Tnkase: Uses, Side Effects and Dosage

Serious warnings and precautions box

What is TNKase used for?

TNKase (tenecteplase for injection) is used in adults to treat:

• acute ischemic stroke (AIS). Treatment is to begin as soon as possible and within 4.5 hours after stroke symptoms start.
• acute myocardial infarctions (heart attacks). Treatment should begin as soon as possible after heart attack symptoms start.

How does TNKase work?

TNKase belongs to a group of medicines called thrombolytics. This medicine is involved in the process of dissolving blood clots that have formed in the blood vessels of the brain or the heart. This helps to prevent the damage caused by stroke and heart attacks, and when given at the right time, it has been shown to save lives.

What are the ingredients in TNKase?

Medicinal ingredients: tenecteplase

Non-medicinal ingredients: L-arginine, phosphoric acid, polysorbate 20

TNKase comes in the following dosage forms:

A single-use vial containing 25 mg (5000 units) TNKase to be prepared for intravenous injection.

A single-use vial containing 50 mg (10 000 units) TNKase to be prepared for intravenous injection.

Do not use TNKase if:

• you are allergic to TNKase or any of the ingredients it contains

In addition, TNKase will not be given by your doctor if you have, or have recently had, an illness that increases your risk of bleeding, including:

• a bleeding disorder or recent history of bleeding
• TNKase is a drug known to cause severe bleeding and an increased incidence of bleeding in the skull.
• Use of TNKase for the treatment of stroke is limited to physicians experienced in acute stroke management, who are treating patients in a hospital setting
• active bleeding in the brain or history of bleeding in the brain
• recent history of stroke
• recent major surgery or trauma to your brain or spine
• brain tumour
• abnormality of the blood vessels or aneurysm
• severe high blood pressure

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TNKase. Talk about any health conditions or problems you may have, including if you have/had:

• recent major surgery
• stroke
• recent bleeding in the gastrointestinal or urinary systems
• recent trauma
• high blood pressure
• problems with your heart or heartbeat
• bleeding disorder
• severe liver failure

• pregnancy

• serious infection or inflammation
• advanced age
• taken medications that affect blood clotting

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TNKase:

• Medications that affect blood clotting may increase the risk of bleeding prior to, during or after therapy with TNKase.

How to take TNKase:

• TNKase is given as a single injection into a vein.
• If you are being treated for stroke, your doctor will give you TNKase within 4.5 hours after your symptoms start.
• If you are being treated for a heart attack, your doctor will give TNKase as soon as possible after your chest pain starts.

Usual dose:

The doctor calculates your dose of TNKase according to your body weight, with a maximum dose of 25 mg (5000 units) for acute ischemic stroke and 50 mg (10 000 units) for acute myocardial infarction.

For acute ischemic stroke, TNkase is usually given alone.

For acute myocardial infarction, antiplatelets and antithrombotics are usually given as part of your treatment.

Overdose:

In the event of overdose, there may be an increased risk of bleeding. Any patients receiving greater than the recommended dose should be carefully monitored.

If you think you, or a person you are caring for, have taken too much TNKase, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

What are possible side effects from using TNKase?

These are not all the possible side effects you may have when taking TNKase. If you experience any side effects not listed here, tell your healthcare professional.

Like all medicines, TNKase can have side effects.

The most frequent side effect associated with TNKase is bleeding. Most of the time the bleeding is minor, however sometimes major bleeding can occur leading to instability in blood pressure which may decrease blood flow to organs. If major bleeding occurs, your doctor will stop any medications that can make bleeding worse, may need to consider a blood transfusion, or invasive procedures to halt uncontrolled bleeding. Death or permanent disability can occur in patients who experience stroke, a heart attack, bleeding into the brain, or other serious bleeding episodes.

Allergic-type reactions such as swelling of the skin and throat, rash or hives can occur.

Other serious side effects affecting the heart and lungs have been reported among patients receiving TNKase. These are often caused by the underlying disease. These effects can be life-threatening and may lead to death.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store the vials below 30°C or in a refrigerator at 2°C - 8°C.

The reconstituted solution may be stored for 8 hours in a refrigerator at 2°C - 8°C.

TNKase is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

Keep out of reach and sight of children.

If you want more information about TNKase:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.rochecanada.com, or by calling 1-888-762-4388.

^©Copyright 2001 - 2025, Hoffmann-La Roche Limited

TNKase® is a registered trademark of Hoffmann-La Roche Limited

ACTIVASE® is a registered trademark of Genentech, Inc. used under licence.

All other trademarks are the property of its respective owner.

Hoffmann-La Roche Limited

Mississauga, ON L5N 5M8

Date of Authorization: 2025-11-13