Xarelto

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Xarelto on Prescriptsy

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Xarelto is a direct oral anticoagulant (DOAC) containing rivaroxaban, a selective direct factor Xa inhibitor manufactured by Bayer.

It is prescribed to prevent stroke and systemic embolism in adults with non-valvular atrial fibrillation (AF), treat and prevent venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE), prevent VTE after elective hip or knee replacement surgery, and reduce atherothrombotic events after acute coronary syndrome (ACS).

Xarelto is a prescription-only medicine (POM) in the United Kingdom and is widely used across the NHS as a first-line anticoagulant.

Venous thromboembolism affects approximately 1 in 1,000 adults in the UK each year, with DVT and PE together responsible for an estimated 25,000 preventable deaths annually in England.

Atrial fibrillation, the most common sustained cardiac arrhythmia, affects over 1.4 million people in the UK and increases stroke risk approximately fivefold.

The introduction of DOACs including rivaroxaban has transformed anticoagulation management by eliminating the need for routine INR monitoring and offering more predictable pharmacokinetics compared with warfarin.

This page provides a comprehensive clinical guide to Xarelto, covering its mechanism of action, licensed indications, dosage, side effects, safety warnings, and how to obtain a prescription in the United Kingdom.

Important safety information about Xarelto

Before reading further, note these essential safety points about Xarelto.

• Xarelto increases the risk of bleeding. Seek immediate medical attention (call 999) for signs of serious bleeding including prolonged or unexplained bleeding, blood in stools or vomit, coughing up blood, or sudden severe headache.
• Do not stop taking Xarelto without medical advice, as this increases the risk of blood clots, stroke, or pulmonary embolism.
• The 15 mg and 20 mg tablets must be taken with food to ensure adequate absorption.
• Carry an anticoagulant alert card at all times and inform all healthcare professionals that you take Xarelto.
• Xarelto is contraindicated in pregnancy, breastfeeding, and patients with mechanical heart valves.

Understanding blood clotting and anticoagulation

Blood clotting (coagulation) is a complex physiological process that prevents excessive bleeding following blood vessel injury.

The coagulation cascade involves a series of enzymatic reactions where inactive clotting factors (zymogens) are sequentially activated, ultimately generating thrombin (factor IIa), which converts soluble fibrinogen into an insoluble fibrin mesh that stabilises the platelet plug.

Factor Xa occupies a pivotal position in this cascade, sitting at the convergence of the intrinsic and extrinsic pathways, and a single molecule of factor Xa catalyses the generation of approximately 1,000 molecules of thrombin through the prothrombinase complex.

Pathological thrombosis occurs when clots form inappropriately within blood vessels, obstructing blood flow.

In venous thromboembolism, clots typically form in the deep veins of the legs (DVT) and may dislodge and travel to the pulmonary arteries (PE), which can be fatal.

In atrial fibrillation, the irregular and often rapid atrial contraction causes blood stasis in the left atrial appendage, promoting thrombus formation that can embolise to the brain and cause ischaemic stroke.

Anticoagulant therapy reduces clot formation by inhibiting specific components of the coagulation cascade.

How Xarelto works

Rivaroxaban is a highly selective, direct inhibitor of factor Xa that does not require antithrombin III as a cofactor (unlike heparin).

It binds directly to the active site of factor Xa, inhibiting both free factor Xa circulating in plasma and factor Xa already bound within the prothrombinase complex or incorporated into existing clots.

This dual inhibition distinguishes rivaroxaban from indirect factor Xa inhibitors such as fondaparinux, which only inhibit free factor Xa.

By inhibiting factor Xa, rivaroxaban reduces thrombin generation in a dose-dependent and predictable manner. Reduced thrombin generation decreases fibrin clot formation and thrombin-mediated platelet activation.

The anticoagulant effect begins within 2 to 4 hours of oral administration (time to peak plasma concentration) and persists for approximately 24 hours with once-daily dosing.

Unlike warfarin, rivaroxaban does not inhibit vitamin K-dependent clotting factor synthesis and therefore has a much faster onset and offset of action.

Rivaroxaban has high oral bioavailability that is dose-dependent. The 10 mg tablet achieves 80 to 100% bioavailability regardless of food intake.

The 15 mg and 20 mg tablets have reduced bioavailability in the fasted state (approximately 66%), which increases to nearly 100% when taken with food.

This is why the higher doses must be taken with a meal.

