Summary

Health Canada has officially authorized TNKase® (tenecteplase) for the treatment of acute ischemic stroke (AIS) in adults, marking a major shift in emergency care. This "clot-buster" can be administered as a single five-second injection in a hospital setting, replacing the traditional hour-long infusion to provide faster, life-saving relief for patients across Canada.

A significant milestone in Canadian emergency medicine was reached this November as Health Canada officially authorized TNKase® (tenecteplase) for the treatment of acute ischemic stroke (AIS). While the medication has long been a staple in treating heart attacks, its approval for stroke marks a “new era” in how hospitals across the country will manage one of the leading causes of disability.

The “Time is Brain” Advantage

In the world of stroke care, every second counts. When a clot blocks blood flow to the brain, nearly two million brain cells die every minute. For decades, the gold standard has been a medication called alteplase. While effective, alteplase requires a complex 60-minute intravenous infusion.

TNKase changes the math. Administered as a single, five-second intravenous bolus, it allows doctors to deliver life-saving medicine almost instantly.

“The approval of tenecteplase for acute ischemic stroke marks an important moment in Canadian stroke care,” says Dr. Bijoy Menon, Professor and Head of Neurology at the University of Calgary. “It exemplifies how innovative, investigator-initiated research can directly improve patient outcomes.”

Clinical Settings and Public Coverage

Because TNKase is a high-potency “clot-buster,” it is administered exclusively in a controlled hospital setting, typically in the Emergency Department or a specialized Stroke Unit, immediately following a CT scan to confirm the type of stroke. It is never a “take-home” medication; patients are closely monitored by medical staff for at least 24 hours to manage blood pressure and watch for potential complications like internal bleeding.

For Canadians, there is no out-of-pocket cost for this life-saving treatment. As a medication administered within the hospital, TNKase is fully covered by provincial and territorial health insurance plans.

Made in Canada: The AcT Trial

The authorization was driven by Canadian leadership. The pivotal AcT (Alteplase Compared to Tenecteplase) trial was led by the University of Calgary and conducted at 22 stroke centers across Canada.

The study, which enrolled 1,600 patients, proved that TNKase is just as safe and effective as the previous standard of care. Because it is easier to administer, TNKase is particularly revolutionary for rural hospitals. If a patient needs to be transferred to a larger city for surgery, they can receive their “clot-buster” bolus and be moved immediately, without the need for a complex infusion pump during transport.

Recognizing the Signs

While medical technology is advancing, the critical reality remains: treatment is most effective when administered as soon as possible after symptoms begin. Use the FAST acronym to recognize a stroke:

  • Face: Is it drooping?
  • Arms: Can you raise both?
  • Speech: Is it slurred or jumbled?
  • Time: To call 9-1-1 right away.

With Health Canada’s latest approval, Canadian doctors now have a faster, simpler tool to help ensure that for stroke patients, time, and brain are on their side.

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