• Not recommended for use in children < 18 years of age.

• Clinically significant active bleeding, including gastrointestinal bleeding
• Lesions or conditions at increased risk of clinically significant bleeding
• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
• Concomitant treatment with any other anticoagulant, including unfractionated heparin (UFH); except at doses used to maintain a patent central venous or arterial catheter; low molecular weight heparins (LMWH), such as enoxaparin and dalteparin; heparin derivatives, such as fondaparinux; and oral anticoagulants, such as warfarin, dabigatran, apixaban and rivaroxaban, except under circumstances of switching therapy to or from LIXIANA^®
• Pregnancy
• Nursing women
• Hypersensitivity to edoxaban or any ingredients in the formulation

Most serious warnings and precautions

Bleeding: LIXIANA^® like other anticoagulants, should be used with caution in patients with an increased bleeding risk. Any unexplained fall in hemoglobin or blood pressure should lead to a search for a bleeding site. Patients at high risk of bleeding should not be prescribed LIXIANA^®. Should severe bleeding occur, treatment with LIXIANA^® must be discontinued and the source of bleeding investigated promptly.

Premature discontinuation: increases the risk of thrombotic events

International normalized ratio (INR) monitoring: not a valid measure to assess anticoagulant activity of LIXIANA^®

Peri-operative spinal/epidural anesthesia, lumbar puncture: increased risk of hematoma

• Concomitant use of drugs affecting hemostasis
• Concomitant use of LIXIANA^® with unfractionated heparin (UFH) is contraindicated, except at doses used to maintain a patent central venous or arterial catheter
• Patients with prosthetic mechanical heart valves; patients with hemodynamically significant rheumatic heart disease
• Hepatic impairment
• Anticoagulant-related nephropathy
• A specific anticoagulant reversal agent for LIXIANA^® is not commercially available
• Renal impairment; renal failure
• Peri-operative/procedural and post-operative considerations
• Patients who have undergone elective total knee or hip surgery
• Patients with pulmonary embolism who are hemodynamically unstable or may receive thrombolysis or pulmonary embolectomy
• Patients with antiphospholipid syndrome

Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing that has not been discussed in this piece.

The Product Monograph is also available by calling us at 1-800-363-6093 or by visiting www.servier.ca.

Access the study parameters and reference list.