What are the contraindications for Xarelto (rivaroxaban)?

Contraindications for Xarelto (Rivaroxaban)

Xarelto (rivaroxaban) is contraindicated in patients with active pathological bleeding and in patients with severe hypersensitivity reaction to the medication. 1

Absolute Contraindications

• Active pathological bleeding 1
• Severe hypersensitivity reaction to rivaroxaban (e.g., anaphylactic reactions) 1
• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk 2
• Child-Pugh B and C liver cirrhosis 2, 3

Renal Function Contraindications

• Severe renal impairment (CrCl <15 mL/min) for VTE indication 2, 4
• End-stage renal disease (eGFR <15 mL/min) 4
• Dialysis patients - use is best avoided 2

Drug Interaction Contraindications

• Concomitant use with strong inhibitors of both CYP3A4 and P-glycoprotein, including:
  • Azole antimycotics (e.g., ketoconazole, itraconazole) 2
  • HIV protease inhibitors 2, 4

Special Populations and Precautions

Renal Impairment

• For patients with moderate to severe renal impairment (CrCl 15-49 mL/min), dose reduction from 20 mg once daily to 15 mg once daily is recommended 2, 4
• Regular monitoring of renal function is essential, especially in patients with fluctuating renal function 4

Hepatic Impairment

• Avoid use in patients with elevated liver enzymes >2 times the upper limit of normal 2
• Use with caution in patients with mild (Child-Pugh A) hepatic impairment 3

Other High-Risk Populations

• Use with caution in elderly patients (>75 years) with renal dysfunction 4
• Use with caution in patients weighing less than 50 kg 4
• Patients with gastric or gastroesophageal tumors may have increased risk of hemorrhage with direct oral anticoagulants 2

Clinical Considerations

When considering rivaroxaban therapy, a thorough evaluation of patient characteristics is essential, including:

1. Renal function assessment using creatinine clearance calculation (Cockcroft-Gault formula preferred) 2
2. Liver function tests (transaminases, bilirubin) 2
3. Complete blood count 2
4. Assessment for potential drug interactions 2

Bleeding Risk Management

• For patients requiring elective surgery, rivaroxaban should be discontinued 20-30 hours before the procedure if renal and liver function are normal 5
• In case of major bleeding, consider prothrombin complex concentrate (PCC) 4, 5
• Abrupt discontinuation increases thrombotic risk; consider transitioning to another anticoagulant if stopping 4, 1

Important Caveats

• Unlike warfarin, routine coagulation monitoring (PT/INR) is not required for rivaroxaban 4
• In emergency situations, a sensitive thromboplastin time test can provide initial information about anticoagulation status 5
• Rivaroxaban should be taken with food when prescribed at 15 mg or 20 mg doses for better absorption 4
• Premature discontinuation increases the risk of thrombotic events 1

By carefully screening for these contraindications and following appropriate dosing adjustments, the risk of adverse events with rivaroxaban therapy can be minimized while maintaining efficacy.