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

Reassuring Safety

A safety profile comparable to the current standard of care

In adult patients undergoing elective knee and hip replacement surgery, Xarelto® has a reassuring safety profile comparable with that of enoxaparin. In clinical trials, there was similar incidence of major and non-major bleeds, including haemorrhagic wound complications and drug-related adverse events, between Xarelto® and enoxaparin.2, 3, 4
The findings are based on the RECORD1-3 clinical study programme for Xarelto® involving more than 9,500 patients. Patients commonly seen in clinical practice were well represented in the RECORD studies. These studies included a wide range of patient types from both genders spread across a broad range of age (18 to 93 years) and weight (33 to 190 kg) groups as well as various ethnic backgrounds.2, 3, 4
Xarelto® requires no routine coagulation monitoring, nor is it associated with dietary restrictions.1

Low bleeding rates comparable to enoxaparin, with superior clot prevention

Across the RECORD1, RECORD2, and RECORD3 studies the incidence of major bleeding, non-major bleeding, and haemorrhagic wound complications was low and similar between the Xarelto® and enoxaparin groups.2, 3, 4

 

Reassuring liver safety

There has been no evidence of drug-induced liver injury attributable to Xarelto®. There was extensive monitoring throughout RECORD1-3, which provided a solid basis for confirming the favourable liver safety profile.2, 3, 4
Xarelto® is eliminated via both the renal and the hepatic/biliary route, with two thirds of the compound being cleared though metabolism in the liver.1

Extensive evidence on hepatic safety

  • In over 9,500 patients included in the studies RECORD1-3, there has been no evidence of drug-induced liver injury.2, 3, 4
  • Xarelto® is contraindicated in patients with significant hepatic disease, which is associated with coagulopathy and clinically relevant bleeding risk.1
  • The incidence of elevated alanine transferase (ALT) during and after treatment with Xarelto® was low and similar to that of enoxaparin.2, 3, 4

 

Comparable adverse event profile

  • The overall incidence of any adverse events, including serious drug-related adverse events, was similar in the Xarelto® arm and the enoxaparin arm for the RECORD1-3 studies.
  • There was also a similar incidence in drug-related adverse events between Xarelto® and enoxaparin in the RECORD1-3 studies.2, 3, 4

Treatment-emergent events and cardiovascular (CV) events

The rate of CV events before and after treatment with Xarelto® was low and similar to that of enoxaparin.2, 3, 4

 

Contraindications

  • Patients with clinically significant active bleeding
  • Patients with liver disease associated with coagulopathy and a clinically relevant bleeding risk
  • Pregnant and breast-feeding women
  • Patients with hypersensitivity to rivaroxaban or to any component of the tablet1

Warnings and precautions for use

Use of Xarelto® is not recommended in:
  • Patients undergoing hip fracture surgery due to lack of data
  • Patients with creatinine clearance <15mL/min.
  • Patients on systemic treatment with azole-antimycotics (eg. ketoconazole) or an HIV protease inhibitor (eg. ritonavir)
Xarelto® should be used with caution in:
  • Patients with an increased bleeding risk (evaluation for bleeding disorders should be done before administration)
  • Patients with severe renal impairment (creatinine clearance of 15–29 mL/min)
  • Patients with moderate renal impairment (creatinine clearance of 30–49 mL/min) concomitantly receiving medications or other medicinal products leading to increased rivaroxaban plasma concentrations
  • Patients taking concomitant nonsteroidal anti-inflammatory drugs (NSAIDs/acetylsalicylic acid), platelet aggregation inhibitors, or other antithrombotic drugs
  • Coadministration with Strong CYP3A4 inducers
  • Patients receiving neuraxial anaesthesia1

For complete information, please refer to full Summary of Product Characteristics


Simplicity and convenience

With one tablet once daily and fixed dosing, Xarelto® offers outstanding convenience, supporting patient compliance, from hospital to home.1, 8

  • 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.
  • 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.

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The incidence of first-time VTE increases exponentially with age.
a. Under 15 years of age: <5 cases per 100, 000 per year
b. Over 80 years of age: 450–600 cases per 100,000 per year (~0.5%/year)63

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