Kalbe Farma
Full Prescribing Info
To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) CHADS2 score of at least 2 and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, following 5 to 10 days of initial therapy with a parenteral anticoagulant.
Dosage/Direction for Use
NVAF: The recommended dose is 60 mg edoxaban once daily with or without food. Therapy with edoxaban in NVAF patients should be continued long term.
DVT & PE: The recommended dose is 60 mg edoxaban once daily following initial use of parenteral anticoagulant for at least 5-10 days with or without food. Duration of therapy (at least 3 months) should be based on risk profile of the patient.
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 and/or concomitant use of the following P-glycoprotein (P-gp) inhibitors: cyclosporine, dronedarone, erythromycin, or ketoconazole.
The 15 mg dose of edoxaban is not indicated as monotherapy and should only be used during a switch from edoxaban to VKA.
Overdose with edoxaban may lead to hemorrhage. A specific antidote antagonizing the pharmacodynamic effect of edoxaban is not available. Early administration of activated charcoal may be considered in case of edoxaban overdose to reduce absorption. This recommendation is based on standard treatment of drug overdose and data available with similar compounds, as the use of activated charcoal to reduce absorption of edoxaban has not been specifically studied in the edoxaban clinical program.
Hypersensitivity to the active substance or to any of the excipients.
Clinically significant active bleeding.
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal (GI) ulceration, presence of malignant neoplasms at high risks of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
Uncontrolled severe hypertension.
Concomitant treatment with any other anticoagulants e.g. UFH, low molecular weight heparins (enoxaparin, dalteparin, etc), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban, etc.) except under specific circumstances of switching oral anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter.
Pregnancy and breastfeeding.
Special Precautions
The anticoagulant effect of edoxaban cannot be reliably monitored with standard laboratory testing. A specific anticoagulant reversal agent for edoxaban is not available. Haemodialysis does not significantly clear edoxaban.
Renal impairment: Renal function should be assessed prior to initiation of edoxaban and afterwards when clinically indicated. Not recommended in patients with end stage renal disease or on dialysis.
Hepatic impairment: Not recommended in patients with severe hepatic impairment and should be used with caution in patients with mild or moderate hepatic impairment. Edoxaban should be used with caution in patients with elevated liver enzymes (ALT/AST >2 x ULN) or total bilirubin ≥1.5 x ULN.
Prosthetic heart valves and moderate to severe mitral stenosis: Not recommended.
Discontinuation for surgery and other interventions: If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, LIXIANA should be stopped as soon as possible and preferably at least 24 hours before the procedure. In deciding whether a procedure should be delayed until 24 hours after the last dose of LIXIANA, the increased risk of bleeding should be weighed against the urgency of the intervention. LIXIANA should be restarted after the surgical or other procedures as soon as adequate haemostasis has been established, noting that the time to onset of the edoxaban anticoagulant therapeutic effect is 1-2 hours. If oral medicinal products cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant and then switch to oral once daily LIXIANA.
Hemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy: Not recommended as an alternative to unfractionated heparin.
Patients with active cancer: Efficacy and safety of edoxaban in the treatment and/or prevention of VTE in patients with active cancer have not been established.
Use In Pregnancy & Lactation
Pregnancy: Not recommended.
Breastfeeding: Discontinue breastfeeding or edoxaban therapy.
Adverse Reactions
Common: anaemia, epistaxis, lower GI haemorrhage, upper GI haemorrhage, oral/pharyngeal haemorrhage, nausea, blood bilirubin increased, gamma GT increased, cutaneous soft tissue haemorrhage, rash, pruritus, macroscopic haematuria/urethral haemorrhage, vaginal haemorrhage, puncture site haemorrhage, liver function test abnormal, dizziness, headache, abdominal pain.
Drug Interactions
The P-gp inhibitors cyclosporine, dronedarone, erythromycin, or ketoconazole result in increased concentration of edoxaban and a dose reduction of 30 mg is required. Edoxaban should be used with caution with concomitant P-gp inducers (e.g. phenytoin, carbamazepine, phenobarbital or St John's Wort). Concomitant high dose ASA (325 mg) or chronic NSAIDs is not recommended.
ATC Classification
B01AF03 - edoxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
FC tab 15 mg x 10's. 30 mg x 28's. 60 mg x 28's.
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