A. Menarini


Zuellig Pharma
Concise Prescribing Info
Edoxaban tosilate
Prevention of stroke & systemic embolism in adult patients w/ nonvalvular atrial fibrillation (NVAF) w/ ≥1 risk factors eg, CHF, HTN, age ≥75 yr, DM, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) & pulmonary embolism (PE) in adults. Prevention of recurrent DVT & PE in adults.
Dosage/Direction for Use
Prevention of stroke & systemic embolism 60 mg once daily. Treatment of DVT & PE, prevention of recurrent DVT & PE 60 mg once daily following initial parenteral anticoagulant for 5 days. NVAF & VTE 30 mg once daily in patient w/ moderate or severe renal impairment (CrCl 15-50 mL/min), ≤60 kg or using P-gp inhibitors. Mild renal impairment & mild to moderate hepatic impairment 60 mg once daily. Moderate or severe renal impairment 30 mg once daily.
Hypersensitivity. Clinically significant active bleeding; lesion or condition considered to be significant risk for major bleeding eg, current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophth surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, AV malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; uncontrolled severe HTN. Concomitant use w/ any other anticoagulants eg, unfractionated heparin (UFH), LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban) except under specific circumstances of switching oral anticoagulants therapy or when UFH is given at doses necessary to maintain open central nervous or arterial catheter. Hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Pregnancy & lactation.
Special Precautions
Discontinue use if severe haemorrhage occurs. Not recommended in patients w/ mechanical heart valves, 1st 3 mth after bioprosthetic heart valve implantation, moderate to severe mitral stenosis; antiphospholipid syndrome. Not an alternative to UFH in haemodynamically unstable PE patients or patients requiring thrombolysis or pulmonary embolectomy. Increased risk of bleeding. Active cancer. Discontinue use at least 24 hr prior to surgery & other interventions. Patients undergoing cardioversion. Concomitant use w/ acetylsalicylic acid (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, SSRIs or SNRIs, chronic NSAIDs. Perform liver function testing prior to initiation; periodic hepatic monitoring in treatment >1 yr. Assess renal function prior to & when clinically indicated. Not recommended in patients w/ end-stage renal disease (CrCl <15 mL/min) or on dialysis; severe hepatic impairment. Mild to moderate hepatic impairment; patients w/ elevated liver enzymes [ALT/AST >2 x upper limit of normal (ULN)] or total bilirubin ≥1.5 x ULN. Women of childbearing potential should use effective contraception. Childn & adolescents <18 yr. Co-administration w/ ASA in elderly.
Adverse Reactions
Anaemia; dizziness, headache; epistaxis; abdominal pain, upper & lower GI haemorrhage, oral/pharyngeal haemorrhage, nausea; increased blood bilirubin & γ-glutamyltransferase; cutaneous soft tissue haemorrhage, rash, pruritus; macroscopic haematuria/urethral haemorrhage; vag haemorrhage; puncture site haemorrhage; abnormal liver function test.
Drug Interactions
Increased plasma conc w/ P-gp inhibitors eg, ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, verapamil. Reduced plasma conc w/ P-gp inducers eg, rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort. Increased risk of bleeding w/ other anticoagulants, high-dose ASA, chronic NSAIDs, SSRIs/SNRIs. Increased Cmax of digoxin. Decreased Cmax & AUC of verapamil.
ATC Classification
B01AF03 - edoxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Lixiana FC tab 30 mg
2 × 14's
Lixiana FC tab 60 mg
2 × 14's
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