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Direct Oral Anticoagulant — Factor Xa Inhibitor Pregnancy: CONTRAINDICATED IN PREGNANCY AND BREAST-FEEDING (UK). UK SPC 4.6, verbatim: 'Safety and efficacy of Rivaroxaban have not been established in pregnant women. Studies in animals have shown reproductive toxicity. Due to the potential reproductive toxicity, the intrinsic risk of bleeding and the evidence that rivaroxaban passes the placenta, Rivaroxaban is contraindicated during pregnancy. Women of child bearing potential should avoid becoming pregnant during treatment with rivaroxaban.' BREAST-FEEDING: 'Safety and efficacy of Rivaroxaban have not been established in breast-feeding women. Data from animals indicate that rivaroxaban is secreted into milk. Therefore Rivaroxaban is contraindicated during breast-feeding. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy.' The US label is less absolute and should not be substituted for the UK position: 'The limited available data on XARELTO in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. Use XARELTO with caution in pregnant patients because of the potential for pregnancy related hemorrhage and/or emergent delivery. The anticoagulant effect of XARELTO cannot be reliably monitored with standard laboratory testing.'

Rivaroxaban (Stroke Prevention — AF)

Brand names: Xarelto

Rivaroxaban is an oral direct factor Xa inhibitor used here for stroke and systemic embolism prevention in non-valvular atrial fibrillation. This page concerns its anticoagulant role in AF rather than venous thromboembolism treatment.

Adult dose

Dose: 20 mg once daily for patients with creatinine clearance greater than 50 mL/min
Route: Oral. UK SPC 4.2 method of administration: 'Rivaroxaban is for oral use.' 'For patients who are unable to swallow whole tablets, Rivaroxaban tablet may be crushed and mixed with water or apple puree immediately prior to use and administered orally. The crushed tablet may also be given through gastric tubes.'
Frequency: Once daily, taken with the evening meal
SCOPE: this is the page's primary indication and route - reduction in the risk of stroke and systemic embolism in non-valvular atrial fibrillation, by mouth, in adults - and it comes from US labelling because the UK SPC fetched in this bundle covers only the 10 mg tablet's orthopaedic-prophylaxis and DVT/PE-treatment indications. VERBATIM US LABEL, section 2.1 Table 1: 'Reduction in Risk of Stroke in Nonvalvular Atrial Fibrillation | CrCl >50 mL/min | 20 mg once daily | Take with evening meal'. Section 2 Highlights: 'Nonvalvular Atrial Fibrillation: 15 or 20 mg, once daily with food (2.1)'. CAUTION - CORRUPTED SOURCE TEXT: the 'CrCl <=50 mL/min' row of that same Table 1 is mangled in the fetched text (it reads 'Patients with CrCl 13 and 13 and < 18 years', the comparators and the dose having been lost), so NO reduced dose for impaired renal function is asserted here; the Highlights line above shows the indication's dosage range is 15 or 20 mg once daily, and the exact renal threshold and reduced dose must be read from the full prescribing information or the UK SPC. CORROBORATION ONLY (not a posology statement): the UK SPC's own section 4.8 trial table lists 'Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, 7,750 [patients], 20 mg [total daily dose], 41 months'. MISSED DOSE (US label 2.5): 'For patients receiving 20 mg, 15 mg or 10 mg once daily: The patient should take the missed XARELTO dose immediately. The dose should not be doubled within the same day to make up for a missed dose.' SWITCHING (US label 2.3): 'When switching patients from warfarin to XARELTO, discontinue warfarin and start XARELTO as soon as the International Normalized Ratio (INR) is below 3.0 in adults'; converting from a parenteral anticoagulant (UK SPC 4.2), 'start Rivaroxaban 0 to 2 hours before the time that the next scheduled administration of the parenteral medicinal product... would be due'. DISCONTINUATION RISK (US label 5.1, boxed): 'Premature discontinuation of any oral anticoagulant, including XARELTO, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events.' NO MAXIMUM DOSE with an explicit ceiling cue appears anywhere in either fetched label for this indication, so maxDose is left empty rather than inferred from the 20 mg figure.

