Edoxaban Teva GmbH: Uses, Dosage & Side Effects
Direct oral anticoagulant (DOAC) – selective factor Xa inhibitor for stroke prevention and blood clot treatment
Quick facts about Edoxaban Teva GmbH
Key Takeaways
- Edoxaban Teva GmbH is a generic direct oral anticoagulant (DOAC) containing edoxaban, which prevents blood clots by selectively blocking factor Xa in the coagulation cascade.
- 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 is dosed once daily, does not require routine INR monitoring, and has fewer food and drug interactions.
- The 15 mg strength is the lowest available dose, used for patients meeting specific criteria for dose reduction such as renal impairment (CrCl 15–50 mL/min), low body weight (≤60 kg), or concomitant use of certain P-gp inhibitors.
- Andexanet alfa is an approved specific reversal agent for edoxaban in cases of life-threatening bleeding, though its relatively short half-life (10–14 hours) means effects diminish within 1–2 days of the last dose.
What Is Edoxaban Teva GmbH and What Is It Used For?
Quick Answer: Edoxaban Teva GmbH is a generic direct oral anticoagulant (DOAC) containing edoxaban, a selective 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 dose strength, typically prescribed for patients requiring dose reduction.
Edoxaban is a prescription anticoagulant medication that works by selectively and reversibly inhibiting factor Xa, a serine protease that occupies a pivotal position in the blood coagulation cascade. Factor Xa sits at the convergence of the intrinsic and extrinsic coagulation pathways, catalysing the conversion of prothrombin to thrombin. By blocking factor Xa, edoxaban effectively reduces thrombin generation and, consequently, the formation of blood clots (thrombi). This mechanism provides reliable anticoagulation with a more predictable pharmacological profile compared to vitamin K antagonists such as warfarin.
Edoxaban was originally developed by Daiichi Sankyo and first 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 the same year. Edoxaban Teva GmbH is a generic version manufactured by Teva Pharmaceutical Industries, one of the world’s largest generic medicine companies. Generic versions contain the same active ingredient and have demonstrated bioequivalence to the originator product, ensuring the same clinical efficacy and safety profile.
Edoxaban belongs to the family of direct oral anticoagulants (DOACs), also referred to as novel oral anticoagulants (NOACs). This group includes apixaban, rivaroxaban, and dabigatran. DOACs have become the first-line oral anticoagulants for many conditions, largely replacing warfarin due to their more predictable pharmacokinetics, reduced monitoring requirements, and improved safety profiles in clinical trials. Among the DOACs, edoxaban is notable for its once-daily dosing schedule, which may improve patient adherence compared to agents requiring twice-daily administration.
Approved Indications
Edoxaban is approved for the following clinical indications across major regulatory agencies (EMA, FDA, and other national authorities):
- 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, diabetes mellitus, or prior stroke or transient ischaemic attack (TIA). Importantly, edoxaban should only be used in patients with NVAF once adequate anticoagulation with a parenteral anticoagulant has been established for at least 5 days, or in patients already receiving an oral anticoagulant.
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, following initial treatment with a parenteral anticoagulant administered for at least 5 days.
A critical consideration specific to edoxaban is the relationship between renal function and efficacy. In the ENGAGE AF-TIMI 48 trial, edoxaban appeared to be less effective in patients with a creatinine clearance (CrCl) above 95 mL/min compared to warfarin. For this reason, the EMA states that edoxaban should only be used in patients with NVAF after careful evaluation of the individual thromboembolic and bleeding risk, and the FDA contraindicates edoxaban in patients with CrCl >95 mL/min. This is a unique characteristic among DOACs that prescribers must consider when selecting an appropriate anticoagulant.
Mechanism of Action
Edoxaban is a highly selective, direct and reversible inhibitor of factor Xa, active both on free factor Xa and on factor Xa within the prothrombinase complex. Unlike heparin-based anticoagulants, edoxaban does not require antithrombin III as a cofactor for its anticoagulant activity. By inhibiting factor Xa, edoxaban reduces the generation of thrombin, which is the final effector enzyme in the coagulation cascade responsible for converting fibrinogen to fibrin, the structural component of blood clots.
