Lixiana

Lixiana

edoxaban

Manufacturer:

Daiichi Sankyo

Distributor:

Zuellig Pharma

Marketer:

Daiichi Sankyo
Concise Prescribing Info
Contents
Edoxaban
Indications/Uses
Prevention of stroke & systemic embolism in adults w/ nonvalvular atrial fibrillation (NVAF). 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 DVT & PE & prevention of recurrent DVT & PE 60 mg once daily following initial use of parenteral anticoagulant for at least 5 days. Duration of therapy should be individualized. Patients w/ moderate or severe renal impairment (CrCl 15-50 mL/min), ≤60 kg or using P-gp inhibitors NVAF & VTE 30 mg once daily. Mild renal & 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 & relevant bleeding risk. Lesion or condition at 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, low molecular wt heparin (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban) except under specific circumstances of switching oral anticoagulants therapy or when unfractionated heparin is given at doses necessary to maintain an open central nervous or aterial catheter.
Special Precautions
Mild to severe hepatic impairment & end stage renal disease or on dialysis. Patients w/ increased risk of bleeding, mechanical heart valves, during the first 3 mth after implantation of a bioprosthetic heart valve, w/or w/o atrial fibrillation, or moderate to severe mitral stenosis. Discontinue use if severe hemorrhage occurs. Monitor for signs & symptoms of bleeding complications & anemia after initiation of treatment, & CrCl at the start of therapy & thereafter. Perform liver function testing prior to initiation of treatment. Delay for at least 24 hr before surgery to reduce risk of bleeding & restart after surgery if adequate haemostasis is established. Concomitant use w/ acetylsalicylic (ASA), P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, & 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.
Adverse Reactions
Anaemia; dizziness; headache; abdominal pain; epistaxis; lower or upper 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 (ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine or verapamil). Decreased plasma conc w/ P-gp inducers (rifampicin, phenytoin, carbamazepine, phenobarb or St. John's wort). Increased risk of bleeding w/ anticoagulants, acetylsalicylic acid & NSAIDs (chronic use). Increase Cmax of digoxin. Decrease Cmax & AUC of verapamil.
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 60 mg
Packing/Price
14 × 2's
Form
Lixiana FC tab 15 mg
Packing/Price
14 × 1's
Form
Lixiana FC tab 30 mg
Packing/Price
14 × 2's
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