Edoxaban Teva: Uses, Dosage & Side Effects
Direct oral anticoagulant (DOAC) – selective factor Xa inhibitor for stroke prevention and blood clot treatment
Quick facts about Edoxaban Teva
Key Takeaways
- Edoxaban Teva is a generic version of edoxaban (originally marketed as Lixiana/Savaysa), a direct oral anticoagulant that prevents blood clots by selectively blocking factor Xa.
- The ENGAGE AF-TIMI 48 trial demonstrated that edoxaban was non-inferior to warfarin for stroke prevention in atrial fibrillation, with significantly lower rates of major bleeding and cardiovascular death.
- Edoxaban is taken once daily, which may improve medication adherence compared to twice-daily DOACs. It does not require routine INR monitoring.
- The standard dose is 60 mg once daily, with a reduced dose of 30 mg once daily for patients with low body weight (≤60 kg), moderate to severe renal impairment (CrCl 15–50 mL/min), or concomitant use of certain P-gp inhibitors. The 15 mg strength is available for further dose adjustment.
- Edoxaban should not be used in patients with atrial fibrillation and creatinine clearance above 95 mL/min due to increased ischaemic stroke rates observed in this group compared with warfarin.
What Is Edoxaban Teva and What Is It Used For?
Quick Answer: Edoxaban Teva is a generic direct oral anticoagulant (DOAC) containing edoxaban, a factor Xa inhibitor. It is used to prevent stroke in atrial fibrillation and to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE). The 15 mg tablet is the lowest available strength, used when further dose reduction is required.
Edoxaban Teva is a prescription anticoagulant medication that contains edoxaban tosilate as its active substance. Edoxaban belongs to the class of direct oral anticoagulants (DOACs), also known as novel oral anticoagulants (NOACs), which have largely replaced warfarin as first-line therapy for many conditions requiring anticoagulation. It works by directly and reversibly inhibiting factor Xa, a serine protease that occupies a central position in the coagulation cascade where the intrinsic and extrinsic pathways converge.
The original edoxaban product was developed by Daiichi Sankyo and marketed under the brand name Lixiana in Europe and Savaysa in the United States. It received marketing authorisation from the European Medicines Agency (EMA) in 2015 and approval from the U.S. Food and Drug Administration (FDA) in 2015. Edoxaban Teva is a generic version manufactured by Teva Pharmaceutical Industries, one of the world’s largest generic medicine producers. As a generic medicine, it has been demonstrated to be bioequivalent to the original product, meaning it delivers the same amount of active substance at the same rate and achieves the same therapeutic effect.
Unlike warfarin, which requires frequent blood monitoring (INR tests) and has numerous food and drug interactions, edoxaban offers the significant practical advantage of once-daily fixed dosing. This once-daily regimen is a distinguishing feature among DOACs, as some alternatives such as apixaban and dabigatran require twice-daily administration. The predictable pharmacokinetics of edoxaban eliminate the need for routine coagulation monitoring, though periodic assessment of renal function is essential because dose adjustments are based on creatinine clearance.
Edoxaban belongs to the same pharmacological family as apixaban and rivaroxaban (all factor Xa inhibitors), while dabigatran is a direct thrombin inhibitor. The factor Xa inhibitors share a common mechanism of action but differ in their pharmacokinetic profiles, dosing regimens, and clinical evidence base. Edoxaban is unique among the DOACs in that its efficacy for stroke prevention in atrial fibrillation is reduced in patients with very high creatinine clearance (above 95 mL/min), which represents an important prescribing consideration.
Approved Indications
Edoxaban Teva is approved for the following clinical indications, consistent with the indications established for the originator product through major regulatory agencies including the EMA and FDA:
- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, or prior stroke or transient ischaemic attack (TIA).
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, following at least 5 days of initial treatment with a parenteral anticoagulant (such as low molecular weight heparin or unfractionated heparin).
It is important to note that unlike apixaban and rivaroxaban, edoxaban requires initial parenteral anticoagulation for 5 to 10 days before switching to oral therapy in the treatment of acute VTE. This is because the Hokusai-VTE trial, which established the efficacy and safety of edoxaban for VTE treatment, used a heparin lead-in design. The European Society of Cardiology (ESC) 2024 guidelines recommend DOACs, including edoxaban, as preferred oral anticoagulants over warfarin for stroke prevention in patients with atrial fibrillation, except in patients with mechanical heart valves or moderate-to-severe mitral stenosis.
