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Oral Factor Xa Inhibitor (DOAC — Extended Duration) Pregnancy: Avoid — insufficient data.

Betrixaban (Extended VTE Prophylaxis — Medical Patients)

Brand names: Bevyxxa (US — not MHRA licensed)

Adult dose

Dose: 160 mg loading dose then 80 mg once daily for 35–42 days (extended VTE prophylaxis in acutely ill medical patients)
Route: Oral
Frequency: Once daily (maintenance)
Max: 80 mg/day
NOT currently licensed by MHRA/EMA — FDA approved 2017 only. Included for clinical awareness and future potential availability. Uniquely designed for extended-duration VTE prophylaxis (5–6 weeks vs standard 6–14 days LMWH) in acutely ill hospitalised medical patients. Long half-life (~19 hours) and minimal renal clearance make it attractive in CKD.

Paediatric dose

Route:
Not licensed in paediatrics.

Dose adjustments

Renal

eGFR <15 mL/min: halve dose (40 mg OD). Advantage: only 17% renal clearance (vs 80% dabigatran, 35% rivaroxaban) — safer profile in CKD.

Hepatic

No dose adjustment required.

Clinical pearls

  • APEX trial (Cohen et al. NEJM 2016): betrixaban 35–42 days vs enoxaparin 6–14 days in acutely ill medical patients — primary endpoint (symptomatic/asymptomatic VTE composite) in the most elevated D-dimer subgroup showed significant benefit; overall modified intention-to-treat population: no significant difference in primary endpoint. FDA approved based on pre-specified subgroup analysis — controversial
  • CKD advantage: betrixaban has the lowest renal clearance of all DOACs (17%) — potentially valuable in patients with moderate-severe CKD who need extended VTE prophylaxis where LMWH accumulation is a concern; however, no MHRA/EMA licence limits UK use
  • Extended duration VTE prophylaxis context: acutely ill medical inpatients remain at elevated VTE risk for weeks after discharge — traditional LMWH covers only the admission period. Betrixaban's 5–6-week regimen bridges this gap, but questions remain about bleeding risk and patient selection

Contraindications

  • Active major bleeding
  • Hypersensitivity to betrixaban
  • Concurrent strong P-gp inhibitors (dronedarone, systemic ketoconazole — halve dose)

Side effects

  • Bleeding (major: similar to enoxaparin standard prophylaxis; clinically relevant: slightly increased)
  • Nausea
  • Constipation
  • Hypertension

Interactions

  • P-gp inhibitors (amiodarone, verapamil, dronedarone — halve betrixaban dose)
  • Antiplatelets and anticoagulants (additive bleeding)

Monitoring

  • Bleeding signs (especially at 2–3 weeks when extended beyond LMWH duration)
  • Renal function (eGFR — dose adjustment criterion)
  • D-dimer/symptomatic VTE signs (clinical monitoring)

Reference: BNFc; APEX Trial (Cohen et al. NEJM 2016); FDA Bevyxxa Prescribing Information 2017; ESC VTE Prevention in Medical Patients 2023; BNF 90 (not MHRA licensed). Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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