Edoxaban inhibits factor Xa in a concentration-dependent manner, with a rapid onset of action. Peak plasma concentrations are reached within 1–2 hours after oral administration, and the anticoagulant effect correlates closely with plasma drug levels. The elimination half-life is approximately 10–14 hours, supporting once-daily dosing. Approximately 50% of the absorbed dose is eliminated renally, which is a higher proportion than apixaban (approximately 27%) and explains why renal function has a greater impact on edoxaban’s pharmacokinetics and dosing.
Edoxaban also has minimal effects on platelet aggregation and does not prolong bleeding time when used as monotherapy. However, when combined with antiplatelet agents such as aspirin or clopidogrel, the risk of bleeding is significantly increased, which is an important consideration in clinical practice, particularly in patients with recent acute coronary syndrome or coronary stent implantation.
The 15 mg tablet is the lowest available strength of edoxaban. The standard recommended dose for most indications is 60 mg once daily, with a reduced dose of 30 mg once daily for patients meeting specific criteria. The 15 mg dose may be used in particular clinical circumstances as determined by the prescribing physician, particularly when further dose reduction is warranted. Edoxaban is available in 15 mg, 30 mg, and 60 mg film-coated tablets.
What Should You Know Before Taking Edoxaban Teva GmbH?
Quick Answer: Before starting edoxaban, your doctor will assess your kidney function, body weight, bleeding risk, and other medications. Edoxaban is contraindicated in active clinically significant bleeding, severe liver disease, uncontrolled severe hypertension, and in patients with prosthetic heart valves. Dose adjustments are required based on renal function, body weight, and concomitant medications.
Before prescribing edoxaban, your healthcare provider will conduct a comprehensive assessment of your medical history, current medications, and overall health status. Anticoagulant therapy inherently involves balancing the benefit of preventing potentially life-threatening blood clots against the risk of bleeding. Several patient-specific factors can influence this balance and determine whether edoxaban is the most appropriate choice, and at what dose.
Renal function assessment is particularly important for edoxaban because approximately 50% of the drug is eliminated through the kidneys. Changes in kidney function can significantly alter drug levels and, consequently, both the efficacy and safety of treatment. Your doctor will typically measure your creatinine clearance (CrCl) before initiating therapy and monitor it periodically, especially in elderly patients or those with conditions that may affect kidney function over time.
Contraindications
Edoxaban 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.
- Hypersensitivity: Known allergy to edoxaban or any of the excipients in the formulation.
- Severe hepatic disease: Liver disease associated with coagulopathy and clinically relevant bleeding risk.
- Uncontrolled severe arterial hypertension: Significantly elevated blood pressure that has not been adequately controlled with treatment.
- 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, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities.
- Prosthetic heart valves: Edoxaban has not been studied and is not recommended for patients with mechanical heart valves requiring anticoagulation.
- Concomitant treatment with other anticoagulants: Except when transitioning between anticoagulant agents or when unfractionated heparin is used at doses necessary to maintain a patent central venous or arterial catheter.
Premature discontinuation of edoxaban without switching to an alternative anticoagulant significantly increases the risk of ischaemic events, including stroke. Patients with atrial fibrillation who stop anticoagulation therapy without adequate bridging are at substantially elevated risk of thromboembolic complications. Never stop taking edoxaban without consulting your prescriber, who will provide specific guidance on transitioning to another anticoagulant if necessary.
Warnings and Precautions
Special caution is required when using edoxaban in the following situations:
- Increased bleeding risk: Conditions that predispose to bleeding include thrombocytopenia, recent biopsy or major trauma, bacterial endocarditis, active peptic ulcer disease, or gastrointestinal disorders associated with erosion. Concomitant use of antiplatelet agents, other anticoagulants, fibrinolytic agents, or chronic NSAID use significantly increases bleeding risk.
- Renal impairment: Dose reduction to 30 mg once daily is required for patients with moderate or severe renal impairment (CrCl 15–50 mL/min). In patients with CrCl below 15 mL/min, edoxaban is not recommended due to very limited clinical data. In patients with NVAF and CrCl >95 mL/min, edoxaban should be used only after careful evaluation because efficacy may be reduced.
- Hepatic impairment: Edoxaban is not recommended in patients with severe hepatic impairment. It can be used with caution in mild to moderate hepatic impairment (Child-Pugh A or B), though patients with elevated liver enzymes (ALT/AST >2× ULN or total bilirubin ≥1.5× ULN) were excluded from clinical trials.
