Xarelto Disease Interactions

The use of factor Xa inhibitors is contraindicated in patients with active pathological bleeding as these agents increase the risk of bleeding and can cause serious or fatal hemorrhages. Caution is recommended when prescribing factor Xa inhibitors to patients at increased risk of bleeding, including patients undergoing procedures where bleeding may cause serious complications. Such patients include those undergoing spinal/epidural anesthesia or spinal puncture; these patients are at high risk of an epidural or spinal hematoma, which can result in long-term or permanent paralysis. In general, when using factor Xa inhibitors, the risk of thrombotic events should be weighed against the risk of bleeding.

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The use of some factor Xa inhibitors (including apixaban, edoxaban, and rivaroxaban) is not recommended in patients with prosthetic heart valves; safety and efficacy have not been established in such patients.

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Direct acting oral anticoagulants including factor Xa inhibitors and some thrombin inhibitors as dabigatran, are not recommended for use in patients with antiphospholipid syndrome (APS). Treatment with these drugs has been associated with increased rates of recurrent thrombotic events, especially in patients with triple positive APS.

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The use of rivaroxaban should be avoided in patients with moderate and severe liver dysfunction (Child-Pugh B and C) or with any liver disease associated with coagulopathy as drug exposure and bleeding risk may be increased.

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For most indications, rivaroxaban exposure and pharmacodynamic effects are increased in patients with CrCl less than 30 mL/min compared to patients with normal renal function; these indications include treatment of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), reduction in the risk of recurrence of DVT and/or PE, prophylaxis of DVT after hip/knee replacement surgery, and prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding. Limited clinical data are available in patients with CrCl 15 to less than 30 mL/min, and there are no clinical data in patients with CrCl less than 15 mL/min (including those on dialysis). Patients with CrCl 15 to less than 30 mL/min should be observed closely and any signs/symptoms of blood loss should be evaluated promptly; use of rivaroxaban should be avoided in patients with CrCl less than 15 mL/min (including those on dialysis). This drug should be discontinued in patients who develop acute renal failure while on treatment.

In patients with nonvalvular atrial fibrillation, renal function should be periodically assessed, as clinically indicated (i.e., more often in situations in which renal function may decline), and therapy should be adjusted accordingly; dose adjustment or discontinuation of rivaroxaban should be considered in patients who develop acute renal failure during therapy.

In patients with coronary artery disease or peripheral artery disease, no dose adjustment is needed based on CrCl.

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Initiation of rivaroxaban is not recommended acutely as an alternative to unfractionated heparin in patients with pulmonary embolism who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy.

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