Apixaban Viatris Pharma: Uses, Dosage & Side Effects
Generic direct oral anticoagulant (DOAC) – selective factor Xa inhibitor for stroke prevention and blood clot treatment
Quick facts about Apixaban Viatris Pharma
Key Takeaways
- Apixaban Viatris Pharma is a generic version of apixaban (Eliquis) approved by the European Medicines Agency, containing the same active ingredient at bioequivalent doses.
- It is a direct oral anticoagulant (DOAC) that prevents blood clots by selectively blocking factor Xa in the coagulation cascade, with proven efficacy from the landmark ARISTOTLE trial.
- Unlike warfarin, apixaban does not require routine INR blood monitoring, has fewer food interactions, and has a predictable dose-response relationship.
- The standard dose for stroke prevention in atrial fibrillation is 5 mg twice daily, with a reduced dose of 2.5 mg twice daily for patients meeting specific criteria (age ≥80, weight ≤60 kg, or creatinine ≥133 µmol/L).
- Andexanet alfa is an approved specific reversal agent for apixaban in cases of life-threatening bleeding, providing an important safety net for patients on this medication.
What Is Apixaban Viatris Pharma and What Is It Used For?
Quick Answer: Apixaban Viatris Pharma is a generic direct oral anticoagulant (DOAC) containing apixaban, a selective factor Xa inhibitor. It is used to prevent stroke in atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and prevent blood clots after hip or knee replacement surgery. It is bioequivalent to the originator product Eliquis.
Apixaban Viatris Pharma is a prescription anticoagulant medication manufactured by Viatris, one of the world's largest generic pharmaceutical companies. It contains apixaban as its active ingredient, which works by selectively and reversibly inhibiting factor Xa, a critical enzyme in the blood coagulation cascade. Factor Xa occupies a central position where the intrinsic and extrinsic coagulation pathways converge, making it an effective target for anticoagulation therapy. By blocking factor Xa, apixaban reduces the generation of thrombin, which in turn reduces the formation of blood clots (thrombi).
The active substance apixaban was originally developed by Bristol-Myers Squibb and Pfizer and marketed under the brand name Eliquis. Apixaban Viatris Pharma is a generic version that has been approved by the European Medicines Agency (EMA) based on bioequivalence studies demonstrating that it delivers the same amount of active substance in the same way as the reference product. This means that Apixaban Viatris Pharma and Eliquis are interchangeable in clinical practice, offering patients and healthcare systems a more cost-effective alternative without compromising therapeutic outcomes.
Apixaban belongs to a family of medications known as direct oral anticoagulants (DOACs), sometimes referred to as novel oral anticoagulants (NOACs). This group also includes rivaroxaban (Xarelto), edoxaban (Lixiana/Savaysa), and dabigatran (Pradaxa). DOACs have largely replaced warfarin as the first-line oral anticoagulant for many conditions due to their more predictable pharmacology, fixed dosing, fewer drug and food interactions, and improved safety profile, particularly with respect to intracranial haemorrhage.
The availability of generic apixaban formulations such as Apixaban Viatris Pharma is an important development in cardiovascular medicine. Generic anticoagulants improve access to evidence-based therapy by reducing costs for patients and healthcare systems while maintaining the same high standards of efficacy and safety. The World Health Organization (WHO) includes apixaban on its Model List of Essential Medicines, underscoring its importance in global health.
Approved Indications
Apixaban Viatris Pharma is approved for the following clinical indications, consistent with the approved uses of the reference product Eliquis:
- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) who have one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age ≥75, hypertension, diabetes mellitus, or symptomatic heart failure (NYHA class ≥II).
- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.
- Prevention of recurrent DVT and PE in adults who have completed at least 6 months of anticoagulation therapy for DVT or PE.
- Prevention of venous thromboembolism (VTE) in adult patients who have undergone elective hip or knee replacement surgery (thromboprophylaxis).
