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LIXIANA® (Edoxaban)

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LIXIANA® (Edoxaban) Important Risk Minimisation Information for Healthcare Professionals Prescriber Guide LIXIANA® (edoxaban) This educational material is essential to ensure the safe and effective use of the product and appropriate management of the important selected risks, therefore it is advised to be read carefully before prescribing/dispensing the product This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See page 14 for information on how to report adverse reactions OVERVIEW PATIENT ALERT CARD THIS GUIDE IS SPECIFICALLY FOR PRESCRIBERS IN A PATIENT ALERT CARD MUST BE PROVIDED TO RELATION TO THE USE OF LIXIANA® (EDOXABAN). EACH PATIENT WHO IS PRESCRIBED EDOXABAN IT INCLUDES INFORMATION ON THE FOLLOWING: A patient alert card is included within each edoxaban tablet pack. • Indications This will inform doctors, dentists, pharmacists and other • Dosing recommendations and dose reduction healthcare professionals about the patient’s anticoagulation • Information on switching patients to or from edoxaban treatment, along with emergency contact details. Encourage • Populations at higher risk of bleeding patients to have this card with them at all times and to show it to healthcare professionals prior to any consultation • Perioperative management or procedure. • Temporary discontinuation Patients should be reminded of the importance of compliance • Overdose to their treatment regimen, the need to watch for signs and • Bleeding complications symptoms of bleeding and when to seek medical advice. • Coagulation testing Patient Alert Cards are available from [email protected] or by calling (01) 489 3000 Please consult the Summary of Product Characteristics (SmPC) for full prescribing information. 1 2 INDICATIONS Edoxaban is indicated for: Recommended dose • Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more 60 mg risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) DOSE REDUCTION • Treatment of deep vein thrombosis (DVT) and pulmonary For NVAF and VTE (DVT and PE) a dose of 30 mg once daily embolism (PE), and prevention of recurrent DVT and PE in adults is required for certain patients who fall into one or more of the following sub-groups. DOSING These are: Moderate or severe renal THE RECOMMENDED DOSE OF EDOXABAN IS impairment (Creatinine clearance 60 MG IN A ONCE-DAILY TABLET. [CrCl]15–50 ml/min) It can be taken with water, with or without food. To aid compliance, patients should be encouraged to take their dose at the same time every day. Body weight ≤60 kg Treatment with edoxaban in patients with NVAF should be continued long term. 30 mg The duration of therapy for treatment of DVT and PE (venous Concomitant use of the P-gp thromboembolism, VTE) and prevention of recurrent VTE inhibitors dronedarone, ciclosporin, should be individualised after careful assessment of the erythromycin, ketoconazole treatment benefit against the risk for bleeding. Short duration of therapy (at least 3 months) should be based on transient risk factors (e.g. recent surgery, trauma, immobilisation) and In this case, patients should take one 30 mg tablet longer durations should be based on permanent risk factors at the same time every day, with or without food. or idiopathic DVT or PE. 3 4 SWITCHING TO AND FROM EDOXABAN INITIATING TREATMENT Switching patients to or from treatment with edoxaban is the same for For the treatment of VTE, patients should receive an initial both the VTE and NVAF indications. It should be noted that once a course of heparin for at least 5 days prior to treatment with patient is switched to treatment with edoxaban, International Normalised edoxaban. This is not required for the initiation of edoxaban in Ratio (INR), prothrombin time (PT), or activated partial thromboplastin patients with NVAF for the prevention of stroke and systemic time (aPTT) are not useful measurements for anticoagulation effect. embolism. Information on switching patients to edoxaban from other FROM NON-VKA ORAL ANTICOAGULANTS TO EDOXABAN treatments can be found on pages 6 to 9. Discontinue the non-Vitamin K antagonist (VKA) oral anticoagulant and start edoxaban at the time of the next non-VKA dose. MISSED DOSE If a patient misses a dose of edoxaban he/she should take FROM VKA THERAPY TO EDOXABAN it immediately and then continue the following day with the When converting patients from VKA therapy to edoxaban, discontinue once-daily intake as recommended. warfarin or other VKA therapy and start edoxaban treatment when the INR is ≤2.5. The patient should not take double the