alteplase: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
alteplase: clinical details
Prescribing considerations
- Confirm the licensed indication and undertake indication-specific clinical, imaging and laboratory assessment before treatment.
- Treatment should be led by clinicians experienced in thrombolysis, with monitoring and resuscitation facilities immediately available.
- Record the product name and batch number for biological-medicine traceability.
- Minimise non-essential arterial or venous puncture, intramuscular injection and invasive handling.
Contraindications and cautions
- Hypersensitivity to alteplase or an excipient.
- Active, recent or significant bleeding, haemorrhagic diathesis or another condition carrying a high bleeding risk.
- Known or suspected intracranial haemorrhage or relevant intracranial pathology.
- Severe uncontrolled hypertension.
- Recent major surgery, significant trauma, obstetric delivery or puncture of a non-compressible vessel.
- Severe liver disease, active ulcerative gastrointestinal disease, vascular malformation or a tumour with increased bleeding risk.
- Effective anticoagulation or other indication-specific clinical, imaging, platelet, coagulation or glucose exclusions listed in the SmPC.
- For acute ischaemic stroke, use below 16 years is contraindicated.
Monitoring
- Observe neurological state, consciousness and all potential bleeding sites during and after treatment.
- Monitor blood pressure closely, particularly in acute ischaemic stroke.
- Review haemoglobin, platelet count and coagulation results when clinically relevant.
- Monitor for angioedema during treatment and for up to 24 hours afterwards, especially with concurrent ACE-inhibitor use.
- For myocardial infarction, monitor cardiac rhythm and haemodynamic status for reperfusion-related complications.
Clinical pharmacology
Alteplase is a recombinant tissue-type plasminogen activator with relative fibrin specificity. Fibrin binding promotes local conversion of plasminogen to plasmin; circulating alteplase is rapidly cleared, mainly by the liver.
Formulation and product differences
- The selected systemic product is supplied as powder with water for injections and must be reconstituted aseptically.
- The reconstituted solution should be clear and colourless to pale yellow; do not use it if particulate matter is present.
- Only sodium chloride solution is suitable for supported further dilution; carbohydrate solutions may cause turbidity.
- The catheter-clearance presentation is separate and is not interchangeable with the systemic presentations for these indications.
- A transfer cannula is included with larger pack presentations but not the smallest pack.
alteplase interactions
The treating team needs an urgent and complete record of prescribed, over-the-counter and recently stopped medicines.
Anticoagulants, including warfarin, heparins and direct oral anticoagulants
Existing anticoagulation may substantially increase bleeding risk and can make alteplase unsuitable, depending on the medicine, timing and coagulation results.
Antiplatelets, including aspirin and clopidogrel
Platelet inhibition increases bleeding risk; use around alteplase requires indication-specific specialist assessment.
Glycoprotein IIb/IIIa inhibitors
Concomitant use increases bleeding risk.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.