The drug is approximately 92 to 95% protein-bound, primarily to albumin, and has a volume of distribution of approximately 50 litres.

Elimination occurs through dual pathways: approximately two-thirds via hepatic metabolism (CYP3A4/3A5, CYP2J2, and CYP-independent hydrolysis) and one-third by direct renal excretion of unchanged drug.

Licensed indications for Xarelto in the UK

Stroke prevention in non-valvular atrial fibrillation

Xarelto 20 mg once daily (or 15 mg once daily with moderate renal impairment) is licensed for the prevention of stroke and systemic embolism in adult patients with non-valvular AF who have one or more risk factors for stroke, including congestive heart failure, hypertension, age 75 years or over, diabetes mellitus, and prior stroke or transient ischaemic attack.

This indication is based on the ROCKET AF trial, which enrolled 14,264 patients and demonstrated that rivaroxaban was non-inferior to dose-adjusted warfarin for the primary endpoint of stroke and systemic embolism, with a similar overall bleeding rate but significantly lower rates of intracranial and fatal bleeding.

Treatment and prevention of VTE

Xarelto is licensed for the treatment of DVT and PE, and prevention of recurrent DVT and PE in adults.

The EINSTEIN-DVT and EINSTEIN-PE trials demonstrated that rivaroxaban was non-inferior to standard therapy (enoxaparin followed by a vitamin K antagonist) for the treatment of symptomatic VTE, with a comparable safety profile.

The EINSTEIN-CHOICE trial showed that extended treatment with rivaroxaban 10 mg or 20 mg once daily was superior to aspirin for preventing recurrent VTE without a significant increase in major bleeding.

VTE prevention after hip or knee replacement

Xarelto 10 mg once daily is licensed for the prevention of VTE following elective total hip replacement (5 weeks of treatment) and total knee replacement (2 weeks of treatment).

The RECORD clinical trial programme (RECORD 1 through 4) demonstrated superior efficacy of rivaroxaban compared with enoxaparin for VTE prevention in these surgical settings.

Prevention of atherothrombotic events after ACS

Xarelto 2.5 mg twice daily, co-administered with aspirin alone or with aspirin plus clopidogrel or ticlopidine, is licensed for the prevention of atherothrombotic events in adult patients after an ACS with elevated cardiac biomarkers.

The ATLAS ACS 2-TIMI 51 trial demonstrated that rivaroxaban 2.5 mg twice daily plus standard antiplatelet therapy significantly reduced the composite endpoint of cardiovascular death, myocardial infarction, and stroke compared with antiplatelet therapy alone.

Xarelto compared with other anticoagulants

Four DOACs are available in the UK: rivaroxaban (Xarelto), apixaban (Eliquis), dabigatran (Pradaxa), and edoxaban (Lixiana).

Rivaroxaban and apixaban both inhibit factor Xa, while dabigatran is a direct thrombin (factor IIa) inhibitor and edoxaban is also a factor Xa inhibitor.

NICE technology appraisal guidance (TA256 for rivaroxaban in AF, TA261 for apixaban in AF, TA249 for dabigatran in AF, TA355 for edoxaban in AF) recommends all four DOACs as options for stroke prevention in AF, and the choice depends on individual patient factors, renal function, concomitant medications, and preference.

Compared with warfarin, all DOACs offer advantages including no requirement for routine INR monitoring, fewer dietary interactions, more predictable pharmacokinetics, a faster onset and offset of action, and lower rates of intracranial haemorrhage.

Rivaroxaban has the advantage of once-daily dosing for most indications (compared with twice-daily for apixaban and dabigatran).

It has higher rates of gastrointestinal bleeding compared with warfarin in the ROCKET AF trial and compared with apixaban in indirect comparisons, which may influence the choice between DOACs in patients at high risk of gastrointestinal bleeding.

Dosage and administration

Dosing varies by indication. For stroke prevention in non-valvular AF: 20 mg once daily with food (15 mg once daily if creatinine clearance is 30 to 49 mL/min).

For VTE treatment: 15 mg twice daily with food for the first 21 days, then 20 mg once daily with food.

For extended VTE prevention: 10 mg once daily (or 20 mg once daily for high-risk patients).

For VTE prophylaxis after hip replacement: 10 mg once daily for 5 weeks, starting 6 to 10 hours post-surgery.

For VTE prophylaxis after knee replacement: 10 mg once daily for 2 weeks. For ACS: 2.5 mg twice daily with standard antiplatelet therapy.

