Actilyse®

Alteplase
THROMBOLYTIC AGENT
Mode of Action
Alteplase is a recombinant human tissue-type
plasminogen activator.
When administered intravenously, alteplase remains
relatively inactive in the circulatory system.
Once bound to fibrin, it is activated, inducing the
conversion of plasminogen to plasmin leading to the
dissolution of the fibrin clot.
 Indications
1. Thrombolytic treatment in acute myocardial
infarction (STEMI)
2. Thrombolytic treatment in acute massive pulmonary
embolism with haemodynamic instability
3. Fibrinolytic treatment of acute ischaemic stroke
Contra-indications
Known hypersensitivity to alteplase, gentamicin or excipients
High risk of haemorrhage
Any known history of haemorrhagic stroke or stroke of unknown origin
Known history of ischaemic stroke or TIA in the last 6 months
Severe uncontrolled hypertension
Severe liver disease
Cancer
Bacterial endocarditis or pericarditis
Acute pancreatitis
Dose in Acute Myocardial Infarction
90 minutes (accelerated) dose regimen for patients starting treatment within 6 hours after
symptom onset:

Weight = 65kg or more Weight less than 65kg

15mg IV bolus, followed by (see below) 15mg IV bolus, followed by (see below)
50mg infused over 30 minutes, followed by 0.75mg/kg (max 50mg) infusion over 30
(see below) minutes, followed by (see below)

35mg over 60 minutes (max total dose =100mg) 0.5mg/kg (maximum 35mg) over 60mins
Dose in Acute Myocardial Infarction
3 h dose regimen for patients starting treatment between 6 and 12 hours after symptom onset:

10mg as intravenous bolus injection

Then 50mg as an infusion over the first hour

Followed by infusions of 10mg over 30 minutes until the maximal total dose of 100mg or

1.5mg/kg (whichever is less), over 3 hours is achieved. 
Dose in acute massive pulmonary embolism
Give 10mg as a bolus intravenous injection

Follow with an infusion of 90mg over two hours

Maximum total dose of 1.5mg/kg for patients weighing less than 65kg

After treatment with alteplase, heparin therapy should be initiated (or resumed) when aPTT
values are less than twice the upper limit of normal
Dose in acute ischaemic stroke
Treatment must be started within 4.5 hours of onset of the stroke symptoms and after prior
exclusion of intracranial haemorrhage by means of appropriate imaging techniques

The recommended dose is 0.9mg per kg (maximum 90mg)

The first 10% of this dose should be administered as an IV bolus dose

The remainder of the dose should be infused over 60 minutes 

Reconstitution
Side effects
•Bleeding
•Hypotension
•Nausea
•Vomiting
•High temperature
•Seizures – rare
•Reperfusion arrhythmias (acute MI)
•Hypersensitivity reactions
Complications
•Intracerebral haemorrhage

•Major extracranial bleeding

•Orolingual Angio-oedema

•Anaphylaxis