Edoxaban Hexal
Direct Oral Anticoagulant (DOAC) — Factor Xa Inhibitor
Quick Facts About Edoxaban Hexal
Key Takeaways About Edoxaban Hexal
- Once-daily dosing: Edoxaban Hexal is taken once a day, with or without food, making it convenient compared to twice-daily anticoagulants
- No routine monitoring needed: Unlike warfarin, edoxaban does not require regular INR blood tests, though periodic renal function checks are recommended
- Dose reduction criteria: The 15 mg dose applies to patients with moderate renal impairment (CrCl 15–50 mL/min), low body weight (≤60 kg), or concomitant P-glycoprotein inhibitor use
- Bleeding is the main risk: As with all anticoagulants, the most significant adverse effect is bleeding — seek immediate medical attention for any unusual or prolonged bleeding
- Do not stop abruptly: Discontinuing edoxaban without medical guidance increases the risk of stroke and thromboembolic events — always consult your doctor before stopping
What Is Edoxaban Hexal and What Is It Used For?
Edoxaban Hexal is a prescription anticoagulant (blood thinner) containing edoxaban, a direct factor Xa inhibitor. It is primarily used to prevent stroke in patients with atrial fibrillation and to treat venous thromboembolism (deep vein thrombosis and pulmonary embolism). The 15 mg tablet is the reduced-dose formulation used in specific patient populations.
Edoxaban belongs to the class of medications known as direct oral anticoagulants (DOACs), also sometimes referred to as novel oral anticoagulants (NOACs). These medications represent a significant advancement over traditional anticoagulants such as warfarin, offering more predictable pharmacokinetics, fewer drug and food interactions, and the convenience of fixed dosing without routine coagulation monitoring. Edoxaban was first approved by regulatory authorities in Japan in 2011, followed by the United States (FDA, 2015) and the European Union (EMA, 2015), based on robust evidence from large-scale randomised controlled trials.
The medication works by selectively and reversibly inhibiting factor Xa, a critical serine protease in the coagulation cascade. Factor Xa sits at the convergence point of the intrinsic and extrinsic coagulation pathways, where it catalyses the conversion of prothrombin to thrombin as part of the prothrombinase complex. By blocking factor Xa, edoxaban effectively reduces thrombin generation, which in turn decreases fibrin clot formation and reduces the risk of pathological thrombus development. Importantly, edoxaban inhibits both free factor Xa and factor Xa within the prothrombinase complex, as well as prothrombinase activity itself.
Edoxaban Hexal is specifically indicated for two major clinical scenarios. The first is the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) who have one or more risk factors, such as congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, or prior stroke or transient ischaemic attack. The landmark ENGAGE AF-TIMI 48 trial, which enrolled over 21,000 patients, demonstrated that edoxaban was non-inferior to warfarin for the prevention of stroke and systemic embolism, while causing significantly less major bleeding.
The second indication is the treatment and prevention of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults. In the Hokusai-VTE trial, which enrolled over 8,200 patients, edoxaban was shown to be non-inferior to warfarin for the prevention of recurrent VTE, with a significantly lower rate of clinically relevant bleeding. For VTE treatment, edoxaban therapy is initiated after at least 5 days of initial parenteral anticoagulation (such as low-molecular-weight heparin or unfractionated heparin).
The 15 mg tablet of Edoxaban Hexal is the reduced-dose formulation. It is prescribed for patients who require a lower dose due to moderate renal impairment (creatinine clearance 15–50 mL/min), low body weight (60 kg or less), or concomitant use of certain P-glycoprotein (P-gp) inhibitors such as ciclosporin, dronedarone, erythromycin, or ketoconazole. The standard dose of edoxaban is 60 mg once daily, reduced to 30 mg once daily for patients meeting one or more of these criteria. The 15 mg dose is used when further dose reduction is clinically indicated according to product labelling.
What Should You Know Before Taking Edoxaban Hexal?
Before starting Edoxaban Hexal, your doctor must assess your kidney function, bleeding risk, and current medications. This drug is contraindicated in patients with active bleeding, severe liver disease, or prosthetic heart valves. Special care is needed in pregnancy, breastfeeding, and in patients with certain concomitant medications.
