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XARELTO® Management Considerations

Bleed risk

XARELTO® increases the risk of bleeding and can cause serious or fatal bleeding. In clinical trials, the most common adverse reactions with XARELTO® were bleeding complications. XARELTO® is contraindicated in patients with active pathological bleeding.

  • In deciding whether to prescribe XARELTO® to patients at increased risk of bleeding, the risk of thrombotic events should be weighed against the risk of bleeding

  • Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include:

Drugs affecting hemostatis
Aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs)
 
  • In drug interaction studies conducted in subjects with normal renal function, the concomitant use of drugs that are combined P-gp and strong CYP3A4 inhibitors, or a moderate CYP3A4 inhibitor (fluconazole) increases rivaroxaban exposure and may increase bleeding risk. These include:

Drugs that are combined P-gp and strong CYP3A4 inhibitors
For example, ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir, and conivaptan
 
Bleed management*
 
Promptly evaluate any signs and symptoms of blood loss and consider the need for blood replacement.
 
Discontinue XARELTO® in patients with active pathological hemorrhage.
 
Partial reversal of prothrombin time prolongation has been seen after administration of prothrombin complex concentrates (PCCs) in healthy volunteers.
 
The use of other procoagulant reversal agents like activated prothrombin complex concentrates (aPCCs) or recombinant factor VIIa (rFVIIa) has not been evaluated.
 

*This is not intended to replace clinical judgment or determine individual patient care.

Considerations

  • A specific antidote for XARELTO® is not available

  • The terminal elimination half-life of XARELTO® is 5 to 9 hours in healthy subjects 20 to 45 years of age and 11 to 13 hours in healthy, elderly subjects

  • XARELTO® is not dialyzable due to high plasma protein binding

  • Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of XARELTO®

 

Indications

 

IMPORTANT SAFETY INFORMATION

 

Indication and Important saftey Information

 

  • Reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). There are limited data on the relative effectiveness of XARELTO® (rivaroxaban) and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well controlled.
  • Treatment of deep vein thrombosis (DVT).
  • Treatment of pulmonary embolism (PE).
  • Reduction in the risk of recurrence of DVT and of PE following initial 6 months treatment for DVT and/or PE.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing knee replacement surgery.
  • Prophylaxis of DVT, which may lead to PE in patients undergoing hip replacement surgery.