Prescription medicine
Tenecteplase Brand names: Tnkase
Tenecteplase (Tnkase) is a prescription medicine with an FDA approval on record since 2000. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tenecteplase FDA label on DailyMed (effective December 15, 2025, Genentech, Inc.); the BLA 103909 record on Drugs@FDA; every tenecteplase label on DailyMed.
Highlights of the record
FDA label of December 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTNKase is a tissue plasminogen activator (tPA) indicated: for the treatment of acute ischemic stroke (AIS) in adults.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- June 2, 2000 Tnkase, Genentech; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,560 through July 30, 2026
What is tenecteplase used for?
From the label: indications and usageTNKase is a tissue plasminogen activator (tPA) indicated: for the treatment of acute ischemic stroke (AIS) in adults. ( 1.1 ) to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults. ( 1.2 ) 1.1 Acute Ischemic Stroke TNKase is indicated for the treatment of acute ischemic stroke (AIS) in adults. 1.2 Acute ST Elevation Myocardial Infarction TNKase is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI) in adults.
Conditions named in the indications of tenecteplase's FDA labels, with every medicine labeled for each:
Source: FDA drug label (TNKase), Genentech, Inc., effective December 15, 2025 (SPL set e647640d-c395-4b4b-a0be-1162f9c21d84), via openFDA; the full label on DailyMed
Is there a generic for tenecteplase (Tnkase)?
No generic tenecteplase is approved (Drugs@FDA, October 8, 2026).
- 2000 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tenecteplase label say about other medicines?
The tenecteplase label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | warnings and precautions | Because heparin, aspirin, or TNKase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. |
| Epinephrine | warnings and precautions | If symptoms of hypersensitivity occur, initiate appropriate therapy (e.g., antihistamines, corticosteroids, epinephrine). |
| Heparin | warnings and precautions | Should serious bleeding that is not controlled by local pressure occur, discontinue any concomitant heparin or antiplatelet agents immediately and treat appropriately. |
| Warfarin | warnings and precautions | … site Advanced age [see Use in Specific Populations (8.5) ] Patients currently receiving anticoagulants (e.g., warfarin sodium) Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location. |
Source: FDA drug label (TNKase), Genentech, Inc., effective December 15, 2025 (SPL set e647640d-c395-4b4b-a0be-1162f9c21d84), via openFDA; the full label on DailyMed
What do FAERS reports show for tenecteplase?
The FDA Adverse Event Reporting System holds 1,560 reports that list tenecteplase among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 365 are coded as a death and 422 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tenecteplase side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other