UThe new specialty METALYSE (tenecteplase) is marketed on the French market (hospital circuit):
METALYSE: 2 dosages, 2 distinct indications
METALYSE 5,000 U powder for solution for injection is a range complement.
In addition to a lower dosage of tenecteplase (25 mg), METALYSE 5,000 U powder for solution for injection differs from METALYSE 10,000 U powder and solvent for solution for injection (50 mg) by its therapeutic indication:
- thrombolytic treatment indicated in adults in case ofacute ischemic strokewithin 4.5 hours following the last time the patient was seen in good health, and after exclusion of intracranial hemorrhage.
For the record, METALYSE 10,000 U is indicated in adults in the event of suspected myocardial infarction with either persistent ST segment elevation or recent left bundle branch block, within 6 hours of the onset of symptoms of acute myocardial infarction.
It is therefore appropriate to carefully select the presentation of tenecteplase suited to the indication:
- METALYSE 5,000 U (25 mg tenecteplase): exclusively for the treatment of ischemic stroke in the acute phase;
- METALYSE 10,000 U (50 mg tenecteplase): only for the treatment of acute myocardial infarction.
An alternative to ACTILYSE (altpelase)
In a notice dated October 23, 2024 [1]the Transparency Commission (CT) attributed to METALYSE 5,000 U a significant actual benefit (SMR) in the indication of its marketing authorization (AMM).
In a pivotal study, METALYSE 5,000 U demonstrated its non-inferiority compared to altpelase (ACTILYSE) in terms of complete functional recovery at 3 months (clinically relevant criterion for the patient) in patients with a disabling acute ischemic stroke treated within 4.5 hours of the onset of symptoms,
In the therapeutic strategy of acute ischemic stroke, METALYSE 5,000 U corresponds to a thrombolytic treatment of 1re intention, and represents an alternative to ACTILYSE.
METALYSE 5,000 U in practice
As the treatment has a time-dependent effect, its early initiation increases the chances of a favorable outcome. It must be started as soon as possible, no later than 4.5 hours after the last time the patient was seen in good health, and after excluding intracranial hemorrhage using appropriate imaging techniques.
-The dose of tenecteplase should be adjusted according to body weight (cf. Tableau) and cannot exceed 5,000 units (25 mg of tenecteplase) in a single dose in the indication of acute ischemic stroke.
Table – Doses according to weight according to the VIDAL monograph
The METALYSE 5,000 U injection solution must be reconstituted with 5 mL of sterile water for injections. The solvent is not provided (unlike the METALYSE 10,000 U dosage).
Once reconstituted, it should be administered immediately, as a single intravenous (IV) bolus, over 5 to 10 seconds approximately.
Any unused reconstituted solution should be discarded.
Administrative identity
List I
Reserved for hospital use or in emergency situations according to article R.5121-96 of the Public Health Code
10 mL Flacon, CIP 3400955099567
Approval for communities [2]
Laboratoire Boehringer Ingelheim
