Pediatric dosing guidance for the direct oral anticoagulant rivaroxaban

Patient's weight	Rivaroxaban dose*
2.6 to <3 kg	0.8 mg 3 times daily
3 to <4 kg	0.9 mg 3 times daily
4 to <5 kg	1.4 mg 3 times daily
≥5 to <7 kg	1.6 mg 3 times daily
≥7 to <8 kg	1.8 mg 3 times daily
8 to <9 kg	2.4 mg 3 times daily
9 to <10 kg	2.8 mg 3 times daily
10 to <12 kg	3 mg 3 times daily
12 to <30 kg	5 mg twice daily
30 to <50 kg	15 mg once daily
≥50 kg	20 mg once daily^¶

The dosing guidance in this table is for treatment of VTE in patients with normal kidney function. Patients should receive at least 5 days of parenteral anticoagulant therapy (eg, with LMWH or UFH) prior to transitioning to rivaroxaban. There are limited data on the use of rivaroxaban in pediatric patients with kidney impairment. Rivaroxaban should not be used in patients with severe kidney failure (ie, estimated glomerular filtration rate <30 mL/minute). In addition, rivaroxaban should not be used in patients with severe liver disease (ie, alanine aminotransferase >5 times the upper limit of normal, total bilirubin >2 times the upper limit of normal with direct bilirubin >20% of total, and/or coagulopathy due to liver disease).

VTE: venous thrombosis and thromboembolism; LMWH: low molecular weight heparin; UFH: unfractionated heparin.

* Where available, rivaroxaban oral suspension should be used for patients weighing <30 kg; rivaroxaban tablets or an oral suspension may be used for patients ≥30 kg. Tablets should not be split to achieve a lower dose.

¶ This dose differs slightly from the recommended dose for treatment of VTE in adult patients, in whom a twice-daily dosing regimen is used for the first 21 days of therapy. In addition, adult patients can start rivaroxaban without initial parenteral therapy. If this approach is used in a pediatric patient weighing ≥50 kg (ie, if the patient is not treated with initial parenteral therapy), then the adult dosing regimen should be used. This consists of rivaroxaban 15 mg twice daily for 21 days, followed thereafter by 20 mg once daily.

References:

Janssen Pharmaceuticals. Product Monograph: Xarelto/rivaroxaban. 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859s000lbl.pdf (Accessed on January 14, 2022).
Male C, Lensing AWA, Palumbo JS, et al. Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomised, controlled, phase 3 trial. Lancet Haematol 2020; 7:e18.

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