TNKase FDA Approval History
Last updated by Judith Stewart, BPharm on March 4, 2025.
FDA Approved: Yes (First approved June 2, 2000)
Brand name: TNKase
Generic name: tenecteplase
Dosage form: Lyophilized Powder for Injection
Company: Genentech, Inc.
Treatment for: Heart Attack, Ischemic Stroke
TNKase (tenecteplase) is a tissue plasminogen activator for use in the treatment of ischemic stroke and heart attack.
- TNKase is indicated:
- for the treatment of acute ischemic stroke (AIS) in adults.
- to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. - TNKase contains tenecteplase, a modified form of human tissue plasminogen activator (tPA) that works by breaking down fibrin, a component of blood clots.
- TNKase is administered by intravenous injection, as a single bolus over 5 seconds.
- Warnings and precautions associated with TNKase include an increased the risk of bleeding, hypersensitivity reactions, an increased risk of thrombo-embolic events in patients with high likelihood of left heart thrombus, cholesterol embolization, arrhythmias, and an increased risk of heart failure and recurrent ischemia when used with planned percutaneous coronary intervention in STEMI.
- The most common adverse reaction associated with TNKase is bleeding.
Development timeline for TNKase
| Date | Article |
|---|---|
| Mar 3, 2025 | Approval FDA Approves TNKase (tenecteplase) for the Treatment of Acute Ischemic Stroke in Adults |
| Jun 2, 2000 | Approval FDA Approves TNKase (tenecteplase) for Treatment of Heart Attack |
Further information
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