Edoxaban


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation ≤60 kg: 30 mg once daily. >60 kg: 60 mg once daily. Deep vein thrombosis; Pulmonary embolism Treatment, and prophylaxis of recurrent cases following initial therapy with parenteral anticoagulant for at least 5 days: ≤60 kg: 30 mg once daily. >60 kg: 60 mg once daily. Duration of treatment is individualised based on assessment of benefit of treatment against the risk for bleeding. Dose reduction or discontinuation may be required when switching to and from edoxaban and based on patient safety and tolerability (refer to detailed product guideline).
Dosage Details
Oral
Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation
Adult: ≤60 kg: 30 mg once daily. >60 kg: 60 mg once daily. Dose may be modified or discontinued when switching to and from edoxaban based on patient safety and tolerability (refer to detailed product guideline).

Oral
Deep vein thrombosis, Pulmonary embolism
Adult: Treatment, and prophylaxis of recurrent cases following initial therapy with parenteral anticoagulant for at least 5 days: ≤60 kg: 30 mg once daily. >60 kg: 60 mg once daily. Duration of treatment is individualised based on assessment of benefit of treatment against the risk for bleeding. Dose may be modified or discontinued when switching to and from edoxaban based on patient safety and tolerability (refer to detailed product guideline).
Special Patient Group
Patient taking P-glycoprotein (P-gp) inhibitors (e.g. verapamil, ciclosporin, erythromycin, ketoconazole): 30 mg once daily. Increase dose to 60 mg upon discontinuation of therapy.
Renal Impairment
Patient on dialysis: Not recommended.

Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation
 CrCl (mL/min) Dosage 
<15 Not recommended. 
15-50 30 mg once daily.
51-80  60 mg once daily.
>95 Contraindicated.

Deep vein thrombosis; Pulmonary embolism
CrCl (mL/min) Dosage 
<15 Not recommended. 
15-50 30 mg once daily.
51-80 60 mg once daily.
Hepatic Impairment
Prophylaxis of stroke and systemic embolism in non-valvular atrial fibrillation
Mild to moderate: 60 mg once daily. Severe: Contraindicated.
Deep vein thrombosis; Pulmonary embolism
Mild to moderate: 60 mg once daily. Severe: Not recommended.
Administration
Film-Coated Tab: May be taken with or without food.
Contraindications
Active pathological bleeding; hepatic disease associated with coagulopathy and clinically relevant bleeding risk; conditions with significant risk of bleeding (e.g. current or recent gastrointestinal ulceration, malignant neoplasms, recent brain, spinal, ophthalmic injury and/or surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities); uncontrolled severe hypertension. Concomitant use with parenteral anticoagulants except when given to maintain an open central venous or arterial catheter, oral anticoagulants except when switching oral anticoagulant therapy. Pregnancy.
Special Precautions
Patient with increased risk of bleeding; history of traumatic or repeated spinal/epidural puncture, spinal deformity or surgery. Renal and hepatic impairment. Elderly. Lactation. Not recommended for the treatment in patient with prosthetic heart valve or significant rheumatic heart disease. Concomitant use with neuraxial anaesthesia.
Adverse Reactions
Significant: Thromboembolic events, spinal or epidural haematoma resulting to long term or permanent paralysis.
Blood and lymphatic system disorders: Anaemia.
Gastrointestinal disorders: Nausea, abdominal pain, lower and upper gastrointestinal haemorrhage, oral/pharyngeal haemorrhage.
General disorders and administration site conditions: Puncture site haemorrhage.
Investigations: Increased serum gammaglutamyltransferase, increased serum bilirubin, abnormal LFT.
Nervous system disorders: Headache, dizziness.
Renal and urinary disorders: Macroscopic haematuria/urethral haemorrhage.
Reproductive system and breast disorders: Vaginal haemorrhage.
Skin and subcutaneous tissue disorders: Cutaneous and soft tissue haemorrhage rash, pruritus.
Vascular disorders: Epistaxis.
Potentially Fatal: Bleeding.
MonitoringParameters
Assess renal function and CBC prior to initiation of therapy, and when clinically indicated. Monitor LFT; signs and symptoms of bleeding complications and anaemia, neurologic impairment (e.g. leg numbness or weakness, bowel/bladder dysfunction).
Overdosage
Symptoms: Haemorrhage. Management: Individualised based on the severity and location of haemorrhage. May administer activated charcoal if ingestion occurred within 1-2 hours of presentation. May consider mechanical compression for severe epistaxis, surgical haemostasis with bleeding control procedures; administration of fluid replacement and haemodynamic support, blood products (e.g. platelets, packed RBC, fresh frozen plasma) depending on associated anaemia or coagulopathy. Administer recombinant factor VIIa or 4-factor prothrombin complex concentrate at 50 IU/kg to reverse severe bleeding uncontrolled by transfusion or haemostasis.
Drug Interactions
Increased risk of spinal or epidural haematomas with neuraxial anaesthesia. Decreased plasma concentration with P-gp inducers (e.g. rifampicin, carbamazepine). Increased plasma concentration and systemic exposure with potent P-glycoprotein inhibitors (e.g. ciclosporin, erythromycin, azithromycin, itraconazole, ketoconazole, amiodarone, verapamil, quinidine).
Potentially Fatal: Increased risk of bleeding with other anticoagulants (e.g. aspirin), or other antiplatelet (e.g. clopidogrel), SSRIs, serotonin norepinephrine reuptake inhibitors (SNRIs), NSAIDs.
Food Interaction
Decreased plasma concentration with St. John’s wort.
Lab Interference
May prolong clotting test (e.g. prothrombin time, INR and aPTT).
Action
Description: Edoxaban, a selective, reversible and direct inhibitor of factor Xa. It blocks the free factor Xa, prothrombinase activity and thrombin-induced platelet aggregation in the coagulation cascade thereby reducing thrombin generation, prolonging clotting time and decreasing the risk of thrombus formation.
Pharmacokinetics:
Absorption: Absorbed from the upper gastrointestinal tract. Bioavailability: Approx 62%. Time to peak plasma concentration: 1-2 hours.
Distribution: Volume of distribution: 107 L. Plasma protein binding: Approx 55%.
Metabolism: Minimally metabolised via hydrolysis by carboxylesterase 1, conjugation and oxidation by CYP3A4 enzyme to active metabolite M-4.
Excretion: Via urine as unchanged drug. Elimination half-life: 10-14 hours.
Chemical Structure

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Storage
Store between 20-25°C.
ATC Classification
B01AF03 - edoxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Disclaimer: This information is independently developed by MIMS based on Edoxaban 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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