemorrhage (predominantly superficial at the injection site)
  • Common: epistaxis; gastrointestinal haemorrhage (gastric, ulcer, rectal, haematemesis, melaena, mouth); ecchymosis; urogenital haemorrhage (haematuria, urinary tract haemorrhage); injection site and puncture site haemorrhage
  • Uncommon: intracranial haemorrhage (cerebral haemorrhage/haematoma, haemorrhagic stroke, subarachnoid haemorrhage) with associated symptoms such as somnolence, aphasia, hemiparesis, convulsion; eye haemorrhage; reperfusion arrhythmias; retroperitoneal haemorrhage
  • Rare: anaphylactoid reaction (including rash, urticaria, bronchospasm, laryngeal oedema); pericardial haemorrhage; pulmonary haemorrhage; thrombotic embolisation; blood pressure decreased
  • Not known: nausea, vomiting; body temperature increased; fat embolism. Death and permanent disability are reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes

Interactions

  • Oral anticoagulants — effective oral anticoagulation (e.g. vitamin K antagonists with INR > 1.3) is a contraindication; Metalyse may only be considered when dosing or time since last intake makes residual efficacy unlikely and anticoagulant activity tests show no clinically relevant activity (§4.3/§4.4)
  • Heparin — concomitant heparin anticoagulation may contribute to bleeding; if serious bleeding occurs, stop heparin immediately and consider protamine if heparin was given within the preceding 4 hours (§4.4)
  • Other drugs impairing haemostasis (platelet inhibitors, anticoagulants) — increased bleeding risk (§4.4)
  • Laboratory tests — during tenecteplase therapy results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless precautions are taken to prevent in vitro artefacts (US label §7.1)

Clinical monograph

How it works

It is a fibrin-specific plasminogen activator that converts plasminogen to plasmin at the clot surface, degrading fibrin and dissolving the occluding thrombus.

Prescribing in practice

  • Major bleeding, including intracranial haemorrhage, is the principal hazard, so active bleeding, recent stroke, recent surgery or trauma and uncontrolled hypertension must be excluded before administration.
  • It should be given as early as possible after symptom onset, with adjunctive antithrombotic therapy as per local STEMI protocols.
  • The dose is weight-adjusted and incompatible with glucose-containing infusions, which must be flushed from the line before and after administration.

Monitoring

Monitor closely for bleeding, reperfusion arrhythmias and signs of stroke, with continuous cardiac monitoring and serial assessment of haemodynamics.

Counselling the patient

  • A clot-dissolving injection given to restore blood flow to the heart during a heart attack.
  • Report any bleeding, severe headache or new neurological symptoms immediately.
  • Team: screen carefully for bleeding contraindications before giving.

Evidence & guidelines

Tenecteplase single-bolus thrombolysis for STEMI is supported by the ASSENT-2 trial and reflected in NICE and ESC acute coronary syndrome guidance.

Reference: ESC STEMI Guidelines 2023; ASSENT-2 trial Lancet 1999; 354(9180):716-722; NICE NG185; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

📚 MRCEM Revision

Featured in these MRCEM clinical pathways

Tenecteplase is a core drug in the following exam-focused workups on our sister siteReviseMRCEM.

MRCEM Primary / Intermediate / OSCE candidates: each pathway includes exam-style questions, RCEM/NICE citations, and FAQ summaries.