Edoxaban Hexal, like all anticoagulants, carries an inherent risk of bleeding, which is its primary mechanism of action working as intended. Before your prescriber initiates therapy, they will perform a thorough assessment of your individual risk-benefit profile. This evaluation includes reviewing your medical history, current medications, kidney function (creatinine clearance), body weight, and any factors that may increase your bleeding risk. Understanding these considerations is essential for the safe and effective use of this medication.
Contraindications
Edoxaban Hexal must not be used in the following situations:
- Active clinically significant bleeding: Including gastrointestinal bleeding, intracranial haemorrhage, or any other site of active pathological bleeding
- Hepatic disease associated with coagulopathy: Liver conditions that impair the body's natural clotting ability and present a clinically relevant bleeding risk
- Lesions or conditions at significant risk of major bleeding: Such as current or recent gastrointestinal ulceration, malignant neoplasms at high risk of bleeding, recent brain or spinal injury or surgery, or known oesophageal varices
- Uncontrolled severe hypertension: Blood pressure that remains dangerously elevated despite treatment
- Concomitant treatment with other anticoagulants: Such as unfractionated heparin, low-molecular-weight heparins, warfarin, or other DOACs, except when switching between therapies or when heparin is used to maintain an open venous or arterial catheter
- Prosthetic heart valves requiring anticoagulation: Edoxaban has not been studied in this population and its efficacy and safety are not established
- Hypersensitivity: To edoxaban or any of the excipients in the formulation
Warnings and Precautions
Several clinical situations require special caution when using Edoxaban Hexal. Your healthcare provider should be informed about all of the following conditions:
Haemorrhagic risk: Edoxaban should be used with caution in patients with conditions that increase the risk of haemorrhage, including congenital or acquired bleeding disorders, active peptic ulcer disease, recent gastrointestinal bleeding, recent surgical procedures, or concurrent use of medications that affect haemostasis such as antiplatelet drugs and NSAIDs. If severe haemorrhage occurs, treatment should be discontinued and the source of bleeding investigated.
Renal impairment: Since edoxaban is partially eliminated by the kidneys (approximately 50% renal excretion), renal function should be assessed before initiation and periodically thereafter. Creatinine clearance (CrCl) is used to determine whether dose reduction is necessary. Patients with CrCl above 95 mL/min showed a trend towards reduced efficacy compared to warfarin in the ENGAGE AF-TIMI 48 trial, so edoxaban should only be used in patients with high creatinine clearance after careful evaluation of their individual thromboembolic and bleeding risk. In patients with end-stage renal disease (CrCl below 15 mL/min) or on dialysis, edoxaban is not recommended due to insufficient clinical data.
Hepatic impairment: Edoxaban is not recommended in patients with severe hepatic impairment (Child-Pugh C). In patients with mild to moderate hepatic impairment (Child-Pugh A or B), no dose adjustment is needed but careful monitoring is advised. Patients with elevated liver enzymes (ALT/AST above 2 times the upper limit of normal) or total bilirubin above 1.5 times the upper limit of normal were excluded from clinical trials, and edoxaban should be used with caution in these patients.
Spinal/epidural anaesthesia or puncture: As with all anticoagulants, there is a risk of epidural or spinal haematoma when neuraxial anaesthesia or spinal puncture is performed. The risk may be increased by the use of indwelling epidural catheters or the concomitant use of drugs that affect haemostasis. Patients should be monitored frequently for signs and symptoms of neurological impairment.
Premature discontinuation of any oral anticoagulant, including edoxaban, in the absence of adequate alternative anticoagulation increases the risk of ischaemic events such as stroke. If edoxaban must be discontinued for reasons other than pathological bleeding or completion of therapy, consider alternative anticoagulant coverage. Always consult your prescribing physician before stopping this medication.
Pregnancy and Breastfeeding
Pregnancy: The safety of edoxaban during pregnancy has not been established. Animal studies have shown reproductive toxicity. Edoxaban is not recommended during pregnancy due to the inherent risk of haemorrhage and because it may cross the placental barrier. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs or is planned, the healthcare provider should be consulted immediately regarding alternative anticoagulation strategies.
Breastfeeding: It is unknown whether edoxaban or its metabolites are excreted in human breast milk. Animal data indicate excretion into breast milk. A risk to the breastfeeding infant cannot be excluded. A decision must be made whether to discontinue breastfeeding or discontinue edoxaban therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.
