Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Rivaroxaban

Generic name
Rivaroxaban
Brand name
ATC Code
B01AF01

Pharmacokinetics in children

Cl and Vss after oral administration are dependent on body weight and were estimated on the basis of pharmacokinetic population modeling in children to average 8 L/hr and 113 L, respectively, for an individual weighing 82.8 kg.

Mean t½ (estimated with pharmacokinetic population modeling):

0-6 months 1,6 hours
6 month - 2 years 1,9 hours
2-12 years 3 hours
Adolescenten 4,2 hours


[SmPC Xarelto]

 

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Treatment of venous thrombo-embolic events (VTE) and prevention of recurrent venous thrombo-embolic events (VTE)
  • Oral
    • 2.6 up to 12 kg

      • 2,6 to 3 kg: 2,4 mg/day in 3 doses
        > 3 to 4 kg: 2,7 mg/day in 3 doses
        > 4 to 5 kg: 4,2 mg/day in 3 doses
        > 5 to 7 kg: 4,8 mg/day in 3 doses
        > 7 to 8 kg: 5,4 mg/day in 3 doses
        > 8 to 9 kg: 7,2 mg/day in 3 doses
        > 9-10 kg: 8,4 mg/day in 3 doses
        > 10 to 12 kg: 9 mg/day in 3 doses

      • Initiate treatment only after

        • at least 5 days of initial parenteral anticoagulation
        • at least 10 days of oral feeding (for children < 6 months)
    • 12 up to 30 kg
      • 10 mg/day in 2 doses.

      • Initiate treatment only after at least 5 days of initial parenteral anticoagulation

    • 30 up to 50 kg
      • 15 mg/day in 1 dose

      • Initiate treatment only after at least 5 days of initial parenteral anticoagulation

    • ≥ 50 kg
      • 20 mg/day in 1 dose

      • Initiate treatment only after at least 5 days of initial parenteral anticoagulation
Thromboprophylaxis in Congenital Heart Disease after the Fontan Procedure
  • Oral
    • 2 years up to 18 years and 7 up to 8 kg
      • 2.2 mg/day in 2 doses.
    • 2 years up to 18 years and 8 up to 10 kg
      • 3.2 mg/day in 2 doses.
    • 2 years up to 18 years and 10 up to 12 kg
      • 3.4 mg/day in 2 doses.
    • 2 years up to 18 years and 12 up to 20 kg
      • 4 mg/day in 2 doses.
    • 2 years up to 18 years and 20 up to 30 kg
      • 5 mg/day in 2 doses.
    • 2 years up to 18 years and 30 up to 50 kg
      • 7.5 mg/day in 1 dose
    • 2 years up to 18 years and ≥ 50 kg
      • 10 mg/day in 1 dose

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Renal impaiment in children > 3 months

> 1 jaar
> 50 - 80 mL/min/1.73 m2: Dose adjustment not needed (based on data in adults and limited data in children)
< 50 mL/min/1.73 m2: no data available

< 1 jaar: not recommended in children with serum creatinine results above 97.5th percentile

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Overall, the safety profile in the 412 children and adolescents treated with
rivaroxaban was similar to that observed in the adult population and consistent across age subgroups: The adverse drug reactions in paediatric patients were primarily mild to moderate in severity. The following side effects were reported more frequently as compared to adults.

Very common: headache, fever, epistaxis, vomiting

Common: tachycardia, increase in bilirubin, menorrhagia, thrombocytopenia 

Uncommon: increase in conjugated bilirubin

 

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Vitamin K antagonists
B01AA07
B01AA04
Heparin group
B01AB04
B01AB09
B01AB05
B01AB01
B01AB06
B01AB10
Platelet aggregation inhibitors excl. heparin
B01AC06
B01AC04
B01AC09
Enzymes
B01AD02
B01AD01
B01AD04
Direct thrombin inhibitors
B01AE07
Direct factor Xa inhibitors
B01AF02

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References

  1. Bayer AG, SmPC Xarelto granules for oral suspension (EU/1/08/472) Rev 36, 13-12-2021, www.ema.europa.eu
  2. Bayer HealthCare AG, Product Information Leaflet (FDA) Xarelto (Reference ID: 5122861 (, www.accessdata.fda.gov, 02/2023

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Changes

Changes