Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 50 mg) |
Drug Class | Tissue plasminogen activators |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI).
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Summary
- This summary is based on the review of 23 systematic review(s)/meta-analysis(es). [1-23]
- Complete Recanalization: In Asian patients, tenecteplase achieved significantly higher rates of complete recanalization (relative risk (RR): 1.91, 95% confidence interval (CI): 1.30 to 2.80), while no significant difference was observed in Caucasian patients compared to alteplase (RR: 0.99, 95% CI: 0.87 to 1.14).
- Modified Rankin Scale (mRS): At three months, tenecteplase 0.25 mg/kg ranked highest for achieving mRS 0-1 (surface under the cumulative ranking curve (SUCRA) = 0.68) and mRS 0-2 (SUCRA = 0.86), showing similar effectiveness to alteplase in both outcomes.
- Early Neurological Improvement: Tenecteplase, particularly at the 0.25 mg/kg dose, demonstrated higher rates of early neurological improvement compared to alteplase (OR = 1.52, 95% CI: 1.13-2.05).
- Extended Time Window (>4.5 hours): Tenecteplase 0.25 mg/kg was associated with a higher likelihood of a 3-month excellent functional outcome (mRS ≤1) compared to no thrombolysis (RR = 1.17, 95% CI: 1.01-1.36).
- Mortality: Higher mortality rates were observed with tenecteplase compared to alteplase in Asian patients (RR: 1.18, 95% CI: 0.87-1.62).
- Intracranial Hemorrhage (ICH): Symptomatic and overall ICH rates were similar between tenecteplase and alteplase across various studies, though tenecteplase at 0.40 mg/kg had a higher rate of symptomatic ICH compared to 0.25 mg/kg (RR = 2.39, 95% CrI = 1.00-7.92).
- Symptomatic Intracranial Hemorrhage (sICH): No significant difference was noted between tenecteplase and alteplase for sICH overall, but tenecteplase 0.25 mg/kg was associated with a lower rate of sICH in elderly patients compared to alteplase 0.9 mg/kg.
- Significant differences in effectiveness and safety profiles of tenecteplase were observed between Asian and Caucasian patients, with Asian patients exhibiting higher recanalization rates (RR: 1.91, 95% CI: 1.30 to 2.80) but also higher mortality rates (RR: 1.18, 95% CI: 0.87-1.62). Tenecteplase 0.25 mg/kg demonstrated superior safety in elderly patients concerning symptomatic intracranial hemorrhage compared to alteplase 0.9 mg/kg.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
TNKase (tenecteplase) Prescribing Information. | 2024 | Genentech, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Canadian Stroke Best Practice Recommendations: Acute Stroke Management, 7th Edition Practice Guidelines Update, 2022 | 2024 | The Canadian Journal of Neurological Sciences |
Tenecteplase in acute ischemic stroke: Review of the literature and expert consensus from the French Neurovascular Society | 2023 | Revue Neurologique |
European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke | 2021 | European Stroke Journal |
Management of acute ST segment elevation myocardial infarction (STEMI). | 2019 | National Heart Association of Malaysia |