Alteplase (tPA)

SPC (Actilyse) gives three separate indication-specific regimens. ACUTE MYOCARDIAL INFARCTION — 90-minute (accelerated) regimen when treatment can start within 6 hours of symptom onset: body weight >=65 kg — 15 mg IV bolus, then 50 mg as constant-rate infusion over the first 30 minutes, then 35 mg as constant-rate infusion over 60 minutes, to a maximum total dose of 100 mg; body weight <65 kg — 15 mg IV bolus, then 0.75 mg/kg over the first 30 minutes, then 0.5 mg/kg over 60 minutes. 3-hour regimen when treatment starts between 6 and 12 hours after symptom onset: >=65 kg — 10 mg IV bolus, then 50 mg over the first hour, then 40 mg over 2 hours, to a maximum total dose of 100 mg; <65 kg — 10 mg IV bolus, then constant-rate infusion over 3 hours up to a maximum total dose of 1.5 mg/kg. ACUTE MASSIVE PULMONARY EMBOLISM — >=65 kg: total dose 100 mg over 2 hours (10 mg IV bolus over 1-2 minutes, then 90 mg as constant-rate infusion over 2 hours); <65 kg: 10 mg IV bolus over 1-2 minutes, then constant-rate infusion over 2 hours up to a maximum total dose of 1.5 mg/kg. After PE treatment, heparin should be started or resumed when aPTT is less than twice the upper limit of normal, and the infusion adjusted to maintain aPTT 50-70 seconds. ACUTE ISCHAEMIC STROKE — treatment must only be performed under the responsibility and follow-up of a physician trained and experienced in neurovascular care; the SPC states treatment must be started for adults and adolescents >=16 years of age. Beyond 4.5 hours from stroke onset the benefit-risk ratio is negative and Actilyse should not be administered. Intravenous heparin or platelet aggregation inhibitors such as acetylsalicylic acid should be avoided in the first 24 hours after treatment (increased haemorrhagic risk). ADJUNCTIVE THERAPY in AMI: antithrombotic adjunctive therapy per current international STEMI guidelines. FORMULATION WARNING: 2 mg vials of alteplase are NOT indicated for AMI, massive PE or acute ischaemic stroke (risk of massive under-dosing) — only 10 mg, 20 mg or 50 mg vials. NOTE ON US LABEL: the openFDA record fetched for this bundle was Cathflo Activase (2 mg instillation for restoration of function to occluded central venous access devices) — a different indication from this page, so it was NOT used for the dose.