Lixiana Special Precautions

The anticoagulant effect of edoxaban cannot be reliably monitored with standard laboratory testing. A specific anticoagulant reversal agent for edoxaban is not available. Haemodialysis does not significantly clear edoxaban.
Renal impairment: Renal function should be assessed prior to initiation of edoxaban and afterwards when clinically indicated. Not recommended in patients with end stage renal disease or on dialysis.
Hepatic impairment: Not recommended in patients with severe hepatic impairment and should be used with caution in patients with mild or moderate hepatic impairment. Edoxaban should be used with caution in patients with elevated liver enzymes (ALT/AST >2 x ULN) or total bilirubin ≥1.5 x ULN.
Prosthetic heart valves and moderate to severe mitral stenosis: Not recommended.
Discontinuation for surgery and other interventions: If anticoagulation must be discontinued to reduce the risk of bleeding with surgical or other procedures, LIXIANA should be stopped as soon as possible and preferably at least 24 hours before the procedure. In deciding whether a procedure should be delayed until 24 hours after the last dose of LIXIANA, the increased risk of bleeding should be weighed against the urgency of the intervention. LIXIANA should be restarted after the surgical or other procedures as soon as adequate haemostasis has been established, noting that the time to onset of the edoxaban anticoagulant therapeutic effect is 1-2 hours. If oral medicinal products cannot be taken during or after surgical intervention, consider administering a parenteral anticoagulant and then switch to oral once daily LIXIANA.
Hemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy: Not recommended as an alternative to unfractionated heparin.
Patients with active cancer: Efficacy and safety of edoxaban in the treatment and/or prevention of VTE in patients with active cancer have not been established.