Fertility: No human data on the effects of edoxaban on fertility are available. Animal studies showed no effects on male or female fertility at therapeutic doses.
How Does Edoxaban Hexal Interact with Other Drugs?
Edoxaban interacts with several medications primarily through P-glycoprotein (P-gp) transport and, to a lesser extent, CYP3A4 metabolism. Medications that increase bleeding risk (anticoagulants, antiplatelets, NSAIDs) have additive effects. Certain P-gp inhibitors require dose reduction, while strong P-gp inducers may reduce edoxaban's efficacy.
Drug interactions with edoxaban are generally less extensive than those seen with warfarin, which is one of the key advantages of DOACs. However, clinically significant interactions do exist, and healthcare providers must review all concomitant medications before prescribing. Edoxaban is a substrate of the efflux transporter P-glycoprotein (P-gp) and is metabolised to a minor extent by cytochrome P450 3A4 (CYP3A4). These pathways represent the main mechanisms through which drug interactions can alter edoxaban exposure and effect.
The pharmacokinetic interactions are primarily mediated through P-gp inhibition or induction. P-gp inhibitors increase edoxaban plasma concentrations, potentially increasing the risk of bleeding. Conversely, P-gp inducers decrease edoxaban levels, potentially reducing its anticoagulant efficacy and increasing the risk of thromboembolic events. The pharmacodynamic interactions arise from the concurrent use of medications that independently affect haemostasis.
Major Interactions
| Drug/Class | Interaction Type | Clinical Significance | Recommended Action |
|---|---|---|---|
| Ciclosporin | P-gp inhibitor | Increases edoxaban exposure by ~73% | Reduce edoxaban dose to 30 mg (or 15 mg if already on reduced dose) |
| Dronedarone | P-gp inhibitor | Increases edoxaban exposure by ~85% | Reduce edoxaban dose to 30 mg (or 15 mg if already on reduced dose) |
| Erythromycin | P-gp inhibitor | Increases edoxaban exposure by ~85% | Reduce edoxaban dose to 30 mg (or 15 mg if already on reduced dose) |
| Ketoconazole | P-gp inhibitor + CYP3A4 inhibitor | Increases edoxaban exposure by ~87% | Reduce edoxaban dose to 30 mg (or 15 mg if already on reduced dose) |
| Rifampicin | P-gp inducer | Decreases edoxaban exposure by ~34%; may reduce efficacy | Avoid concomitant use; consider alternative anticoagulation |
| Warfarin / other anticoagulants | Pharmacodynamic (additive) | Markedly increased bleeding risk | Contraindicated; do not combine except during switching periods |
| Aspirin (high dose) / Antiplatelets | Pharmacodynamic (additive) | Significantly increased bleeding risk | Use with extreme caution; assess risk-benefit individually |
Minor Interactions
| Drug/Class | Effect | Clinical Guidance |
|---|---|---|
| Verapamil | Increases edoxaban exposure by ~53% | No dose adjustment needed; monitor clinically |
| Quinidine | Increases edoxaban exposure by ~77% | No dose adjustment per SmPC; monitor for bleeding |
| Amiodarone | Increases edoxaban exposure by ~40% | No dose adjustment needed |
| Phenytoin / Carbamazepine | May decrease edoxaban exposure (P-gp induction) | Concomitant use not recommended; monitor if unavoidable |
| SSRIs / SNRIs | May increase bleeding risk (pharmacodynamic) | Monitor for signs of bleeding; no dose change |
| NSAIDs (ibuprofen, naproxen) | Increased risk of gastrointestinal bleeding | Use short-term if necessary; avoid long-term concurrent use |
| Proton pump inhibitors | No clinically relevant interaction | No dose adjustment needed |
| Digoxin | No clinically relevant interaction | No dose adjustment needed |
| Atorvastatin | No clinically relevant interaction | No dose adjustment needed |
Food does not significantly affect the absorption of edoxaban and the tablet can be taken with or without food. Grapefruit juice does not have a clinically relevant effect on edoxaban pharmacokinetics. Alcohol does not directly interact with edoxaban pharmacokinetics; however, excessive alcohol consumption can increase bleeding risk and impair liver function. Patients should be advised to drink alcohol in moderation while on anticoagulant therapy.
What Is the Correct Dosage of Edoxaban Hexal?
