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Direct Oral Anticoagulant — Factor Xa Inhibitor Pregnancy: Contraindicated — LMWH throughout pregnancy

Rivaroxaban (Stroke Prevention — AF)

Brand names: Xarelto

Adult dose

Dose: AF stroke prevention: 20 mg once daily with evening meal; DVT/PE treatment: 15 mg BD for 21 days then 20 mg once daily
Route: Oral
Frequency: Once daily with food (AF); twice daily for acute phase (DVT/PE)
Max: 20 mg/day (AF)
Once-daily dosing — key adherence advantage over dabigatran and apixaban. Must be taken with the largest meal of the day (increases absorption from 66% to 100%). ROCKET-AF trial: non-inferior to warfarin for stroke prevention in AF.

Paediatric dose

Route:
Seek specialist opinion — not licensed in children under 18 for AF. Limited paediatric VTE data.

Dose adjustments

Renal

Reduce to 15 mg once daily if CrCl 15–49 mL/min (AF indication). Avoid if CrCl <15 mL/min.

Hepatic

Avoid in hepatic impairment with coagulopathy or Child-Pugh B/C.

Clinical pearls

  • Antidote: ANDEXANET ALFA (Ondexxya) — recombinant factor Xa decoy that reverses rivaroxaban (and apixaban) for life-threatening bleeding. Also: 4-factor PCC (Beriplex/Octaplex) used off-label.
  • Food is essential for adequate absorption at 20 mg dose — emphasise to patients. Missing meals while on rivaroxaban reduces drug exposure.
  • MHRA: DOACs NOT suitable for mechanical heart valves — RE-ALIGN trial (dabigatran) and GALILEO (rivaroxaban) showed excess thromboembolism and bleeding

Contraindications

  • Active bleeding
  • Mechanical heart valve
  • Significant mitral stenosis
  • CrCl <15 mL/min
  • Severe hepatic impairment

Side effects

  • Bleeding
  • Nausea
  • Elevated LFTs
  • Anaemia
  • Constipation

Interactions

  • Strong CYP3A4/P-gp inhibitors — ketoconazole, ritonavir (increase rivaroxaban levels — avoid)
  • Strong inducers — rifampicin, carbamazepine, phenytoin (reduce levels — avoid)
  • Aspirin/NSAIDs (additive bleeding)

Monitoring

  • Renal function annually
  • LFTs at baseline
  • Signs of bleeding
  • Adherence assessment (once-daily — higher risk of missed doses)

Reference: BNFc; BNF 90; ROCKET-AF Trial (NEJM 2011); NICE NG196 (AF); MHRA DOAC Safety Update. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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