Fast Facts

• Rivaroxaban was FDA-approved for the treatment of pediatric VTE in 2021 based on results from the EINSTEIN Jr Phase 3 Randomized Controlled Trial.
  • The EINSTEIN Jr trial showed that the risk of clot recurrence and bleeding events was low in patients treated with rivaroxaban, which was similar to standard anticoagulation therapies used in pediatrics.
• Advantages include:
  • Oral medication with tablet and oral suspension formulations
  • No drug monitoring requirements
• Available products at Children’s Mercy:
  • Rivaroxaban (Xarelto®)
• Rivaroxaban half-life is age-dependent
  • < 6 months of age: 1.6 hours
  • 6 months to 2 years of age: 1.9 hours
  • Children ≥ 2 years of age: 3 hours
  • Adolescents: 4.2 hours
  • Adults: 5 to 9 hours
• The dosing regimen in pediatrics is bodyweight-adjusted and the exposure range matches the therapeutic dosing of rivaroxaban in young adults.
• Rivaroxaban can prolong the PT or aPTT but does not do so reliably for drug-monitoring or evaluating the presence of the drug.
• Rivaroxaban is metabolized by CYP3A4, CYP3A5, CYP2J2 and the P-glycoprotein substrate.

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.