The European Society of Cardiology (ESC) 2024 guidelines for the management of atrial fibrillation recommend DOACs, including apixaban, as the preferred oral anticoagulants over vitamin K antagonists (warfarin) for stroke prevention, except in patients with mechanical heart valves or moderate-to-severe mitral stenosis. The American Heart Association (AHA) and American College of Cardiology (ACC) guidelines similarly endorse this recommendation.
Mechanism of Action
Apixaban is a potent, oral, reversible, direct and highly selective active-site inhibitor of factor Xa. Unlike heparin-based anticoagulants, it does not require antithrombin III for its anticoagulant activity. Apixaban inhibits both free and clot-bound factor Xa, as well as prothrombinase activity. By inhibiting factor Xa, it decreases thrombin generation and thrombus development without directly affecting existing clots. This mechanism provides effective anticoagulation while maintaining a more predictable pharmacological profile than vitamin K antagonists such as warfarin.
The selectivity of apixaban for factor Xa means it does not directly inhibit thrombin (factor IIa) or affect platelet aggregation. However, by inhibiting factor Xa, apixaban indirectly reduces thrombin-driven platelet activation. This targeted mechanism contributes to the favourable bleeding profile observed in clinical trials, particularly the significantly lower rate of intracranial haemorrhage compared to warfarin.
Pharmacokinetics
Apixaban is rapidly absorbed after oral administration, with peak plasma concentrations (Cmax) typically reached within 3 to 4 hours. The absolute bioavailability is approximately 50% for doses up to 10 mg. Apixaban can be taken with or without food, as food does not have a clinically meaningful effect on its absorption. The drug is approximately 87% bound to plasma proteins, primarily albumin. Apixaban is metabolised mainly via the cytochrome P450 enzyme CYP3A4/5, with minor contributions from CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP2J2. The elimination half-life is approximately 12 hours, which supports twice-daily dosing. Approximately 27% of the total dose is excreted renally, and about 73% is eliminated via the faecal route, making apixaban suitable for patients with mild to moderate renal impairment without dose adjustment for most indications.
What Should You Know Before Taking Apixaban Viatris Pharma?
Quick Answer: Before starting Apixaban Viatris Pharma, your doctor will assess your kidney and liver function, bleeding risk, and other medications. It is contraindicated in active clinically significant bleeding, severe liver disease, and in patients with prosthetic heart valves. Special dose adjustments are needed for certain patient groups.
Before prescribing Apixaban Viatris Pharma, your healthcare provider will conduct a thorough assessment of your medical history, current medications, and overall health status. This evaluation is essential to ensure that apixaban is safe and appropriate for your specific situation. Anticoagulant therapy always involves balancing the benefit of preventing blood clots against the risk of bleeding, and several factors can influence this balance. Understanding these considerations will help you participate in informed discussions with your healthcare team about your treatment.
Because Apixaban Viatris Pharma contains the same active substance as Eliquis, all contraindications, warnings, precautions, and special population considerations are identical. The comprehensive safety data from the ARISTOTLE, AMPLIFY, ADVANCE, and other pivotal clinical trials all apply equally to this generic formulation.
Contraindications
Apixaban Viatris Pharma 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. This is an absolute contraindication, as apixaban would impair the body's ability to control the bleed.
- Hypersensitivity: Known allergy to apixaban or any of the excipients in the formulation. Excipients vary slightly between manufacturers, so patients with known excipient sensitivities should check the specific formulation.
- Severe hepatic disease: Liver disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhosis classified as Child-Pugh C. The liver plays a crucial role in both the metabolism of apixaban and the production of coagulation factors.
- Lesions at risk of clinically significant bleeding: Such as current or recent gastrointestinal ulceration, malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, or major intraspinal or intracerebral vascular abnormalities.
- Prosthetic heart valves: Apixaban has not been studied and is not recommended for patients with mechanical heart valves requiring anticoagulation. The safety and efficacy of DOACs in this population have not been established, and warfarin remains the standard treatment.
Premature discontinuation of Apixaban Viatris Pharma without switching to an alternative anticoagulant increases the risk of thrombotic events, including stroke. If you need to stop apixaban for surgery or other reasons, your doctor will provide specific guidance on when to stop and restart the medication. Never stop taking apixaban without consulting your prescriber. The risk of rebound thrombosis is a class effect of all anticoagulants and requires careful perioperative management.
