Idarucizumab


Concise Prescribing Info
Indications/Uses
Reversal of anticoagulant effects of dabigatran.
Dosage/Direction for Use
Adult : IV 5 g, given as 2 consecutive doses of 2.5 g, via infusion over 5-10 minutes, no more than 15 minutes apart or by bolus inj. May consider a further dose of 5 g after 12-24 hours, if necessary.
Dosage Details
Intravenous
Reversal of anticoagulant effects of dabigatran
Adult: 5 g, given as 2 consecutive doses of 2.5 g, via infusion over 5-10 minutes, no more than 15 minutes apart or by bolus inj. May consider a further dose of 5 g after 12-24 hours, if necessary.
Special Precautions
Patient with risk factors for thromboembolic events. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions, thromboembolic events, transient proteinuria, incomplete reversal.
Gastrointestinal disorders: Constipation.
General disorders and administration site conditions: Fever.
Immune system disorders: Bronchospasm.
Infections and infestations: Pneumonia.
Metabolism and nutrition disorders: Hypokalaemia.
Nervous system disorders: Headache.
Psychiatric disorders: Delirium, hyperventilation.
Skin and subcutaneous tissue disorders: Rash, pruritus.
MonitoringParameters
Monitor coagulation parameters [e.g. activated partial thromboplastin time (aPTT) or ecarin clotting time (ECT)] at baseline, repeat at 2 hours then every 12 hours thereafter; signs and symptoms of bleeding and thromboembolic events.
Action
Description: Idarucizumab is a humanised monoclonal antibody fragment (Fab) used as a specific reversal agent for dabigatran and its acylglucuronide metabolites to form a stable inactive complex, thereby neutralizing its anticoagulant effects.
Onset: Within 5 minutes.
Duration: Approx 24 hours.
Pharmacokinetics:
Distribution: Volume of distribution: 8.9 L.
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).
Storage
Store between 2-8°C. Protect from light. Do not freeze or shake.
ATC Classification
V03AB37 - idarucizumab ; Belongs to the class of antidotes. Used to reverse anticoagulant effects of dabigatran.
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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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