What is the indication and administration protocol for Reteplase (reteteplase) in acute ischemic stroke and myocardial infarction?

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Reteplase: Indications and Administration Protocol

Reteplase is indicated for acute myocardial infarction (STEMI) with a recommended administration of two 10U bolus doses given 30 minutes apart, each administered over 2 minutes. It is not FDA-approved or recommended for acute ischemic stroke treatment.

Indications for Reteplase

Acute Myocardial Infarction

  • Approved for treatment of ST-segment elevation myocardial infarction (STEMI)
  • Can be administered as a non-weight-based bolus dose, making it suitable for pre-hospital initiation of thrombolytic treatment 1, 2
  • Particularly valuable when rapid administration is needed and when treatment is administered under time pressure

Acute Ischemic Stroke

  • Not FDA-approved for acute ischemic stroke
  • Alteplase (0.9 mg/kg, maximum 90 mg) remains the standard FDA-approved thrombolytic for acute ischemic stroke 3, 4
  • Guidelines specifically note that other thrombolytic agents including reteplase have not been tested extensively for stroke treatment 3

Administration Protocol for Myocardial Infarction

Dosing

  • Two 10U bolus doses, each administered over 2 minutes, 30 minutes apart 1, 2
  • Non-weight-based dosing (unlike alteplase which requires weight-based calculations)

Timing

  • Can be initiated up to 12 hours from symptom onset, though earlier treatment is associated with better outcomes 5
  • The ease of bolus administration makes reteplase suitable for pre-hospital initiation, which can reduce time to treatment 1

Adjunctive Therapy

  • Intravenous heparin should be administered for at least 24 hours after reteplase 5
  • Monitor for bleeding complications, which occur at rates similar to other fibrin-specific thrombolytic agents 1

Comparative Efficacy

Versus Alteplase in Myocardial Infarction

  • Superior to alteplase for coronary artery patency (TIMI flow) at 60 and 90 minutes 1, 2
  • No significant difference in mortality rates or incidence of intracranial bleeding compared to alteplase 6
  • The GUSTO-III trial (15,059 patients) showed mortality rates of 7.47% for reteplase vs. 7.24% for alteplase (not statistically significant) 6

Versus Streptokinase in Myocardial Infarction

  • Equivalent 35-day mortality rates compared to streptokinase 5
  • Reduced incidence of cardiac complications (atrial fibrillation, asystole, cardiac shock, heart failure, and hypotension) compared to streptokinase 5
  • Higher incidence of hemorrhagic stroke compared to streptokinase 1

Advantages of Reteplase

  • Bolus administration (rather than infusion) promotes rapid and safe administration 1, 2
  • Non-weight-based dosing minimizes calculation errors in emergency situations 1
  • Fibrin-specific action (third-generation recombinant form of t-PA) 1, 2
  • Conducive to pre-hospital initiation of thrombolytic treatment 1

Important Considerations and Contraindications

  • Similar bleeding risk profile to other thrombolytic agents 2
  • Not recommended for routine use in acute ischemic stroke
  • Standard contraindications for thrombolytics apply (severe uncontrolled hypertension, active bleeding, recent intracranial hemorrhage, etc.) 3

Key Takeaway

While reteplase offers advantages in ease of administration for myocardial infarction treatment, it is not currently recommended for acute ischemic stroke, where alteplase remains the standard thrombolytic agent of choice. The simple bolus administration of reteplase makes it particularly valuable in pre-hospital settings for STEMI treatment.

References

Research

Spotlight on reteplase in thrombotic occlusive disorders.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2007

Research

Reteplase: a review of its use in the management of thrombotic occlusive disorders.

American journal of cardiovascular drugs : drugs, devices, and other interventions, 2006

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Acute Ischemic Stroke Management

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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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