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Therapy with edoxaban in NVAF patients should be continued long term.
Treatment of DVT, treatment of PE and prevention of recurrent DVT and PE (VTE): The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5 days (see Pharmacology: Pharmacodynamics under Actions). Edoxaban and initial parenteral anticoagulant should not be administered simultaneously.
The duration of therapy for treatment of DVT and PE (venous thromboembolism, VTE), and prevention of recurrent VTE should be individualised after careful assessment of the treatment benefit against the risk for bleeding (see Precautions). Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and longer durations should be based on permanent risk factors or idiopathic DVT or PE.
For NVAF and VTE the recommended dose is 30 mg edoxaban once daily in patients with one or more of the following clinical factors: Moderate or severe renal impairment (creatinine clearance (CrCL) 15 - 50 mL/min); Low body weight ≤60 kg; Concomitant use of the following P-glycoprotein (P-gp) inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole. (See Table 10.)
Click on icon to see table/diagram/imageMissed 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 to and from edoxaban: Continued anticoagulant therapy is important in patients with NVAF and VTE. There may be situations that warrant a change in anticoagulation therapy (Table 11). (See Table 11.)
Click on icon to see table/diagram/imageSpecial populations: Elderly population: No dose reduction is required (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: Renal function should be assessed in all patients by calculating the creatinine clearance (CrCL) prior to initiation of treatment with edoxaban to exclude patients with end stage renal disease (i.e. CrCL <15 mL/min), to use the correct edoxaban dose in patients with CrCL 15 - 50 mL/min (30 mg once daily), in patients with CrCL >50 mL/min (60 mg once daily) and when deciding on the use of edoxaban in patients with increased CrCL (see Precautions).
Renal function should also be assessed when a change in renal function is suspected during treatment (e.g. hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).
The method used to estimate renal function (CrCL in mL/min) during the clinical development of edoxaban was the Cockcroft-Gault method. The formula is as follows: See equation.
Click on icon to see table/diagram/imageThis method is recommended when assessing patients' CrCL prior to and during edoxaban treatment.
In patients with mild renal impairment (CrCL >50 - 80 mL/min), the recommended dose is 60 mg edoxaban once daily.
In patients with moderate or severe renal impairment (CrCL 15 - 50 mL/min), the recommended dose is 30 mg edoxaban once daily (see Pharmacology: Pharmacokinetics under Actions).
In patients with end stage renal disease (ESRD) (CrCL <15 mL/min) or on dialysis, the use of edoxaban is not recommended (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Edoxaban is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk (see Contraindications).
In patients with severe hepatic impairment edoxaban is not recommended (see Precautions and Pharmacology: Pharmacokinetics under Actions).
In patients with mild to moderate hepatic impairment the recommended dose is 60 mg edoxaban once daily (see Pharmacology: Pharmacokinetics under Actions). Edoxaban should be used with caution in patients with mild to moderate hepatic impairment (see Precautions).
Patients with elevated liver enzymes (alanine aminotransferase (ALT) / aspartate transaminase (AST) >2 x upper limit of normal (ULN)) or total bilirubin ≥1.5 x ULN were excluded in clinical studies. Therefore edoxaban should be used with caution in this population (see Precautions and Pharmacology: Pharmacokinetics under Actions). Prior to initiating edoxaban, liver function testing should be performed.
Body weight: For patients with body weight ≤60 kg, the recommended dose is 30 mg edoxaban once daily (see Pharmacology: Pharmacokinetics under Actions).
Gender: No dose reduction is required (see Pharmacology: Pharmacokinetics under Actions).
Concomitant use of Lixiana with P-glycoprotein (P-gp) inhibitors: In patients concomitantly taking Lixiana and the following P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole, the recommended dose is 30 mg Lixiana once daily (see Interactions).
No dose reduction is required for concomitant use of amiodarone, quinidine or verapamil (see Interactions).
The use of Lixiana with other P-gp inhibitors including HIV protease inhibitors has not been studied.
Paediatric population: The safety and efficacy of edoxaban in children and adolescents less than 18 years of age have not been established. No data are available.
Patients undergoing cardioversion: Lixiana can be initiated or continued in patients who may require cardioversion. For transoesophageal echocardiogram (TEE) guided cardioversion in patients not previously treated with anticoagulants, Lixiana treatment should be started at least 2 hours before cardioversion to ensure adequate anticoagulation (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). Cardioversion should be performed no later than 12 hours after the dose of Lixiana on the day of the procedure.
For all patients undergoing cardioversion: Confirmation should be sought prior to cardioversion that the patient has taken Lixiana as prescribed. Decisions on initiation and duration of treatment should follow established guidelines for anticoagulant treatment in patients undergoing cardioversion.
Method of administration: For oral use.
Edoxaban can be taken with or without food (see Pharmacology: Pharmacokinetics under Actions).
For patients who are unable to swallow whole tablets, Lixiana tablets may be crushed and mixed with water or apple puree and immediately administered orally (see Pharmacology: Pharmacokinetics under Actions).
Alternatively, Lixiana tablets may be crushed and suspended in a small amount of water and immediately delivered through a gastric tube after which it should be flushed with water (see Pharmacology: Pharmacokinetics under Actions). Crushed Lixiana tablets are stable in water and apple puree for up to 4 hours.
