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Lixiana

Lixiana

edoxaban

Manufacturer:

Daiichi Sankyo

Distributor:

A. Menarini
Concise Prescribing Info
Contents
Edoxaban
Indications/Uses
Prevention of stroke & systemic embolism in adults w/ nonvalvular atrial fibrillation w/ ≥1 risk factors, eg, CHF, HTN, age ≥75 yr, DM, prior stroke or transient ischaemic attack. Treatment of DVT & pulmonary embolism, & prevention of recurrent DVT & pulmonary embolism in adults.
Dosage/Direction for Use
Mild renal impairment (CrCl >50-80 mL/min) 60 mg once daily, moderate or severe renal impairment (CrCl 15-50 mL/min) 30 mg once daily. Mild to moderate hepatic impairment 60 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Clinically significant active bleeding; hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk; lesion or condition that is considered significant risk for major bleeding including 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, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; uncontrolled severe HTN. Concomitant treatment w/ anticoagulants eg, unfractionated heparin, LMWH, heparin derivatives, oral anticoagulants except under specific circumstances of switching oral anticoagulant therapy or when unfractionated heparin is given at doses necessary to maintain an open central venous or arterial catheter. Pregnancy& lactation.
Special Precautions
Not indicated as monotherapy. Patient undergoing cardioversion. Increased risk of bleeding; discontinue if severe haemorrhage occurs. Renal function in nonvalvular atrial fibrillation. Monitor CrCl at the beginning of treatment in all patients & afterwards when clinically indicated. Perform liver function testing prior to initiating treatment & periodic hepatic monitoring is recommended for patients on treatment >1 yr. Stop use at least 24 hr before surgery or other procedures. Concomitant use w/ acetylsalicylic acid in elderly patients; P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, SSRIs or serotonin norepinephrine reuptake inhibitors, & chronic NSAIDs. Not recommended in patients w/ prosthetic heart valves & moderate to severe mitral stenosis; pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy; history of thrombosis who are diagnosed w/ antiphospholipid syndrome. Patients w/ active cancer. Prolonged standard clotting tests eg, prothrombin time, INR, & activated partial thromboplastin time. Not recommended in patients w/ end stage renal disease (CrCl <15 mL/min) or on dialysis; w/ severe hepatic impairment. Mild to moderate hepatic impairment. Childn <18 yr.
Adverse Reactions
Anaemia; dizziness, headache; epistaxis; abdominal pain, lower & upper GI haemorrhage, oral/pharyngeal haemorrhage, nausea; increased blood bilirubin & γ-glutamyl-transferase; cutaneous soft tissue haemorrhage, rash, pruritus; macroscopic haematuria/urethral haemorrhage; vag haemorrhage; puncture site haemorrhage; abnormal liver function test.
Drug Interactions
Possibility of reduced dissolution & absorption w/ medicines or disease conditions that increase gastric emptying & gut motility. Increased plasma conc w/ ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, or verapamil. Decreased mean AUC & shortened t½ w/ rifampicin. Reduced plasma conc w/ phenytoin, carbamazepine, phenobarb or St. John's wort. Increased risk of bleeding w/ anticoagulants, antiplatelets, NSAIDs & SSRIs/serotonin norepinephrine reuptake inhibitors; acetylsalicylic acid; platelet inhibitors. Decreased Cmax & AUC of verapamil. Increased Cmax of digoxin.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AF03 - edoxaban ; Belongs to the class of direct factor Xa inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
Form
Lixiana FC tab 30 mg
Packing/Price
28's
Form
Lixiana FC tab 60 mg
Packing/Price
28's (P147/film-coated tab)
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