Edoxaban

Edoxaban is a selective inhibitor of FXa. It does not require antithrombin III for antithrombotic activity.

• SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) ( 1.1 ) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant ( 1.2 ) 1.1 Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation SAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Limitation of Use for NVAF SAVAYSA should not be used in patients with CrCL > 95 mL/min because of an increased risk of ischemic stroke compared to warfarin [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) and Clinical Studies (14.1) ] .ICD-10: I26.99, I48.91, I63.9, I82.409

• SAVAYSA is contraindicated in patients with: Active pathological bleeding [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] .contraindicated

Treatment of NVAF: Assess CrCL before initiating therapy ( 2.1 ) The recommended dose is 60 mg once daily in patients with CrCL >50 to ≤ 95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min ( 2.1 ) Reduce dose to 30 mg once daily in patients with creatinine clearance 15 to 50 mL/min ( 2.1 ) Treatment of DVT and PE: The recommended dose is 60 mg once daily ( 2.2 ) Reduce dose to 30 mg once daily for patients with CrCL 15 to 50 mL/min or body weight less than or equal to 60 kg or who use certain P-gp inhibitors ( 2.2 ) 2.1 Nonvalvular Atrial Fibrillation The recommended dose of SAVAYSA is 60 mg taken orally once daily [see Warnings and Precautions (5.1) and Clinical Studies (14.1) ] . Assess creatinine clearance, as calculated using the Cockcroft-Gault equation Cockcroft-Gault CrCL = (140-age) × (weight in kg) × (0.85 if female) / (72 × creatinine in mg/dL). , before initiating therapy with SAVAYSA. Do not use SAVAYSA in patients with CrCL > 95 mL/min. Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min [see Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] . 2.2 Treatment of Deep Vein Thrombosis and Pulmonary Embolism The recommended dose of SAVAYSA is 60 mg taken orally once daily following 5 to 10 days of initial therapy with a parenteral anticoagulant [see Clinical Studies (14.2) ] . Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15 to 50 mL/min, patients who weigh less than or equal to 60 kg, or patients who are taking certain concomitant P-gp inhibitor medications [see Clinical Studies (14.2) ] .

Bleeding: Serious and potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss ( 5.3 ) Mechanical Heart Valves or Moderate to Severe Mitral Stenosis: Use is not recommended ( 5.5 ) Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: SAVAYSA use not recommended. ( 5.6 ) 5.1 Reduced Efficacy in Nonvalvular Atrial Fibrillation Patients with CrCL > 95 mL/min SAVAYSA should not be used in patients with CrCL > 95 mL/min. In the randomized ENGAGE AF-TIMI 48 study, NVAF patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg daily compared to patients treated with warfarin. In these patients another anticoagulant should be used [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . 5.2 Increased Risk of Stroke with Discontinuation of SAVAYSA in Patients with Nonvalvular Atrial Fibrillation Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance [see Dosage and Administration (2.4) and Clinical Studies (14.1) ] . 5.3 Risk of Bleeding SAVAYSA increases the risk of bleeding and can cause serious and potentially fatal bleeding. Promptly evaluate any signs or symptoms of blood loss. Discontinue SAVAYSA in patients with active pathological bleeding.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information. Increased Risk of Stroke with Discontinuation of SAVAYSA in Patients with Nonvalvular Atrial Fibrillation [see Warnings and Precautions (5.2) ] Risk of Bleeding [see Warnings and Precautions (5.3) ] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.4) ] Treatment of NVAF : The most common adverse reactions (≥ 5%) are bleeding and anemia ( 6.1 ) Treatment of DVT and PE : The most common adverse reactions (≥ 1%) are bleeding, rash, abnormal liver function tests and anemia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of SAVAYSA was evaluated in the ENGAGE AF-TIMI 48, Hokusai VTE, and Hokusai VTE Cancer studies including 11,530 patients exposed to SAVAYSA 60 mg and 7124 patients exposed to SAVAYSA 30 mg once daily [see Clinical Studies (14) ] . The ENGAGE AF-TIMI 48 Study In the ENGAGE AF-TIMI 48 study, the median study drug exposure for the SAVAYSA and warfarin treatment groups was 2.5 years. Bleeding was the most common reason for treatment discontinuation.

Lactation: Advise not to breastfeed. ( 8.2 ) Impaired renal function (CrCL 15 to 50 mL/min): Reduce dose ( 2.1 , 2.2 , 8.6 ) Moderate or severe hepatic impairment: Not recommended ( 8.7 ) 8.1 Pregnancy Risk Summary Available data about SAVAYSA use in pregnant women are insufficient to determine whether there are drug-associated risks for adverse developmental outcomes. In animal developmental studies, no adverse developmental effects were seen when edoxaban was administered orally to pregnant rats and rabbits during organogenesis at up to 16-times and 8-times, respectively, the human exposure, when based on body surface area and AUC, respectively (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnancy confers an increased risk of thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions.

