Idarucizumab (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- PRAXBIND
Indications and Usage
PRAXBIND is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding
Contraindications
None.
Adverse Reactions
The following serious adverse reactions are described in more detail elsewhere in the labeling: Thromboembolic Risk [see Warnings and Precautions (5.1)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient [see Warnings and Precautions (5.4)]
Mechanism of Action
Idarucizumab is a specific reversal agent for dabigatran. It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin, neutralizing their anticoagulant effect.