Mechanism of Action
Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, a serine protease found at the convergence point of the intrinsic and extrinsic coagulation pathways. Factor Xa catalyses the conversion of prothrombin to thrombin via the prothrombinase complex. By inhibiting factor Xa, edoxaban reduces thrombin generation, which in turn decreases fibrin clot formation and thrombus development. Edoxaban inhibits both free factor Xa and factor Xa within the prothrombinase complex, as well as clot-bound factor Xa.
Unlike heparin and low molecular weight heparins, edoxaban does not require antithrombin III as a cofactor for its anticoagulant activity. This direct mechanism of action provides a more predictable anticoagulant response compared with vitamin K antagonists (such as warfarin), which act indirectly by inhibiting the synthesis of multiple coagulation factors. The onset of anticoagulant effect occurs within 1 to 2 hours of oral administration, reaching peak plasma concentrations rapidly, and the anticoagulant effect is directly proportional to the plasma concentration of the drug.
What Should You Know Before Taking Edoxaban Teva?
Quick Answer: Before starting edoxaban, your doctor will assess your kidney function, bleeding risk, body weight, and current medications. Edoxaban is contraindicated in active clinically significant bleeding, severe liver disease, and in patients with prosthetic heart valves. It should not be used for atrial fibrillation when creatinine clearance exceeds 95 mL/min.
Before prescribing edoxaban, your healthcare provider will conduct a thorough assessment of your medical history, current medications, kidney and liver function, body weight, and overall health status. Anticoagulant therapy always involves carefully balancing the benefit of preventing potentially life-threatening blood clots against the inherent risk of bleeding. Several patient-specific factors influence this balance and determine whether edoxaban is the most appropriate anticoagulant choice and at what dose it should be prescribed.
Assessment of renal function is particularly critical with edoxaban because creatinine clearance directly determines both the appropriate dose and whether the drug should be used at all. Unlike some other DOACs, edoxaban has both an upper and a lower creatinine clearance threshold that defines its suitability. Patients with very good kidney function (CrCl >95 mL/min) should generally not receive edoxaban for atrial fibrillation, while those with severely impaired function (CrCl <15 mL/min) have insufficient clinical data to support its use.
Contraindications
Edoxaban Teva should not be used in the following situations:
- Active clinically significant bleeding: Patients with ongoing haemorrhage from any site, including gastrointestinal, intracranial, or urogenital bleeding, must not take edoxaban.
- Hypersensitivity: Known allergy to edoxaban tosilate or any of the excipients in the formulation.
- Severe hepatic disease: Liver disease associated with coagulopathy and clinically relevant bleeding risk, including hepatic disease associated with coagulopathy.
- Lesions or conditions at significant risk of major bleeding: Such as current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury or surgery, oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities.
- Uncontrolled severe arterial hypertension.
- Concomitant treatment with any other anticoagulant except in specific circumstances of switching anticoagulant therapy or when unfractionated heparin is given at doses necessary to maintain an open central venous or arterial catheter.
- Prosthetic heart valves: Edoxaban has not been studied and is not recommended for patients with mechanical heart valves. Warfarin remains the standard anticoagulant for this population.
In patients with non-valvular atrial fibrillation and creatinine clearance above 95 mL/min, edoxaban should not be used because it demonstrated an increased rate of ischaemic stroke compared with warfarin in this population in the ENGAGE AF-TIMI 48 trial. This is attributed to lower drug exposure in patients with high renal clearance. Alternative anticoagulants such as apixaban, rivaroxaban, or dabigatran should be considered for these patients.
Warnings and Precautions
Special caution is required when using edoxaban in the following situations:
- Increased bleeding risk: Conditions that increase bleeding risk include thrombocytopenia, active peptic ulcer disease, recent biopsy or major trauma, bacterial endocarditis, haemorrhagic disorders, or vascular retinopathy. Concomitant use of antiplatelet agents, other anticoagulants, fibrinolytics, chronic NSAID use, or SSRIs/SNRIs further increases bleeding risk.
- Renal impairment: Edoxaban dose must be reduced to 30 mg once daily in patients with creatinine clearance 15–50 mL/min. In patients with CrCl below 15 mL/min, clinical experience is very limited and edoxaban is not recommended. Renal function should be assessed at baseline and at least annually thereafter, or more frequently when renal function is expected to decline.
