Idarucizumab is an active pharmaceutical ingredient in the Antidotes group (V03AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
EUOfficial regulatory label· revised April 23, 2026[1]
Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required: • For emergency surgery/urgent procedures; • In life-threatening or uncontrolled bleeding.
How to take
EU
GBUnited Kingdom· MHRA
1 product
Uses
GBOfficial regulatory label· revised March 13, 2026[2]
Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with dabigatran etexilate when rapid reversal of its anticoagulant effects is required: • For emergency surgery/urgent procedures; • In life-threatening or uncontrolled bleeding.
How to take
GB
CACanada· Health Canada
1 product
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS .................................................................................
4 ADVERSE REACTIONS ................................................................................................... 6 DRUG INTERACTIONS .................................................................................................
11 DOSAGE AND ADMINISTRATION ............................................................................. 11 OVERDOSAGE ...............................................................................................................
13 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 13 STORAGE AND STABILITY ......................................................................................... 17 SPECIAL HANDLING INSTRUCTIONS ......................................................................
[1]European Medicines Agency · EMEA/H/C/003986 · revised April 23, 2026
[2]MHRA (UK) · PLGB145980220 · revised March 13, 2026
[3]Health Canada (DPD) · 02454343 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Restricted to hospital use only. 5 g/50 mL). 1). Administration of a second 5 g dose of idarucizumab may be considered in the following situations: • recurrence of clinically relevant bleeding together with prolonged clotting times, or • if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or • patients require a second emergency surgery/urgent procedure and have prolonged clotting times.
1). 3 A maximum daily dose has not been investigated. Restarting antithrombotic therapy Dabigatran etexilate treatment can be re-initiated 24 hours after administration of idarucizumab, if the patient is clinically stable and adequate haemostasis has been achieved.
g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved. Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
2). Patients with renal impairment No dose adjustment is required in renally impaired patients. 2). 2). Paediatric population The safety and efficacy of Praxbind in children below the age of 18 years have not been established. 1. Method of administration Intravenous use.
5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised April 23, 2026[1]
In a phase III study the safety of Praxbind has been evaluated in 503 patients, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with Pradaxa (dabigatran etexilate), as well as in 224 volunteers in phase I studies.
Furthermore, 359 patients were enrolled in a global idarucizumab administration surveillance program to collect data on usage patterns in a real-world-setting. One paediatric patient was treated in the context of a paediatric safety trial.
No adverse reactions have been identified. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised April 23, 2026[1]
Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. 1). Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate. 4 Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Praxbind should be discontinued immediately and appropriate therapy initiated.
Hereditary fructose intolerance The recommended dose of Praxbind contains 4 g sorbitol as an excipient. In patients with hereditary fructose intolerance, parenteral administration of sorbitol has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death.
Therefore, in patients with hereditary fructose intolerance the risk of treatment with Praxbind must be weighed against the potential benefit of such an emergency treatment. If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.
Thromboembolic events Patients being treated with dabigatran have underlying disease states that predispose them to thromboembolic events. Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
2). 2). The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing. 5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This is not medical advice. Consult a qualified healthcare professional.
Restricted to hospital use only. 5 g/50 mL). 1). Administration of a second 5 g dose of idarucizumab may be considered in the following situations: • recurrence of clinically relevant bleeding together with prolonged clotting times, or • if potential re-bleeding would be life-threatening and prolonged clotting times are observed, or • patients require a second emergency surgery/urgent procedure and have prolonged clotting times.
1). A maximum daily dose has not been investigated. Restarting antithrombotic therapy Dabigatran etexilate treatment can be re-initiated 24 hours after administration of idarucizumab, if the patient is clinically stable and adequate haemostasis has been achieved.
g. low-molecular weight heparin) can be started at any time, if the patient is clinically stable and adequate haemostasis has been achieved. Absence of antithrombotic therapy exposes patients to the thrombotic risk of their underlying disease or condition.
2). Patients with renal impairment No dose adjustment is required in renally impaired patients. 2). 2). Paediatric population The safety and efficacy of Praxbind in children below the age of 18 years have not been established. 1. Method of administration Intravenous use.
