Efficacy

Consider Metalyse® 25 mg as your new standard of care for IV thrombolysis in all eligible patients with acute ischaemic stroke.

CI: confidence interval; IV: intravenous; RD: risk difference
*
Tenecteplase was administrated within 4.5 hours after onset of stroke symptoms, as a weight-tiered bolus dose, based on 0.25 mg/kg for the maximum weight at each tier: < 60 kg, 15 mg tenecteplase; ≥ 60 to < 70 kg, 17.5 mg; ≥ 70 to < 80 kg, 20 mg; ≥ 80 to < 90 kg, 22.5 mg; and ≥ 90 kg, 25 mg.³
†
The AcT phase III trial was a multicentre, open-label, parallel-group, registry-linked, randomised trial, in which 1600 patients, presenting within 4.5 hrs of symptom onset, and eligible for thrombolysis, were enrolled from 22 stroke centres across Canada and randomly assigned to tenecteplase (0.25 mg/kg, to a maximum of 25 mg; n=816) or alteplase (0.9 mg/kg to a maximum of 90 mg; n=784). The primary outcome occurred in 36.9% patients receiving tenecteplase and 34.8% patients receiving alteplase (unadjusted RD 2.1% [95% CI -2.6 to 6.9]).³
§
In the AcT phase III clinical trial, the rates of AEs were similar for tenecteplase compared to alteplase. The main AEs were: death within 90 days (15.3% for tenecteplase vs. 15.4% for alteplase; RD -0.1 [95% CI -3.7, 3.5]), symptomatic intracerebral haemorrhage (3.4% vs. 3.2%; RD 0.2 [95% CI -1.5, 2.0]), extracranial bleeding (0.8% vs. 0.8%; RD 0.0 [(95% CI -0.9, 0.8]), and orolingual angio-oedema (1.1% vs. 1.2%; RD -0.1 [95% CI -1.1, 1.0]).³

PC-AE-102393 | Expiry Date: 02/18/2029

Metalyse® 25 mg is administered  by a single IV bolus injection over 5 to 10 seconds^1,3-4

Stroke is the second leading cause of death globally, with more than 5 million deaths each year²