Actilyse Dosage/Direction for Use

ACTILYSE should be given as early as possible after symptom onset.
Posology: Acute myocardial infarction: 90 minutes (accelerated) dose regimen for patients with acute myocardial infarction, in whom treatment can be started within 6 hours after symptom onset.
In patients with a body weight ≥65 kg: 15 mg as an intravenous bolus, immediately followed by 50 mg as an intravenous infusion over the first 30 minutes, immediately followed by an intravenous infusion of 35 mg over 60 minutes, until the maximum dose of 100 mg.
In patients with a body weight <65 kg the total dose should be weight adjusted with: 15 mg as an intravenous bolus, immediately followed by 0.75 mg/kg body weight as an intravenous infusion over the first 30 minutes (maximum 50 mg), immediately followed by an intravenous infusion of 0.5 mg/kg over 60 minutes (up to a maximum of 35 mg).
3 hours dose regimen for patients with acute myocardial infarction, in whom treatment can be started between 6 and 12 hours after symptom onset: In patients with a body weight ≥65 kg: 10 mg as an intravenous bolus, immediately followed by 50 mg as an intravenous infusion over the first hour, immediately followed by an intravenous infusion of 40 mg over two hours, until the maximum total dose of 100 mg.
In patients with a body weight <65 kg: 10 mg as an intravenous bolus, immediately followed by an intravenous infusion over three hours up to a maximum total dose of 1.5 mg/kg body weight.
Adjunctive therapy: Antithrombotic adjunctive therapy is recommended according to the current international guidelines for the management of patients with ST-elevation myocardial infarction.
Acute massive pulmonary embolism: In patients with a body weight ≥65 kg: A total dose of 100 mg should be administered in 2 hours. The most experience available is with the following dose regimen: 10 mg as an intravenous bolus over 1-2 minutes, immediately followed by 90 mg as an intravenous infusion over two hours until the total dose of 100mg.
In patients with a body weight <65 kg: 10 mg as an intravenous bolus over 1-2 minutes, immediately followed by an intravenous infusion up to a maximum total dose of 1.5 mg/kg.
Adjunctive therapy: After treatment with ACTILYSE heparin therapy should be initiated (or resumed) when aPTT values are less than twice the upper limit of normal. The infusion should be adjusted to maintain aPTT between 50-70 seconds (1.5 to 2.5 fold of the reference value).
Acute ischaemic stroke: The recommended total dose is 0.9 mg/kg body weight (maximum of 90 mg) infused starting with 10% of the total dose as an initial intravenous bolus, immediately followed by the remainder of the total dose infused intravenously over 60 minutes.
Treatment should be initiated as early as possible within 4.5 hours of symptom onset, see Precautions. The treatment effect is time-dependent; therefore earlier treatment increases the probability of a favourable outcome. Beyond 4.5 hours after onset of stroke symptoms there is a negative benefit risk ratio associated with Actilyse administration and so it should not be administered (see Pharmacology: Pharmacodynamics under Actions). (See Table 1.)

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Adjunctive therapy: The safety and efficacy of this regimen with concomitant administration of heparin or platelet aggregation inhibitors such as acetylsalicylic acid during the first 24 hours after the symptom-onset has not been investigated sufficiently. Therefore, administration of intravenous heparin or platelet aggregation inhibitors such as acetylsalicylic acid should be avoided in the first 24 hours after treatment with ACTILYSE due to an increased haemorrhagic risk.
If heparin is required for other indications (e.g. prevention of deep vein thrombosis) the dose should not exceed 10,000 IU per day, administered subcutaneously.
Method of administration: The reconstituted solution should be administered intravenously and is for immediate use.