rivaroxaban

Brand: Xarelto

⚠ BBW ISMP High Alert Prototype Drug
Drug Class: anticoagulant
Drug Family: anticoagulant
Subclass: DOAC — direct factor Xa inhibitor
Organ Systems: cardiovascularhematology-oncology

Mechanism of Action

Direct competitive Xa inhibitor; inhibits free and prothrombinase complex-bound Xa; once-daily dosing; must be taken with food at higher doses.

factor Xa (direct, competitive)

Indications

  • AF stroke prevention
  • DVT/PE treatment and prevention
  • post-arthroplasty thromboprophylaxis
  • secondary ACS/CAD prevention (2.5 mg BID with aspirin)

Contraindications

  • severe renal impairment
  • active bleeding
  • mechanical prosthetic valves
  • moderate-severe mitral stenosis

Adverse Effects

Common

  • bleeding
  • GI upset
  • rash

Serious

  • major hemorrhage

Pharmacokinetics (ADME)

Absorption 80-100% with food (high doses); 60% fasted
Distribution moderate
Metabolism CYP3A4 (1/3) and hydrolysis (1/3); direct renal (1/3)
Excretion renal 36%, fecal 28%
Half-life 5-9 hours
Onset 2-4 hours
Peak 2-4 hours
Duration 12-24 hours
Protein Binding 92-95%
Vd 50 L

Drug Interactions

Drug / Agent Mechanism Severity
strong CYP3A4/P-gp inhibitors (azoles, HIV PIs) markedly increases rivaroxaban — avoid major
strong CYP3A4/P-gp inducers (rifampin) significantly reduces rivaroxaban major

Nursing Considerations

  1. Take 20 mg or 15 mg doses with EVENING MEAL for maximum absorption
  2. 2.5 mg BID with aspirin for COMPASS indication
  3. Antidote: andexanet alfa (Andexxa) or 4-factor PCC as alternative
  4. Monitor CBC and renal function

Clinical Pearls

  • ROCKET AF: non-inferior to warfarin for AF stroke prevention
  • COMPASS: rivaroxaban 2.5 mg BID plus aspirin reduces CV events in stable CAD/PAD
  • Food requirement unique: 15/20 mg doses require meal for absorption

Safety Profile

Pregnancy avoid
Lactation avoid
Renal Adjustment Required
Hepatic Adjustment Required
TDM Not required
Guideline Update pending