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Direct Oral Anticoagulant / AF / ACS Pregnancy: Contraindicated — crosses placenta; fetal/neonatal bleeding risk. Use LMWH in pregnancy.

Rivaroxaban (AF / ACS)

Brand names: Xarelto

Adult dose

Dose: AF stroke prevention: 20 mg once daily with evening meal (15 mg OD if CrCl 15-49). Post-ACS (vascular protection): 2.5 mg twice daily + aspirin 75-100 mg OD.
Route: Oral
Frequency: Once daily (AF); twice daily (post-ACS vascular dose)
Max: 20 mg/day (AF); 5 mg/day total (post-ACS vascular dose)
Direct factor Xa inhibitor. ROCKET-AF trial (AF). ATLAS ACS2-TIMI 51 trial (post-ACS vascular protection — very low dose 2.5 mg BD). Must take 20 mg dose WITH food (bioavailability food-dependent). CrCl monitoring required.

Paediatric dose

Route: Oral
Weight-based paediatric dosing licensed for VTE treatment/prophylaxis. Specialist haematology guidance.

Dose adjustments

Renal

CrCl 15-49: 15 mg OD with food (AF). CrCl <15: avoid. Post-ACS 2.5 mg BD: use with caution CrCl 15-29.

Hepatic

Avoid in hepatic disease with coagulopathy or moderate-severe hepatic impairment (Child-Pugh B/C with coagulopathy)

Clinical pearls

  • ROCKET-AF trial (Patel et al. NEJM 2011): rivaroxaban 20 mg OD vs warfarin in AF — non-inferior for stroke prevention; lower intracranial and fatal bleeding. Notably enrolled higher-risk patients (mean CHADS2 3.5) than other DOAC trials.
  • ATLAS ACS2-TIMI 51 trial (Mega et al. NEJM 2012): very low dose rivaroxaban 2.5 mg BD added to DAPT post-ACS — significant reduction in cardiovascular death, MI, stroke (8.9% vs 10.7%) at cost of increased major bleeding. Licensed in EU for this indication.
  • Food-dependent absorption: the 20 mg (AF) and 15 mg (CrCl <50) doses MUST be taken with food (fat-containing meal). Bioavailability falls from 66% (fasted) to >80% (fed) for 20 mg dose. The 10 mg dose does NOT require food.
  • APS contraindication: RAPS and TRAPS trials demonstrated rivaroxaban inferior to warfarin in triple-positive antiphospholipid syndrome. DOACs are contraindicated in APS — warfarin remains standard.
  • Andexanet alfa (Ondexxya) reversal: specific anti-Xa reversal agent for rivaroxaban/apixaban/edoxaban. High-dose (800 mg bolus + 8 mg/min x120 min) for rivaroxaban >=10 mg or >8h before; low-dose for smaller/earlier doses.

Contraindications

  • Active significant bleeding
  • Mechanical prosthetic heart valves
  • Moderate-severe mitral stenosis
  • CrCl <15 mL/min
  • Antiphospholipid syndrome (RAPS trial — inferior to warfarin in APS)
  • Severe hepatic disease with coagulopathy

Side effects

  • Bleeding (GI, intracranial — lower intracranial than warfarin)
  • Nausea
  • Anaemia
  • Elevated LFTs

Interactions

  • Strong CYP3A4 + P-gp inhibitors (ketoconazole, itraconazole, ritonavir) — markedly increase levels; avoid
  • Strong CYP3A4 + P-gp inducers (rifampicin, phenytoin, carbamazepine) — significantly reduce levels; avoid
  • Aspirin/NSAIDs — additive bleeding risk

Monitoring

  • CrCl (Cockcroft-Gault) at baseline and annually
  • Signs of bleeding
  • LFTs (baseline)
  • Adherence (once-daily AF dosing with evening meal)

Reference: BNFc; BNF 90; ROCKET-AF Trial (Patel et al. NEJM 2011); ATLAS ACS2-TIMI 51 (Mega et al. NEJM 2012); NICE TA256; SPC Xarelto. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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