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Venous Thromboembolism Pregnancy: Contraindicated — crosses placenta; risk of fetal/neonatal bleeding; use LMWH in pregnancy

Rivaroxaban (PE Treatment)

Brand names: Xarelto

Adult dose

Dose: 15 mg twice daily for 21 days (acute treatment), then 20 mg once daily with evening meal
Route: Oral
Frequency: BD for 21 days, then OD
Max: 15 mg BD (acute); 20 mg OD (maintenance)
Direct factor Xa inhibitor. EINSTEIN-PE trial. Extended prophylaxis after >=6 months: 10 mg OD. Take 20 mg and 15 mg doses with food — CRITICAL for absorption. No routine coagulation monitoring needed.

Paediatric dose

Route: Oral
Weight-based paediatric dosing licensed (>=30 kg — adult doses; 20-<30 kg use BNFc tables). Seek specialist haematology/respiratory opinion for paediatric PE.

Dose adjustments

Renal

eGFR 15-29: use with caution — increased bleeding risk. eGFR <15: avoid

Hepatic

Avoid in hepatic disease with coagulopathy (Child-Pugh B with coagulopathy; Child-Pugh C — avoid)

Clinical pearls

  • EINSTEIN-PE trial (NEJM 2012): rivaroxaban non-inferior to LMWH/warfarin for PE treatment with similar major bleeding rate — simplified single-drug approach vs parenteral bridging
  • Antiphospholipid syndrome — RAPS and TRAPS trials: DOAC inferior to warfarin in triple-positive APS; rivaroxaban contraindicated in APS
  • Dose with food for 15 mg and 20 mg doses — rivaroxaban absorption is food-dependent at higher doses; 10 mg dose does not require food
  • No routine anti-Xa monitoring required; in extremes of weight or renal impairment, anti-Xa levels can be checked 2-4 hours (peak) and 24 hours (trough) post-dose
  • Reversal agent: andexanet alfa (Ondexxya) — licensed for anti-Xa reversal including rivaroxaban in life-threatening bleeding

Contraindications

  • Active significant bleeding
  • Severe hepatic disease with coagulopathy
  • eGFR <15 mL/min
  • Antiphospholipid syndrome — warfarin preferred
  • Pregnancy

Side effects

  • Bleeding (GI, intracranial — lower risk than warfarin for intracranial)
  • Nausea
  • Anaemia
  • Elevated transaminases
  • Dizziness

Interactions

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

Monitoring

  • Renal function (eGFR — baseline and periodically)
  • Hepatic function
  • Haemoglobin
  • Signs and symptoms of bleeding

Reference: BNFc; BNF 90; EINSTEIN-PE Trial (NEJM 2012); RAPS Trial (Cohen et al. Lancet Haematol 2016); NICE NG158; SPC Xarelto. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.