Products
Idarucizumab is commercially available as an injection/infusion solution (Praxbind). It was approved in the EU and US in 2015 and in many countries in 2016.
Structure and properties
Idarucizumab is a humanized Fab fragment of an IgG1 monoclonal antibody. It has a molecular weight of approximately 47.8 kDa. Idarucizumab binds to dabigatran in a 1:1 ratio. The drug is produced by biotechnological methods.
Effects
Idarucizumab (ATC V03AB) binds with picomolar binding affinity to free and thrombin-bound dabigatran and its metabolites and inactivates the effects of the thrombin inhibitor within minutes. It counteracts bleeding, which can occur as a side effect of dabigatran therapy. The terminal half-life is approximately 10 hours.
Indications
Idarucizumab is intended for use in patients who have severe and uncontrollable bleeding while receiving treatment with dabigatran (Pradaxa).
Dosage
According to the SmPC. The drug is administered in a hospital setting as an intravenous infusion or bolus injection.
Contraindications
For complete precautions, see the drug label.
Interactions
There are no known drug-drug interactions.
Adverse effects
The most common possible adverse effects include headache (in healthy subjects) and hypokalemia, delirium, constipation, fever, and pneumonia (in patients).
