Actilyse Dosage/Direction for Use

Dosage: Alteplase (Actilyse) should be given as early as possible after symptom onset.
Acute myocardial infarction: a) 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: See Table 1.

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In patients with a body weight <65 kg the total dose should be weight adjusted according to the following table: See Table 2.

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b) 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 of >65 kg: See Table 3.

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In patients with a body weight <65 kg: See Table 4.

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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 of ≥65 kg: A total dose of 100 mg should be administered in 2 hours. The most experience available is with the following dose regimen: See Table 5.

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In patients with a body weight <65 kg: See Table 6.

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Adjunctive therapy: After treatment with Alteplase (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 over 60 minutes with 10% of the total dose administered 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. (See Table 7.)

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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 Alteplase (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.