- Low body weight: Patients weighing 60 kg or less require dose reduction to 30 mg once daily due to increased drug exposure.
- Spinal or epidural anaesthesia: Patients receiving neuraxial anaesthesia or undergoing spinal/epidural puncture are at risk of developing epidural or spinal haematoma. Specific timing guidelines for withholding and restarting edoxaban around these procedures must be followed meticulously.
- Haemodynamically unstable PE: Edoxaban has not been evaluated in patients with pulmonary embolism who are haemodynamically unstable or who may receive thrombolysis or pulmonary embolectomy. It should not be used as an alternative to unfractionated heparin in these critically ill patients.
Pregnancy and Breastfeeding
There are very limited data on the use of edoxaban during pregnancy. Animal reproductive studies have shown evidence of adverse effects on pregnancy and embryo-foetal development, including increased spontaneous abortions and changes in offspring growth at doses that were clinically relevant. Edoxaban is not recommended during pregnancy. Women of childbearing potential should use effective contraception while taking edoxaban and should discuss family planning with their prescriber.
It is not known whether edoxaban or its metabolites are excreted in human breast milk. Animal studies have demonstrated that edoxaban is secreted in breast milk. A risk to the newborn or infant cannot be excluded. Breastfeeding should be discontinued during treatment with edoxaban. 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 therapy for the mother.
The standard dose of edoxaban is 60 mg once daily. Dose reduction to 30 mg once daily is required if any one of the following factors is present: creatinine clearance 15–50 mL/min, body weight ≤60 kg, or concomitant use of certain P-glycoprotein (P-gp) inhibitors (ciclosporin, dronedarone, erythromycin, or ketoconazole). This contrasts with apixaban, where at least two of three criteria must be met for dose reduction in atrial fibrillation.
How Does Edoxaban Teva GmbH Interact with Other Drugs?
Quick Answer: Edoxaban is primarily eliminated by P-glycoprotein (P-gp) and, to a lesser extent, by CYP3A4 metabolism. P-gp inhibitors such as ketoconazole, ciclosporin, dronedarone, and erythromycin increase edoxaban levels and require dose reduction. P-gp inducers such as rifampicin may decrease edoxaban efficacy. Concomitant use of other anticoagulants, antiplatelet agents, and NSAIDs increases bleeding risk.
Drug interactions with edoxaban are primarily mediated through the P-glycoprotein (P-gp) drug transporter system. Edoxaban is a substrate of P-gp, and drugs that inhibit or induce this transporter can significantly alter edoxaban plasma levels. Unlike some other DOACs, edoxaban undergoes minimal hepatic metabolism via CYP3A4 (<4% of total elimination), meaning that CYP3A4 inhibitors and inducers generally have a lesser impact on edoxaban levels compared to their effect on apixaban or rivaroxaban.
It is essential to inform your prescriber about all medications you are taking, including prescription drugs, over-the-counter medicines, herbal supplements, and vitamins. While edoxaban has a more limited drug interaction profile than warfarin, certain combinations can be clinically significant and may require dose adjustments, enhanced monitoring, or avoidance of the combination altogether.
Major Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Ciclosporin (Cyclosporine) | Strong P-gp inhibitor; increases edoxaban AUC by approximately 73% | Reduce edoxaban dose to 30 mg once daily |
| Dronedarone | P-gp inhibitor; increases edoxaban AUC by approximately 85% | Reduce edoxaban dose to 30 mg once daily |
| Ketoconazole | Strong P-gp inhibitor and CYP3A4 inhibitor; increases edoxaban AUC by approximately 87% | Reduce edoxaban dose to 30 mg once daily |
| Erythromycin | P-gp inhibitor; increases edoxaban AUC by approximately 85% | Reduce edoxaban dose to 30 mg once daily |
| Rifampicin | Strong P-gp inducer; decreases edoxaban AUC by approximately 34% | Avoid concomitant use; reduced edoxaban efficacy |
| Phenytoin, carbamazepine, phenobarbital | P-gp inducers; expected to decrease edoxaban levels | Avoid concomitant use |
| St John’s Wort (Hypericum perforatum) | P-gp inducer; may decrease edoxaban levels | Avoid concomitant use |
| Other anticoagulants (heparin, warfarin, enoxaparin) | Additive anticoagulant effect; markedly increased bleeding risk | Avoid concomitant use except during transition between agents |
Minor Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Verapamil, quinidine | P-gp inhibitors; modest increase in edoxaban levels (approximately 29–53%) | No dose adjustment required; monitor for signs of bleeding |
| Amiodarone | P-gp inhibitor; modest increase in edoxaban levels (approximately 40%) | No dose adjustment required; clinical monitoring recommended |
| Aspirin (low-dose) | No pharmacokinetic interaction; increased bleeding risk due to additive antiplatelet effect | Use with caution; monitor for signs of bleeding. Consider the necessity of dual therapy |
| NSAIDs (ibuprofen, naproxen, diclofenac) | No pharmacokinetic interaction; increased gastrointestinal bleeding risk | Avoid chronic use; use short courses only if essential with enhanced monitoring |
| Proton pump inhibitors (omeprazole) | Minimal effect on edoxaban absorption | No dose adjustment required; can be co-administered safely |
| Digoxin | Both P-gp substrates; no clinically significant interaction | No dose adjustment required |
A notable advantage of edoxaban over warfarin is the absence of dietary interactions. Edoxaban’s efficacy is not affected by vitamin K intake, and there are no food restrictions while taking this medication. Edoxaban can be taken with or without food, as food does not significantly affect its bioavailability. This is a meaningful benefit for patients who found the dietary restrictions associated with warfarin therapy burdensome.