Warnings and Precautions
Special caution is required when using Apixaban Viatris Pharma in the following situations:
- Increased bleeding risk: Conditions that increase bleeding risk include uncontrolled severe arterial hypertension, vascular retinopathy, recent biopsy or major trauma, active peptic ulcer disease, bacterial endocarditis, or thrombocytopenia. Concomitant use of antiplatelet agents, other anticoagulants, or non-steroidal anti-inflammatory drugs (NSAIDs) further increases this risk.
- Renal impairment: Apixaban can be used in mild to moderate renal impairment without dose adjustment for most indications. However, in patients with creatinine clearance 15–29 mL/min, it should be used with caution, and in patients with creatinine clearance below 15 mL/min or on dialysis, clinical data are limited and apixaban is not recommended.
- Hepatic impairment: Apixaban can be used with caution in mild hepatic impairment (Child-Pugh A). It should be used with caution in moderate hepatic impairment (Child-Pugh B) and is contraindicated in severe hepatic impairment (Child-Pugh C).
- Spinal or epidural anaesthesia: 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. Specific timing guidelines for discontinuation and reinitiation around these procedures must be followed. The recommended minimum interval between the last dose of apixaban and catheter removal is 20–30 hours.
- Hip fracture surgery: Apixaban has not been studied in patients undergoing hip fracture surgery and is therefore not recommended in this population. Alternative thromboprophylaxis should be used.
- Antiphospholipid syndrome: DOACs including apixaban are not recommended for patients with antiphospholipid syndrome, particularly those who are triple-positive for antiphospholipid antibodies, as clinical trials have shown inferior outcomes compared to warfarin.
Pregnancy and Breastfeeding
There are limited data on the use of apixaban during pregnancy. Animal studies have not shown direct or indirect harmful effects with respect to reproductive toxicity. However, as a precautionary measure, Apixaban Viatris Pharma is not recommended during pregnancy. The potential risk of bleeding associated with apixaban may increase the risk of haemorrhagic complications during pregnancy and delivery. Women of childbearing potential should discuss effective contraception with their doctor while taking apixaban.
It is not known whether apixaban or its metabolites are excreted in human breast milk. Animal studies have shown that apixaban is present in breast milk. A risk to the breastfed infant cannot be excluded. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue Apixaban Viatris Pharma therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. If anticoagulation is essential during breastfeeding, discuss alternative agents with your healthcare provider.
No dose adjustment is needed based on gender, race, or ethnicity. For elderly patients (age ≥80), patients with low body weight (≤60 kg), or those with renal impairment (serum creatinine ≥133 µmol/L or 1.5 mg/dL), a dose reduction to 2.5 mg twice daily is recommended when at least two of these three criteria are present in patients being treated for atrial fibrillation. This dose reduction is based on pharmacokinetic modelling and the ARISTOTLE trial subgroup analyses, which demonstrated maintained efficacy with improved safety in these populations.
How Does Apixaban Viatris Pharma Interact with Other Drugs?
Quick Answer: Apixaban is metabolised primarily by CYP3A4 and is a substrate for P-glycoprotein (P-gp). Strong dual inhibitors of CYP3A4 and P-gp (such as ketoconazole and ritonavir) significantly increase apixaban levels, while strong dual inducers (such as rifampicin and phenytoin) significantly decrease them. Concomitant use of other anticoagulants, antiplatelet agents, and NSAIDs increases bleeding risk.
Drug interactions are an important consideration with Apixaban Viatris Pharma, although apixaban has fewer clinically significant interactions than warfarin. Apixaban is metabolised primarily by the cytochrome P450 enzyme CYP3A4, with minor contributions from CYP1A2, CYP2C8, CYP2C9, CYP2C19, and CYP2J2. It is also a substrate for the drug efflux transporter P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Drugs that affect these pathways can alter apixaban plasma levels and potentially change its efficacy or safety profile.