Paediatric dose

NO PAEDIATRIC DOSE FOR THIS INDICATION EXISTS IN EITHER FETCHED LABEL - atrial fibrillation is not a paediatric indication for rivaroxaban in the fetched text. UK SPC 4.2, verbatim: 'The safety and efficacy of Rivaroxaban 10mg tablets in children aged 0 to 18 years have not been established. No data are available. Therefore, Rivaroxaban 10mg tablets are not recommended for use in children below 18 years of age.' The US label's paediatric experience (section 8.4) is confined to a different indication: 'The safety and effectiveness of XARELTO have been established in pediatric patients from birth to less than 18 years for the treatment of VTE and the reduction in risk of recurrent VTE', plus patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure. Those paediatric regimens are body-weight-banded rather than per-kilogram, and the US label's paediatric dosing table (section 2.2) was corrupted and truncated in the fetched text, so no paediatric figure is published here. Seek specialist paediatric haematology advice and verify against a children's formulary.

Dose adjustments

Renal

Renal function determines both eligibility and dose, but the atrial-fibrillation reduced dose could not be read from this bundle. US label section 2.1 gives '20 mg once daily' for CrCl >50 mL/min; the 'CrCl <=50 mL/min' row of the same table is corrupted in the fetched text, and the section 2 Highlights give the indication's range only as '15 or 20 mg, once daily with food' - so no reduced-dose figure is asserted here. UK SPC 4.2/4.4 (written for the 10 mg tablet's own indications, but stating the drug-level limits): 'Limited clinical data for patients with severe renal impairment (creatinine clearance 15 - 29 ml/min) indicate that rivaroxaban plasma concentrations are significantly increased. Therefore, Rivaroxaban is to be used with caution in these patients. Use is not recommended in patients with creatinine clearance < 15 ml/min.' 'In patients with moderate renal impairment (creatinine clearance 30 - 49 ml/min) concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations Rivaroxaban is to be used with caution.' US label 7.2: 'XARELTO should not be used in patients with CrCl 15 to <80 mL/min who are' [sentence truncated at the source-fetch limit] receiving combined P-gp and moderate CYP3A inhibitors.

Hepatic

UK SPC 4.2: 'Rivaroxaban is contraindicated in patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C.' No dose-reduction option is offered - it is a contraindication, not an adjustment.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients (UK SPC 4.3). US label section 4: 'severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions)'
  • Active clinically significant bleeding (UK SPC 4.3). US label section 4: 'active pathological bleeding'
  • Lesion or condition considered a significant risk for major bleeding - UK SPC 4.3 names 'current or recent gastrointestinal ulceration, presence of 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, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities'
  • Concomitant treatment with any other anticoagulant - unfractionated heparin, low molecular weight heparins (enoxaparin, dalteparin), heparin derivatives (fondaparinux), other oral anticoagulants (warfarin, dabigatran etexilate, apixaban) - except under the specific circumstances of switching anticoagulant therapy, or when unfractionated heparin is given at doses necessary to maintain an open central venous or arterial catheter (UK SPC 4.3)
  • Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients with Child Pugh B and C (UK SPC 4.3)
  • Pregnancy and breast-feeding (UK SPC 4.3)
  • Not a contraindication but a labelled 'not recommended' (US label section 5): prosthetic heart valves - 'XARELTO use not recommended (5.8)'; and triple positive antiphospholipid syndrome - 'Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: XARELTO use not recommended (5.10)'
  • Use is not recommended in patients with creatinine clearance below 15 ml/min (UK SPC 4.2 and 4.4)

