Edoxaban Reddy: Uses, Dosage & Side Effects
Direct oral anticoagulant (Factor Xa inhibitor) - Film-coated tablet
Quick Facts: Edoxaban Reddy
Key Takeaways About Edoxaban Reddy
- Direct oral anticoagulant (DOAC): Edoxaban Reddy selectively inhibits factor Xa to prevent blood clot formation, reducing stroke risk in atrial fibrillation
- 15 mg is a reduced dose: This strength is used for patients with moderate renal impairment (CrCl 15-50 mL/min), body weight ≤60 kg, or concomitant use of certain P-gp inhibitors
- Once-daily dosing: Taken once daily with or without food, making it convenient compared to twice-daily anticoagulants
- Bleeding is the main risk: As with all anticoagulants, the most serious side effect is bleeding; patients should watch for unusual bruising, blood in urine or stools, or prolonged bleeding
- Do not stop without medical advice: Abruptly discontinuing edoxaban in patients with atrial fibrillation increases the risk of stroke and blood clots
What Is Edoxaban Reddy and What Is It Used For?
Edoxaban Reddy is a direct oral anticoagulant (DOAC) that works by inhibiting factor Xa, a key enzyme in the blood clotting process. It is primarily used to prevent stroke in patients with atrial fibrillation and to treat deep vein thrombosis (DVT) and pulmonary embolism (PE).
Edoxaban belongs to the class of direct oral anticoagulants (DOACs), also known as non-vitamin K antagonist oral anticoagulants (NOACs). Unlike older anticoagulants such as warfarin, which work by inhibiting vitamin K-dependent clotting factors, edoxaban directly and selectively inhibits factor Xa. This enzyme plays a critical role in the coagulation cascade, converting prothrombin to thrombin, which is ultimately responsible for forming fibrin clots.
Edoxaban Reddy is manufactured by Dr. Reddy's Laboratories and is a generic equivalent of the originator brand Lixiana (Daiichi Sankyo). The 15 mg tablet strength is specifically designed for patients who require dose reduction due to certain clinical factors. The European Medicines Agency (EMA) has approved edoxaban for two primary indications in adults:
- Prevention of stroke and systemic embolism: In adult patients with nonvalvular atrial fibrillation (NVAF) who have 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 venous thromboembolism (VTE): Including deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, following initial treatment with a parenteral anticoagulant administered for at least 5 days
The ENGAGE AF-TIMI 48 trial, a landmark randomised controlled study involving over 21,000 patients, demonstrated that edoxaban was noninferior to warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation, while causing significantly less bleeding. Similarly, the Hokusai-VTE trial showed edoxaban to be noninferior to warfarin for the treatment of symptomatic venous thromboembolism, with a significantly lower rate of clinically relevant bleeding.
The standard dose of edoxaban is 60 mg once daily. The 15 mg dose is a reduced dose prescribed when certain clinical criteria apply. Your doctor will determine the appropriate dose based on your kidney function, body weight, and other medications you take. The 15 mg dose is specifically used when the standard 30 mg reduced dose needs to be halved further, or during the transition period from parenteral anticoagulation. Never change your dose without consulting your prescriber.
How does edoxaban work in the body?
Edoxaban is a highly selective, direct, and reversible inhibitor of factor Xa. Factor Xa is a serine protease that occupies a pivotal position in the common pathway of the coagulation cascade, where it forms part of the prothrombinase complex that converts prothrombin (factor II) to thrombin (factor IIa). Thrombin, in turn, converts fibrinogen to fibrin and activates platelets, leading to clot formation.
By inhibiting factor Xa, edoxaban reduces thrombin generation and prolongs clotting time. This anticoagulant effect is rapid, with peak plasma concentrations achieved within 1 to 2 hours after oral administration. The drug has a predictable pharmacokinetic profile, with an oral bioavailability of approximately 62% and a terminal elimination half-life of 10 to 14 hours, supporting once-daily dosing. Approximately 50% of the absorbed dose is excreted unchanged by the kidneys, which is why dose adjustment is required in patients with moderate-to-severe renal impairment.