prescribed dose on the same day to make up for a missed dose. Discontinue warfarin or other VKA therapy Monitor INR until ≤2.5 Start edoxaban once daily 5 6 PARENTERAL ROUTE FROM EDOXABAN TO Stop previous treatment with edoxaban VKA THERAPY Discontinue edoxaban treatment, Reduce dose Initiate VKA Initiate administer parenteral anticoagulant ORAL OPTION of edoxaban and VKA treatment at the time (30 mg or treatment INR testing If switching a patient from of the next scheduled edoxaban Adjust edoxaban 60 mg to VKA therapy, 15 mg) Initiate VKA Initiate dose. When a stable INR of ≥2.0 parenteral treatment INR testing administer a 30 mg dose of is achieved, stop the parenteral anticoagulant edoxaban once daily alongside anticoagulant and continue with appropriate VKA dose. VKA treatment. If switching a patient from INR ≥2.0 edoxaban 30 mg to VKA therapy, INR ≥2.0 Stop administer a 15 mg dose of Continue treatment Continue edoxaban once daily alongside with VKA with INR testing Stop Continue appropriate VKA dose. treatment Continue edoxaban parenteral with VKA INR testing It is recommended that during anticoagulant treatment the first 14 days of concomitant therapy, the INR is measured at least 3 times just prior to taking the daily dose of edoxaban. Continue to co-administer until stable INR ≥2.0 is achieved. At this point discontinue edoxaban. 7 8 PATIENTS AT POTENTIALLY HIGHER RISK OF BLEEDING FROM PARENTERAL ANTICOAGULANT TO EDOXABAN As an anticoagulant, edoxaban may increase the risk of bleeding. Therefore, patients prescribed edoxaban should Patients on continuously administered parenteral drug such as be carefully observed for signs of bleeding. intravenous (IV) heparin: Edoxaban is contraindicated in the following patients: Discontinue parental Wait 4 hours Start edoxaban once daily anticoagulant • Those with hypersensitivity to the active substance • Those with clinically significant active bleeding Patients on parenteral drug fixed dose such as low molecular • Those with a lesion or condition at significant risk of major bleeding such as: weight heparin (LMWH): – Current or recent gastrointestinal (GI) ulceration – Recent intracranial haemorrhage – Malignant neoplasms at high risk of bleeding – Suspected or diagnosed oesophageal varices, – Recent brain or spinal injury or surgery arteriovenous malformations, vascular aneurysms or Begin edoxaban treatment at the time of next – Recent ophthalmic surgery major intraspinal or intracerebral vascular abnormalities scheduled dose of previous treatment • Those with hepatic disease associated with coagulopathy and clinically relevant bleeding risk • Those on concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low FROM EDOXABAN TO PARENTERAL ANTICOAGULANT molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban, etc.) except under the circumstances Administer the initial dose of parenteral anticoagulant at the of switching therapy to or from edoxaban or when UFH is given at doses necessary to maintain an open time of the next scheduled dose of edoxaban. central venous or arterial catheter Edoxaban should not be administered simultaneously with • Edoxaban is contraindicated during pregnancy and women of child-bearing potential should avoid parenteral anticoagulant. becoming pregnant during treatment. As edoxaban is also contraindicated during breast feeding, it should be decided whether to cease therapy or to discontinue breast feeding • Those with uncontrolled severe hypertension 9 10 SPECIAL PATIENT POPULATIONS Several groups of patients are at increased risk of bleeding and should be carefully monitored for signs and symptoms of bleeding complications. Any treatment decision must be based on careful assessment of the treatment benefit against risk of bleeding. Patients with renal impairment Patients receiving concomitant treatment End stage renal disease: dialysis, renal failure (CrCl <15 mL/min) Not recommended P-gp inhibitors: cyclosporine, dronedarone, Dose reduction to 30 mg OD erythromycin, ketoconazole (see Dose Reduction section) Moderate or severe renal impairment (CrCl 15–50 mL/min) Dose reduction to 30 mg once daily (OD) (see Dose Reduction section) Amiodarone, quinidine, or verapamil No dose reduction required – 60 mg OD Mild renal impairment (CrCl 51–80 mL/min) No dose reduction required – 60 mg OD P-gp inducers (e.g. rifampicin, phenytoin, Use with caution carbamazepine, phenobarbitol or St Johns Wort) Prior to initiation of edoxaban and when clinically indicated, renal function testing should be performed P-gp substrates (digoxin) No dose modification – 60 mg OD Patients with
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