Rivaroxaban Dosing

Table 1 – Rivaroxaban Treatment Dosing by Weight: Infants, Children, and Adolescents*

*There is no data regarding safety or efficacy for the 2.5mg tablet, therefore it is not recommended in the pediatric age-group.

Table 2 – Rivaroxaban Prophylaxis** Dosing by Weight: Children ≥2 years and Adolescents*

*There is no data regarding safety or efficacy for the 2.5mg tablet, therefore it is not recommended in the pediatric age-group.
**Dosing extrapolated from FDA-approved prophylaxis dosing in patients with congenital heart disease

***Note for infants < 7 kg, prophylaxis dosing is equivalent to treatment dosing

Dosing for impaired renal function: 

·         Infants ≥2.6 kg: Avoid use when serum Creatinine is above the 97.5^th percentile

·         Children and Adolescents: Avoid use when eGFR is < 50 mL/minute/1.73 m²

Dosing for impaired hepatic function:

·         Avoid use in moderate or severe hepatic impairment or hepatic disease that is associated with coagulopathy

References:

Goldenberg, N.A., Kittelson, J.M., Abshire, T.C., et al. (2022, Jan 11). Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous Thromboembolism: The Kids-DOTT Randomized Clinical Trial. JAMA. 327(2),129-137.

Lexicomp Online, Pediatric and Neonatal Lexi-Drugs. Rivaroxaban. Retrieved May 2, 2023, from https:online.lexi.com.

Male, C., Lensing, A.W.A., Palumbo, J.S., et al. (2020). Rivaroxaban compared with standard anticoagulants for the treatment of acute venous thromboembolism in children: a randomized, controlled, phase 3 trial. Lancet Hematology, 7(1), e18-e27. doi:10.1016/S2352-3026(19)30219-4.  

Martin K.A., Lee C.R., Farrell T.M., Moll S. (2017). Oral Anticoagulant Use After Bariatric Surgery: A Literature Review and Clinical Guidance. Am J Med, 130(5), 517-524. doi:10.1016/j.amjmed.2016.12.033.

Xarelto. Highlights of prescribing information. (2023, February). https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/XARELTO-pi.pdf.

These pathways do not establish a standard of care to be followed in every case. It is recognized that each case is different, and those individuals involved in providing health care are expected to use their judgment in determining what is in the best interests of the patient based on the circumstances existing at the time. It is impossible to anticipate all possible situations that may exist and to prepare a pathway for each. Accordingly, these pathways should guide care with the understanding that departures from them may be required at times.