Unlike vitamin K antagonists (such as warfarin), edoxaban does not require routine coagulation monitoring (INR testing) or frequent dose adjustments, and it has fewer food and drug interactions. However, certain medications that affect P-glycoprotein (P-gp) transport can alter edoxaban levels and may necessitate dose adjustment.
What Should You Know Before Taking Edoxaban Reddy?
Before taking Edoxaban Reddy, inform your doctor about all medical conditions, especially kidney or liver disease, bleeding disorders, recent surgery, or if you have artificial heart valves. Edoxaban is not recommended during pregnancy or breastfeeding. Several medications interact with edoxaban and may require dose adjustments.
Edoxaban Reddy is a potent anticoagulant that requires careful medical evaluation before initiation. Your prescribing physician will assess your renal function, bleeding risk, and concomitant medications before starting treatment. It is essential to provide a complete medical history, including any previous episodes of abnormal bleeding, recent surgeries, or planned procedures.
Contraindications
Edoxaban Reddy must not be used in the following situations:
- Active clinically significant bleeding: Including gastrointestinal haemorrhage, intracranial bleeding, or any active pathological bleeding
- Hepatic disease associated with coagulopathy: Liver conditions that lead to clinically relevant bleeding risk
- Lesions or conditions at significant risk of major bleeding: Such as recent brain or spinal injury, recent surgery of the brain, spine, or eye, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities
- Uncontrolled severe hypertension: Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg
- Concomitant treatment with any other anticoagulant agent: Including unfractionated heparin, low-molecular-weight heparins, heparin derivatives, oral anticoagulants (warfarin, dabigatran, apixaban, rivaroxaban), except in specific switching situations or when heparin is given to maintain an open central venous or arterial catheter
- Hypersensitivity to edoxaban or any excipient: Allergic reactions to any component of the formulation
- Prosthetic heart valves requiring anticoagulation: Edoxaban has not been studied in this population
Warnings and Precautions
Several clinical situations require special caution when using edoxaban:
Edoxaban increases the risk of bleeding and can cause serious, potentially fatal haemorrhage. Promptly evaluate any signs or symptoms of blood loss, such as unexpected drops in haemoglobin or blood pressure, dark stools, blood in urine, unusual bruising, prolonged bleeding from cuts, or coughing up blood. Contact your healthcare provider immediately if you experience any of these symptoms.
- Renal impairment: Dose adjustment is required. Patients with creatinine clearance (CrCl) 15-50 mL/min should receive 30 mg once daily (or 15 mg if other dose-reduction criteria also apply). Edoxaban is not recommended in patients with CrCl <15 mL/min or on dialysis
- Hepatic impairment: Not recommended in patients with severe hepatic impairment. Caution in patients with mild-to-moderate hepatic impairment and elevated liver enzymes (ALT/AST >2x ULN) or total bilirubin ≥1.5x ULN
- Spinal/epidural anaesthesia or puncture: Epidural or spinal haematoma may occur, potentially resulting in long-term or permanent paralysis. The risk is increased by the use of indwelling epidural catheters, concomitant use of other drugs affecting haemostasis, traumatic or repeated epidural or spinal puncture, or a history of spinal deformity or spinal surgery
- Increased stroke risk upon discontinuation: Premature discontinuation of edoxaban in patients with atrial fibrillation increases the risk of ischaemic events. If edoxaban must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant
- Elderly patients (≥75 years): May have increased bleeding risk; however, no dose adjustment based on age alone is required
- Low body weight (≤60 kg): Dose reduction to 30 mg once daily is recommended (15 mg if additional criteria apply)
Pregnancy and Breastfeeding
Edoxaban Reddy is not recommended during pregnancy. Animal studies have shown reproductive toxicity, and the risk to the human foetus is unknown. Women of childbearing potential should use effective contraception during treatment with edoxaban. If pregnancy occurs during treatment, a careful risk-benefit assessment should be made, considering the risk of bleeding and the potential for harm to the foetus.
It is not known whether edoxaban or its metabolites are excreted in human breast milk. Animal data have shown excretion of edoxaban in milk. Therefore, breastfeeding is not recommended during treatment with edoxaban. A decision must be made whether to discontinue breastfeeding or to discontinue edoxaban therapy, considering the benefit of breastfeeding for the child and the benefit of therapy for the mother.
