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tenecteplase

Metalyse · ATC code B01AD11

Also known as: Tenekteplaz

Key facts
Active substance
tenecteplase
Drug class
Antithrombotic enzyme
ATC code
B01AD11
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Metalyse 8 000 units (40 mg) powder and solvent for solution for injection / Metalyse 10 000 units (50 mg) powder and solvent for solution for injection · Metalyse 5 000 units (25 mg) powder for solution for injection
Marketing authorisation holder
Boehringer Ingelheim International GmbH
Information as of
2026-10-28

Key facts

Tenecteplase (Metalyse) is a fibrin-specific thrombolytic (plasminogen activator) used for suspected ST-elevation myocardial infarction and for acute ischaemic stroke in adults.

What it is used for

  • Metalyse 8 000 units (40 mg) and 10 000 units (50 mg): thrombolytic treatment in adults of suspected myocardial infarction with persistent ST elevation or recent left bundle branch block within 6 hours after symptom onset.
  • Metalyse 5 000 units (25 mg): thrombolytic treatment in adults of acute ischaemic stroke within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.

Dosing

  • Myocardial infarction (40 mg/50 mg presentations): single intravenous bolus over approximately 10 seconds, by body weight: < 60 kg 6 000 units; ≥ 60 to < 70 kg 7 000 units; ≥ 70 to < 80 kg 8 000 units; ≥ 80 to < 90 kg 9 000 units; ≥ 90 kg 10 000 units (maximum 50 mg). Adjunctive antithrombotic therapy and acetylsalicylic acid according to guidelines.
  • Acute ischaemic stroke (25 mg presentation only): weight-based single dose, maximum 5 000 units (25 mg), started as early as possible; see the full text for the weight table.
  • The presentation must match the indication. Caution in the elderly (≥ 75 years) with myocardial infarction due to higher bleeding risk.

Contraindications

  • Hypersensitivity to the active substance, excipients or gentamicin.
  • Significant bleeding disorder at present or within the past 6 months; known haemorrhagic diathesis; any history of central nervous system damage.
  • Effective anticoagulation (myocardial infarction: vitamin K antagonists with INR > 1.3; stroke: INR > 1.7).
  • Severe uncontrolled hypertension.
  • Stroke indication additionally: known or suspected intracranial haemorrhage, symptoms suggestive of subarachnoid haemorrhage, severe stroke (e.g. NIHSS > 25), non-disabling deficit or rapidly improving symptoms; see the full text for the complete list.

Important warnings

  • Bleeding is the most common complication; puncture sites need careful attention, and intramuscular injections and rigid catheters should be avoided.
  • If primary PCI is scheduled according to guidelines, tenecteplase should not be given; after thrombolysis, patients should be transferred for angiography within 6-24 hours.
  • Reperfusion arrhythmias may lead to cardiac arrest; antiarrhythmic therapy should be available.
  • Thrombo-embolic risk in patients with existing thrombi (e.g. left heart thrombus).
  • Stroke: blood pressure monitoring during the first 24 hours; intravenous antihypertensives if systolic BP > 180 mmHg or diastolic BP > 105 mmHg.

Side effects

  • Very common: haemorrhage, predominantly superficial at the injection site.
  • Common: ecchymoses.
  • Serious: stroke including intracranial bleeding and other serious bleeding, which may cause death or permanent disability.

Interactions

  • Medicines affecting coagulation or platelet function (e.g. ticlopidine, clopidogrel, LMWH) may increase bleeding risk; GPIIb/IIIa antagonists increase bleeding risk.
  • No clinically relevant interactions were seen with medicines commonly used in myocardial infarction.

Pregnancy and breastfeeding

  • Limited data; the benefit must be weighed against potential risks.
  • Caution during breast-feeding; whether to discontinue breast-feeding within the first 24 hours after administration must be decided.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • MetalyseBoehringer Ingelheim International GmbH · EMEA/H/C/000306

Source: European Medicines Agency (EMA), product information

Turkey

  • MetalyseBOEHRİNGER INGELHEİM İLAÇ TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Metalyse
Liechtenstein
Metalyse
Norway
Metalyse

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Metalyse – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/metalyse-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC B01AD.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.