What Is the Correct Dosage of Edoxaban Teva GmbH?
Quick Answer: The standard dose of edoxaban is 60 mg once daily. Dose reduction to 30 mg once daily is required for patients with CrCl 15–50 mL/min, body weight ≤60 kg, or concomitant use of certain P-gp inhibitors. The 15 mg tablet may be used in specific clinical circumstances. Edoxaban for DVT/PE must be initiated after at least 5 days of parenteral anticoagulation.
Edoxaban dosing is relatively straightforward compared to warfarin, with a fixed once-daily regimen. However, accurate dose selection depends on careful assessment of the patient’s renal function, body weight, and concomitant medications. The 15 mg tablet manufactured by Teva GmbH represents the lowest available strength and is typically used in patients requiring further dose reduction or in specific clinical scenarios determined by the prescribing physician.
Adults
| Indication | Standard Dose | Reduced Dose | Notes |
|---|---|---|---|
| Atrial fibrillation (NVAF) | 60 mg once daily | 30 mg once daily | Reduce if CrCl 15–50 mL/min, weight ≤60 kg, or concomitant P-gp inhibitors. Not recommended if CrCl >95 mL/min (EMA) or contraindicated (FDA) |
| Treatment of DVT/PE | 60 mg once daily | 30 mg once daily | Must follow at least 5 days of parenteral anticoagulation (e.g. LMWH or UFH). Same dose reduction criteria apply |
| Prevention of recurrent VTE | 60 mg once daily | 30 mg once daily | Duration based on individual risk-benefit assessment. Same dose reduction criteria apply |
Children
Edoxaban 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 through adequately powered clinical trials. Anticoagulation in children is managed through different protocols, typically involving low-molecular-weight heparins, unfractionated heparin, or warfarin under specialist paediatric haematology guidance. Research into paediatric DOAC use is ongoing, and future developments may expand the evidence base for edoxaban in younger patients.
Elderly
No dose adjustment based solely on age is required for edoxaban. However, elderly patients often have multiple risk factors that individually warrant dose reduction, including declining renal function (CrCl 15–50 mL/min), lower body weight, and polypharmacy that may include P-gp inhibitors. In practice, a significant proportion of elderly patients will require the reduced 30 mg once-daily dose based on these clinical characteristics. Regular reassessment of renal function is recommended, as age-related renal decline can progress and affect drug clearance over time.
The ENGAGE AF-TIMI 48 trial included a substantial proportion of elderly patients (approximately 40% were aged 75 years or older), and the safety and efficacy of edoxaban were consistent across age subgroups. The reduction in intracranial haemorrhage compared to warfarin was particularly notable in elderly patients, for whom this complication carries an especially poor prognosis.
Missed Dose
If you miss a dose of edoxaban, take the missed dose as soon as you remember on the same day. Then continue with your normal dosing schedule the following day. Do not take a double dose to make up for a forgotten dose, as this significantly increases the risk of bleeding. If you are unable to remember whether you have taken your daily dose, do not take an additional tablet; simply take your next scheduled dose at the usual time.