Metabolism

Edoxaban displays approximately dose-proportional pharmacokinetics for doses of 15 to 150 mg and 60 to 120 mg following single and repeat doses, respectively, in healthy subjects. Absorption Following oral administration, peak plasma edoxaban concentrations are observed within 1-2 hours.

A specific reversal agent for edoxaban is not available. Overdose of SAVAYSA increases the risk of bleeding. The following are not expected to reverse the anticoagulant effects of edoxaban: protamine sulfate, vitamin K, and tranexamic acid [see Warnings and Precautions (5.3) ] . Hemodialysis does not significantly contribute to edoxaban clearance [see Clinical Pharmacology (12.3) ] .

• Jan 8, 2015NDANDA206316Daiichi Sankyo Inc

1. 1Anaemia3014.8%
2. 2Off Label Use2864.5%
3. 3Renal Impairment2784.4%
4. 4Dyspnoea2604.1%
5. 5Cardiac Failure2534.0%
6. 6Cerebral Infarction2524.0%
7. 7Nausea2303.6%
8. 8Pneumonia2053.3%
9. 9Atrial Fibrillation1973.1%
10. 10Diarrhoea1943.1%
11. 11Fall1923.0%
12. 12Gastrointestinal Haemorrhage1873.0%
13. 13Fatigue1852.9%
14. 14Dizziness1792.8%
15. 15Acute Kidney Injury1782.8%

The 10 most recently updated of 200 ClinicalTrials.gov registrations naming Edoxaban as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Antithrombotic Treatment Strategies in Cervical Artery Dissection
  Not yet recruiting · Interventional · 1,100 enrolled · University Department of Geriatric Medicine FELIX PLATTER
  NCT07639892updated 2026-06-10
• AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation
  Completed · Phase 3 · Interventional · 360 enrolled · Oslo University Hospital
  NCT05035277updated 2026-06-09
• Stepwise vs Standard Anticoagulation for AF Patients Undergoing CIED Implantation (STEP-AF)
  Not yet recruiting · Interventional · 424 enrolled · Fu Wai Hospital, Beijing, China
  NCT07616414updated 2026-06-01
• Oral Anticoagulation After Stroke With Prior ICH in Subjects With AF
  Not yet recruiting · Phase 4 · Interventional · 852 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07609654updated 2026-05-27
• Anticoagulation in Patients With Venous Thromboembolism and Cancer
  Active not recruiting · Observational · 1 enrolled · Pfizer
  NCT04618913updated 2026-05-26
• STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism
  Not yet recruiting · Observational · 1,300 enrolled · Nanjing First Hospital, Nanjing Medical University
  NCT07603700updated 2026-05-22
• Abbreviated Antithrombotic Therapy After PCI in Patients With AF and AMI
  Not yet recruiting · Interventional · 860 enrolled · Chonnam National University Hospital
  NCT07583784updated 2026-05-13
• International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
  Recruiting · Observational · 500 enrolled · Stéphane Zuily
  NCT04262492updated 2026-05-08
• Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
  Recruiting · Interventional · 224 enrolled · Beijing Tiantan Hospital
  NCT06101667updated 2026-05-05
• Registry of Patients Prescribed Anticoagulation
  Recruiting · Observational · 10,000 enrolled · Mayo Clinic
  NCT03504007updated 2026-04-27

Frequently asked questions

How does Edoxaban work?

Edoxaban is a selective inhibitor of FXa. It does not require antithrombin III for antithrombotic activity.

What is Edoxaban used for?

According to FDA labeling, Edoxaban carries indications including: SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) ( 1.1 ) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant ( 1.2 ) 1.1 Reduction in the Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation SAVAYSA is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Limitation of Use for NVAF SAVAYSA should not be used in patients with CrCL > 95 mL/min because of an increased risk of ischemic stroke compared to warfarin [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) and Clinical Studies (14.1) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Edoxaban?

Edoxaban is classified as Direct factor Xa inhibitors, Factor Xa Inhibitor, Factor Xa Inhibitors, Decreased Coagulation Factor Activity.

What are the brand names for Edoxaban?

Edoxaban is marketed under brand names including Savaysa.

What are the contraindications for Edoxaban?

Edoxaban labeling lists contraindications including: SAVAYSA is contraindicated in patients with: Active pathological bleeding [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] .. Always consult the full prescribing information and a clinician.