Tenecteplase is a prescription medicine indicated for the treatment of acute ischemic stroke (AIS) in adults, among other approved uses. It is available as kits. MedsAcross supplies Tenecteplase for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
TNKase is a tissue plasminogen activator (tPA) 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.
Source: US FDA prescribing information
Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that tenecteplase-mediated conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin. This fibrin specificity decreases systemic activation of plasminogen and the resulting degradation of circulating fibrinogen as compared to a molecule lacking this property. The clinical significance of fibrin-specificity on safety (e.g., bleeding) or efficacy has not been established.
Source: US FDA prescribing information
TNKase is for intravenous administration only, administered as a single bolus over 5 seconds. AIS Initiate treatment as soon as possible and within 3 hours after the onset of stroke symptoms. Individualize dosage based on patient's weight, the maximum recommended dose is 25 mg (5 mL). Acute STEMI Initiate treatment as soon as possible after the onset of STEMI symptoms. Individualize dosage based on patient's weight, the maximum recommended dose is 50 mg (10 mL).
Source: US FDA prescribing information
AIS and STEMI Active internal bleeding. Intracranial or intraspinal surgery or trauma within 2 months. Known bleeding diathesis. Current severe uncontrolled hypertension. Presence of intracranial conditions that may increase the risk of bleeding (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm). AIS Active intracranial hemorrhage. Acute STEMI History of intracranial hemorrhage History of ischemic stroke within 3 months.
Source: US FDA prescribing information
Bleeding: Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding. Hypersensitivity: Monitor patients treated with TNKase during and for several hours after administration. If symptoms of hypersensitivity occur, initiate appropriate therapy (e.g., antihistamines, corticosteroids, epinephrine). Thromboembolism: The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus. Cholesterol Embolization: Has been reported in patients treated with thrombolytic agents. Arrhythmias: It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered.
Source: US FDA prescribing information
The following clinically significant adverse reactions are discussed in other sections of the label: Bleeding Hypersensitivity Thromboembolism Cholesterol Embolization Arrhythmias Increased Risk of Heart Failure and Recurrent Ischemia when used with Planned Percutaneous Coronary Intervention (PCI) in STEMI The most common adverse reaction is bleeding.
Source: US FDA prescribing information
During TNKase therapy, results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless specific precautions are taken to prevent in vitro artifacts.
Source: US FDA prescribing information
Store lyophilized TNKase at room temperature up to 30°C (86°F) or refrigerated at 2°C to 8°C (36°F to 46°F). For storage information for reconstituted TNKase, see Dosage and Administration.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Tenecteplase, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| TNKase kit Cold chain | Genentech | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Tenecteplase in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Tenecteplase and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tenecteplase, including TNKase.
Yes. The US FDA first approved Tenecteplase on 2 June 2000, according to Drugs@FDA.
Yes. Tenecteplase has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Tenecteplase must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tenecteplase is classified under ATC code B01AD11 (Tenecteplase).
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