It is critical to inform your prescriber about all medications you are taking, including over-the-counter medicines, herbal supplements, and vitamins. While apixaban has a more favourable drug interaction profile compared to warfarin (which interacts with hundreds of substances), certain combinations can be dangerous and may require dose adjustments or alternative therapy. Your pharmacist can also help identify potential interactions whenever a new medication is added to your regimen.
Major Interactions
| Interacting Drug | Effect | Clinical Recommendation |
|---|---|---|
| Ketoconazole, itraconazole, voriconazole, posaconazole | Strong CYP3A4 and P-gp inhibitors; significantly increase apixaban plasma levels (approximately 2-fold) | Reduce apixaban dose by 50% (i.e. 2.5 mg twice daily instead of 5 mg) or avoid combination if already on reduced dose |
| HIV protease inhibitors (ritonavir, nelfinavir) | Strong CYP3A4 and P-gp inhibitors; significantly increase apixaban levels | Reduce apixaban dose by 50% or avoid combination |
| Rifampicin | Strong CYP3A4 and P-gp inducer; decreases apixaban levels by approximately 54% | Avoid concomitant use; apixaban efficacy is substantially reduced |
| Phenytoin, carbamazepine, phenobarbital | Strong CYP3A4 inducers; expected to significantly decrease apixaban levels | Avoid concomitant use |
| St John’s Wort (Hypericum perforatum) | Strong CYP3A4 inducer; expected to decrease apixaban 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 |
|---|---|---|
| Diltiazem | Moderate CYP3A4 and P-gp inhibitor; increases apixaban levels by approximately 40% | No dose adjustment needed; use with caution |
| Naproxen, ibuprofen, diclofenac (NSAIDs) | Do not alter apixaban levels but independently increase bleeding risk, particularly gastrointestinal | Use with caution; avoid long-term concomitant use if possible |
| Aspirin (low dose) | Increases bleeding risk through additional antiplatelet effect | Use only when clinically indicated (e.g. recent acute coronary syndrome); shortest duration possible |
| Clopidogrel, ticagrelor, prasugrel | Antiplatelet agents; additive bleeding risk | Use only when clinically indicated; monitor for signs of bleeding |
| SSRIs/SNRIs (fluoxetine, sertraline, venlafaxine) | May impair platelet function and increase bleeding risk | Use with caution; monitor for unusual bleeding |
Unlike warfarin, Apixaban Viatris Pharma does not have significant interactions with vitamin K-containing foods. You do not need to restrict your intake of green leafy vegetables, broccoli, or other vitamin K-rich foods. Apixaban can be taken with or without food, as food does not significantly affect its absorption. Grapefruit juice has a minimal effect on apixaban levels and does not require dose adjustment. This dietary freedom is one of the practical advantages of DOACs over warfarin for patients managing long-term anticoagulation.
What Is the Correct Dosage of Apixaban Viatris Pharma?
Quick Answer: The standard dose of Apixaban Viatris Pharma varies by indication. For atrial fibrillation, the usual dose is 5 mg twice daily. A reduced dose of 2.5 mg twice daily is used for specific patient groups and for VTE prevention after surgery. Apixaban should be taken approximately 12 hours apart, with or without food.
Apixaban dosing is straightforward compared to warfarin, as it uses fixed doses without the need for individualised titration based on blood test results. However, the correct dose depends on the indication being treated and certain patient characteristics. It is essential to take the dose prescribed by your doctor and not to adjust it yourself. Apixaban Viatris Pharma is available as 2.5 mg film-coated tablets, which can be used alone or in combination to achieve the required dose for each indication.
The tablets should be swallowed whole with water. For patients who have difficulty swallowing, apixaban tablets can be crushed and mixed with water, apple juice, or applesauce for immediate administration. The crushed tablet suspension can also be delivered through a nasogastric tube. However, always follow your pharmacist's specific instructions for preparation to ensure accurate dosing.
