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Edoxaban oral

Updated 2 Feb 2023 | Oral Factor Xa inhibitors


Oral formulations of edoxaban.

Drugs List

  • edoxaban 15mg tablets
  • edoxaban 30mg tablets
  • edoxaban 60mg tablets
  • LIXIANA 15mg tablets
  • LIXIANA 30mg tablets
  • LIXIANA 60mg tablets
  • Therapeutic Indications


    Deep vein thrombosis - prophylaxis
    Deep vein thrombosis - treatment
    Nonvalvular atrial fibrillation; prevention of stroke and systemic embolism
    Pulmonary embolism - prophylaxis
    Pulmonary embolism - treatment

    Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as congestive heart failure, hypertension; age equal to or greater than 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

    Treatment and prevention of recurrent deep vein thrombosis (DVT).

    Treatment and prevention of recurrent pulmonary embolism (PE).



    Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation
    The recommended dose is 60mg once daily.

    Therapy with edoxaban in patients with NVAF should be continued long term.

    Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE
    The recommended dose is 60mg once daily following an initial use of parenteral anticoagulant for at least 5 days.

    Edoxaban and initial parenteral anticoagulant should not be administered simultaneously.

    The duration of therapy for the treatment of DVT and PE and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding. Short duration therapy (at least 3 months) should be based on transient risk factor and longer durations should be based on permanent risk factors or idiopathic DVT or PE.

    Patients with Renal Impairment

    Mild renal impairment (creatinine clearance greater than 50 to 80ml/minute)
    The recommended dose is 60mg once daily.

    Moderate or severe renal impairment (creatinine clearance 15 to 50ml/minute)
    The recommended dose is 30mg once daily.

    Additional Dosage Information

    Dose reduction in patients with low body weight
    For all indications the recommended dose is 30mg once daily in patients with a body weight less than or equal to 60kg.

    Missed dose
    If a dose of edoxaban is missed, the dose should be taken immediately and then be continued the following day with the once daily intake as recommended. The patient should not take double the prescribed dose on the same day to make up for a missed dose.

    Switching from Vitamin K Antagonist (VKA) to edoxaban
    Discontinue the VKA and start edoxaban when the international normalised ratio (INR) is less than or equal to 2.5.

    Switching from oral anticoagulants other than VKA to edoxaban
    Discontinue oral anticoagulant and start edoxaban at the time of the next dose of the oral anticoagulant.

    Switching from parenteral anticoagulants to edoxaban
    Parenteral anticoagulants should not be administered simultaneously with edoxaban.

    From subcutaneous anticoagulants
    Discontinue subcutaneous anticoagulant and start edoxaban at the time of the next scheduled subcutaneous anticoagulant dose.

    From intravenous unfractionated heparin (UFH)
    Discontinue the UFH infusion and start edoxaban 4 hours later.

    Switching from edoxaban to VKA
    There is a potential for inadequate anticoagulation during the transition from edoxaban to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant.

    Using oral VKA
    For patients currently on a 60mg dose, administer 30mg edoxaban once daily together with an appropriate VKA dose.
    For patients currently on a 30mg dose, administer 15mg edoxaban once daily together with an appropriate VKA dose.

    Patients should not take a loading dose of VKA in order to promptly achieve a stable INR between 2 and 3. Take into account the maintenance dose of VKA and if the patient was previously taking a VKA or to use valid INR driven VKA treatment algorithm.

    Once an INR greater than or equal to 2 is achieved, edoxaban should be discontinued. Most patients should be able to achieve an INR of greater than or equal to 2 within 14 days of concomitant administration of edoxaban and VKA. After 14 days it is recommended that edoxaban is discontinued and the VKA continued to be titrated to achieve an INR between 2 and 3.

    Concomitant edoxaban and VKA can increase the INR post edoxaban dose, it is recommended that during the first 14 days of concomitant therapy the INR is measured at least 3 times just prior to taking the daily dose of edoxaban to minimise the influence of edoxaban on INR measurements.

    Using a parenteral anticoagulant and oral VKA
    Discontinue edoxaban and administer a parenteral anticoagulant and VKA at the time of the next scheduled edoxaban dose. Once a stable INR of greater than or equal to 2 is achieved, the parenteral anticoagulant should be discontinued and the VKA continued.

    Switching from edoxaban to oral anticoagulants other than VKA
    Discontinue edoxaban and start the non-VKA anticoagulant at the time of the next scheduled dose of edoxaban.

    Switching from edoxaban to parenteral anticoagulants
    These agents should not be administered simultaneously.
    Discontinue edoxaban and start the parenteral anticoagulant at the time of the next scheduled dose of edoxaban.

    Patients undergoing cardioversion
    Edoxaban can be initiated or continued in patients who may require cardioversion.
    Transoesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, edoxaban should be started at least 2 hours before cardioversion to ensure adequate anticoagulation.
    Cardioversion should be performed no later than 12 hours after the dose of edoxaban. Confirmation should be sought prior to cardioversion that the patient has taken edoxaban as prescribed.


    For patients unable to swallow whole tablets, edoxaban tablets may be crushed and mixed with water or apple puree immediately prior to use and administered orally.


