idarucizumabi

Idarucizumab is a humanized monoclonal antibody fragment (Fab) that acts as a specific reversal agent for dabigatran, an oral direct thrombin inhibitor. By binding dabigatran with high affinity, idarucizumab neutralizes its anticoagulant effect, allowing normal coagulation to resume. It does not reverse the activity of other direct oral anticoagulants.

Indications for idarucizumab include emergency reversal of dabigatran in adults who have life-threatening or uncontrolled bleeding or who require urgent surgery or a procedure. It is used when rapid restoration of hemostasis is necessary and dabigatran must be neutralized promptly.

Administration and dosing involve a fixed regimen of 5 grams given as two consecutive intravenous infusions of 2.5 grams each. Each infusion is administered relatively quickly, typically within minutes. Most patients achieve rapid reversal within minutes of administration. A second course may be considered if there is reemergence of dabigatran activity due to ongoing absorption or redistribution, or if renewed bleeding occurs.

Pharmacology and clinical considerations include rapid reversal of the anticoagulant effect, with laboratory measurements such as diluted thrombin time or other dabigatran-sensitive assays showing normalization after dosing. The effect is specific to dabigatran; idarucizumab does not reverse the effects of other anticoagulants. Safety considerations include the potential for thromboembolic events after reversal if anticoagulation is not promptly reinitiated when appropriate. Contraindications include hypersensitivity to idarucizumab or its components.

Regulatory status places idarucizumab on the market under the brand name Praxbind in many regions, including approval in the United States in 2015, as a targeted antidote for dabigatran-related bleeding or urgent procedural needs.