Take Xarelto at the same time each day. Swallow tablets whole with water. If you have difficulty swallowing, the tablet may be crushed and mixed with water or applesauce immediately before taking. Store below 30 degrees Celsius.

Side effects of Xarelto

Common side effects

Bleeding is the principal risk.

Common bleeding events (1 in 10 to 1 in 100 patients) include gum bleeding, nosebleeds, gastrointestinal bleeding (which may present as blood in stools, dark tarry stools, or vomiting blood), blood in urine, bruising, and heavy menstrual bleeding.

Post-procedural haemorrhage and wound complications may occur after surgery. Nausea, constipation, diarrhoea, and abdominal pain are reported in 1 to 10% of patients.

Dizziness, headache, and fatigue are common non-bleeding adverse effects.

Uncommon and serious side effects

Intracranial haemorrhage (bleeding within the skull) is rare but can be life-threatening. Signs include sudden severe headache, confusion, weakness on one side, visual disturbance, and loss of consciousness.

Retroperitoneal haemorrhage, haemarthrosis, and muscle haemorrhage are uncommon. Elevated liver enzymes (transaminases, gamma-GT, bilirubin) occur uncommonly and are usually transient and asymptomatic. Thrombocytopenia (low platelet count) is rare.

Allergic reactions including rash, pruritus, urticaria, and rarely anaphylaxis have been reported.

When to seek urgent medical help

Call 999 or go to A&E immediately if you experience prolonged or uncontrollable bleeding from any site, vomit blood or pass blood in stools, develop a sudden severe headache, experience sudden weakness or numbness (signs of stroke despite anticoagulation), or develop chest pain and difficulty breathing (signs of PE despite treatment).

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .

Warnings and precautions

Contraindications

Xarelto is contraindicated in active clinically significant bleeding, lesions at increased risk of clinically significant bleeding (such as current or recent gastrointestinal ulceration, malignant neoplasms at high risk of bleeding), recent brain or spinal injury or surgery, oesophageal varices, arteriovenous malformations, and vascular aneurysms.

It is contraindicated in hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients classified as Child-Pugh B and C with coagulopathy.

It must not be used in patients with prosthetic heart valves requiring anticoagulation, or during pregnancy and breastfeeding.

Renal impairment

Rivaroxaban exposure increases with declining renal function because approximately one-third of the drug is eliminated unchanged by the kidneys.

Renal function should be assessed before starting treatment and at least annually during treatment, more frequently if renal decline is expected.

Dose reduction is required for AF patients with creatinine clearance 30 to 49 mL/min.

Use with caution in patients with creatinine clearance 15 to 29 mL/min (limited clinical data). Xarelto is not recommended in patients with creatinine clearance below 15 mL/min.

Drug interactions

Strong inhibitors of both CYP3A4 and P-glycoprotein (such as ketoconazole, itraconazole, voriconazole, posaconazole, and HIV protease inhibitors boosted with ritonavir) significantly increase rivaroxaban plasma levels and are contraindicated.

Strong CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, and St John's wort) significantly decrease rivaroxaban levels and should be avoided.

Concomitant use with other anticoagulants, antiplatelet agents, and NSAIDs increases bleeding risk.

Discontinuation and bridging

Do not stop Xarelto without medical advice. Premature discontinuation of anticoagulation increases the risk of thrombotic events.

If Xarelto must be discontinued for reasons other than pathological bleeding, consider covering the patient with an alternative anticoagulant.

Before invasive procedures, stop Xarelto at least 24 hours before the procedure (48 hours for high bleeding risk procedures).

Before spinal or epidural anaesthesia, stop Xarelto at least 18 hours before the procedure.

How to get Xarelto in the UK

Xarelto is available on NHS prescription from your GP, hospital specialist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

It is recommended by NICE as an option for stroke prevention in non-valvular AF (TA256), treatment of VTE (TA261), and prevention of VTE after hip or knee replacement (TA170).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.

Prepayment certificates (PPC) are available for patients who require multiple prescription items regularly.

Sources

• Xarelto 20 mg, Summary of Product Characteristics (EMC)
• Rivaroxaban, British National Formulary (BNF)
• NICE TA256: Rivaroxaban for preventing stroke in non-valvular atrial fibrillation
• Oral anticoagulation, NICE CKS
• Rivaroxaban, NHS
• MHRA Yellow Card Scheme