    Children under 18 years
    Arteriovenous malformation
    Coagulopathy due to hepatic disorder
    Gastrointestinal ulcer
    History of gastrointestinal ulceration
    Moderate mitral stenosis
    Neoplasm with increased bleeding risk
    Oesophageal varices
    Prosthetic heart valve
    Recent central nervous system surgery
    Recent central nervous system trauma
    Recent intracranial haemorrhage
    Recent ocular surgery
    Renal dialysis
    Renal impairment - creatinine clearance below 15ml/minute
    Severe hepatic impairment
    Uncontrolled severe hypertension
    Vascular disorder

    Precautions and Warnings

    Females of childbearing potential
    Risk of haemorrhage
    Weight below 61kg
    Antiphospholipid syndrome
    Elevated serum transaminases - greater than twice the upper limit of normal
    Haemodynamic instability
    Hepatic impairment
    Renal impairment - creatinine clearance 15-50ml/minute
    Serum bilirubin above 1.5 times upper limit of normal

    Reduce dose in patients with creatinine clearance of 15 - 50ml/min
    Anticoagulant effect cannot be reliably monitored with standard tests
    Evaluate renal function before and during treatment
    Perform liver function tests before commencing therapy
    Monitor for bleeding during treatment
    Monitor for unexplained fall in blood pressure or haematocrit
    Monitor liver function on prolonged therapy
    Reduce dose in patients who weigh less than 61kg
    Discontinue if severe haemorrhage occurs
    Discontinue prior to surgery
    Advise patient not to take NSAIDs unless advised by clinician
    Advise patient not to take St John's wort concurrently
    Female: Ensure adequate contraception during treatment
    Advise patient of risk of bleeding
    Remind patient of importance of carrying Alert Card with them at all times

    Haemorrhagic risk
    Mucosal bleedings and anaemia have been seen more frequently during long term edoxaban treatment compared with VKA treatment.

    Discontinuation for surgery and other interventions
    If the need for a procedure is identified less than 24 hours after the last dose of edoxaban the risk of bleeding should be weighed against the urgency of treatment. Following the procedure, edoxaban should be restarted once adequate haemostasis is established.
    If oral medication cannot be taken following a procedure then consider using a parenteral anticoagulant then switching to edoxaban when the oral route is available.

    Prosthetic heart valves and moderate to severe mitral stenosis
    Edoxaban is not recommended in patients with mechanical heart valves, during the first 3 months after implantation of bioprosthetic heart valves or in patients with moderate to severe mitral stenosis.

    Haemodynamically unstable PE patients or those who require thrombolysis or pulmonary embolectomy
    Edoxaban is not recommended as an alternative to unfractionated heparin in patients with PE who are either haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy.

    Patients with active cancer
    Efficacy and safety of edoxaban in the treatment and/or prevention of VTE in patients with active cancer has not been established.

    Antiphospholipid syndrome
    Direct acting Oral Anticoagulants (DOACs) including edoxaban are not recommended for patients with a history of thrombosis who are diagnosed with antiphospholipid syndrome. In particular for patients that are triple positive (for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein 1 antibodies), treatment with DOACs could be associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy.

    Pregnancy and Lactation


    Edoxaban is contraindicated during pregnancy.

    Use of edoxaban during pregnancy is contraindicated by the manufacturer. There is limited published experience concerning the use of edoxaban during pregnancy. Animal studies have shown reproductive toxicity. Edoxaban is known to cross the placenta. The potential risk to the foetus is unknown.


    Edoxaban is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues edoxaban or discontinues breastfeeding. There is limited published experience concerning the use of edoxaban during breastfeeding. Animal studies haven shown the excretion of edoxaban in breast milk, however the presence in human breast milk and the effects in exposed infants are unknown.

    Side Effects

    Abdominal pain
    Abnormal liver function tests
    Anaphylactic reaction
    Aspartate aminotransferase increased
    Bleeding (surgical site)
    Cerebral haemorrhage
    Conjunctival haemorrhage
    Gamma glutamyl transferase (GGT) increased
    Gastro-intestinal haemorrhage
    Haematoma (injection site)
    Hypersensitivity reactions
    Increase in alkaline phosphatase
    Increase in serum transaminases
    Intracranial bleeding
    Joint/bone haemorrhage
    Macroscopic haematuria
    Menstrual bleeding increased
    Muscle haemorrhage
    Ocular haemorrhage
    Pericardial haemorrhage
    Pharyngeal haemorrhage
    Retroperitoneal bleeding
    Serum bilirubin increased
    Skin/soft tissue haemorrhage
    Subdural haematoma
    Urethral bleeding
    Vaginal haemorrhage


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: May 2019.

    Reference Sources

    Summary of Product Characteristics: Lixiana 15mg tablets. Daiichi Sankyo UK Ltd. Revised November 2020.
    Summary of Product Characteristics: Lixiana 30mg tablets. Daiichi Sankyo UK Ltd. Revised November 2020.
    Summary of Product Characteristics: Lixiana 60mg tablets. Daiichi Sankyo UK Ltd. Revised November 2020.

    HPRA Safety Notices May 2019.
    Available at:
    Last accessed: 07 June 2019.

    MHRA Drug Safety Update June 2020
    Available at:
    Last accessed: 06 November 2020

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