Tenectase® is indicated in thrombolytic treatment of acute ischemic stroke (AIS) within 3 hours of stroke initiation. For the indication of AIS, Tenecteplase is provided in a single dose of 20 mg along with 10 mL of sterile water for injection. A 20 mg vial of Tenectase contains 21 mg of Tenectase®, L-arginine, phosphoric acid and polysorbate 20, which includes a 20 % overfill. This will deliver 20 mg of Tenecteplase.
Published efficacy and safety
The study concludes that intravenous TNK-tPA given within 3 hours of symptom onset, is a safe, efficacious and well tolerated option in patients with acute ischemic stroke.
Global Perspective :
TENECTASE® is approved for Acute Ischemic Stroke
We have affordable solution for :
- ~3800 new cases of ischemic stroke every day in India
- 6.2 million deaths globally due to stroke
- About 85% of global stroke mortality which occurs in low and middle income countries
3rd Generation Thrombolytic
- Administered as a single bolus
- Dose: 0.2 mg/kg body weight
- Longer half life of 18-22 min
- 14 fold greater fibrin specificity than alteplase
- 80 times lesser susceptibility to PAI-1 than alteplase
Aim: To evaluate whether routine use of TNK-tPA within 3 hours after onset of stroke symptoms is
(a) safe (primary endpoint) and
(b) beneficial (secondary endpoint)
NIHSS score
Median (Interquartile Range, 25th-75th Percentile)
Horizontal Line inside the box indicates median
IRIS-TNK (Indian Registry in Ischemic Stroke-Tenecteplase)
- Open-label, Prospective, Multicenter, Non Randomized, Ongoing, Observational study
- Patients (satisfying the eligibility criteria), would be followed up for three months post thrombolysis
- Primary safety outcome variable: Symptomatic ICH within 36±6 h after start of thrombolysis treatment
- Secondary efficacy outcome variable: NIHSS improvement ≥4 points or 0 at 24 h, 7 days (or day of discharge) post treatment initiation
- Modified Rankin Scale (mRS) Score 0-2 at three months (Functional Independence)
- mRS 0-1 at three months (Excellent Outcome)
Symptomatic ICH
SITS-NEW (Alteplase, Asia)
SITS-MOST (Alteplase, Europe)
CASES Study (Alteplase, Canada)
STARS Study (Alteplase, USA)
