© 2016, Bayer AS
Siste oppdatering 08 april 2016
L.NO.MKT.03.2016.1478

Convenient Oral Therapy Enhances Control of Clot Risk

One tablet once daily, with no need for routine coagulation monitoring, facilitates patient protection from hospital to home

Xarelto® is simple and convenient to use for the patient and the physician, which facilitates protection from hospital to home. Xarelto® simplifies anticoagulation therapy for preventing venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery compared with enoxaparin and other injectables.1, 8 Xarelto® offers superior efficacy compared to enoxaparin in patients undergoing elective hip or knee replacement surgery with a similar and low incidence of bleeding.2, 3, 4
Other advantages of Xarelto®:1, 2, 3, 4, 8
  • Predictable pharmacokinetics with good bioavailability
  • Rapid onset of action following oral administration (2–4 hours)
  • Relatively short half-life (5–9 hours at steady state)
  • No need for routine coagulation monitoring, as demonstrated by the good efficacy and safety data generated in a wide range of patient groups (age, weight, BMI)
Because two thirds of the Xarelto® dose is metabolised in the liver and one third is directly excreted by the kidneys, there is no need to adjust dosing for most patients with renal impairment. However, Xarelto® is not recommended in patients with severe renal impairment with creatinine clearance < 15 mL/min and should be used with caution in patients with severe renal impairment with creatinine clearance of 15–29 mL/min.1

Clinical advantages of Xarelto®

Xarelto® is administered as one tablet once a day at a fixed dose of 10 mg, without the need for routine coagulation monitoring. In addition, there are:1, 2, 3, 4, 10
  • No dietary restrictions
  • No dose adjustment with regard to age, gender, weight, or ethnicity
  • No evidence of drug-induced liver injury attributable to Xarelto®

Dosing

The dose of Xarelto® for prevention of VTE in patients undergoing elective hip or knee replacement surgery is one 10 mg tablet once daily. Xarelto® can be administered with or without food.
No dose adjustment of Xarelto® is necessary for gender, age, or weight.
Xarelto® 10 mg is presented as a 6-mm-diameter light-red biconvex film-coated tablet. Each tablet contains 10 mg of rivaroxaban in an immediate-release formulation.
Starting dose: the first dose should be administered 6–10 hours after surgery, provided that haemostasis has been established.
Treatment duration: a treatment duration of 5 weeks is recommended for patients undergoing elective hip replacement surgery and 2 weeks for patients undergoing elective knee replacement surgery.1

Superior efficacy in clot prevention

Along with a simplified therapeutic regimen, it has been shown in studies that Xarelto®, given as one tablet once daily, is significantly more effective than enoxaparin in preventing venous blood clots in adult patients undergoing elective hip and knee replacement surgery. This has been shown in head-to-head comparisons with enoxaparin when both drugs were given over the same time period (RECORD1 over 5 weeks and RECORD3 over 2 weeks) and when comparing extended-duration (5 weeks) Xarelto® with short-duration (2 weeks) enoxaparin (RECORD2).1, 2, 3, 4

  • 1 - Xarelto® (rivaroxaban) Summary of Product Characteristics as approved by the European Commission.
  • 8 - Kubitza D, Haas S. Novel factor Xa inhibitors for prevention and treatment of thromboembolic diseases. Expert Opin Investig Drugs. 2006;15(8):843-855.
  • 2 - Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775.
  • 3 - Kakkar AK, Brenner B, Dahl OE, et al; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39.
  • 4 - Lassen MR, Ageno W, Borris LC, et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.
  • 10 - Data on file. Turpie, 2008 EFORT Presentation RECORD4.
Efficacy
The ability of a drug to produce the desired effect.
Venous thromboembolism
A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.

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Xarelto® is excreted by a dual mode of elimination: 2/3 is metabolized by the liver, 1/3 of active drug is eliminated unchanged via the kidneys. 1

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