- Hepatic impairment: Edoxaban can be used without dose adjustment in mild hepatic impairment (Child-Pugh A). It is not recommended in moderate to severe hepatic impairment (Child-Pugh B and C), as these patients may have intrinsic coagulation abnormalities. Patients with elevated liver enzymes (ALT/AST >2 × ULN) or total bilirubin ≥1.5 × ULN were excluded from clinical trials.
- Spinal or epidural anaesthesia: As with all anticoagulants, patients receiving neuraxial anaesthesia or undergoing spinal/epidural puncture are at risk of developing epidural or spinal haematoma, which may result in long-term or permanent paralysis. Edoxaban should be discontinued at least 12 hours before the procedure.
- Body weight: Dose reduction to 30 mg once daily is recommended for patients weighing 60 kg or less, due to increased drug exposure in low-weight individuals.
- Premature discontinuation: Stopping edoxaban without adequate alternative anticoagulation increases the risk of thrombotic events. If edoxaban must be discontinued for a reason other than pathological bleeding or completion of therapy, consider initiating an alternative anticoagulant.
Pregnancy and Breastfeeding
There are no adequate and well-controlled studies of edoxaban use during pregnancy. Animal reproductive studies have shown that edoxaban crosses the placenta. Based on its mechanism of action, edoxaban may increase the risk of haemorrhage during pregnancy and delivery. Therefore, edoxaban is not recommended during pregnancy unless the potential benefit justifies the potential risk to the foetus. Women of childbearing potential should use effective contraception while taking edoxaban.
It is not known whether edoxaban or its metabolites are excreted in human breast milk. Animal studies have demonstrated the presence of edoxaban in breast milk. A risk to the breastfed infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue edoxaban therapy, taking into account the benefit of breastfeeding for the child and the benefit of anticoagulation therapy for the mother. Breastfeeding is not recommended during treatment with edoxaban.
The standard dose of edoxaban is 60 mg once daily. The dose should be reduced to 30 mg once daily in patients with any one of the following: body weight ≤60 kg, moderate or severe renal impairment (CrCl 15–50 mL/min), or concomitant use of the P-glycoprotein (P-gp) inhibitors ciclosporin, dronedarone, erythromycin, or ketoconazole. The 15 mg tablet provides further flexibility for dose adjustments in clinical practice.
How Does Edoxaban Teva Interact with Other Drugs?
Quick Answer: Edoxaban is a substrate of P-glycoprotein (P-gp) and has minimal metabolism via CYP3A4. P-gp inhibitors such as dronedarone, ciclosporin, ketoconazole, and erythromycin increase edoxaban levels and require dose reduction to 30 mg daily. P-gp inducers such as rifampicin reduce edoxaban levels and should be co-administered with caution. Concomitant use of antiplatelet agents, NSAIDs, and other anticoagulants increases bleeding risk.
Drug interactions with edoxaban primarily involve the P-glycoprotein (P-gp) efflux transporter system rather than the cytochrome P450 enzyme system, which distinguishes it from some other DOACs. Edoxaban undergoes minimal hepatic metabolism via CYP3A4, and its clearance is primarily renal (approximately 50%) with the remainder via the faecal/biliary route. The relatively low dependence on CYP-mediated metabolism means that edoxaban has fewer pharmacokinetic drug interactions compared with apixaban and rivaroxaban.
Nevertheless, drugs that inhibit or induce P-gp can significantly alter edoxaban plasma concentrations. It is critical to inform your prescriber about all medications you are taking, including over-the-counter medicines, herbal supplements, and vitamins, before starting edoxaban therapy. Some interactions require mandatory dose adjustments, while others may necessitate avoidance of the combination altogether.