The standard dose of edoxaban is 60 mg once daily. The dose is reduced to 30 mg once daily for patients with moderate renal impairment (CrCl 15–50 mL/min), low body weight (≤60 kg), or concomitant use of specific P-gp inhibitors. The 15 mg tablet facilitates dose adjustments. Edoxaban should be taken at the same time each day, with or without food.
Correct dosing of Edoxaban Hexal is essential for balancing the prevention of thromboembolic events against the risk of bleeding. The dose must be individualised based on the patient's clinical characteristics, and healthcare providers should regularly reassess the appropriateness of the dose, particularly when there are changes in renal function, body weight, or concomitant medications. The 15 mg tablet strength is designed to enable appropriate dose adjustments and facilitate transitioning between doses.
Adults
| Indication | Standard Dose | Reduced Dose | Dose Reduction Criteria |
|---|---|---|---|
| Stroke prevention in NVAF | 60 mg once daily | 30 mg once daily | CrCl 15–50 mL/min, body weight ≤60 kg, or concomitant P-gp inhibitors (ciclosporin, dronedarone, erythromycin, ketoconazole) |
| Treatment of DVT/PE | 60 mg once daily (after ≥5 days parenteral anticoagulation) | 30 mg once daily | Same criteria as above |
| VTE prevention (recurrence) | 60 mg once daily | 30 mg once daily | Same criteria; duration based on individual risk assessment |
Children
Edoxaban Hexal is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of edoxaban in the paediatric population have not been established. There are currently no data available from clinical trials in this age group. Alternative anticoagulants with established paediatric dosing should be used for children who require anticoagulation therapy.
Elderly
No dose adjustment is required based on age alone for elderly patients. 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 the ENGAGE AF-TIMI 48 trial, patients aged 75 years and older showed consistent efficacy and safety with edoxaban compared to the overall study population. Healthcare providers should monitor renal function regularly in elderly patients, as age-related decline in kidney function may necessitate dose adjustment over time.
Missed Dose
If you forget to take your dose of Edoxaban Hexal, the following guidance applies:
- If you remember on the same day: Take the missed dose as soon as you remember, then continue with your normal schedule the next day
- If you do not remember until the next day: Skip the missed dose entirely and take your next scheduled dose at the usual time
- Never take a double dose to compensate for a missed dose, as this significantly increases the risk of bleeding
- If you frequently forget doses, consider setting a daily alarm or using a pill organiser to help maintain adherence
Overdose
Overdose of edoxaban increases the risk of bleeding. There is no specific antidote for edoxaban, although andexanet alfa (a recombinant modified factor Xa protein) has been approved in some regions for the reversal of factor Xa inhibitor-related life-threatening bleeding. In the event of an overdose, supportive measures should be taken:
- Activated charcoal: If administered within 2 hours of ingestion, activated charcoal can reduce the absorption of edoxaban
- Prothrombin complex concentrate (PCC): 4-factor PCC (50 IU/kg) may be considered to reverse anticoagulant effects in cases of serious bleeding
- Andexanet alfa: A specific reversal agent for factor Xa inhibitors, approved in some countries for life-threatening or uncontrolled bleeding
- Haemodialysis: Edoxaban is not effectively removed by haemodialysis due to its protein binding (~55%) and large volume of distribution
- Supportive care: Maintain adequate haemostasis through local pressure, surgical intervention, blood product replacement, and haemodynamic support as needed
If you suspect an overdose or experience severe, uncontrolled bleeding (such as blood in urine or stool, persistent nosebleeds, vomiting blood, or unusual bruising), seek emergency medical attention immediately. Do not wait for symptoms to resolve on their own.
What Are the Side Effects of Edoxaban Hexal?
The most common side effects of edoxaban are related to bleeding, including skin and soft tissue bleeding, nosebleeds (epistaxis), and gastrointestinal bleeding. Other side effects include rash, abnormal liver function tests, and dizziness. Serious but rare adverse effects include intracranial haemorrhage and severe allergic reactions.
As an anticoagulant, edoxaban's primary adverse effects are naturally related to its pharmacological action of inhibiting blood clotting. The safety profile of edoxaban has been extensively characterised through large-scale clinical trials involving over 21,000 patients (ENGAGE AF-TIMI 48) and over 8,200 patients (Hokusai-VTE). In the ENGAGE AF-TIMI 48 trial, the overall incidence of major bleeding was significantly lower with edoxaban (2.75% per year) compared to warfarin (3.43% per year). The frequency categories below are based on pooled data from these pivotal clinical trials.
