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Indications and Dosage
Intravenous
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.
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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.
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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. |
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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.
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Action
Description:
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. Pharmacokinetics: 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). |
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Storage
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).
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MIMS Class
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ATC Classification
V03AB37 - idarucizumab ; Belongs to the class of antidotes. Used to reverse anticoagulant effects of dabigatran.
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References
Anon. Idarucizumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 16/05/2023. Anon. Idarucizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 16/05/2023. Boehringer Ingelheim (N.Z.) Limited. Praxbind 50 mg/mL Solution for Injection/Infusion data sheet 07 February 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 16/05/2023. Buckingham R (ed). Idarucizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/05/2023. Joint Formulary Committee. Idarucizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 16/05/2023. Praxbind (Boehringer Ingelheim [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 16/05/2023. Praxbind 2.5 g/50 mL Solution for Injection/Infusion (Boehringer Ingelheim International GmbH). MHRA. https://products.mhra.gov.uk. Accessed 16/05/2023. Praxbind Injection (Boehringer Ingelheim Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 16/05/2023.
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