Major Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Ciclosporin | P-gp inhibitor; increases edoxaban plasma levels by approximately 73% | Reduce edoxaban dose to 30 mg once daily |
| Dronedarone | P-gp inhibitor; increases edoxaban exposure by approximately 85% | Reduce edoxaban dose to 30 mg once daily |
| Erythromycin | P-gp inhibitor; increases edoxaban levels by approximately 68% | Reduce edoxaban dose to 30 mg once daily |
| Ketoconazole | P-gp and CYP3A4 inhibitor; increases edoxaban levels by approximately 87% | Reduce edoxaban dose to 30 mg once daily |
| Rifampicin | P-gp inducer; decreases edoxaban exposure by approximately 34% | Avoid concomitant use; reduced efficacy expected |
| Phenytoin, carbamazepine, phenobarbital | P-gp inducers; expected to decrease edoxaban levels | Co-administer with caution; consider alternative anticoagulant |
| St John’s Wort (Hypericum perforatum) | P-gp inducer; expected to decrease edoxaban levels | Avoid concomitant use |
| Other anticoagulants (heparin, warfarin, enoxaparin) | Additive anticoagulant effect; markedly increased bleeding risk | Contraindicated except during transition between anticoagulants |
Minor Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Aspirin (low-dose, ≤100 mg) | Increased bleeding risk due to antiplatelet effect; no significant pharmacokinetic interaction | Use with caution; monitor for bleeding signs |
| Clopidogrel, prasugrel, ticagrelor | Increased bleeding risk with dual antithrombotic therapy | Use only when clearly indicated; shortest possible duration |
| NSAIDs (ibuprofen, naproxen, diclofenac) | Increased risk of gastrointestinal bleeding | Avoid chronic use; short courses with caution and gastroprotection |
| SSRIs / SNRIs (fluoxetine, sertraline, venlafaxine) | May increase bleeding risk via serotonergic effects on platelets | Monitor for signs and symptoms of bleeding |
| Verapamil, quinidine, amiodarone | P-gp inhibitors with modest effect on edoxaban levels (increase of 29–40%) | No dose adjustment required; monitor clinically |
| Proton pump inhibitors (omeprazole, pantoprazole) | No clinically significant pharmacokinetic interaction | No dose adjustment required |
| Digoxin | Both are P-gp substrates; no clinically significant interaction observed | No dose adjustment required |
Edoxaban can be taken with or without food, as food does not significantly affect its bioavailability. Unlike warfarin, edoxaban does not interact with vitamin K-containing foods such as green leafy vegetables, making dietary management considerably simpler for patients on anticoagulation therapy.
What Is the Correct Dosage of Edoxaban Teva?
Quick Answer: The standard dose of edoxaban is 60 mg once daily. It is reduced to 30 mg once daily for patients weighing ≤60 kg, those with creatinine clearance 15–50 mL/min, or those taking specific P-gp inhibitors. Edoxaban should be taken at the same time each day, with or without food. The 15 mg tablet is available for further dose adjustment when clinically necessary.
Edoxaban is administered orally once daily, which is a practical advantage compared with twice-daily DOACs. Consistent timing of the daily dose helps maintain stable plasma drug levels and optimal anticoagulant effect. The tablets should be swallowed whole with water. Edoxaban can be taken with or without food, as food does not significantly affect its absorption. Establishing a routine, such as taking edoxaban at the same time each day, can help ensure adherence to therapy.
Adults
| Indication | Standard Dose | Reduced Dose | Duration |
|---|---|---|---|
| Prevention of stroke and systemic embolism in NVAF | 60 mg once daily | 30 mg once daily | Long-term (as long as benefit outweighs risk) |
| Treatment of DVT and PE | 60 mg once daily (after ≥5 days parenteral anticoagulation) | 30 mg once daily | Minimum 3 months; extended treatment based on individual risk assessment |
Dose Reduction to 30 mg Once Daily
The dose must be reduced to 30 mg once daily in patients with any one of the following factors:
- Body weight ≤60 kg
- Moderate to severe renal impairment (creatinine clearance 15–50 mL/min)
- Concomitant use of the P-gp inhibitors ciclosporin, dronedarone, erythromycin, or ketoconazole
Children
Edoxaban is not approved for use in children and adolescents below 18 years of age. There are currently insufficient data on the safety and efficacy of edoxaban in paediatric patients. Anticoagulation in paediatric populations requires specialised assessment and typically involves different agents depending on the clinical scenario.
Elderly
No dose adjustment is required based on age alone. However, elderly patients are more likely to have reduced renal function and lower body weight, both of which are independent criteria for dose reduction. In clinical trials, approximately 40% of patients in the ENGAGE AF-TIMI 48 trial were aged 75 years or older. The risk of bleeding increases with age, and careful monitoring for signs and symptoms of bleeding is recommended in elderly patients.
Missed Dose
If you miss a dose of edoxaban, take the missed dose as soon as you remember on the same day. Resume the normal once-daily dosing schedule on the following day. Do not take a double dose on the same day to compensate for a missed dose. The convenience of once-daily dosing is one of edoxaban’s advantages, but consistent adherence is essential because missing doses increases the risk of thromboembolic events. If you frequently forget to take your medication, consider setting a daily alarm or using a pill organiser.
