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Direct Oral Factor Xa Inhibitor — VTE / PAD / AF Stroke Prevention Pregnancy: Contraindicated — teratogenic in animal studies; use LMWH instead

Rivaroxaban

Brand names: Xarelto

Adult dose

Dose: VTE treatment: 15 mg BD (days 1–21), then 20 mg OD with evening meal; VTE prophylaxis (orthopaedic): 10 mg OD; AF stroke prevention: 20 mg OD with evening meal; PAD (with aspirin): 2.5 mg BD
Route: Oral
Frequency: Once or twice daily (indication-dependent)
Max: 20 mg/day (VTE/AF); 5 mg/day (PAD — 2.5 mg BD)
Take with food (increases absorption by 39% at 20 mg dose). 15 mg and 20 mg doses must be taken with food. Antidote: andexanet alfa (licensed) for life-threatening bleeding. PAD indication (COMPASS trial): 2.5 mg BD + aspirin 100 mg OD reduces MACE and MALE.

Paediatric dose

Route:
Seek specialist opinion — weight-based dosing in children being studied; not routinely licensed

Dose adjustments

Renal

CrCl 15–49: 15 mg OD for AF; CrCl <15: avoid; VTE treatment — avoid if CrCl <30; review individually

Hepatic

Contraindicated in Child-Pugh B/C or coagulopathy

Clinical pearls

  • COMPASS trial established 2.5 mg BD + aspirin for PAD/stable CAD — reduces major adverse limb events (MALE) and CV death at expense of increased (non-fatal) bleeding
  • Andexanet alfa (Ondexxya) is the licensed reversal agent — binds Xa inhibitors; 4-factor PCC is alternative if andexanet not available
  • Unlike warfarin, rivaroxaban does not require routine INR monitoring — but anti-Xa levels available if needed (e.g., renal failure, obesity)
  • Missed dose: take same day if remembered; never double dose
  • Significant P-glycoprotein substrate — many interactions via efflux transporter, not just CYP3A4

Contraindications

  • Active significant bleeding
  • CrCl <15 mL/min
  • Child-Pugh B/C hepatic impairment
  • Concurrent strong CYP3A4 + P-gp inhibitors (e.g., ketoconazole, ritonavir)
  • Pregnancy
  • Prosthetic heart valves

Side effects

  • Bleeding (major and minor)
  • Anaemia
  • Nausea
  • Elevated LFTs
  • Pruritus
  • Dizziness

Interactions

  • Strong CYP3A4/P-gp inhibitors (azole antifungals, HIV PIs) — increase levels
  • Strong CYP3A4/P-gp inducers (rifampicin, carbamazepine, phenytoin) — reduce levels
  • NSAIDs/antiplatelets — additive bleeding
  • Antifungals — significant interaction — avoid

Monitoring

  • Renal function annually (or if clinical change)
  • LFTs at baseline
  • FBC
  • Signs of bleeding
  • Anti-Xa level if concern (e.g., extremes of weight, renal impairment)

Reference: BNFc; BNF 90; COMPASS Trial 2017; EINSTEIN-DVT/PE Trials; ROCKET-AF Trial; NICE TA354 (Rivaroxaban for VTE). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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