Tenecteplase is a thrombolytic drug that is used to dissolve blood clots in the brain. It is a type of medication called a tissue plasminogen activator (tPA). Tenecteplase is administered as a single intravenous bolus injection, which means that it is given all at once through a vein.
On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Metalyse. The marketing authorisation holder for this medicinal product is Boehringer Ingelheim International GmbH.
The CHMP adopted a new pharmaceutical form and strength (5 000 units (25 mg) powder for solution for injection) together with a new indication for the thrombolytic treatment of acute ischaemic stroke in adults.
For information, the full indications for Metalyse will therefore be as follows:1
Metalyse 8 000 units (40 mg) powder and solvent for solution for injection and Metalyse 10 000 units (50 mg) powder and solvent for solution for injection:
Metalyse is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.
Metalyse 5 000 units (25 mg) powder for solution for injection:
Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Tenecteplase is a newer thrombolytic drug than alteplase, which is the other main option for treating ischemic stroke. Tenecteplase has several advantages over alteplase, including:
- It is more fibrin-specific, which means that it is less likely to cause bleeding.
- It has a longer half-life, which means that it stays in the bloodstream for longer and can continue to work to dissolve clots.
- It can be administered as a single bolus injection, which is simpler and faster than alteplase, which must be given as an infusion.
As a result of these advantages, tenecteplase is becoming the preferred thrombolytic drug for treating ischemic stroke. However, alteplase is still available, and it may be used in some cases, such as in patients with very large or complicated clots.
Here is a summary of the key points about tenecteplase and stroke:
- Tenecteplase is a thrombolytic drug that is used to dissolve blood clots in the brain.
- Tenecteplase is more fibrin-specific, has a longer half-life, and can be administered as a single bolus injection than alteplase.
- Tenecteplase is the preferred thrombolytic drug for treating ischemic stroke, but alteplase is still available.
strokefocus 