Lixiana里先安

Lixiana

edoxaban

Manufacturer:

Daiichi Sankyo

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Edoxaban
Indications/Uses
Prevention of stroke & systemic embolism in adult patients w/ nonvalvular atrial fibrillation (NVAF) w/ ≥1 risk factors eg, CHF, HTN, ≥75 yr of age, DM, prior stroke or transient ischaemic attack. Treatment of DVT & pulmonary embolism (PE), & 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 (VTE) 60 mg once daily following initial use of parenteral anticoagulant for at least 5 days. Moderate or severe renal impairment (CrCl 15-50 mL/min), ≤60 kg body wt, concomitant use of the following P-gp inhibitors: ciclosporin, dronedarone, erythromycin, or ketoconazole 30 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, if considered to be a 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/ any other anticoagulants eg, unfractionated heparin (UFH), LMWH (enoxaparin, dalteparin, etc), heparin derivatives (fondaparinux, etc), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban, etc) except under specific circumstances of switching oral anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter. Pregnancy & lactation.
Special Precautions
Lixiana 15 mg is not indicated as monotherapy. Haemorrhagic risk. Caution in elderly patients concomitantly taking acetylsalicylic acid (ASA); patients w/ moderate (CrCl 30-50 mL/min) or severe (CrCL <30 mL/min but not undergoing dialysis) renal impairment; patients w/ NVAF & high CrCl; patients w/ mild or moderate hepatic impairment, elevated liver enzymes (ALT/AST >2 x ULN) or total bilirubin ≥1.5 x ULN. CrCl should be monitored prior to treatment initiation & afterwards when clinically indicated. Periodic hepatic monitoring for patients on Lixiana treatment beyond 1 yr. To reduce the risk of bleeding w/ surgical or other procedures, stop treatment as soon as possible & preferably at least 24 hr before the procedure. Concomitant use of medicines affecting haemostasis (ASA, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, SSRIs or serotonin norepinephrine reuptake inhibitors (SNRIs) & chronic NSAIDs). Not recommended as an alternative to unfractionated heparin in patients w/ pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Not recommended in patients w/ end-stage renal disease or on dialysis; severe hepatic impairment; patients w/ mechanical heart valves, patients during the 1st 3 mth after implantation of a bioprosthetic heart valve, w/ or w/o atrial fibrillation, or in patients w/ moderate to severe mitral stenosis; patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome particularly those who are triple positive (for lupus anticoagulant, anticardiolipin Abs & anti-beta-2-glycoprotein I Abs). Patients w/ active cancer. Women of childbearing potential should avoid becoming pregnant during treatment.
Adverse Reactions
Anaemia; dizziness, headache; epistaxis; abdominal pain, lower/upper GI haemorrhage, oral/pharyngeal haemorrhage, nausea; increased blood bilirubin, increased γ-glutamyltransferase; cutaneous soft tissue haemorrhage, rash, pruritus; macroscopic haematuria/urethral haemorrhage; vag haemorrhage; puncture site haemorrhage; abnormal liver function test.
Drug Interactions
Reduced dissolution & absorption w/ medicines or disease conditions that increase gastric emptying & gut motility. Increased plasma conc w/ P-gp inhibitors (ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine, verapamil, amiodarone). Reduced plasma conc w/ P-gp inducers (rifampicin; phenytoin, carbamazepine, phenobarb or St. John's wort). Increased risk of bleeding w/ other anticoagulants; SSRIs or SNRIs. Increased bleeding time w/ ASA (≥100 mg). Increased clinically relevant bleeding w/ thienopyridines (eg, clopidogrel); NSAIDs.
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 15 mg
Packing/Price
14's
Form
Lixiana FC tab 30 mg
Packing/Price
28's
Form
Lixiana FC tab 60 mg
Packing/Price
28's
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