Overview
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.
Background
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.
Indication
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.
Associated Conditions
- Anticoagulant effects of dabigatran
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/08/20 | N/A | Completed | University Hospital, Essen | ||
2017/11/17 | Phase 3 | Completed | |||
2017/03/22 | Phase 1 | Completed | |||
2016/07/13 | Phase 3 | Completed | |||
2016/06/28 | Phase 3 | Completed | |||
2016/06/14 | N/A | Withdrawn | |||
2014/04/07 | Phase 3 | Completed | |||
2014/01/07 | Phase 1 | Completed | |||
2013/10/07 | Phase 1 | Completed | |||
2012/09/20 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0197 | INTRAVENOUS | 50 mg in 1 mL | 11/30/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/20/2015 | ||
Authorised | 11/20/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PRAXBIND SOLUTION FOR INJECTION/INFUSION 50 MG/ML | SIN15083P | INJECTION, SOLUTION | 50.00 mg/ml | 8/31/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Idarucizumab Injection | 国药准字SJ20180012 | 生物制品 | 注射剂 | 12/22/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PRAXBIND SOLUTION FOR INJECTION/ INFUSION 2.5G/50ML | N/A | boehringer ingelheim (hk) ltd | N/A | N/A | 10/26/2016 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PRAXBIND idarucizumab (rch) 50 mg/ml solution for injection/infusion vial | 237761 | Medicine | A | 5/11/2016 |