Table 3.

Published rivaroxaban dosing strategy in Einstein Jr and UNIVERSE clinical trials

Einstein Jr phase 3 (VTE treatment)
Body weight–adjusted rivaroxaban regimens in a 20-mg equivalent dose
UNIVERSE phase 3 (post-Fontan thromboprophylaxis)
Body weight–adjusted rivaroxaban regimens in a 10-mg equivalent dose (mg or mL)
Body weightDoseTotalBody weightDoseTotal
2.6 to <3 kg 0.8 mg per dose TID 2.4 mg 7 to <8 kg 1.1 mg per dose BID 2.2 mg 
3 to <4 kg 0.9 mg per dose TID 2.7 mg 8 to <10 kg 1.6 mg per dose BID 3.2 mg 
4 to <5 kg 1.4 mg per dose TID 4.2 mg 10 to <12 kg 1.7 mg per dose BID 3.4 mg 
5 to <7 kg 1.6 mg per dose TID 4.8 mg 12 to <20 kg 2 mg per dose BID 4.0 mg 
7 to <8 kg 1.8 mg per dose TID 5.4 mg 20 to <30 kg 2.5 mg per dose BID 5.0 mg 
8 to <9 kg 2.4 mg per dose TID 7.2 mg  
9 to <10 kg 2.8 mg per dose TID 8.4 mg  
10 to <12 kg 3 mg per dose TID 9 mg  
12 to <30 kg 5 mg per dose BID 10 mg  
30 to <50 kg 15 mg per dose OD 15 mg  
≥50 kg 20 mg per dose OD 20 mg  
Einstein Jr phase 3 (VTE treatment)
Body weight–adjusted rivaroxaban regimens in a 20-mg equivalent dose
UNIVERSE phase 3 (post-Fontan thromboprophylaxis)
Body weight–adjusted rivaroxaban regimens in a 10-mg equivalent dose (mg or mL)
Body weightDoseTotalBody weightDoseTotal
2.6 to <3 kg 0.8 mg per dose TID 2.4 mg 7 to <8 kg 1.1 mg per dose BID 2.2 mg 
3 to <4 kg 0.9 mg per dose TID 2.7 mg 8 to <10 kg 1.6 mg per dose BID 3.2 mg 
4 to <5 kg 1.4 mg per dose TID 4.2 mg 10 to <12 kg 1.7 mg per dose BID 3.4 mg 
5 to <7 kg 1.6 mg per dose TID 4.8 mg 12 to <20 kg 2 mg per dose BID 4.0 mg 
7 to <8 kg 1.8 mg per dose TID 5.4 mg 20 to <30 kg 2.5 mg per dose BID 5.0 mg 
8 to <9 kg 2.4 mg per dose TID 7.2 mg  
9 to <10 kg 2.8 mg per dose TID 8.4 mg  
10 to <12 kg 3 mg per dose TID 9 mg  
12 to <30 kg 5 mg per dose BID 10 mg  
30 to <50 kg 15 mg per dose OD 15 mg  
≥50 kg 20 mg per dose OD 20 mg  

Reprinted from McCrindle et al17 (© 2021 by the authors; published on behalf of the American Heart Association, Inc, by Wiley Blackwell), with permission from Wiley Blackwell, and from Male et al16 with permission from Elsevier.

BID, twice daily; OD, once daily; TID, 3 times daily.

Oral suspension 0.1% (1 mg/mL).

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