Direct Oral Factor Xa Inhibitor — VTE / PAD / AF Stroke Prevention Pregnancy: Contraindicated in pregnancy and breast-feeding (eMC §4.3, §4.6); women of child-bearing potential should avoid becoming pregnant during treatment.

Rivaroxaban

Brand names: Xarelto

Rivaroxaban is an oral direct factor Xa inhibitor (a DOAC) used to prevent and treat venous thromboembolism, prevent stroke in non-valvular atrial fibrillation, and, at low dose with aspirin, to reduce atherothrombotic events in vascular disease.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: CAD or PAD (prevention of atherothrombotic events): 2.5 mg twice daily, in combination with aspirin 75–100 mg once daily

Route: Oral (with or without food)

Frequency: Twice daily

Source note: the CAD/PAD (vascular) regimen is taken from the US label (openFDA §2.1); the UK 10 mg product SPC §4.2 posology provided did not itemise the CAD/PAD dose. eMC §4.8 corroborates a total daily dose of 5 mg (i.e. 2.5 mg twice daily) co-administered with aspirin for CAD/PAD — verify against the current UK 2.5 mg product SPC. Post-acute coronary syndrome (ACS): rivaroxaban 2.5 mg twice daily (total 5 mg/day) co-administered with ASA, or with ASA plus clopidogrel/ticlopidine (per eMC §4.8 study table). Other rivaroxaban indications covered by other product strengths: VTE prevention after hip/knee surgery — 10 mg once daily; DVT/PE treatment — 15 mg twice daily for 3 weeks then 20 mg once daily; non-valvular AF stroke prevention — 15–20 mg once daily.

Dose adjustments

Renal

Use with caution at CrCl 15–29 mL/min; use not recommended if CrCl <15 mL/min. Avoid in CrCl 15–<80 mL/min patients also receiving combined P-gp and moderate CYP3A inhibitors (US label).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or any excipient
Active clinically significant bleeding
Lesion or condition at significant risk of major bleeding (e.g. recent/current GI ulceration, malignant neoplasm at high bleeding risk, recent brain/spinal injury or surgery, recent intracranial haemorrhage, known/suspected oesophageal varices, arteriovenous malformations, vascular aneurysms)
Concomitant treatment with other anticoagulants, except when switching therapy or for catheter-patency UFH
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk (including cirrhosis Child-Pugh B and C)
Pregnancy and breast-feeding

Side effects

Bleeding (most common)
Epistaxis
Gastrointestinal tract haemorrhage
Anaemia
Mucosal bleeding (gingival, genitourinary)

Interactions

Concomitant aspirin/antiplatelet therapy is integral to the vascular regimen but increases bleeding risk — monitor closely
Not recommended with systemic azole-antimycotics (ketoconazole, itraconazole, voriconazole, posaconazole) or HIV protease inhibitors (e.g. ritonavir) — strong combined CYP3A4 and P-gp inhibitors that raise rivaroxaban levels and bleeding risk
Concomitant anticoagulants are contraindicated (except during switching); combined P-gp and strong CYP3A inducers may increase thromboembolic risk

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

Bleeding is the principal hazard — avoid in active clinically significant bleeding and in hepatic disease with coagulopathy, and assess bleeding risk before and during treatment; andexanet alfa or prothrombin complex concentrate may be used for life-threatening bleeds.
Avoid concomitant strong dual inhibitors or inducers of CYP3A4 and P-glycoprotein (such as azole antifungals, certain protease inhibitors, rifampicin), and do not use in pregnancy or breastfeeding.
Treatment-dose tablets must be taken with food for reliable absorption, and the drug is contraindicated in severe renal impairment with caution as creatinine clearance falls.

Monitoring

Routine coagulation monitoring is not required, but check renal and hepatic function and full blood count periodically and review for signs of bleeding or anaemia.

Counselling the patient

Take treatment doses with food at the same time each day.
Report unusual bruising, blood in urine or stool, or prolonged bleeding.
Carry an anticoagulant alert card and tell any dentist or surgeon.

Evidence & guidelines

Its indications are supported by the ROCKET-AF, EINSTEIN and COMPASS trial programmes and endorsed in NICE technology appraisals.

Reference: COMPASS Trial 2017; EINSTEIN-DVT/PE Trials; ROCKET-AF Trial; NICE TA354 (Rivaroxaban for VTE); 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways