Article date: January 2008
Bivalirudin (Angiox▼) is a direct thrombin inhibitor that is approved for use as an anticoagulant in patients who are undergoing percutaneous coronary intervention (PCI). The approved dose for this indication is a 0·75-mg/kg bolus followed immediately by a 1·75-mg/kg/h infusion for the duration of the intervention.
About 35% of patients entered into a European registry study (enrolled from various countries, but not the UK) received a single bolus or double bolus of bivalirudin without the required maintenance infusion. Most affected patients were recruited in Germany. These non-approved regimens resulted in substantial underdosing and were associated with an increased incidence of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, and urgent revascularisation.
Advice for healthcare professionals explains:
- the approved dosing regimen for bivalirudin should be used in PCI. Use of a maintenance infusion after an initial bolus is necessary to ensure adequate anticoagulation during PCI.
Letter sent to healthcare professionals in October 2007
summary of product characteristics for Angiox▼
Article citation: Drug Safety Update Jan 2008; Vol 1 Issue 6: 7