Lixiana

Edoxaban

DVT & pulmonary embolism (PE), & prevention of recurrent DVT & PE in adults. Prevention of stroke & systemic embolism in adults w/ non-valvular atrial fibrillation (NVAF) w/ ≥1 risk factors eg, CHF, HTN, age ≥75 yr, DM, prior stroke or transient ischaemic attack.

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: Individualized. Prevention of stroke & systemic embolism 60 mg once daily. NVAF & VTE (DVT & PE) Recommended dose: 60 mg once daily. Moderate or severe renal impairment (CrCl 15-50 mL/min), low body wt ≤60 kg or concomitant use of P-gp inhibitors (ciclosporin, dronedarone, erythromycin, or ketoconazole) 30 mg once daily. Prevention of ischemic stroke & systemic embolism in patients w/ NVAF; NVAF in elderly patients ≥80 yr (w/ at least 1 of the following hemorrhagic diatheses: history of hemorrhage including intracranial, intraocular & GI tract hemorrhage; low body wt ≤45 kg; CrCl ≥15 mL/min & <30 mL/min; regular use of NSAIDs; use of antiplatelet drugs) Consider reducing dose to 15 mg once daily depending on patient's age & condition. Mild renal (CrCl >50-80 mL/min) & mild to moderate hepatic impairment 60 mg once daily. Patients undergoing cardioversion Start treatment at least 2 hr before cardioversion. Perform cardioversion no later than 12 hr after the dose on the day of procedure.

May be taken with or without food.

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 (UFH), LMWH (enoxaparin, dalteparin), heparin derivatives (fondaparinux), oral anticoagulants (warfarin, dabigatran etexilate, rivaroxaban, apixaban) except under specific circumstances of switching oral anticoagulant therapy or when UFH is given at doses necessary to maintain an open central nervous or arterial catheter. Pregnancy & lactation.

Discontinue use if severe haemorrhage occurs. Stop for at least 24 hr before surgery to reduce risk of bleeding & restart after surgery if adequate haemostasis is established. Not recommended in patients w/ mechanical heart valves, during 1st 3 mth after implantation of bioprosthetic heart valve, w/ or w/o atrial fibrillation, or moderate to severe mitral stenosis, & history of thrombosis who are diagnosed w/ antiphospholipid syndrome; as alternative to UFH in patients w/ pulmonary embolism who are haemodynamically unstable or may receive thrombolysis or pulmonary embolectomy. Patients w/ increased risk of bleeding; elevated liver enzymes (ALT/AST >2x ULN) or total bilirubin ≥1.5x ULN; active cancer. Perform lab testing of Hb/haematocrit to detect occult bleeding; liver function testing prior to initiating treatment. Monitor for signs & symptoms of bleeding complications & anaemia after initiation of treatment; CrCl at beginning of treatment & thereafter. Periodic hepatic monitoring for treatment >1 yr. Concomitant use w/ ASA, P2Y₁₂ platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, SSRIs, SNRIs & chronic NSAIDs. Prolonged standard clotting tests eg, prothrombin time, INR & aPTT. Not recommended in patients w/ severe hepatic impairment, ESRD or on dialysis. Mild or moderate hepatic impairment. Women of childbearing potential should avoid becoming pregnant during treatment. Childn & adolescent <18 yr. Elderly ≥80 yr w/ NVAF (increased risk of hemorrhage).

Anaemia; dizziness, headache; epistaxis; abdominal pain, 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 LFT.

Increased plasma conc, AUC & C_max w/ P-gp inhibitors (ciclosporin, dronedarone, erythromycin, ketoconazole, quinidine or verapamil). Decreased mean AUC & shortened t_½ w/ P-gp inducer (rifampicin). Reduced plasma conc w/ P-gp inducers (phenytoin, carbamazepine, phenobarb or St. John's Wort). Increased C_max w/ digoxin. Increased risk of bleeding w/ anticoagulants, ASA & NSAIDs (chronic use), SSRIs/SNRIs. 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.

D