Company: Daiichi Sankyo Ireland Ltd.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredient: Edoxaban (as tosilate) 15mg, 30mg, 60mg.
Description: Orange, pink or yellow, round, film-coated tablets marked with DSC and L15, L30 or L60, respectively.
Presentation: 15mg-10, €22.00; 30mg-28, €61.60; 60mg-28, €61.60.
Indications: Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE).
Pharmacology: Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, the serine protease located in the final common pathway of the coagulation cascade. Factor Xa inhibition reduces thrombin generation, prolongs clotting time and reduces the risk of thrombus formation. Edoxaban inhibits free factor Xa, and prothrombinase activity.
Dosage: Adult: Stroke and systemic embolism: 60mg once daily. NVAF patients should continue long term. DVT, PE: 60mg once daily following at least 5 days of initial parenteral anticoagulant (do not administer simultaneously). Base duration (assess risk/benefit) on transient/permanent risk factors or idiopathic DVT/PE. Use 30mg once daily in NVAF and DVT/PE patients with one or more of the following: Renal impairment (cc 15-50ml/min), ≤60kg body weight, concomitant P-glycoprotein (Pgp) inhibitors (ciclosporin, dronedarone, erythromycin, ketoconazole). Switching to and from Edoxaban: See SPC. Elderly: As per adults. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Significant active bleeding. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk. Lesion or condition (if major bleeding risk). Uncontrolled severe hypertension. Pregnancy, lactation.
Special precautions: Assess renal function before initiation and when indicated. Test liver function prior to initiation and periodically if treated beyond one year. Not recommended: End stage renal disease, dialysis, severe hepatic impairment, prosthetic heart valves, moderate to severe mitral stenosis, haemodynamically unstable PE patients, patients who require thrombolysis or pulmonary embolectomy, active cancer. Caution: Mild to moderate hepatic impairment, elevated liver enzymes (ALT/AST >2 x ULN) or total bilirubin (≥1.5 x ULN), increased bleeding risk including elderly (discontinue if severe haemorrhage occurs). Suspend at least 24 hours before surgery and other interventions until adequate haemostasis established. NVAF patients with high creatinine clearance, assess risk/benefit. Conditions increasing gastric emptying and gut motility.
Drug interactions: Contraindicated: Other anticoagulants (except unfractionated heparin doses necessary to maintain open central venous/arterial catheter or when switching anticoagulants). Not recommended: High dose acetylsalicylic acid (325mg), chronic nonsteroidal anti-inflammatory drug use. Caution: P-gp inducers. Antiplatelets, thrombolytics, drugs increasing gastric emptying and gut motility. Standard clotting tests.
Adverse drug reactions: Anaemia, epistaxis, nausea, increased blood bilirubin, increased gammaglutamyltransferase, haemorrhage (gastrointestinal, cutaneous soft tissue, macroscopic haematuria/urethral, vaginal, puncture site), rash, pruritus, abnormal liver function test.
Full prescribing information and references available from Daiichi Sankyo Ireland Ltd.
E-mail: medinfo@daiichi-sankyo.ie.