SIX INDICATIONS STRONG
To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation ( AF ). There are limited data on the relative effectiveness of XARELTO ® and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled
For the treatment of deep vein thrombosis ( DVT ) For the treatment of pulmonary embolism ( PE )
For the reduction in the risk of recurrence of DVT and of PE following initial 6 months treatment for DVT and / or PE
For the prophylaxis of DVT , which may lead to PE in patients undergoing knee replacement surgery
For the prophylaxis of DVT , which may lead to PE in patients undergoing hip replacement surgery
IMPORTANT SAFETY INFORMATION ( cont ’ d ) WARNINGS AND PRECAUTIONS ( cont ’ d )
Risk of Bleeding : XARELTO ® increases the risk of bleeding and can cause serious or fatal bleeding . Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement . Discontinue XARELTO ® in patients with active pathological hemorrhage .
• A specific antidote for rivaroxaban is not available . Because of high plasma protein binding , rivaroxaban is not expected to be dialyzable .
• Concomitant use of other drugs that impair hemostasis increases the risk of bleeding . These include aspirin , P2Y 12 platelet inhibitors , other antithrombotic agents , fibrinolytic therapy , NSAIDs , selective serotonin reuptake inhibitors ( SSRIs ), and serotonin norepinephrine reuptake inhibitors ( SNRIs ).
Spinal / Epidural Anesthesia or Puncture : When neuraxial anesthesia ( spinal / epidural anesthesia ) or spinal puncture is employed , patients treated with anticoagulant agents for prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma , which can result in long-term or permanent paralysis . To reduce the potential risk of bleeding associated with the concurrent use of rivaroxaban and epidural or spinal anesthesia / analgesia or spinal puncture , consider the pharmacokinetic profile of rivaroxaban . Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is low ; however , the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known . An epidural catheter should not be removed earlier than
18 hours after the last administration of XARELTO ® . The next XARELTO ® dose is not to be administered earlier than 6 hours after the removal of the catheter . If traumatic puncture occurs , the administration of XARELTO ® is to be delayed for 24 hours . Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia / analgesia or lumbar puncture , monitor frequently to detect any signs or symptoms of neurological impairment , such as midline back pain , sensory and motor deficits ( numbness , tingling , or weakness in lower limbs ), or bowel and / or bladder dysfunction . Instruct patients to immediately report if they experience any of the above signs or symptoms . If signs or symptoms of spinal hematoma are suspected , initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae .
Use in Patients With Renal Impairment :
• Nonvalvular Atrial Fibrillation : Periodically assess renal function as clinically indicated ( ie , more frequently in situations in which renal function may decline ) and adjust therapy accordingly . Consider dose adjustment or discontinuation of XARELTO ® in patients who develop acute renal failure while on XARELTO ® .
• Treatment of Deep Vein Thrombosis ( DVT ), Pulmonary Embolism ( PE ), and Reduction in the Risk of Recurrence of DVT and of PE : Avoid the use of XARELTO ® in patients with CrCl < 30 mL / min due to an expected increase in rivaroxaban exposure and pharmacodynamic effects in this patient population .
Please see Important Safety Information throughout . Please see accompanying Brief Summary of full Prescribing Information , including Boxed WARNINGS , or visit www . XareltoHCP . com / PI .