Active Ingredient: Rivaroxaban
Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in term neonates, infants and toddlers, children, and adolescents aged less than 18 years after at least 5 days of initial parenteral anticoagulation treatment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≥ 2.6 kg and patient weight is < 3 kg, oral, 0.8 milligrams rivaroxaban, 3 times daily.
Regimen B: In case that patient weight is ≥ 3 kg and patient weight is < 4 kg, oral, 0.9 milligrams rivaroxaban, 3 times daily.
Regimen C: In case that patient weight is ≥ 4 kg and patient weight is < 5 kg, oral, 1.4 milligrams rivaroxaban, 3 times daily.
Regimen D: In case that patient weight is ≥ 5 kg and patient weight is < 7 kg, oral, 1.6 milligrams rivaroxaban, 3 times daily.
Regimen E: In case that patient weight is ≥ 7 kg and patient weight is < 8 kg, oral, 1.8 milligrams rivaroxaban, 3 times daily.
Regimen F: In case that patient weight is ≥ 8 kg and patient weight is < 9 kg, oral, 2.4 milligrams rivaroxaban, 3 times daily.
Regimen G: In case that patient weight is ≥ 9 kg and patient weight is < 10 kg, oral, 2.8 milligrams rivaroxaban, 3 times daily.
Regimen H: In case that patient weight is ≥ 10 kg and patient weight is < 12 kg, oral, 3 milligrams rivaroxaban, 3 times daily.
Regimen I: In case that patient weight is ≥ 12 kg and patient weight is < 30 kg, oral, 5 milligrams rivaroxaban, 2 times daily.
Regimen J: In case that patient weight is ≥ 30 kg and patient weight is < 50 kg, oral, 15 milligrams rivaroxaban, once daily.
Regimen K: In case that patient weight is ≥ 50 kg, oral, 20 milligrams rivaroxaban, once daily.
The dose and frequency of administration are determined based on body weight (see Table 1).
Table 1. Recommended dose for rivaroxaban 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:
| Bodyweight [kg] | Regimen Dose rivaroxaban | Total daily dose | |||
|---|---|---|---|---|---|
| (1 mg rivaroxaban corresponds to 1 mL of the suspension) | |||||
| Min | Max | once a day | 2 times a day | 3 times a day | |
| 2.6 | <3 | 0.8 mg | 2.4 mg | ||
| 3 | <4 | 0.9 mg | 2.7 mg | ||
| 4 | <5 | 1.4 mg | 4.2 mg | ||
| 5 | <7 | 1.6 mg | 4.8 mg | ||
| 7 | <8 | 1.8 mg | 5.4 mg | ||
| 8 | <9 | 2.4 mg | 7.2 mg | ||
| 9 | <10 | 2.8 mg | 8.4 mg | ||
| 10 | <12 | 3.0 mg | 9.0 mg | ||
| 12 | <30 | 5 mg | 10 mg | ||
| 30 | <50 | 15 mg | 15 mg | ||
| ≥50 | 20 mg | 20 mg | |||
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.
For a once a day regimen: The doses should be taken approximately 24 hours apart.
For a two times a day regimen: The doses should be taken approximately 12 hours apart.
For a three times a day regimen: The doses should be taken approximately 8 hours apart.
Treatment for paediatric patients from term neonates to less than 6 months of age, who at birth had at least 37 weeks of gestation, weigh at least 2.6 kg, and have had at least 10 days of oral feeding should be initiated following at least 5 days of initial parenteral anticoagulation treatment. Rivaroxaban is dosed based on body weight using the oral suspension formulation (see Table 1).
Treatment for paediatric patients from 6 months to less than 18 years of age should be initiated following at least 5 days of initial parenteral anticoagulation treatment. Rivaroxaban is dosed based on body weight (see Table 1).
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.
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.
If taken once a day, a missed dose should be taken as soon as possible after it is noticed, but only on the same day. If this is not possible, the patient should skip the dose and continue with the next dose as prescribed. The patient should not take two doses to make up for a missed dose.
If taken twice a day, a missed morning dose should be taken immediately when it is noticed, and it may be taken together with the evening dose. A missed evening dose can only be taken during the same evening, the patient should not take two doses the next morning.
If taken three times a day, the three times daily administration schedule with approximately 8-hour intervals should simply be resumed at the next scheduled dose without compensating for the missed dose.
On the following day, the child should continue with the regular once, twice or three times daily regimen.
For patients currently receiving a parenteral anticoagulant, start rivaroxaban 0 to 2 hours before the time of the next scheduled administration of the parenteral medicinal product (e.g. LMWH) or at the time of discontinuation of a continuously administered parenteral medicinal product (e.g. intravenous unfractionated heparin).
Discontinue rivaroxaban and give the first dose of parenteral anticoagulant at the time that the next rivaroxaban dose would be taken.
VKA treatment should be stopped and rivaroxaban therapy should be initiated once the International Normalised Ratio (INR) is ≤2.5.
When converting patients from VKAs to rivaroxaban, INR values will be falsely elevated after the intake of rivaroxaban. The INR is not valid to measure the anticoagulant activity of rivaroxaban, and therefore should not be used.
There is a potential for inadequate anticoagulation during the transition from rivaroxaban to VKA. Continuous adequate anticoagulation should be ensured during any transition to an alternate anticoagulant. It should be noted that rivaroxaban can contribute to an elevated INR.
Children who convert from rivaroxaban to VKA need to continue rivaroxaban for 48 hours after the first dose of VKA. After 2 days of co-administration an INR should be obtained prior to the next scheduled dose of rivaroxaban. Co-administration of rivaroxaban and VKA is advised to continue until the INR is ≥2.0. Once rivaroxaban is discontinued INR testing may be done reliably 24 hours after the last dose (see above).
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.