Generic Medicine Info
Indications and Dosage
Reversal of anticoagulant effects of dabigatran
Adult: For life-threatening or uncontrolled bleeding, or emergency surgery/urgent procedures: 5 g (given as 2 consecutive 2.5 g doses no more than 15 minutes apart, via IV infusion over 5-10 minutes each or via IV bolus inj). May consider the administration of another 5 g dose if there is a recurrence of clinically relevant bleeding, prolonged clotting time, or there is a need for a 2nd emergency procedure/surgery.
Special Precautions
Patient with risk factors for thromboembolic events. Dabigatran therapy may be re-initiated 24 hours following the administration of idarucizumab if the patient is clinically stable and adequate haemostasis has been achieved. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reaction, increased risk of thromboembolic events; transient proteinuria as a physiologic reaction to renal protein overflow after short-term IV administration (not indicative of renal damage).
Gastrointestinal disorders: Nausea, constipation.
General disorders and administration site conditions: Fever.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Bronchospasm, hyperventilation.
Skin and subcutaneous tissue disorders: Skin rash, pruritus.
Monitoring Parameters
Monitor coagulation parameters (e.g. active partial thromboplastin time [aPTT]) at baseline, repeat at 2 hours then 12 hourly thereafter until aPTT returns to normal. Assess for signs and symptoms of bleeding and thromboembolic events.
Mechanism of Action: Idarucizumab is a humanised monoclonal antibody fragment (Fab) used as a specific reversal agent for dabigatran. It acts by binding to dabigatran and its acylglucuronide metabolites, thereby neutralising its anticoagulant effects.
Onset: Within minutes.
Duration: Approx 24 hours.
Metabolism: Metabolised via biodegradation into small peptides or amino acids.
Excretion: Via urine (approx 32% within 6 hours; <1% in the following 18 hours). Elimination half-life: 47 minutes (initial); 10.3 hours (terminal).
Intact vial: Store between 2-8°C. Protect from light. Do not freeze or shake. Alternatively, the intact vial may be stored at room temperature below 30°C for up to 48 hours (if kept in the original package to protect from light), or for up to 6 hours (if exposed to light).
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AB37 - idarucizumab ; Belongs to the class of antidotes. Used to reverse anticoagulant effects of dabigatran.
Anon. Idarucizumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. Accessed 16/05/2023.

Anon. Idarucizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 16/05/2023.

Boehringer Ingelheim (N.Z.) Limited. Praxbind 50 mg/mL Solution for Injection/Infusion data sheet 07 February 2023. Medsafe. Accessed 16/05/2023.

Buckingham R (ed). Idarucizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 16/05/2023.

Joint Formulary Committee. Idarucizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 16/05/2023.

Praxbind (Boehringer Ingelheim [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. Accessed 16/05/2023.

Praxbind 2.5 g/50 mL Solution for Injection/Infusion (Boehringer Ingelheim International GmbH). MHRA. Accessed 16/05/2023.

Praxbind Injection (Boehringer Ingelheim Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. Accessed 16/05/2023.

Disclaimer: This information is independently developed by MIMS based on Idarucizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by
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