Alteplase (STEMI Thrombolysis)

Should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use. ALTERNATIVE AMI REGIMEN — 3 hour regimen for patients in whom treatment can be started between 6 and 12 hours after symptom onset: body weight 65 kg or more, 10 mg as an intravenous bolus, then 50 mg as an intravenous constant rate infusion over the first hour, then 40 mg as an intravenous constant rate infusion over 2 hours, until the maximum total dose of 100 mg; body weight under 65 kg, 10 mg as an intravenous bolus then an intravenous constant rate infusion over 3 hours up to a maximum total dose of 1.5 mg/kg body weight. ADJUNCTIVE THERAPY (AMI): antithrombotic adjunctive therapy is recommended according to the current international guidelines for the management of patients with ST-elevation myocardial infarction. OTHER INDICATIONS IN THE SAME SPC — acute massive pulmonary embolism: body weight 65 kg or more, a total dose of 100 mg over 2 hours, most experience being with 10 mg as an intravenous bolus over 1 to 2 minutes then 90 mg as an intravenous constant rate infusion over 2 hours; body weight under 65 kg, 10 mg bolus over 1 to 2 minutes then an intravenous constant rate infusion over 2 hours up to a maximum total dose of 1.5 mg/kg body weight; afterwards heparin should be initiated or resumed when aPTT is less than twice the upper limit of normal, adjusted to maintain aPTT 50 to 70 seconds. Acute ischaemic stroke (adults and adolescents 16 years and over, started as early as possible and no later than 4.5 hours after last known well, after exclusion of intracranial haemorrhage by imaging): recommended total dose 0.9 mg alteplase/kg body weight (maximum 90 mg), starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder infused intravenously over 60 minutes; intravenous heparin and platelet aggregation inhibitors such as acetylsalicylic acid should be avoided in the first 24 hours after treatment, and if heparin is required for other indications the dose should not exceed 10,000 IU per day subcutaneously. PAEDIATRIC: there is limited experience with the use of Actilyse in children and adolescents; it is contraindicated for the treatment of acute ischaemic stroke in children and adolescents under 16 years of age, and the dose for adolescents 16 years and over is the same as for adults. SOURCE SCOPE: dose taken from the UK SPC for Actilyse 10 mg powder and solvent for solution for injection and infusion (eMC product 898). The US record in the same bundle is Cathflo Activase, a catheter-occlusion clearance product (2 mg instilled into a dysfunctional catheter) — a different indication and route, deliberately NOT used here.