Idarucizumab 2.5g/50ml solution for infusion vials
Requires a prescription from a doctor or prescriber
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.
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
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Drug safety updates
MHRA alerts for Idarucizumab
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Idarucizumab
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Idarucizumab
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
1 branded products available
MHRA licensed products
View all licensed products for Idarucizumab on the MHRA register
Praxbind 2.5g/50ml solution for infusion vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(2)
Reversal of the anticoagulant effect of dabigatran: idarucizumab (ESNM73)
DOAC Dipstick for detecting direct oral anticoagulants (MIB248)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & safety information
Official UK regulator monitoring and safety alerts
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. Shortage and safety information sourced from MHRA drug safety updates (gov.uk, Crown Copyright under OGL v3.0).
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 27 · Randomised trials: 1 · 2015–2025
Showing the 50 most relevant studies, sorted by most relevant.
Stephan Glund, Joachim Stangier, Michael Schmohl, et al.
The Lancet, 2015
- Dabigatran
- Benzimidazoles
- Blood Circulation Time
Heuts S, Ceulemans A, Kuiper GJAJM, et al.
2023
- Hemorrhage
- Cardiac Surgical Procedures
- Heparin
ObjectivesLiterature is scarce on the management of patients using direct oral anticoagulants (DOACs) undergoing elective, urgent and emergency surgery. Therefore, we summarize the current evidence and provide literature-based recommendations for the management of patients on DOACs in the perioperative phase.MethodsA general literature review was conducted on the pharmacology of DOACs and for recommendations on the management of cardiac surgical patients on DOACs. Additionally, we performed a systematic review for studies on the use of direct DOAC reversal agents in the emergency cardiac surgical setting.ResultsWhen surgery is elective, the DOAC cessation strategy is relatively straightforward and should be adapted to the renal function. The same approach applies to urgent cases, but additional DOAC activity drug level monitoring tests may be useful. In emergency cases, idarucizumab can be safely administered to patients on dabigatran in any of the perioperative phases. However, andexanet alfa, which is not registered for perioperative use, should not be administered in the preoperative phase to reverse the effect of factor Xa inhibitors, as it may induce temporary heparin resistance. Finally, the administration of (activated) prothrombin complex concentrate may be considered in all patients on DOACs, and such concentrates are generally readily available.ConclusionsDOACs offer several advantages over vitamin K antagonists, but care must be taken in patients undergoing cardiac surgery. Although elective and urgent cases can be managed relatively straightforwardly, the management of emergency cases requires particular attention.
Abstract licence: CC BY-NC
D. Giannandrea, Carla Caponi, A. Mengoni, et al.
Journal of Neurology, Neurosurgery, and Psychiatry, 2018
- Thrombolytic Therapy
- Dabigatran
- Antithrombins
S. Melicine, Paul Billoir, D. Faille, et al.
Research and Practice in Thrombosis and Haemostasis, 2023
Zeller L, Rohr J, Brandi G, et al.
2025
BackgroundDirect oral anticoagulants (DOACs) are widely used but pose significant challenges in emergency neurosurgical settings. Idarucizumab and andexanet alfa are approved reversal agents, yet their effectiveness and safety in neurosurgical emergencies remain unclear.ObjectivesThis systematic review evaluates the current evidence on DOAC reversal in patients undergoing emergency neurosurgical interventions.MethodsWe conducted a systematic review of case series of a minimum of 5 patients on DOACs receiving andexanet or idarucizumab for emergency neurosurgery (ResultsSeven studies, comprising 148 patients, met the inclusion criteria. Andexanet was investigated in 4 studies, including 37 patients. Adequate intraoperative hemostasis was confirmed in 80% to 100% of patients. One study showed a thromboembolic event rate of 8.3% and an in-hospital mortality rate of 50% in 12 patients, while others showed lower rates. Idarucizumab was analyzed in 3 studies of 111 patients, of whom 97 were from a single large cohort. Satisfactory hemostasis was reported in 93.5% to 100% of patients. Thromboembolic event rates ranged from 0% to 4.1% and mortality rates were 0%, 3.1%, and 12.5%, respectively.ConclusionThe use of DOAC reversal agents in emergency neurosurgery appears feasible and may support surgical hemostasis in selected patients. However, further research is warranted, particularly regarding the off-label use of andexanet, given the limited evidence and potential safety concerns.
Abstract licence: CC BY
S. van der Horst, E. Martens, P. D. den Exter, et al.
Research and Practice in Thrombosis and Haemostasis, 2023
Nathan Thibault, Amanda M. Morrill, Kristine C. Willett
American Journal of Therapeutics, 2016
- Dabigatran
- Antithrombins
- Blood Coagulation
Akshay Athavale, N. Jamshidi, D. Roberts
Clinical Toxicology, 2020
André Oliveira Rodrigues, Cláudio David, Joaquim J. Ferreira, et al.
Thrombosis Research, 2020
- Anticoagulants
- Factor Xa
- Antidotes
Charles V. Pollack, Paul Reilly, Joanne van Ryn, et al.
New England Journal of Medicine, 2017
- Dabigatran
- Antibodies
- Anticoagulants
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
47 minutes
Mechanism
Idarucizumab is a specific reversal agent for dabigatran.
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Half-life
47 minutes
terminal half-life: 10.3 h
Volume of distribution
8.9 L
Metabolism
Elimination
32.1%
Clearance
47.0 mL/min
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
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.
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 1100 interactions
How the body processes this drug — absorption, distribution, metabolism, and elimination
terminal half-life: 10.3 h
molecules, i.e., small peptides or amino acids which are then reabsorbed and incorporated in the general protein synthesis.
ATC V03AB37
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Idarucizumab
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72