Adults
| Indication | Standard Dose | Reduced Dose | Duration |
|---|---|---|---|
| Stroke prevention in atrial fibrillation | 5 mg twice daily | 2.5 mg twice daily* | Long-term (indefinite) |
| Treatment of DVT/PE | 10 mg twice daily for 7 days, then 5 mg twice daily | Not applicable | At least 3–6 months |
| Prevention of recurrent DVT/PE | 2.5 mg twice daily | Not applicable | Extended (decision based on individual risk-benefit) |
| VTE prevention after hip replacement | 2.5 mg twice daily (starting 12–24 hours post-surgery) | Not applicable | 32–38 days |
| VTE prevention after knee replacement | 2.5 mg twice daily (starting 12–24 hours post-surgery) | Not applicable | 10–14 days |
*Dose reduction criteria for atrial fibrillation: A reduced dose of 2.5 mg twice daily is recommended for patients with at least two of the following three characteristics: age ≥80 years, body weight ≤60 kg, or serum creatinine ≥133 µmol/L (1.5 mg/dL). This dose reduction is based on pharmacokinetic modelling and the ARISTOTLE trial subgroup analyses, which showed that the 2.5 mg dose in these populations achieved similar plasma levels to the 5 mg dose in the general population.
Children
Apixaban Viatris Pharma is not approved for use in children under 18 years of age. The safety and efficacy of apixaban in the paediatric population have not been established in adequate and well-controlled studies. Alternative anticoagulants, typically low-molecular-weight heparins (such as enoxaparin) or unfractionated heparin, are used in paediatric patients who require anticoagulation. Research into paediatric indications for DOACs is ongoing, but at present, no DOAC has robust paediatric approval for routine use.
Elderly
No general dose adjustment is required solely based on age. However, elderly patients frequently have reduced renal function and lower body weight, which may qualify them for the reduced dose criteria described above. The ARISTOTLE trial included a substantial proportion of patients aged 75 and older (approximately 31% of participants), and subgroup analyses demonstrated that apixaban maintained its favourable efficacy and safety profile compared to warfarin in this population. In fact, the relative benefit of apixaban over warfarin in terms of reduced intracranial haemorrhage appeared to be particularly pronounced in older adults. Elderly patients should be regularly assessed for changes in renal function, falls risk, and bleeding risk.
Missed Dose
If you miss a dose of Apixaban Viatris Pharma, take it as soon as you remember on the same day. Then continue with the regular twice-daily dosing schedule. Do not take a double dose to compensate for a missed dose. If it is almost time for your next scheduled dose, skip the missed dose and take the next dose at the normal time. Missing doses increases the risk of blood clots, so it is important to take apixaban as consistently as possible. Consider using a pill organiser or setting daily reminders to help maintain adherence.
Overdose
There is no specific antidote for apixaban overdose in the outpatient setting, although andexanet alfa (Andexxa/Ondexxya) may be used in hospital for life-threatening bleeding. In case of suspected overdose, seek immediate medical attention. The use of activated charcoal within 2 to 6 hours of ingestion may reduce absorption. Apixaban is not expected to be dialysable due to its high protein binding (approximately 87%). Treatment of overdose is primarily supportive, with management of bleeding complications as they arise. Prothrombin complex concentrates (PCCs), either 3-factor or 4-factor, may be considered if bleeding is severe and andexanet alfa is unavailable.
If you suspect an overdose of Apixaban Viatris Pharma, contact your local poison control centre or go to the nearest emergency department immediately. Symptoms of overdose may include unusual or prolonged bleeding, blood in urine or stool, excessive bruising, vomiting blood, or prolonged bleeding from cuts. Do not attempt to induce vomiting unless instructed by a healthcare professional.
What Are the Side Effects of Apixaban Viatris Pharma?
Quick Answer: The most common side effects of Apixaban Viatris Pharma are bleeding-related, including nosebleeds, bruising, and blood in the urine. Serious side effects include major bleeding events such as gastrointestinal haemorrhage and intracranial bleeding. Apixaban has a lower rate of major bleeding compared to warfarin, as demonstrated in the ARISTOTLE trial.