How Does Edoxaban Reddy Interact with Other Drugs?
Edoxaban interacts with several medications, including other anticoagulants, antiplatelet drugs, NSAIDs, and P-glycoprotein inhibitors or inducers. Some interactions increase bleeding risk, while others affect edoxaban blood levels. Always inform your doctor about all medications, including over-the-counter drugs and supplements.
Edoxaban is primarily metabolised via hydrolysis and is a substrate of the P-glycoprotein (P-gp) efflux transporter. Drugs that inhibit or induce P-gp can significantly alter edoxaban plasma concentrations. Additionally, combining edoxaban with other anticoagulants, antiplatelet agents, or drugs that affect haemostasis increases the risk of bleeding.
Major Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Warfarin / other VKAs | Additive anticoagulant effect; greatly increased bleeding risk | Contraindicated: Do not co-administer |
| Heparin / LMWH | Additive anticoagulant effect | Contraindicated: Except during switching |
| Ciclosporin | P-gp inhibitor; increases edoxaban levels by ~73% | Reduce dose to 30 mg (or 15 mg) once daily |
| Dronedarone | P-gp inhibitor; increases edoxaban levels by ~85% | Reduce dose to 30 mg (or 15 mg) once daily |
| Erythromycin | P-gp inhibitor; increases edoxaban levels by ~85% | Reduce dose to 30 mg (or 15 mg) once daily |
| Ketoconazole | P-gp inhibitor; increases edoxaban levels by ~87% | Reduce dose to 30 mg (or 15 mg) once daily |
| Rifampicin | P-gp inducer; decreases edoxaban exposure by ~34% | Avoid concomitant use if possible |
Minor Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Aspirin (low-dose) | Increased bleeding risk due to antiplatelet effect | Use with caution; monitor for bleeding |
| NSAIDs (ibuprofen, naproxen) | Increased bleeding risk, especially GI bleeding | Avoid chronic use; short courses with monitoring |
| Clopidogrel / Prasugrel | Additive antiplatelet effect; increased bleeding risk | Use with caution; evaluate risk-benefit carefully |
| SSRIs / SNRIs | May impair platelet function; increased bleeding risk | Monitor for signs of bleeding |
| Amiodarone, Verapamil, Quinidine | Mild P-gp inhibition; modest increase in edoxaban levels | No dose adjustment required; monitor clinically |
Always inform all healthcare providers (including dentists and pharmacists) that you are taking Edoxaban Reddy. Carry a patient alert card listing your anticoagulant medication. This is especially important before any surgical or dental procedure, as your doctor may need to temporarily stop or adjust your treatment.
What Is the Correct Dosage of Edoxaban Reddy?
The standard dose of edoxaban is 60 mg once daily. The 15 mg strength (Edoxaban Reddy 15 mg) is a reduced dose used in specific patient populations. Dosage depends on indication, kidney function, body weight, and concomitant medications. Always follow your doctor's prescribed dose.
Edoxaban Reddy tablets should be swallowed whole with water and can be taken with or without food. The tablet should be taken at approximately the same time each day to maintain consistent drug levels. Dose selection is based on the specific clinical indication, renal function (creatinine clearance), body weight, and concomitant P-gp inhibitor use.
Adults
| Indication | Standard Dose | Reduced Dose | Dose Reduction Criteria |
|---|---|---|---|
| NVAF (Stroke Prevention) | 60 mg once daily | 30 mg once daily | CrCl 15-50 mL/min, body weight ≤60 kg, or concomitant P-gp inhibitors |
| DVT/PE Treatment | 60 mg once daily (after ≥5 days parenteral anticoagulation) | 30 mg once daily | CrCl 15-50 mL/min, body weight ≤60 kg, or concomitant P-gp inhibitors |
The 15 mg tablet strength is available for situations requiring further dose reduction beyond the standard 30 mg reduced dose. This may apply during transitions between anticoagulant therapies, specific dose-titration scenarios as directed by your physician, or when multiple dose-reduction criteria overlap. Your doctor will determine whether the 15 mg strength is appropriate for your specific clinical situation. Do not adjust your dose independently.
