idarucizumab
E861730
Idarucizumab is a monoclonal antibody fragment used as a specific antidote to rapidly reverse the anticoagulant effects of dabigatran in cases of emergency or uncontrolled bleeding.
Statements (52)
| Predicate | Object |
|---|---|
| instanceOf |
antidote
ⓘ
biologic medicinal product ⓘ dabigatran reversal agent ⓘ monoclonal antibody fragment ⓘ |
| doesNotReverse | other anticoagulants ⓘ |
| hasAdministrationForm | concentrate for solution for infusion ⓘ |
| hasAdverseEffect |
delirium
ⓘ
headache ⓘ hypersensitivity reactions ⓘ hypokalemia ⓘ thromboembolic events ⓘ |
| hasApprovalBy |
European Medicines Agency
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| hasATCCode | V03AB38 ⓘ |
| hasBindingAffinity | very high affinity for dabigatran ⓘ |
| hasCASNumber | 1458672-75-9 ⓘ |
| hasContraindication | known hypersensitivity to idarucizumab or excipients ⓘ |
| hasDeveloper | Boehringer Ingelheim NERFINISHED ⓘ |
| hasEffectOnCoagulation | normalizes coagulation tests prolonged by dabigatran ⓘ |
| hasEffectOnLaboratoryParameter |
reduces activated partial thromboplastin time
ⓘ
reduces diluted thrombin time ⓘ reduces ecarin clotting time ⓘ |
| hasEMAAuthorizationYear | 2015 ⓘ |
| hasFDAApprovalYear | 2015 ⓘ |
| hasGenericName | idarucizumab NERFINISHED ⓘ |
| hasHalfLife | approximately 45 minutes ⓘ |
| hasIndication |
life-threatening bleeding in patients treated with dabigatran
ⓘ
reversal of dabigatran anticoagulation ⓘ urgent surgery or emergency procedures in patients treated with dabigatran ⓘ |
| hasLegalStatus | prescription-only medicine ⓘ |
| hasMechanismOfAction |
binds dabigatran with high affinity
ⓘ
neutralizes anticoagulant effect of dabigatran ⓘ |
| hasMolecularTargetClass | direct thrombin inhibitor dabigatran ⓘ |
| hasMolecularType | humanized monoclonal antibody fragment ⓘ |
| hasOnsetOfAction | within minutes ⓘ |
| hasPharmacodynamicProperty | does not have intrinsic procoagulant activity ⓘ |
| hasPharmacologicalClass |
hemostatic agent
ⓘ
specific dabigatran reversal agent ⓘ |
| hasPregnancyCategory | insufficient human data ⓘ |
| hasRouteOfAdministration | intravenous ⓘ |
| hasStorageCondition | refrigerated ⓘ |
| hasTarget |
dabigatran
NERFINISHED
ⓘ
dabigatran acylglucuronide metabolites ⓘ |
| hasTradeName | Praxbind NERFINISHED ⓘ |
| hasUNII | W391YH69L8 ⓘ |
| hasUsualDose | 5 g total dose ⓘ |
| hasUsualDoseRegimen | two consecutive 2.5 g intravenous infusions ⓘ |
| isAdministeredAs |
intravenous bolus
ⓘ
intravenous infusion ⓘ |
| isEliminatedBy | renal excretion ⓘ |
| isIndicatedForPopulation | adult patients ⓘ |
| isUsedFor | rapid reversal of dabigatran effects ⓘ |
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.