Rivaroxaban
Regulatory sources consulted
- openfda-label-452610f0-5abb-448d-a1fc-9dd9be02bb66
- ema-epar-EMEA/H/C/005600
- aemps-cima-89321
- PubMed PMID:41812192 ↗
- PubMed PMID:39531021 ↗
- PubMed PMID:41211931 ↗
- PubMed PMID:39842011 ↗
- PubMed PMID:37075273 ↗
- OpenFDA · B01AF01
- RxNorm rxcui 1114195 ↗
Approved indications
- To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
- Reduction in the risk of recurrence of DVT and/or PE in patients at continued risk.
- Prophylaxis of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery.
- To reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk for ischemic events.
Contraindications
Absolute
- Active pathological bleeding.
- Severe hypersensitivity reaction to rivaroxaban (e.g., anaphylactic reactions).
Clinical warnings
- Boxed warning · Premature discontinuation of any oral anticoagulant, including rivaroxaban, increases the risk of thrombotic events. If anticoagulation is discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant. — FDA
- Boxed warning · Epidural or spinal hematomas have occurred in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. — FDA
Drug interactions
- HighCombined P-gp and strong CYP3A4 inhibitors (e.g. Ketoconazole, Ritonavir)J02AB02
Mechanism: Inhibition of rivaroxaban metabolism (CYP3A4) and efflux (P-gp), leading to a significant increase in exposure and bleeding risk.
Recommendation: Avoid concomitant use.
FDA label
- HighCombined P-gp and strong CYP3A4 inducers (e.g. Rifampicin, Carbamazepine)J04AB02
Mechanism: Induction of rivaroxaban metabolism (CYP3A4) and efflux (P-gp), leading to a significant decrease in exposure and risk of thrombotic events.
Recommendation: Avoid concomitant use.
FDA label
- HighOther anticoagulants and NSAIDsB01
Mechanism: Additive pharmacodynamic effect that increases the risk of bleeding.
Recommendation: Avoid concomitant use of other anticoagulants. Use NSAIDs with caution and monitor for signs of bleeding.
FDA label
Adverse events
Common (≥1%)
bleeding
Rare but serious
major bleeding · spinal/epidural hematoma · thrombocytopenia · anaphylactic reaction · hepatotoxicity
Pregnancy and lactation
Use with caution in pregnant patients because of the potential for pregnancy-related hemorrhage. The anticoagulant effect cannot be reliably monitored. Insufficient data to inform a drug-associated risk of adverse developmental outcomes.
Recent literature (PubMed)
En un ensayo aleatorizado internacional (COBRRA), apixabán se asoció con un riesgo significativamente menor de sangrado clínicamente relevante (3.3% vs 7.1%; RR 0.46) en comparación con rivaroxabán para el tratamiento de tromboembolismo venoso agudo durante 3 meses, sin diferencias significativas en mortalidad.
El ensayo AZALEA-TIMI 71 fue detenido prematuramente debido a una reducción drástica del sangrado con abelacimab (un inhibidor del factor XI) en comparación con rivaroxabán en pacientes con fibrilación auricular. La tasa de sangrado mayor o clínicamente relevante fue de 2.6-3.2 eventos/100 persona-años con abelacimab vs 8.4 con rivaroxabán.
Actualización de la guía ASCO que añade rivaroxabán y apixabán como opciones para la profilaxis extendida del TEV después de cirugía oncológica y apixabán para el tratamiento del TEV. Respalda el uso de ACOD en pacientes con cáncer, destacando su seguridad y eficacia en los estudios analizados.
En pacientes con ablación exitosa de FA y factores de riesgo de ictus, no hubo diferencia significativa en el resultado primario (ictus, embolia sistémica o ictus encubierto) entre rivaroxabán y aspirina a 3 años. Sin embargo, el sangrado mayor fue numéricamente mayor con rivaroxabán (1.6% vs 0.6%).
Revisión que discute la evidencia de los anticoagulantes en la trombosis asociada al cáncer (TAC), con énfasis en los ACOD. Apixabán, rivaroxabán y edoxabán son alternativas atractivas a las heparinas de bajo peso molecular, y las guías respaldan su uso, destacando la importancia de la elección individualizada.