Given that edoxaban has a half-life of 10–14 hours, missing a single dose will result in reduced anticoagulant protection that may persist for approximately 24 hours. While a single missed dose is unlikely to cause a thromboembolic event, consistently missed doses can substantially reduce the protective effect of anticoagulation therapy. If you frequently forget to take your medication, discuss adherence strategies with your healthcare provider, such as using a pill organiser, setting daily reminders, or linking the dose to a consistent daily routine.
Overdose
Overdose with edoxaban increases the risk of bleeding. There is no specific widely available antidote for edoxaban overdose, although andexanet alfa (Andexxa/Ondexxya) has been approved as a reversal agent for factor Xa inhibitors in the context of life-threatening or uncontrolled bleeding. In the event of overdose, management is primarily supportive, including discontinuation of the drug, application of mechanical compression where applicable, and consideration of activated charcoal if ingestion was recent (within 2 hours).
Edoxaban is not significantly removed by haemodialysis (approximately 9% clearance over a 4-hour session). In cases of severe bleeding, the administration of 4-factor prothrombin complex concentrate (4F-PCC) may be considered to restore coagulation, although evidence for this approach is largely based on laboratory studies and clinical experience rather than randomised controlled trials. Close monitoring in a hospital setting with serial assessment of haematological parameters and haemodynamic status is essential in all suspected overdose cases.
If you experience severe or uncontrollable bleeding while taking edoxaban (such as heavy bleeding that does not stop, vomiting blood, blood in urine or stool, or signs of intracranial bleeding including sudden severe headache, confusion, or weakness), seek emergency medical attention immediately. Do not wait for the next dose time. Inform emergency personnel that you are taking an anticoagulant.
What Are the Side Effects of Edoxaban Teva GmbH?
Quick Answer: The most common side effects of edoxaban are bleeding-related events, including skin and soft tissue bleeding, nosebleeds, and gastrointestinal bleeding. Common non-bleeding side effects include rash, abnormal liver function tests, and anaemia. Serious but rare side effects include intracranial haemorrhage and severe allergic reactions. Report any unusual bleeding to your doctor immediately.
Like all anticoagulant medications, the principal adverse effect of edoxaban is an increased risk of bleeding. The nature and severity of bleeding events can range from minor (such as bruising or small nosebleeds) to serious and potentially life-threatening (such as gastrointestinal haemorrhage or intracranial bleeding). The overall bleeding risk with edoxaban has been shown to be lower than with warfarin in the major clinical trials, particularly for intracranial haemorrhage, which is the most feared complication of anticoagulant therapy.
In the ENGAGE AF-TIMI 48 trial, the annualised rate of major bleeding with edoxaban 60 mg was 2.75% compared to 3.43% with warfarin (hazard ratio 0.80, p <0.001 for superiority). The rate of intracranial haemorrhage was 0.39% with edoxaban compared to 0.85% with warfarin, representing a 53% relative risk reduction. However, gastrointestinal bleeding was slightly more frequent with the higher dose of edoxaban compared to warfarin.
Very Common Side Effects
Affects more than 1 in 10 people
- Cutaneous soft tissue bleeding (bruising, skin haematomas, petechiae, ecchymosis)
Common Side Effects
Affects 1 in 10 to 1 in 100 people
- Epistaxis (nosebleeds)
- Gastrointestinal bleeding (upper and lower GI tract, rectal bleeding, gingival/oral bleeding)
- Vaginal/urogenital bleeding (menorrhagia, haematuria)
- Anaemia
- Rash and pruritus (itching)
- Abnormal liver function tests (elevated bilirubin, gamma-GT)
- Haemorrhage at puncture or injection sites
- Dizziness
- Headache
- Abdominal pain
- Nausea
Uncommon Side Effects
Affects 1 in 100 to 1 in 1,000 people
- Intracranial haemorrhage (including intracerebral, subdural, and subarachnoid)
- Surgical site haemorrhage
- Haemoptysis (coughing up blood)
- Intraocular haemorrhage (bleeding in the eye)
- Allergic reactions (urticaria, allergic oedema)
- Elevated liver enzymes (AST, ALT, alkaline phosphatase)
- Thrombocytopenia (low platelet count)
Rare Side Effects
Affects fewer than 1 in 1,000 people
- Anaphylactic reactions
- Pericardial haemorrhage (bleeding around the heart)
- Retroperitoneal haemorrhage
- Muscle haemorrhage (intramuscular bleeding)
- Intra-articular haemorrhage (bleeding into joints)
- Adrenal gland haemorrhage
It is important to understand that while these lists may appear extensive, the majority of patients tolerate edoxaban well, and many of these side effects are uncommon or rare. The decision to use edoxaban is always based on a careful assessment of the balance between the benefits of preventing thromboembolic events and the risks of bleeding. If you experience any unexpected symptoms or signs of bleeding (such as prolonged bleeding from cuts, unusual bruising, blood in urine or stool, or vomiting blood), contact your healthcare provider promptly.
