Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 50 mg, 100 mg) |
Drug Class | Tissue plasminogen activators |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of Acute Ischemic Stroke (AIS).
- Indicated for the treatment of Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure.
- Indicated for the treatment of Acute Massive Pulmonary Embolism (PE) for lysis.
Latest News
Summary
- Activase (alteplase) is indicated for the treatment of Acute Ischemic Stroke (AIS), for the treatment of Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure, and for the treatment of Acute Massive Pulmonary Embolism (PE) for lysis.
- This summary is based on the review of 17 systematic reviews/meta-analyses. [1-17]
- No significant difference in 90-day functional outcomes between tenecteplase and alteplase (OR for excellent outcome 1.08, 95% CI 0.93-1.26; OR for poor outcome 0.95, 95% CI 0.75-1.21).
- Tenecteplase 0.25 mg/kg dose was associated with increased early vessel recanalization (OR 2.07, 95% CI 1.19-3.59) and a higher rate of excellent neurological recovery (OR 1.15, 95% CI 1.01-1.32) compared to alteplase 0.9 mg/kg.
- Tenecteplase demonstrated significantly better early major neurological improvement in one study (RR 1.56, 95% CI 1.00-2.43) but no significant difference in another (OR 1.26, 95% CI 0.80-1.96).
- Subgroup analysis suggested that tenecteplase 0.25 mg/kg dose might be more effective than the 0.4 mg/kg dose in certain efficacy outcomes.
- No significant difference in symptomatic intracerebral hemorrhage (sICH) between tenecteplase and alteplase (OR 1.12, 95% CI 0.79-1.59).
- Tenecteplase is associated with an increased incidence of any intracranial hemorrhage compared to alteplase (OR 2.24, 95% CI 1.75-2.86), though no significant differences were observed in symptomatic ICH or parenchymal hematoma.
- Tenecteplase may reduce all-cause mortality compared to alteplase (aOR 0.44, 95% CI 0.30-0.64).
- Subgroup analyses suggest that tenecteplase at 0.25 mg/kg may offer greater efficacy compared to 0.4 mg/kg, particularly in acute ischemic stroke patients, including those with anterior circulation tandem occlusions where it is favored over alteplase for favorable outcomes, mortality, and early recanalization.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Activase (alteplase) Prescribing Information. | 2022 | Genentech, Inc., South San Francisco, CA |