Factor Xa Inhibitor (DOAC) Pregnancy: Contraindicated during pregnancy and breast-feeding. Safety and efficacy have not been established in pregnant or breast-feeding women; animal studies show reproductive toxicity and rivaroxaban passes the placenta and is secreted into milk in animals. Women of childbearing potential should avoid becoming pregnant during treatment.

Rivaroxaban (VTE Prophylaxis — Orthopaedic)

Brand names: Xarelto

Rivaroxaban is an oral direct factor Xa inhibitor anticoagulant used here for venous thromboembolism prophylaxis after major orthopaedic surgery such as hip and knee replacement.

Adult dose

Dose: 10 mg

Route: Oral

Frequency: Once daily; the initial dose should be taken 6 to 10 hours after surgery, provided that haemostasis has been established

Indication: prevention of VTE in adult patients undergoing elective hip or knee replacement surgery. Duration of treatment depends on the individual VTE risk determined by the type of orthopaedic surgery - for patients undergoing major hip surgery a treatment duration of 5 weeks is recommended; for patients undergoing major knee surgery a treatment duration of 2 weeks is recommended. If a dose is missed, the patient should take rivaroxaban immediately and then continue the following day with once daily intake as before. Other regimens on the same SPC, for reference only and NOT the orthopaedic prophylaxis dose: treatment of acute DVT or PE - 15 mg twice daily for the first three weeks followed by 20 mg once daily; extended prevention of recurrent DVT and PE after completing at least 6 months of therapy - 10 mg once daily, or 20 mg once daily where recurrence risk is considered high. Switching to and from vitamin K antagonists and parenteral anticoagulants is set out in SPC section 4.2. Note: the paediatric part of section 4.2 was not captured within the retrieved text (the retrieved posology was truncated at the source-fetch limit after the renal impairment paragraph) - clinician to check the full SPC.

Dose adjustments

Renal

Use with caution in severe renal impairment (creatinine clearance 15-29 mL/min), where rivaroxaban plasma concentrations are significantly increased. Use is not recommended in patients with creatinine clearance below 15 mL/min. Use with caution in moderate renal impairment (creatinine clearance 30-49 mL/min) when concomitant medicines increase rivaroxaban plasma concentrations.

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
Active clinically significant bleeding
Lesion or condition considered to be a significant risk for major bleeding - e.g. 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, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
Concomitant treatment with any other anticoagulant (unfractionated heparin, low molecular weight heparins, heparin derivatives, other oral anticoagulants) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including cirrhotic patients with Child-Pugh B and C
Pregnancy and breast-feeding

Side effects

Bleeding - the most commonly reported bleedings were epistaxis (4.5%) and gastrointestinal tract haemorrhage (3.8%)
Any bleeding occurred in 6.8% of patients receiving rivaroxaban for VTE prevention after elective hip or knee replacement surgery
Anaemia - 5.9% of patients in the elective hip or knee replacement prophylaxis studies
Mucosal bleeding (epistaxis, gingival, gastrointestinal, genito-urinary including abnormal vaginal or increased menstrual bleeding), seen more frequently during long-term treatment

Interactions

Not recommended in patients receiving concomitant systemic azole antimycotics (ketoconazole, itraconazole, voriconazole, posaconazole) or HIV protease inhibitors such as ritonavir - strong inhibitors of both CYP3A4 and P-gp that may increase rivaroxaban plasma concentrations to a clinically relevant degree
Use with caution in patients with moderate renal impairment (creatinine clearance 30-49 mL/min) who are concomitantly receiving other medicinal products that increase rivaroxaban plasma concentrations
Concomitant use with any other anticoagulant is contraindicated except when switching therapy or when UFH is used to keep a central venous or arterial catheter open
INR is not valid for measuring the anticoagulant activity of rivaroxaban and is falsely elevated after intake - do not use it to monitor therapy
(US labelling) Avoid combined P-gp and strong CYP3A inducers, which decrease rivaroxaban exposure and may increase the risk of thromboembolic events

Clinical monograph

How it works

It directly and reversibly inhibits activated factor Xa, reducing thrombin generation and clot formation.

Prescribing in practice

Bleeding is the principal risk, so assess bleeding risk against thrombosis risk, time the first dose appropriately after surgery and around neuraxial anaesthesia, and review concurrent antiplatelets or other anticoagulants.
Avoid in significant renal or hepatic impairment and check for interacting drugs such as combined strong CYP3A4 and P-glycoprotein inhibitors or inducers.
There is no routine coagulation monitoring; a specific reversal agent and supportive measures are used for major bleeding.

Monitoring

Monitor renal function, haemoglobin and clinically for bleeding rather than routine clotting assays.

Counselling the patient

Report unusual bruising, bleeding that will not stop, black stools, or blood in urine.
Tell other healthcare staff and dentists that you are taking an anticoagulant.
Take the course as prescribed for the recommended duration after your operation.

Evidence & guidelines

NICE recommends a direct oral anticoagulant such as rivaroxaban as an option for VTE prophylaxis after elective hip and knee replacement.

Reference: RECORD 1–4 Trials; NICE TA170 (THR/TKR VTE prophylaxis); 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