Idarucizumab
Idarucizumab Uses, Dosage, Side Effects, Food Interaction and all others data.
Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an immunoglobulin G1 isotype molecule that binds to and inactivates the oral anticoagulant dabigatran, thereby reversing its anticoagulant effect. As a direct acting oral anticoagulant (DOAC), one of the risks associated with the use of dabigatran includes bleeding, espeically when given to patients at increased risk (elderly, chronic kidney disease, concomitant NSAID or warfarin use, etc).
Approved under the tradename Praxbind (FDA), idarucizumab is indicated for the emergency treatment of dabigatran-associated bleeding in life-threatening or surgically induced situations. Its use is associated with immediate, complete and sustained reversal of the anticoagulant effects of dabigatran.
Idarucizumab protein structure can be viewed below, with disulfide bridges at the following points: H22-H95, H149-H205, H225-L-219, L23-L93, L139-L199.
| Trade Name | Idarucizumab |
| Availability | Prescription only |
| Generic | Idarucizumab |
| Idarucizumab Other Names | aDabi-Fab, Idarucizumab |
| Related Drugs | Praxbind |
| Weight | 2.5g/50ml, |
| Type | Intravenous Solution, Intravenous |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | United States |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Idarucizumab is an antibody that binds dabigatran for the reversal of anticoagulant effects of dabigatran.
For use in patients treated with Dabigatran when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.
Idarucizumab is also used to associated treatment for these conditions: Anticoagulant effects of dabigatran
How Idarucizumab works
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.
Toxicity
In healthy volunteers, the most frequently reported adverse reactions in greater than or equal to 5% of subjects treated with idarucizumab was headache. In patients, the most frequently reported adverse reactions in greater than or equal to 5% of patients treated with idarucizumab were hypokalemia, delirium, constipation, pyrexia, and pneumonia.
Food Interaction
No interactions found.Idarucizumab Disease Interaction
Volume of Distribution
8.9 L
Half Life
initial half-life: 47 minutes terminal half-life: 10.3 h
Clearance
47.0 mL/min
Elimination Route
After intravenous administration of 5 g idarucizumab, 32.1% (gCV 60.0%) of the dose was recovered in urine within a collection period of 6 hours and less than 1% in the following 18 hours. The remaining part of the dose is assumed to be eliminated via protein catabolism, mainly in the kidney.
Innovators Monograph
You find simplified version here Idarucizumab