5 g/50 mL) is administered intravenously as two consecutive infusions over 5 to 10 minutes each or as a bolus injection. 6.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 13, 2026[2]
In a phase III study the safety of Praxbind has been evaluated in 503 patients, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with Pradaxa (dabigatran etexilate), as well as in 224 volunteers in phase I studies.
Furthermore, 359 patients were enrolled in a global idarucizumab administration surveillance program to collect data on usage patterns in a real-world-setting. One paediatric patient was treated in the context of a paediatric safety trial.
No adverse reactions have been identified. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
GBOfficial regulatory label· Warnings and precautions· revised March 13, 2026[2]
Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. 1). Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate. Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Praxbind should be discontinued immediately and appropriate therapy initiated.
Hereditary fructose intolerance The recommended dose of Praxbind contains 4 g sorbitol as an excipient. In patients with hereditary fructose intolerance, parenteral administration of sorbitol has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death.
Therefore, in patients with hereditary fructose intolerance the risk of treatment with Praxbind must be weighed against the potential benefit of such an emergency treatment. If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.
Thromboembolic events Patients being treated with dabigatran have underlying disease states that predispose them to thromboembolic events. Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease.
2). 2). The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing. 5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This is not medical advice. Consult a qualified healthcare professional.
17 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 17 PART II: SCIENTIFIC INFORMATION ............................................................................... 19 PHARMACEUTICAL INFORMATION .........................................................................
26 TOXICOLOGY ................................................................................................................ 26 PART III: PATIENT MEDICATION INFORMATION ....................................................... 5 g per vial 5 g per dose acetic acid glacial, polysorbate 20, sodium acetate trihydrate, sorbitol, water for injection For a complete listing see DOSAGE FORMS, COMPOSITION AND PACKAGING section.
DESCRIPTION PRAXBIND is a humanized monoclonal antibody fragment that binds to dabigatran thereby inhibiting the activity of dabigatran as an anticoagulant. Idarucizumab binds to dabigatran with very high affinity, approximately 300-fold more potent than the binding affinity of dabigatran for thrombin.
The antidote, idarucizumab, potently and specifically binds to dabigatran and its metabolites and reverses its anticoagulant effect. INDICATIONS AND CLINICAL USE PRAXBIND (idarucizumab) is an antidote, specific for dabigatran, and is indicated for adult patients treated with PRADAXA® when rapid specific reversal of the anticoagulant effects of dabigatran is required for: emergency surgery/urgent procedures; life-threatening or uncontrolled bleeding.
Geriatrics (> 65 years of age):
No overall differences in safety and efficacy were reported between elderly patients (65 years and older) and younger patients (less than 65 years) (see WARNINGS AND PRECAUTIONS Special Populations, Geriatrics and CLINICAL TRIALS).
Praxbind – Product Monograph - Schedule D Page 4 of 30 Pediatrics (< 18 years of age): The safety and efficacy of PRAXBIND have not been established in the pediatric population. CONTRAINDICATIONS Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph. WARNINGS AND PRECAUTIONS General PRAXBIND binds specifically to dabigatran (PRADAXA®) and reverses its anticoagulant effect. It will not reverse the effects of other anticoagulants (see Pharmacodynamics).
Thromboembolic Events Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate (see ADVERSE REACTIONS and CLINICAL TRIALS).
Anaphylactic Reactions and Hypersensitivity Anaphylactic reactions (including anaphylactic shock) have been observed in patients who received PRAXBIND in a clinical trial. A causal relationship could not be excluded. Possible hypersensitivity adverse events including bronchospasm, rash, pyrexia, pruritus, and hyperventilation have been reported in clinical trials with PRAXBIND.
g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment. If an anaphylactic reaction or other serious allergic reaction occurs, administration of PRAXBIND should be discontinued immediately and appropriate therapy initiated.
, diluted thrombin time (dTT), ecarin clotting time (ECT) or activated partial thromboplastin time (aPTT)) have been observed (see DOSAGE AND ADMINISTRATION). If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed after administration of 5 g PRAXBIND, administration of an additional 5 g dose of PRAXBIND may be considered.
Similarly, patients who require a second emergency surgery/ Praxbind – Product Monograph - Schedule D Page 5 of 30 urgent procedure and have elevated coagulation parameters may receive an additional 5 g dose of PRAXBIND. The safety and effectiveness of repeat treatment with PRAXBIND have not been established (see […]