Children
Edoxaban Reddy 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 to support a dosing recommendation in this age group. Paediatric patients requiring anticoagulation should be treated with alternative agents as recommended by their paediatric haematologist.
Elderly
No dose adjustment is required based on age alone in elderly patients (≥65 years). However, elderly patients often have reduced renal function and lower body weight, both of which are criteria for dose reduction. Therefore, renal function should be assessed at baseline and periodically during treatment. In patients ≥75 years, the risk of bleeding may be higher, and careful clinical monitoring is advised. The ENGAGE AF-TIMI 48 trial included a significant proportion of patients over 75 years, providing evidence for the use of edoxaban in this population.
Missed Dose
If you miss a dose of Edoxaban Reddy, take it as soon as you remember on the same day. Do not take a double dose on the same day to compensate for a missed dose. Take the next dose at your regular scheduled time on the following day. It is helpful to set a daily alarm or use a pill organiser to avoid missing doses, as consistent anticoagulation is important for preventing blood clots.
Overdose
Overdose of edoxaban may lead to excessive bleeding. There is no specific antidote that directly reverses edoxaban. In case of suspected overdose, seek emergency medical attention immediately. Management includes:
- Standard supportive measures: mechanical compression of bleeding sites, surgical haemostasis if needed, fluid replacement, and haemodynamic support
- Andexanet alfa (Ondexxya/Andexxa): A recombinant modified factor Xa decoy protein approved in some regions as a specific reversal agent for factor Xa inhibitors in life-threatening or uncontrolled bleeding
- Activated charcoal may reduce absorption if given within 2 hours of ingestion
- Haemodialysis does not significantly contribute to edoxaban clearance (protein binding ~55%)
- Prothrombin complex concentrates (PCC) may be considered in emergency situations, although clinical data are limited
If you suspect an overdose of Edoxaban Reddy, contact your local poison control centre or go to the nearest emergency department immediately. Do not wait for symptoms to appear. Bring your medication packaging with you so healthcare providers can identify the exact product and dose.
What Are the Side Effects of Edoxaban Reddy?
The most common side effects of edoxaban are bleeding-related events, including skin bruising, nosebleeds, and bleeding from the gums. Less common but serious side effects include gastrointestinal haemorrhage, intracranial bleeding, and anaemia. Report any unusual bleeding to your doctor immediately.
Like all medicines, Edoxaban Reddy can cause side effects, although not everybody gets them. The most important adverse effect is bleeding, which is inherent to the mechanism of action of all anticoagulants. The risk of bleeding is higher in elderly patients, those with renal impairment, and those taking concomitant medications that affect haemostasis.
The frequency of side effects reported in clinical trials (ENGAGE AF-TIMI 48 and Hokusai-VTE) is categorised below according to the standard international convention:
Very Common
- Skin bleeding (bruising, subcutaneous haemorrhage, ecchymosis, petechiae)
- Mucosal bleeding (oral, nasal, gingival, conjunctival, urogenital)
Common
- Nosebleeds (epistaxis)
- Gastrointestinal bleeding (stomach, intestinal)
- Blood in urine (haematuria)
- Vaginal bleeding (menorrhagia, metrorrhagia)
- Anaemia
- Nausea
- Rash and pruritus (itching)
- Abnormal liver function tests (elevated bilirubin, gamma-GT)
Uncommon
- Intracranial haemorrhage (bleeding in the brain)
- Surgical site bleeding
- Haemoptysis (coughing up blood)
- Allergic reactions (urticaria, skin oedema)
- Dizziness and headache
- Elevated liver enzymes (ALT, AST)
- Thrombocytopenia (low platelet count)
Rare
- Anaphylactic reaction
- Retroperitoneal bleeding
- Pericardial bleeding
- Intraocular bleeding
- Intramuscular bleeding (with compartment syndrome)
- Subdural haematoma
Contact your doctor or go to the emergency department immediately if you experience: black or tarry stools, blood in your vomit, coughing up blood, severe or persistent headache, sudden weakness or numbness, unusual bruising that is large or spreading, blood in your urine, prolonged or heavy menstrual bleeding, or bleeding from a wound that does not stop.