Contact emergency services or go to the nearest emergency department if you experience: sudden severe headache with no known cause, sudden weakness or numbness (especially on one side of the body), sudden vision changes, coughing or vomiting blood, blood in urine (pink or brown colour) or stool (red or black tar-like), prolonged uncontrollable bleeding from any site, or signs of severe allergic reaction (swelling of face/throat, difficulty breathing, rash with wheezing).
How Should You Store Edoxaban Teva GmbH?
Quick Answer: Store Edoxaban Teva GmbH at room temperature below 30°C (86°F) in the original packaging to protect from moisture. Keep out of reach of children. Do not use after the expiry date printed on the packaging.
Proper storage of medications is essential to maintain their efficacy and safety throughout the shelf life. Edoxaban Teva GmbH film-coated tablets should be stored at room temperature, not exceeding 30°C (86°F). The tablets should be kept in their original blister packaging until the time of use, as this provides protection from moisture and light that could potentially degrade the active ingredient.
Do not store edoxaban in the bathroom or near a sink, as humidity and temperature fluctuations in these environments can affect medication stability. Avoid exposing the tablets to direct sunlight or extreme heat, such as leaving them in a car during warm weather. If you use a weekly pill organiser, ensure that the tablets are stored in a cool, dry location and used within a reasonable timeframe.
Keep all medications out of the sight and reach of children, as accidental ingestion of an anticoagulant by a child could be extremely dangerous. Do not use Edoxaban Teva GmbH after the expiry date shown on the carton and blister pack. The expiry date refers to the last day of that month. If you have any unused or expired medication, do not dispose of it via household waste or down the drain. Return unused medicines to your pharmacist for proper disposal in accordance with local regulations.
What Does Edoxaban Teva GmbH Contain?
Quick Answer: Each Edoxaban Teva GmbH 15 mg film-coated tablet contains edoxaban tosilate tosilate monohydrate as the active ingredient, equivalent to 15 mg of edoxaban. The tablets also contain inactive ingredients (excipients) that aid in manufacturing, stability, and absorption.
The active ingredient in Edoxaban Teva GmbH is edoxaban tosilate tosilate monohydrate. Each 15 mg film-coated tablet contains edoxaban tosilate tosilate monohydrate equivalent to 15 mg of edoxaban free base. Edoxaban tosilate tosilate monohydrate is a white to off-white crystalline powder that is slightly soluble in water. The tosilate salt form was selected to provide optimal pharmaceutical properties, including adequate solubility for oral absorption and chemical stability during storage.
The inactive ingredients (excipients) in the tablet core typically include mannitol, pregelatinised starch, crospovidone, hydroxypropyl cellulose, and magnesium stearate. The film coating typically contains hypromellose, macrogol, titanium dioxide, talc, and iron oxide pigments that give the tablet its distinctive colour. These excipients serve important pharmaceutical functions: mannitol acts as a diluent, crospovidone as a disintegrant to help the tablet break down in the gastrointestinal tract, and magnesium stearate as a lubricant during the manufacturing process.
Patients with known allergies or intolerances to any excipients should review the full list of ingredients provided in the patient information leaflet that accompanies each pack. The film-coated tablet formulation is designed for oral administration and should be swallowed whole with water. The tablets can be taken with or without food, as food does not significantly affect the bioavailability of edoxaban.
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
- Hokusai-VTE Investigators, Buller HR, Decousus H, 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
- 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
- Steffel J, Collins R, Antz M, et al. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. Europace. 2021;23(10):1612–1676. doi:10.1093/europace/euab065
- World Health Organization. WHO Model List of Essential Medicines – 23rd List. WHO, 2023.
- 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. doi:10.1007/s40262-015-0342-7
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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