Not recommended for use in children < 18 years of age.
Contraindications
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
Other relevant warnings and precautions
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
For more information
Please consult the Product Monograph for important information relating to adverse reactions, drug interactions, and dosing that has not been discussed in this piece.
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