BLACK BOX WARNING
- premature discontinuation in AF increases stroke risk
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
- Take 20 mg or 15 mg doses with EVENING MEAL for maximum absorption
- 2.5 mg BID with aspirin for COMPASS indication
- Antidote: andexanet alfa (Andexxa) or 4-factor PCC as alternative
- 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
Concordance Terms
Cross-referenced clinical concepts — click any term to see all content where it appears.