Alteplase

50mg lyophilized powder (IV)

Executive Summary

(August 2021)


Alteplase is a fibrin-specific Tissue Plasminogen Activator (tPA; fibrinolytic) that is widely accepted for emergency revascularization in acute myocardial infarction (MI),  high risk acute pulmonary embolism (PE), and acute ischemic stroke (AIS)(1, 2, 3). In emergency medicine it is also used for intermediate-high risk PE and cardiac arrest when there is a high suspicion of MI or PE as the cause, in both scenarios the decision should be taken cautiously and in very selected cases (2, 4, 10).

 

Always seriously consider the contraindications and balance the risk of intracranial and other major bleeding events versus the benefit of the therapy. Fibrinolysis is an intervention that should be decided -or at least supported- by a specialist (emergency medicine, neurologist, cardiologist, intensivist). 

Dosing Summary

Acute Coronary Syndrome with ST elevation (<12 hours)

FDA approved. 

Adult dose:

 

Acute Ischemic Stroke (<4.5 hours)

FDA approved for <3 hours after symptom onset (1996), Universally accepted use in <4.5 hours.
Adult dose:

 

Pulmonary Embolism

FDA approved. 

Adult dose

Contraindications to systemic fibrinolytic therapy

There isn't a definite and universally accepted list of contraindications, and it seems to be a tendency to become simpler over the years. Beware that references differ in some issues. 

 

Absolute contraindications (1, 2, 3, 9)

 

Relative contraindications (1, 2, 3, 9)

Adult Dose

FDA approval in 1987.

Relevant studies: GUSTO trial, 1993 (5).

Dose, accelerated scheme (6):

 

FDA approval for <3 hours after symptom onset in 1996 (15). Universally accepted use for <4.5 hours (3, 7).

Relevant studies: NINDS trial, 1995 (8). ECASS III trial, 2008 (9).

Dose (6):

 

FDA approval in 2002 for high risk PE, but also for “PE obstructing blood flow to a lobe or multiple lung segments” which is controversial if it is not causing hemodynamic deterioration. Usage in intermediate-high risk PE has been questioned, studied schemes do not support fibrinolysis as a standard intervention; if considered, always decide under the supervision of a specialist, in this scenario Pulmonary Embolism Response Teams (PERTs) are recommended (2, 11, 12). For cardiac arrest it can be used in selected cases, with very limited available data (10). 

Recommended  review: European Society of Cardiology PE Guidelines, 2019 (2).

Dose (6, 2, 10)

Pediatric Dose

Very limited data. Not approved by the FDA. No dosing established by manufacturer (6), 

References

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EMDrugs Team