Bleeding can occur at any site during treatment with edoxaban. Patients should be aware of the signs and symptoms of bleeding and should contact their healthcare provider promptly if they notice any unusual bleeding or bruising. It is important to understand that while bleeding is the most significant risk, most bleeding events are mild to moderate in severity and manageable with appropriate medical care.
Very Common (affects more than 1 in 10 patients)
- Cutaneous soft tissue bleeding (bruising, skin haemorrhage)
Common (affects 1 to 10 in 100 patients)
- Epistaxis (nosebleeds)
- Lower gastrointestinal bleeding (rectal bleeding, melaena)
- Upper gastrointestinal bleeding (gum bleeding, haematemesis)
- Oral/pharyngeal bleeding (mouth bleeding)
- Microscopic haematuria (blood in urine on testing)
- Vaginal bleeding (menorrhagia, metrorrhagia)
- Anaemia
- Rash and pruritus (itching)
- Abnormal liver function tests (elevated transaminases, bilirubin, gamma-GT)
- Dizziness
- Headache
- Abdominal pain
- Nausea
Uncommon (affects 1 to 10 in 1,000 patients)
- Macroscopic haematuria (visible blood in urine)
- Surgical site bleeding (post-procedural haemorrhage)
- Intracranial haemorrhage (bleeding in the brain)
- Conjunctival/scleral haemorrhage (eye bleeding)
- Intra-articular bleeding (bleeding into joints)
- Allergic reactions (urticaria, allergic oedema)
- Elevated blood bilirubin
- Thrombocytopenia (low platelet count)
Rare (affects fewer than 1 in 1,000 patients)
- Anaphylactic reaction / anaphylactic shock
- Subarachnoid haemorrhage
- Pericardial haemorrhage (bleeding around the heart)
- Retroperitoneal haemorrhage
- Muscle haemorrhage (intramuscular bleeding)
- Adrenal bleeding
Contact your doctor or go to the nearest emergency department immediately if you experience: signs of serious bleeding such as coughing up blood, vomiting blood or material that looks like coffee grounds, blood in the urine (red or dark brown), black tarry stools, severe or unexplained bruising, prolonged or uncontrolled bleeding from any site, sudden severe headache with no known cause, signs of stroke (weakness on one side, difficulty speaking, vision changes), or signs of a severe allergic reaction (swelling of face/throat, difficulty breathing, widespread rash).
How Should You Store Edoxaban Hexal?
Store Edoxaban Hexal at room temperature below 30°C in its 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 Hexal ensures the medication remains effective and safe throughout its shelf life. The film-coated tablets should be stored in their original blister packaging until ready to take, as this protects them from moisture and light that could degrade the active ingredient. There are no special temperature requirements beyond normal room storage — the tablets do not need refrigeration.
You should store this medication at temperatures not exceeding 30°C (86°F). Avoid exposing the tablets to excessive heat, direct sunlight, or humid environments such as bathrooms. The original packaging (blister pack within the outer carton) provides adequate protection when stored correctly. Always check the expiry date on the packaging before use — the expiry date refers to the last day of that month. Do not use the medicine if the packaging appears damaged, open, or tampered with.
As with all medications, keep Edoxaban Hexal out of the sight and reach of children. Store it in a secure location, as accidental ingestion of an anticoagulant by a child can cause serious bleeding complications requiring immediate emergency treatment. Do not dispose of unused or expired medications via household waste or down the drain. Return them to your pharmacy for safe disposal in accordance with local regulations to help protect the environment.
What Does Edoxaban Hexal Contain?
Each Edoxaban Hexal 15 mg film-coated tablet contains edoxaban tosilate tosilate hydrate equivalent to 15 mg of edoxaban as the active ingredient, plus several inactive excipients in the tablet core and film coating.
Understanding the composition of your medication is important, particularly if you have known allergies to specific excipients or dietary restrictions. Edoxaban Hexal 15 mg film-coated tablets contain the following ingredients:
Active substance: Each film-coated tablet contains edoxaban tosilate tosilate hydrate, equivalent to 15 mg of edoxaban free base. Edoxaban tosilate is the salt form used in the pharmaceutical formulation to optimise the drug's stability, solubility, and bioavailability.
