Idarucizumab: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Malaysia prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Monitoring Parameters

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.

MIMS Class

Antidotes & Detoxifying Agents

ATC Classification

V03AB37 - idarucizumab ; Belongs to the class of antidotes. Used to reverse anticoagulant effects of dabigatran.

References

Anon. Idarucizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/12/2017.

Boehringer Ingelheim (N.Z.) Limited. Praxbind 50 mg/mL Solution for Injection/Infusion data sheet 17 July 2017. Medsafe. http://www.medsafe.govt.nz/. Accessed 18/12/2017.

Buckingham R (ed). Idarucizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/12/2017.

Joint Formulary Committee. Idarucizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/12/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Idarucizumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 18/01/2018.

Praxbind injection (Boehringer Ingelheim Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/12/2017.

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