As with all anticoagulant medications, the most significant risk associated with Apixaban Viatris Pharma is bleeding. Because this product contains the same active substance as Eliquis, the side effect profile is identical. The ARISTOTLE trial, which compared apixaban with warfarin in over 18,000 patients with atrial fibrillation, demonstrated that apixaban had a significantly lower rate of major bleeding (2.13% per year vs. 3.09% per year with warfarin, p < 0.001). The rate of intracranial haemorrhage was also substantially lower with apixaban compared to warfarin (0.33% vs. 0.80% per year), representing a 58% relative risk reduction.
All patients taking Apixaban Viatris Pharma should be aware of the signs and symptoms of bleeding and know when to seek medical attention. The following side effects are classified by frequency based on clinical trial data from the ARISTOTLE, AMPLIFY, and ADVANCE programmes, as well as post-marketing surveillance data.
Common
Affects 1–10 in 100 patients
- Epistaxis (nosebleeds)
- Bruising (ecchymosis, skin contusion)
- Haematuria (blood in urine)
- Haematoma (collection of blood under the skin)
- Gingival bleeding (bleeding gums)
- Gastrointestinal haemorrhage (bleeding in the stomach or intestines)
- Anaemia (reduced haemoglobin levels due to bleeding)
Uncommon
Affects 1–10 in 1,000 patients
- Hypotension (low blood pressure, often related to haemorrhage)
- Rectal bleeding
- Haemoptysis (coughing up blood)
- Haemorrhoidal bleeding
- Occult blood positive in stool
- Allergic skin reactions (rash, pruritus)
- Abnormal vaginal bleeding (menorrhagia, metrorrhagia)
- Urogenital bleeding
- Post-procedural haemorrhage or haematoma
- Wound secretion or surgical site bleeding
- Elevated liver transaminases (ALT, AST, GGT)
Rare
Affects 1–10 in 10,000 patients
- Intracranial haemorrhage (bleeding in the brain)
- Retroperitoneal haemorrhage
- Intraocular haemorrhage (bleeding in the eye)
- Muscle bleeding
- Hypersensitivity reactions including angioedema
- Anaphylactic reaction
Not Known (cannot be estimated from available data)
Reported from post-marketing surveillance
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Allergic oedema
Contact your doctor or go to the nearest emergency department immediately if you experience any of the following: vomiting blood or material that looks like coffee grounds, black or bloody stools, blood in your urine (pink, red, or dark brown), unusual or prolonged bleeding from any wound, severe or persistent headache, dizziness or fainting, coughing up blood, unexplained swelling, or severe bruising. These may be signs of serious bleeding that require urgent medical evaluation.
It is important to note that the benefits of anticoagulation therapy in preventing stroke, DVT, and PE generally outweigh the risks of bleeding for the vast majority of patients. The decision to start or continue anticoagulation should be made in consultation with your healthcare provider based on your individual risk-benefit profile. Tools such as the CHA₂DS₂-VASc score (for stroke risk in atrial fibrillation) and the HAS-BLED score (for bleeding risk) help guide this decision.
How Should You Store Apixaban Viatris Pharma?
Quick Answer: Store Apixaban Viatris Pharma at room temperature below 30°C in the original packaging. Keep out of reach of children. Do not use after the expiry date. Do not store in the bathroom due to heat and humidity.
Proper storage of Apixaban Viatris Pharma is important to maintain the quality, potency, and safety of the medication throughout its shelf life. Incorrect storage conditions can lead to degradation of the active ingredient, potentially reducing the effectiveness of the medication or creating harmful breakdown products.
Store the tablets at room temperature, generally below 30°C (86°F). Keep the medication in its original packaging (blister pack or bottle) to protect it from moisture and light. Do not remove tablets from the blister pack until you are ready to take them. Avoid storing the medication in the bathroom, near the kitchen sink, or in other damp, humid environments, as moisture can degrade the film-coated tablets.
