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Alteplase: Low dose for Intermediate/High risk PE
Who can administer
Administration restricted- see Appendix 1 below
Important information
- Unlicensed indication
- Patients MUST be discussed with some or all of the following:
- Consultant Anaesthetist/Intensivist
- Consultant Respiratory physician
- Consultant Haematologist
- Consultant Radiologist
- Consultant Cardiologist
- Consider in patient with acute PE where there is clinical concern AND
- Evidence of right heart strain (increased troponin+/- increased pro-BNP) and/or RV dilatation on echo
- Patients not improving on anticoagulation or worsening of biomarkers/RV strain despite anticoagulation
- Patient not a candidate for full dose (100mg) alteplase due to concerns regarding bleeding or who do not meet criteria for 100mg dose for acute massive pulmonary embolism with haemodynamic instability
-
For use in thrombolysis (acute MI), acute massive PE, acute ischaemic stroke - see separate monograph
- For use in Catheter-directed Thrombolysis- see separate monograph
Available preparations
- Actilyse 10mg vial (with 10ml Water for Injection provided)
Reconstitution
- Use 10ml Water for Injection provided
Infusion fluids
Sodium chloride 0.9% only
Dilution | Concentration produced |
10mg added to 40ml infusion fluid to produce a final volume of 50ml | 1mg per 5ml |
The product must only be diluted and reconstituted as outlined here, due to stability issues at other concentrations (SPC)
Methods of intravenous administration
Bolus intravenous injection (ref 1)
- Administer required dose over 1 to 2 minutes
Intermittent intravenous infusion (administer using an electronically controlled infusion device)
- Administer required dose as per Dose below
- May be administered via a peripheral cannula in the Critical care setting
- Syringe must be changed after 8 hours (no stability data beyond 8 hours at room temperature)
Dose in adults
Pulmonary embolism (Low dose for Intermediate/High risk PE)(for patients meeting criteria in Important information above)
- Administer 10mg as a bolus intravenous injection
- Follow bolus injection with an infusion of 1mg/hour (5ml/hour) for 24 hours or until clinical improvement
- Concomitant heparin administration is required (either UFH or LMWH depending on patient's clinical condition)
For doses in other indications see separate monographs
- For use in thrombolysis (acute MI), acute massive PE, acute ischaemic stroke - see separate monograph
- For use in Catheter-directed Thrombolysis- see separate monograph
Monitoring
- Baseline: Check PT, aPTT, FBC, Clauss fibrinogen, troponin, pro-BNP
- Recheck Coag including Clauss fibrinogen 8 hourly (depending on heparin regimen) or if bleeding
- Risk of bleeding is lower with this regimen than the full dose alteplase regimen
- Ensure Clauss fibrinogen is greater than 1.0g/L
Storage
- Store below 250C
- Syringe must be changed after 8 hours (no stability data beyond 8 hours at room temperature)
References
1: Injectable Medicines Administration guide (downloaded from Medusa 21st April 2021)
Locally produced guidelines: approved by Dr. Ruth Gilmore (Haematologist). 29 July 2021.
Therapeutic classification
- Fibrinolytic agent