Overdose
Overdose of edoxaban increases the risk of bleeding. There is no specific antidote that completely reverses the anticoagulant effect of edoxaban, although andexanet alfa (a recombinant modified factor Xa protein) has been approved as a reversal agent for factor Xa inhibitors in life-threatening bleeding situations. If overdose occurs or bleeding develops, the following management strategies may be considered:
- Andexanet alfa: Specific reversal agent for factor Xa inhibitors, approved for life-threatening or uncontrolled bleeding.
- Activated charcoal: May reduce absorption if administered within 2 hours of edoxaban ingestion.
- Prothrombin complex concentrates (PCCs): 4-factor PCC (50 IU/kg) can partially reverse the anticoagulant effect when andexanet alfa is unavailable.
- Supportive measures: Mechanical compression, surgical intervention to control bleeding source, fluid replacement and haemodynamic support, blood products (packed red cells, fresh frozen plasma) as clinically indicated.
- Haemodialysis: Not expected to significantly contribute to edoxaban clearance due to its plasma protein binding (approximately 55%).
Premature discontinuation of edoxaban without switching to an adequate alternative anticoagulant increases the risk of thrombotic events, including ischaemic stroke and venous thromboembolism. If edoxaban must be stopped for surgery or other reasons, your doctor will provide specific guidance on when to stop and restart the medication. Never stop taking edoxaban without consulting your prescriber.
What Are the Side Effects of Edoxaban Teva?
Quick Answer: The most common side effect of edoxaban is bleeding, which can range from mild (such as bruising or nosebleeds) to serious (such as gastrointestinal or intracranial bleeding). Other common side effects include anaemia, rash, abnormal liver function tests, and abdominal pain. Seek immediate medical attention for signs of serious bleeding such as unexplained bruising, blood in urine or stool, prolonged bleeding, or signs of intracranial haemorrhage.
Like all anticoagulants, edoxaban carries a risk of bleeding, which is the most clinically significant adverse effect. The risk of bleeding should be weighed against the benefit of preventing thromboembolic events. In the ENGAGE AF-TIMI 48 trial, edoxaban was associated with significantly lower rates of major bleeding compared with warfarin (2.75% vs 3.43% per year; hazard ratio 0.80). In the Hokusai-VTE trial, the rate of clinically relevant bleeding was also significantly lower with edoxaban than with warfarin.
Patients should be educated about recognising the signs and symptoms of bleeding and instructed to seek immediate medical attention if they experience significant or unusual bleeding. The following frequency categories are based on data from clinical trials and post-marketing surveillance:
Common Side Effects
Affects 1 to 10 in every 100 patients
- Cutaneous soft tissue bleeding (bruising, ecchymosis)
- Epistaxis (nosebleeds)
- Vaginal bleeding (menorrhagia, metrorrhagia)
- Gastrointestinal bleeding (gum bleeding, rectal bleeding, upper GI bleeding)
- Lower urinary tract bleeding (haematuria)
- Anaemia
- Rash and pruritus
- Abnormal liver function tests (elevated bilirubin, gamma-glutamyl transferase)
Uncommon Side Effects
Affects 1 to 10 in every 1,000 patients
- Intracranial haemorrhage (including haemorrhagic stroke)
- Intraocular bleeding (subconjunctival haemorrhage)
- Surgical site bleeding
- Haemoptysis (coughing up blood)
- Allergic oedema
- Urticaria
- Elevated liver transaminases (ALT, AST)
- Elevated alkaline phosphatase
- Thrombocytopenia
- Dizziness and headache
- Abdominal pain and nausea
Rare Side Effects
Affects 1 to 10 in every 10,000 patients
- Anaphylactic reaction
- Subarachnoid haemorrhage
- Pericardial haemorrhage
- Retroperitoneal haemorrhage
- Intramuscular bleeding (compartment syndrome)
- Intra-articular bleeding (haemarthrosis)
- Subdural haemorrhage
- Procedural haemorrhage
Contact your doctor or seek emergency care immediately if you experience any of the following while taking edoxaban: unexplained bruising or bleeding that does not stop; blood in your urine (pink, red, or brown colour); black or bloody stools; coughing up blood or blood clots; vomiting blood or material that looks like coffee grounds; severe headache, confusion, weakness, or vision changes (which may indicate intracranial bleeding); or excessive menstrual bleeding.
How Should You Store Edoxaban Teva?
Quick Answer: Store Edoxaban Teva at room temperature below 30°C in the original packaging to protect from moisture. Keep out of the reach and sight of children. Do not use after the expiry date printed on the packaging.