Side effects

  • Bleeding is the most common adverse reaction. US label section 6: 'The most common adverse reaction (>5%) in adult patients was bleeding'; 'The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis'
  • UK SPC 4.8: 'The most commonly reported bleedings were epistaxis (4.5 %) and gastrointestinal tract haemorrhage (3.8 %)'
  • UK SPC 4.4: 'In the clinical studies mucosal bleedings (i.e. epistaxis, gingival, gastrointestinal, genito urinary including abnormal vaginal or increased menstrual bleeding) and anaemia were seen more frequently during long term rivaroxaban treatment compared with VKA treatment'
  • Anaemia - UK SPC 4.8 rates by indication: treatment of DVT, PE and prevention of recurrence, any bleeding 23% of patients and anaemia 1.6% of patients; prevention of stroke and systemic embolism in non-valvular atrial fibrillation, 28 bleeding events per 100 patient years and anaemia 2.5 per 100 patient years
  • Spinal / epidural haematoma - a boxed warning in the US label (sections 5.3 and 6)
  • Increased risk of thrombotic events, including stroke, after premature discontinuation - US label 5.1: 'An increased rate of stroke was observed during the transition from XARELTO to warfarin in clinical trials in atrial fibrillation patients'
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • UK SPC 4.4: 'Clinical surveillance in line with anticoagulation practice is recommended throughout the treatment period.' 'As with other anticoagulants, patients taking Rivaroxaban are to be carefully observed for signs of bleeding'
  • UK SPC 4.4: 'in addition to adequate clinical surveillance, laboratory testing of haemoglobin/haematocrit could be of value to detect occult bleeding and quantify the clinical relevance of overt bleeding, as judged to be appropriate'. 'Any unexplained fall in haemoglobin or blood pressure should lead to a search for a bleeding site'
  • Renal function - dosing and the decision to treat depend on creatinine clearance; UK SPC 4.4 states use is not recommended below 15 ml/min and requires caution at 15-29 ml/min. US label section 2.1: 'Calculate CrCl based on actual weight'
  • No routine coagulation monitoring - UK SPC 4.4: 'Although treatment with rivaroxaban does not require routine monitoring of exposure, rivaroxaban levels measured with a calibrated quantitative anti-factor Xa assay may be useful in exceptional situations where knowledge of rivaroxaban exposure may help to inform clinical decisions, e.g. overdose and emergency surgery'
  • INR is not valid on rivaroxaban - UK SPC 4.2: 'International Normalised Ratio (INR) values will be falsely elevated after the intake of Rivaroxaban. The INR is not valid to measure the anticoagulant activity of Rivaroxaban, and therefore should not be used'
  • Around procedures - US label 2.4: 'XARELTO should be stopped at least 24 hours before the procedure to reduce the risk of bleeding'

Clinical monograph

How it works

It directly and reversibly inhibits activated factor Xa, interrupting the coagulation cascade and reducing thrombin generation and clot formation.

Prescribing in practice

  • It is contraindicated in active clinically significant bleeding and should be avoided in mechanical heart valves and moderate-to-severe mitral stenosis, where it is not a substitute for a vitamin K antagonist.
  • Dose is adjusted according to renal function, and it should be taken with food at the treatment-dose level to ensure adequate absorption.
  • Concomitant strong dual CYP3A4 and P-glycoprotein inhibitors or inducers, and other antithrombotics, materially alter bleeding risk and should prompt review.

Monitoring

Routine coagulation monitoring is not required, but renal function, haemoglobin and signs of bleeding should be reviewed periodically and before significant procedures.

Counselling the patient

  • Take it at the same time each day and report any unusual bruising, blood in urine or stool, or black stools promptly.
  • Do not stop it abruptly without advice, as this raises stroke risk.
  • Carry an anticoagulant alert card and tell any dentist or surgeon before procedures.

Evidence & guidelines

The ROCKET-AF trial established rivaroxaban as non-inferior to warfarin for stroke prevention in atrial fibrillation, and NICE supports its use in this indication.

Reference: ROCKET-AF Trial (NEJM 2011); NICE NG196 (AF); MHRA DOAC Safety Update; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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