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Xarelto® Tailored treatment and prevention for your Eligible Cardiovascular Patients

Based on results from the EINSTEIN Junior trial in children aged 0-17, you can offer paediatric patients an oral anticoagulation to treat VTE and prevent VTE recurrence
*,§,††

  • The licence was granted following the positive outcomes of the EINSTEIN JUNIOR trial – the first factor Xa study completed in children with VTE.
     

    EINSTEIN JUNIOR was a randomised, open-label, Phase 3 study of 500 patients aged 0–17 years with confirmed VTE. The patients completed 5–9 days of anticoagulation with unfractionated heparin, low molecular weight heparin, or fondaparinux, then were randomly assigned to receive one of the following regimens:

    • Bodyweight adjusted rivaroxaban in a 20 mg-equivalent dose, given once-daily (for bodyweights of ≥30 kg), twice-daily (for bodyweights of 12–<30 kg), or three times daily (for bodyweights of <12 kg)
    • Continuation of heparin treatment or switched to a VKA 

    The main treatment period was 3 months.

    Xarelto

    ¶ Body-weight-adjusted rivaroxaban dose equivalent to 20 mg OD adult dose.
    † Children aged <2 years with catheter-related VTE: extension with maximum two blocks of 1 month; decision to stop or continue treatment made after each 3 or 1-month period.

    Xarelto

    ‡ Patients in the SoC arm either continued treatment with heparin or were switched to a VKA.

    The study confirmed Xarelto® efficacy and safety profile in children with VTE, and demonstrated:

    The risk of VTE is increased in certain populations

    # RRR was calculated as 1-HR.

    Safety Profile

    Patients taking Xarelto are to be carefully observed for signs of bleeding. The risk of bleeding should be carefully evaluated before and during therapy with rivaroxaban.

    ‖ The principal safety outcome was the composite of overt major and clinically relevant non-major bleeding.

  • Recommended dose for Xarelto in paediatric patients from full-term neonates (following at least 10 days of oral feeding and weighing at least 2.6 kg) to children less than 18 years of age.

    Xarelto® in children is based on body weight-adjusted 20 mg-equivalent daily dosing as per the table below§

    Xarelto

    § After at least 5 days of parenteral anticoagulation treatment.

    The weight of the child should be monitored and the dose reviewed regularly, especially for children below 12 kg. This is to ensure that a therapeutic dose is maintained. Dose adjustments should be made based on changes in body weight only.

    Please refer to the Summary of Product Characteristics for full prescribing information.

Footnotes

* Not recommended in patients with CrCl <15 ml/min and in patients with renal impairment when concomitantly receiving medicinal products that increase rivaroxaban plasma concentration.
Not recommended in children 1 year or older with moderate or severe renal impairment (glomerular filtration rate < 50 mL/min/1.73 m),as no clinical data is available.
Not recommended in children younger than 1 year with serum creatinine results above 97.5th percentile, as no clinical data are available.
§ After at least 5 days of parenteral anticoagulation treatment.
†† For all children, except those aged less than 2 years with catheter-related thrombosis: Therapy should be continued for at least 3 months. Treatment can be extended up to 12 months when clinically necessary. There is no data available in children to support a dose reduction after 6 months treatment. The benefit-risk of continued therapy after 3 months should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential bleeding risk. For Children aged less than 2 years with catheter-related thrombosis: Therapy should be continued for at least 1 month. Treatment can be extended up to 3 months when clinically necessary. The benefit-risk of continued therapy after 1 month should be assessed on an individual basis taking into account the risk for recurrent thrombosis versus the potential bleeding risk.
Volume and frequency of administration of Xarelto is dependent on a child’s weight and will need to be adjusted if the child receives Xarelto for a long period of time.

 

VTE, venous thromboembolism; ARR, absolute risk reduction; BID, twice daily; CI, confidence interval; CrCl, creatinine clearance; LMWH, low-molecular-weight heparin; OD, once daily; R, randomisation; UFH, unfractionated heparin; VKA, vitamin K antagonist; SoC, standard of care.

PP-XAR-GB-3587 |  March 2024

    • 1
      Xarelto (rivaroxaban) Summary of Product Characteristics, UK.
    • 2
      Xarelto (rivaroxaban) Summary of Product Characteristics, UK.
    • 3
      Male C, et al. Lancet Haematol. 2020;7:e18–e27.