Proper storage of edoxaban is important to ensure the medication remains effective and safe throughout its shelf life. The film-coated tablets should be stored at room temperature, not exceeding 30°C (86°F). There is no need for refrigeration. The tablets should be kept in their original blister packaging until use to protect them from moisture and light.
Keep edoxaban and all medicines out of the reach and sight of children. Store the medication in a secure location. Do not use edoxaban after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of that month. Do not dispose of unused medicines via wastewater or household waste. Return any unused medication to your pharmacy for safe disposal, as this helps protect the environment.
If you notice any visible changes to the tablets, such as discolouration, crumbling, or an unusual odour, do not take them and consult your pharmacist. When travelling, keep edoxaban in your hand luggage at a comfortable temperature and always carry enough medication for your trip plus a few extra days’ supply in case of delays.
What Does Edoxaban Teva Contain?
Quick Answer: Each Edoxaban Teva 15 mg film-coated tablet contains 15 mg of edoxaban (as tosilate monohydrate) as the active substance. The tablets also contain inactive ingredients (excipients) necessary for manufacturing, stability, and the film coating.
The active substance in Edoxaban Teva is edoxaban, present as edoxaban tosilate monohydrate. The 15 mg film-coated tablet contains an amount of edoxaban tosilate monohydrate equivalent to 15 mg of edoxaban. Edoxaban tosilate is the salt form used to optimise the drug’s stability and absorption characteristics.
The tablets also contain the following inactive ingredients (excipients) in the tablet core and film coating:
- Tablet core: Mannitol, pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate
- Film coating: Hypromellose, macrogol 8000, titanium dioxide (E171), talc, iron oxide yellow (E172), iron oxide red (E172)
The 15 mg tablets are orange, round, and film-coated. Patients with known hypersensitivity to any of the listed excipients should inform their healthcare provider before starting treatment. The tablet colouring agents (iron oxides and titanium dioxide) are standard pharmaceutical-grade pigments used to identify different tablet strengths and have no pharmacological activity.
Edoxaban Teva has been demonstrated to be bioequivalent to the originator product (Lixiana) through rigorous bioequivalence studies required by the European Medicines Agency. This means that the generic formulation delivers the same amount of active substance at the same rate, producing equivalent therapeutic effects. All generic medicines approved in the EU must meet the same stringent quality, safety, and efficacy standards as the original product.
Frequently Asked Questions
References
This article is based on the following peer-reviewed sources, international guidelines, and regulatory documents:
- Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation (ENGAGE AF-TIMI 48). N Engl J Med. 2013;369(22):2093–2104. doi:10.1056/NEJMoa1310907
- Buller HR, Decousus H, Grosso MA, et al. Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism (Hokusai-VTE). N Engl J Med. 2013;369(15):1406–1415. doi:10.1056/NEJMoa1306638
- Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383(9921):955–962. doi:10.1016/S0140-6736(13)62343-0
- European Society of Cardiology. 2024 ESC/EACTS Guidelines for the Management of Atrial Fibrillation. Eur Heart J. 2024. doi:10.1093/eurheartj/ehae176
- European Medicines Agency. Lixiana (edoxaban) – Summary of Product Characteristics. EMA, 2024. EMA – Lixiana
- U.S. Food and Drug Administration. Savaysa (edoxaban) – Prescribing Information. FDA, 2024. FDA – Savaysa
- British National Formulary. Edoxaban. BNF, 2025. BNF – Edoxaban
- World Health Organization. WHO Model List of Essential Medicines – 23rd List. WHO, 2023.
- Connolly SJ, Crowther M, Eikelboom JW, et al. Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors (ANNEXA-4). N Engl J Med. 2019;380(14):1326–1335. doi:10.1056/NEJMoa1814051
- Salazar DE, Mendell J, Gao J, et al. Edoxaban Clinical Pharmacokinetics and Pharmacodynamics. Clin Pharmacokinet. 2017;56(6):641–655. doi:10.1007/s40262-016-0483-1
- Parasrampuria DA, Truitt KE. Pharmacokinetics and Pharmacodynamics of Edoxaban, a Non-Vitamin K Antagonist Oral Anticoagulant that Inhibits Clotting Factor Xa. Clin Pharmacokinet. 2016;55(6):641–655.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed physicians specialising in clinical pharmacology, haematology, and internal medicine.
iMedic Medical Editorial Team – specialists in clinical pharmacology and anticoagulation therapy with extensive experience in evidence-based medical communication.
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