Keep Apixaban Viatris Pharma and all medications out of the sight and reach of children. An accidental dose of an anticoagulant by a child could cause serious bleeding and is a medical emergency. Do not use the medication after the expiry date printed on the packaging. Expired medications should be returned to a pharmacy for safe disposal rather than being discarded in household waste or flushed down the toilet.
If you are travelling, keep the medication in your carry-on luggage in its original packaging. Avoid exposing the tablets to extreme temperatures, such as leaving them in a car during hot weather or freezing conditions. If you are unsure whether your medication has been stored correctly (for example, if it has been exposed to high temperatures), consult your pharmacist before taking it.
What Does Apixaban Viatris Pharma Contain?
Quick Answer: Each Apixaban Viatris Pharma 2.5 mg tablet contains 2.5 mg of the active substance apixaban. The tablets also contain inactive ingredients (excipients) that serve as fillers, binders, and coating agents to form the film-coated tablet.
Understanding the composition of your medication is important, particularly if you have known allergies or intolerances to specific excipients. The active and inactive ingredients of Apixaban Viatris Pharma are detailed below.
Active Ingredient
Each film-coated tablet contains 2.5 mg of apixaban. Apixaban is the pharmacologically active component responsible for the anticoagulant effect of the medication. It is a synthetic small-molecule compound that was developed through rational drug design to specifically target factor Xa in the coagulation cascade.
Inactive Ingredients (Excipients)
The excipients in Apixaban Viatris Pharma are pharmaceutical-grade ingredients used to manufacture the tablet. They include substances that act as fillers, binders, disintegrants, lubricants, and coating agents. Common excipients found in apixaban generic formulations typically include:
- Tablet core: Lactose monohydrate (or anhydrous), microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate.
- Film coating: Hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E171), triethyl citrate, and iron oxide yellow (E172) – giving the tablets their characteristic appearance.
Patients with lactose intolerance should be aware that the tablet formulation may contain lactose. However, the amount of lactose in each tablet is very small (typically less than 100 mg) and is generally well tolerated even by patients with lactose intolerance. If you have severe galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption, consult your doctor or pharmacist before taking this medication.
The excipients in Apixaban Viatris Pharma may differ slightly from those in the originator product Eliquis or other generic versions. However, bioequivalence studies ensure that these differences do not affect the clinical performance of the product. If you have specific excipient allergies, always check the patient information leaflet or consult your pharmacist.
Frequently Asked Questions
References
- Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365(11):981-992. doi:10.1056/NEJMoa1107039
- Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism (AMPLIFY trial). N Engl J Med. 2013;369(9):799-808. doi:10.1056/NEJMoa1302507
- Lassen MR, Gallus A, Raskob GE, et al. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement (ADVANCE-3). N Engl J Med. 2010;363(26):2487-2498. doi:10.1056/NEJMoa1006885
- Van Es N, Coppens M, Schulman S, Middeldorp S, Buller HR. Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials. Blood. 2014;124(12):1968-1975.
- European Society of Cardiology (ESC). 2024 ESC/EACTS Guidelines for the management of atrial fibrillation. Eur Heart J. 2024. doi:10.1093/eurheartj/ehae176
- Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for Diagnosis and Management of Atrial Fibrillation. J Am Coll Cardiol. 2024;83(1):109-279.
- World Health Organization. WHO Model List of Essential Medicines – 23rd List, 2023. Geneva: WHO; 2023.
- European Medicines Agency (EMA). Summary of Product Characteristics – Apixaban. EMA; 2024.
- British National Formulary (BNF). Apixaban. NICE; 2025. Available at: bnf.nice.org.uk
- 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.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in clinical pharmacology, haematology, and internal medicine.
Medical Writing
Written by specialist physicians with clinical experience in anticoagulation therapy and cardiovascular medicine. All content follows GRADE evidence framework methodology.
Medical Review
Independently reviewed by the iMedic Medical Review Board according to WHO, EMA, FDA, and BNF guidelines. No pharmaceutical company involvement.
Conflict of Interest Declaration: The iMedic Medical Editorial Team has no financial relationships with pharmaceutical companies. All content is independently produced without commercial funding or advertising influence.