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Direct Oral Anticoagulant — VTE Prophylaxis Post-Surgery Pregnancy: Contraindicated during pregnancy and breast-feeding. Safety and efficacy have not been established in pregnant women; animal studies show reproductive toxicity and rivaroxaban passes the placenta, with an intrinsic risk of bleeding. Women of childbearing potential should avoid becoming pregnant during treatment. Animal data indicate rivaroxaban is secreted into milk.

Rivaroxaban (Perioperative VTE Prophylaxis)

Brand names: Xarelto

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

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: Prevention of VTE in adult patients undergoing elective hip or knee replacement surgery: 10 mg once daily, the initial dose taken 6 to 10 hours after surgery provided that haemostasis has been established
Route: Oral (tablets may be taken with or without food; may be crushed and mixed with water or apple puree, or given via a gastric tube, if the patient cannot swallow whole tablets)
Frequency: Once daily
Source: UK SPC for Rivaroxaban 10 mg film-coated tablet (§4.2). Duration depends on the type of orthopaedic surgery: 5 weeks after major hip surgery, 2 weeks after major knee surgery. If a dose is missed the patient should take it immediately and then continue the following day with once daily intake as before. OTHER REGIMENS IN THE SAME SPC (not the perioperative prophylaxis dose): treatment of DVT/PE and prevention of recurrence - 15 mg twice daily for the first three weeks (days 1-21), then 20 mg once daily from day 22; extended prevention of recurrent DVT/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: from a parenteral anticoagulant, start rivaroxaban 0 to 2 hours before the next scheduled parenteral dose would be due, or at the time a continuous parenteral infusion is discontinued; from a VKA, stop the VKA and start rivaroxaban once the INR is <= 2.5. INR is not valid for measuring rivaroxaban activity. No dose adjustment for elderly, body weight or gender. Paediatric population: safety and efficacy of the 10 mg tablets in children aged 0 to 18 years have not been established, no data are available, and they are not recommended below 18 years of age - verify any paediatric use against a children's formulary.

Dose adjustments

Renal

For the prevention of VTE in adults undergoing elective hip or knee replacement surgery, no dose adjustment is necessary in mild (creatinine clearance 50-80 ml/min) or moderate (30-49 ml/min) renal impairment. Use with caution in severe renal impairment (creatinine clearance 15-29 ml/min), in whom plasma concentrations are significantly increased; use is not recommended in patients with creatinine clearance <15 ml/min. (For DVT/PE treatment dosing the SPC gives separate reductions - see §4.2.)

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 to any of the excipients
  • Active clinically significant bleeding
  • Lesion or condition considered 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, major intraspinal or intracerebral vascular abnormalities)
  • Concomitant treatment with any other anticoagulant (e.g. unfractionated heparin, low molecular weight heparins such as enoxaparin or dalteparin, heparin derivatives such as fondaparinux, oral anticoagulants such as warfarin, dabigatran etexilate or apixaban), except under the specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to keep a central venous or arterial catheter open
  • 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 adverse reactions; any bleeding occurred in 6.8% of patients in the elective hip or knee replacement VTE prevention studies
  • Epistaxis (4.5%) - the most commonly reported bleeding
  • Gastrointestinal tract haemorrhage (3.8%)
  • Anaemia - 5.9% of patients in the elective hip or knee replacement VTE prevention studies
  • Mucosal bleeding (epistaxis, gingival, gastrointestinal, genito-urinary including abnormal vaginal or increased menstrual bleeding) and anaemia were seen more frequently during long-term rivaroxaban treatment than with vitamin K antagonists (§4.4)

Interactions

  • Systemic azole antimycotics (ketoconazole, itraconazole, voriconazole, posaconazole) and HIV protease inhibitors (e.g. ritonavir) - strong inhibitors of both CYP3A4 and P-gp that may increase rivaroxaban plasma concentrations; concomitant use is not recommended (SPC §4.4)
  • Any other anticoagulant (UFH, LMWH, fondaparinux, warfarin, dabigatran, apixaban) - concomitant treatment is contraindicated except when switching therapy or when UFH is used to maintain an open central venous or arterial catheter (§4.3)
  • Moderate renal impairment (creatinine clearance 30-49 ml/min) with concomitant medicinal products that increase rivaroxaban plasma concentrations - use with caution (§4.4)
  • INR is falsely elevated after intake of rivaroxaban and is not valid to measure its anticoagulant activity; where measurement is needed, a calibrated quantitative anti-factor Xa assay may be used in exceptional situations such as overdose or emergency surgery (§4.2, §4.4)

Clinical monograph

How it works

Rivaroxaban directly and selectively inhibits activated factor Xa, reducing thrombin generation and clot formation.

Prescribing in practice

  • Bleeding is the principal risk — observe a safe interval after surgery and after neuraxial anaesthesia or catheter removal before starting or resuming, to minimise the danger of spinal or epidural haematoma.
  • Avoid in significant renal impairment and with strong dual CYP3A4 and P-glycoprotein inhibitors or inducers, which substantially alter exposure.
  • There is no immediate routine laboratory monitoring; manage major bleeding with the specific reversal agent or prothrombin complex concentrate as locally directed.

Monitoring

Monitor for bleeding, renal function and haemoglobin rather than routine coagulation assays, and confirm appropriate timing around regional anaesthesia.

Counselling the patient

  • This tablet thins the blood to prevent clots in the legs and lungs after your joint surgery.
  • Report unusual bruising, bleeding that will not stop, or black stools.
  • Take it as instructed and do not miss doses.

Evidence & guidelines

Rivaroxaban is a licensed and guideline-supported option for VTE prophylaxis following elective hip and knee replacement.

Reference: NICE TA170/TA261; Xarelto SPC; ESRA Neuraxial Anaesthesia and Anticoagulants Guidelines 2021; 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.