In the ENGAGE AF-TIMI 48 trial, edoxaban 60 mg (with dose reduction to 30 mg where appropriate) was associated with significantly lower rates of major bleeding compared to well-managed warfarin (annualised rate 2.75% vs 3.43%, p<0.001). The rates of intracranial haemorrhage and fatal bleeding were also significantly lower with edoxaban. These findings provide reassurance regarding the bleeding safety profile of edoxaban relative to traditional anticoagulant therapy.
How Should You Store Edoxaban Reddy?
Store Edoxaban Reddy 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 Edoxaban Reddy is important to maintain the effectiveness and safety of the medication throughout its shelf life. Follow these storage guidelines:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze
- Moisture protection: Keep the tablets in the original blister packaging until ready to take. The blister pack protects the tablets from moisture, which can affect the stability of the film coating
- Light protection: No special light protection requirements, but store in a dry place away from direct sunlight
- Child safety: Keep out of the sight and reach of children. Store in a secure location
- Expiry date: Do not use Edoxaban Reddy after the expiry date shown on the carton and blister pack. The expiry date refers to the last day of that month
Do not dispose of medications in household waste or via wastewater. Ask your pharmacist about how to dispose of medicines you no longer use. These measures help protect the environment. If you notice any visible changes in the appearance of the tablets (discolouration, crumbling, unusual odour), do not take them and consult your pharmacist.
What Does Edoxaban Reddy Contain?
Each Edoxaban Reddy 15 mg film-coated tablet contains edoxaban tosilate monohydrate equivalent to 15 mg of edoxaban as the active substance. The tablets also contain several inactive ingredients (excipients) necessary for tablet formation and coating.
The full composition of Edoxaban Reddy 15 mg film-coated tablets includes:
Active substance: Each film-coated tablet contains edoxaban tosilate monohydrate, equivalent to 15 mg of edoxaban. Edoxaban tosilate is the salt form used to improve the stability and bioavailability of the active molecule.
Tablet core excipients:
- Mannitol (E421) - bulking agent and diluent
- Pregelatinised starch - binder and disintegrant
- Crospovidone - superdisintegrant for rapid tablet disintegration
- Hydroxypropylcellulose - binder
- Magnesium stearate (E470b) - lubricant for tablet pressing
Film coating:
- Hypromellose (E464) - film-forming agent
- Titanium dioxide (E171) - white colourant
- Talc - anti-adhesive agent
- Iron oxide red (E172) - colourant
- Iron oxide yellow (E172) - colourant
The 15 mg tablets are typically orange to orange-brown, round, biconvex film-coated tablets. The specific appearance may vary slightly between manufacturers. Check your tablet against the description in the patient information leaflet included with your medication. If the appearance does not match, consult your pharmacist before taking the medication.
Edoxaban Reddy 15 mg tablets do not contain lactose, gluten, or sucrose. However, they do contain mannitol (E421). Patients with rare hereditary problems of fructose intolerance should consult their doctor before taking this medicinal product. If you have known allergies to any of the listed excipients, discuss this with your doctor or pharmacist before starting treatment.
Frequently Asked Questions About Edoxaban Reddy
Medical References
All information is based on international medical guidelines and peer-reviewed research:
- Giugliano RP, Ruff CT, Braunwald E, et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2013;369(22):2093-2104. doi:10.1056/NEJMoa1310907 (ENGAGE AF-TIMI 48 trial)
- Hokusai-VTE Investigators. Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism. N Engl J Med. 2013;369(15):1406-1415. doi:10.1056/NEJMoa1306638
- European Medicines Agency (EMA). Lixiana (edoxaban) - Summary of Product Characteristics. Last updated 2024.
- Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation. Eur Heart J. 2021;42(5):373-498.
- Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2020;41(4):543-603.
- Lip GYH, Banerjee A, Boriani G, et al. Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report. Chest. 2018;154(5):1121-1201.
- World Health Organization (WHO). Model List of Essential Medicines. 23rd Edition, 2023.
- Connolly SJ, Milling TJ Jr, Eikelboom JW, et al. Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors. N Engl J Med. 2016;375(12):1131-1141.
- 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. Europace. 2021;23(10):1612-1676.
- British National Formulary (BNF). Edoxaban tosilate. National Institute for Health and Care Excellence (NICE). Updated 2024.
About This Article
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