Lixiana

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 DVT & pulmonary embolism (PE) in adults. Prevention of recurrent DVT & PE in adults.

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.

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/ ASA, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, SSRIs or SNRIs, chronic NSAIDs. Perform LFT prior to initiation; periodic hepatic monitoring in treatment >1 yr. Assess renal function prior to & when clinically indicated. Not recommended in patients w/ ESRD (CrCl <15 mL/min) or on dialysis; severe hepatic impairment. Mild to moderate hepatic impairment; patients w/ elevated liver enzymes (ALT/AST >2 x 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.

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 LFT.

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 C_max of digoxin. Decreased C_max & AUC of verapamil.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AF03 - edoxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.

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