What is the recommended dose of tenecteplase (tissue plasminogen activator) for acute ischemic stroke?

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Last updated: December 20, 2025View editorial policy

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Tenecteplase Dosing for Acute Ischemic Stroke

The recommended dose of tenecteplase for acute ischemic stroke is 0.25 mg/kg administered as a single intravenous bolus, with a maximum dose of 25 mg. 1

Standard Dosing Protocol

  • Administer 0.25 mg/kg as a single IV bolus (maximum 25 mg) within 4.5 hours of symptom onset 1, 2
  • This single-bolus administration contrasts with alteplase's more complex regimen (10% bolus followed by 1-hour infusion), offering significant workflow advantages particularly when endovascular therapy or patient transfer is being considered 3
  • The longer half-life of tenecteplase (90-130 minutes) enables this convenient single-bolus dosing 1, 2

Critical Dosing Caveat

Do not confuse stroke dosing with myocardial infarction dosing—the stroke dose is 0.25 mg/kg (max 25 mg), NOT the 0.5 mg/kg used for MI. 3 This is a common and potentially dangerous error that clinicians must avoid.

Evidence Supporting the 0.25 mg/kg Dose

The 0.25 mg/kg dose is specifically recommended based on:

  • Superior recanalization rates in large vessel occlusions compared to alteplase 1
  • Improved 3-month functional outcomes relative to alteplase in patients with large vessel occlusions 1
  • The ORIGINAL trial demonstrated noninferiority to alteplase for excellent functional outcomes (mRS 0-1 at 90 days) with similar safety profile 4
  • Meta-analyses of 1,585 randomized patients support noninferiority in disability-free outcomes without increased symptomatic intracranial hemorrhage 5

Why Not Higher Doses?

Avoid the 0.4 mg/kg dose in moderate to severe stroke—pooled analysis from the NOR-TEST trials showed this higher dose resulted in:

  • Worse functional outcomes (OR 0.52 for favorable outcome, p=0.003) 6
  • Significantly higher mortality (OR 2.48, p=0.01) 6
  • Increased rates of intracranial hemorrhage, particularly in severe strokes 6

The 0.25 mg/kg dose has emerged as the optimal balance of efficacy and safety 7, 5

Clinical Context and Patient Selection

The American Heart Association/American Stroke Association suggests tenecteplase as an alternative to alteplase (Class IIb, Level of Evidence B-R) in patients with:

  • Minor neurological impairment and no major intracranial occlusion 1, 3
  • However, the 0.25 mg/kg dose shows particular advantage in large vessel occlusions where superior recanalization has been demonstrated 1

Administration Timing

  • Initiate treatment as soon as possible after CT scan 1
  • Target door-to-needle time <60 minutes in 90% of treated patients 3
  • Patients eligible for IV thrombolysis should receive it even if endovascular therapy is being considered (Class I, Level of Evidence A) 2

Contraindications

Both tenecteplase and alteplase share similar contraindications:

  • Evidence of intracranial hemorrhage 1, 2
  • Recent significant trauma or surgery 1, 2
  • Uncontrolled hypertension 1, 2
  • Recent internal bleeding (within 2-4 weeks), noncompressible vascular punctures, pregnancy, active peptic ulcer, and current oral anticoagulant use are relative contraindications 1, 2

Safety Profile

  • Symptomatic intracranial hemorrhage risk is approximately 1.2%, similar to alteplase 4
  • The absolute increase in symptomatic ICH with thrombolysis is approximately 6% (number needed to harm of 17) 2
  • Number needed to treat for favorable outcomes is 8-14 2

References

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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