Edoxaban
Regulatory sources consulted
- openfda-label-dc54247c-0158-4cae-b692-914717ab3a67
- EMA-EPAR-EMEA/H/C/004339
- AEMPS-CIMA-115993001
- PMID:38033089
- PMID:39133476
- PMID:39680399
- PMID:36194215
- PMID:38035566
- OpenFDA · B01AF03
- AEMPS CIMA · nº registro 115993001 ↗
- EMA EPAR · EMEA/H/C/004339 ↗
- RxNorm rxcui 1599538 ↗
- PubMed PMID:39680399 ↗
- PubMed PMID:36194215 ↗
- PubMed PMID:39133476 ↗
- PubMed PMID:38033089 ↗
- PubMed PMID:38035566 ↗
Approved indications
- Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Limitation of Use: Do not use in patients with NVAF and creatinine clearance (CrCl) > 95 mL/min due to reduced efficacy.
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Requires 5-10 days of initial therapy with a parenteral anticoagulant.
Contraindications
Absolute
- Active pathological bleeding.
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
- Pregnancy.
Clinical warnings
- Boxed warning · Reduced efficacy in NVAF patients with CrCl > 95 mL/min: Edoxaban should not be used in this population due to an increased risk of ischemic stroke compared to warfarin. — FDA
- Boxed warning · Premature discontinuation increases the risk of ischemic events: If discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant. — FDA
- Boxed warning · Spinal/epidural hematoma: May occur in patients receiving neuraxial anesthesia or spinal puncture, resulting in long-term or permanent paralysis. Risk is increased by indwelling epidural catheters or concomitant use of drugs affecting hemostasis. — FDA
Drug interactions
- HighRifampicinJ04AB02
Mechanism: Potent induction of the P-gp transporter, leading to a significant decrease in edoxaban plasma concentrations and efficacy.
Recommendation: Avoid concomitant use.
FDA label
- HighKetoconazoleJ02AB02
Mechanism: Potent inhibition of the P-gp transporter and CYP3A4, leading to a significant increase in edoxaban plasma concentrations and bleeding risk.
Recommendation: For VTE treatment, reduce edoxaban dose to 30 mg once daily. For NVAF, the same dose reduction is recommended.
EMA SPC
- ModerateAntiplatelet agents and NSAIDs
Mechanism: Increased risk of bleeding due to additive pharmacodynamic effect on hemostasis.
Recommendation: Concomitant use increases bleeding risk. Closely monitor patients for signs and symptoms of blood loss.
FDA label
Adverse events
Common (≥1%)
bleeding · anemia · rash · abnormal liver function tests
Rare but serious
major bleeding · intracranial hemorrhage · spinal/epidural hematoma
Pregnancy and lactation
FDA category: X
Contraindicated during pregnancy. Available data are insufficient to determine risk, but bleeding risk is significant. Do not use during breastfeeding.
Recent literature (PubMed)
Guía de práctica clínica fundamental que actualiza las recomendaciones para el manejo de la fibrilación auricular. Reafirma la preferencia por los anticoagulantes orales directos (ACOD), como el edoxabán, sobre la warfarina para la prevención del ictus en la mayoría de los pacientes, basándose en su perfil de seguridad y eficacia.
Revisión que proporciona un enfoque estandarizado para el manejo perioperatorio de los ACOD, incluido el edoxabán. Recomienda suspender el fármaco 1 día antes en procedimientos de riesgo bajo-moderado y 2 días antes en procedimientos de alto riesgo, destacando bajas tasas de tromboembolismo y sangrado mayor con esta estrategia.
Revisión exhaustiva sobre la fibrilación auricular que posiciona a los ACOD como apixabán, rivaroxabán o edoxabán como tratamiento de primera línea sobre la warfarina para la prevención del ictus en la mayoría de los pacientes, debido a menores riesgos de sangrado.
Revisión sobre el manejo de la embolia pulmonar aguda. Señala que los ACOD, incluido el edoxabán, son no inferiores a la terapia estándar con heparina/warfarina para el tratamiento y se asocian con un menor riesgo de sangrado.
Revisa el uso de ACOD en enfermedad renal crónica (ERC). Para edoxabán, destaca que en análisis post hoc de estudios pivotales, se asoció con menores tasas de sangrado y mortalidad en comparación con warfarina en pacientes con ERC moderada (CrCl 30-50 ml/min), y subraya la necesidad de ajuste de dosis.