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Lixiana

Lixiana

edoxaban

Manufacturer:

A. Menarini

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Edoxaban tosilate
Indications/Uses
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) & 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 at least 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 to moderate hepatic impairment & mild renal impairment (CrCl >50 mL/min) 60 mg once daily. Moderate or severe renal impairment 30 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Clinically significant active bleeding; lesion or condition at 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, brain, spinal or ophth surgery & intracranial haemorrhage, known or suspected oesophageal varices, AV malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities; uncontrolled severe HTN. Concomitant use w/ any other anticoagulants except under specific circumstances of switching oral anticoagulants or use of UFH 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/ 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.
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 LFT.
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 bleeding risk w/ other anticoagulants, antiplatelets, high-dose ASA, chronic NSAIDs, SSRIs/SNRIs. Increased Cmax of digoxin. Decreased Cmax & AUC of verapamil.
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
2 × 14's
Form
Lixiana FC tab 60 mg
Packing/Price
2 × 14's
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