Tablet core excipients: The inactive ingredients in the tablet core typically include mannitol (E421), pregelatinised starch, crospovidone, hydroxypropylcellulose, magnesium stearate (E470b), and sodium laurilsulfate. These excipients serve various pharmaceutical functions including acting as fillers, binders, disintegrants, and lubricants to ensure consistent tablet quality and drug release.
Film coating: The tablet film coating contains hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc, carnauba wax, and iron oxide red (E172) and/or iron oxide yellow (E172) depending on the tablet strength. The film coating provides protection, aids swallowing, and enables identification of different tablet strengths by colour.
Edoxaban Hexal tablets contain mannitol as a filler and are generally lactose-free. They do not contain gluten. However, patients with specific allergies or intolerances should review the complete excipient list with their pharmacist, as formulations may vary slightly between manufacturers and markets. Always refer to the patient information leaflet supplied with your specific medication.
Frequently Asked Questions About Edoxaban Hexal
Edoxaban Hexal is a direct oral anticoagulant (DOAC) used to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF) who have one or more risk factors, and to treat and prevent recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE). The 15 mg dose is typically used as a reduced dose for patients with specific risk factors such as moderate renal impairment, low body weight, or concurrent P-glycoprotein inhibitor use.
Yes, Edoxaban Hexal can be taken with or without food. Food does not significantly affect the absorption or efficacy of edoxaban. The tablet should be swallowed whole with water. It is recommended to take it at approximately the same time each day to maintain consistent drug levels in the blood.
If you miss a dose, take it as soon as you remember on the same day. If you cannot take it on the same day, skip the missed dose and take the next dose at the usual scheduled time the following day. Do not take a double dose to make up for a forgotten dose, as this increases the risk of bleeding. If you are unsure, contact your pharmacist or doctor.
There is no specific antidote for edoxaban, but andexanet alfa (Andexxa/Ondexxya) has been approved in some regions as a reversal agent for factor Xa inhibitors in cases of life-threatening or uncontrolled bleeding. Prothrombin complex concentrate (PCC) may also be used. Activated charcoal can reduce absorption if given within 2 hours of ingestion. In emergency situations, the treating team will determine the most appropriate reversal strategy.
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. Unlike warfarin, edoxaban does not require routine INR monitoring, has fewer food and drug interactions, and has a more predictable pharmacokinetic profile with fixed dosing. However, warfarin remains the preferred choice for patients with mechanical heart valves or antiphospholipid syndrome.
Moderate alcohol consumption does not directly interact with edoxaban. However, excessive alcohol intake can increase the risk of bleeding (as alcohol itself affects platelet function and can damage the stomach lining) and can impair liver function, which may affect drug metabolism. It is advisable to limit alcohol consumption to moderate levels while on anticoagulant therapy and to discuss your alcohol habits with your prescribing doctor.
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. New England Journal of Medicine. 2013;369(22):2093-2104. doi:10.1056/NEJMoa1310907 (ENGAGE AF-TIMI 48 trial)
- The Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. New England Journal of Medicine. 2013;369(15):1406-1415. doi:10.1056/NEJMoa1306638
- European Medicines Agency. Lixiana (edoxaban) — Summary of Product Characteristics. EMA/CHMP. Last updated 2024.
- Van Es N, Coppens M, Schulman S, et al. Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials. Blood. 2014;124(12):1968-1975.
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation. European Heart Journal. 2021;42(5):373-498. (Updated 2024)
- National Institute for Health and Care Excellence (NICE). Edoxaban for treating and for preventing deep vein thrombosis and pulmonary embolism. Technology appraisal guidance [TA354]. 2015.
- National Institute for Health and Care Excellence (NICE). Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation. Technology appraisal guidance [TA355]. 2015.
- 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. The Lancet. 2014;383(9921):955-962.
- Connolly SJ, Crowther M, Eikelboom JW, et al. Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. New England Journal of Medicine. 2019;380(14):1326-1335.
- World Health Organization. WHO Model List of Essential Medicines — 23rd List. 2023.
Editorial Team
This article has been written, reviewed, and approved by the iMedic Medical Editorial Team — a group of licensed specialist physicians, clinical pharmacologists, and medical writers with expertise in anticoagulation therapy and cardiovascular medicine.
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