Pediatric VTE & Post-Fontan | XARELTO® (rivaroxaban) HCP

XARELTO^®: the direct oral anticoagulant (DOAC) studied in the largest clinical trials for pediatric
VTE treatment and prevention (N=500) and for pediatric patients post-Fontan procedure (N=110)^4-8

Use in Patients With Renal Impairment: Periodically assess renal function as clinically indicated (ie, more frequently in situations in which renal function may decline) and adjust therapy accordingly. Consider dose adjustment or discontinuation of XARELTO^® in patients who develop any renal failure while on XARELTO^®.²

Patients With End-Stage Renal Disease on Dialysis: Clinical efficacy and safety studies with XARELTO^® did not enroll patients with CrCl <30 mL/min or ESRD on dialysis. In patients with ESRD maintained on intermittent hemodialysis, administration of XARELTO^® 15 mg once daily will result in concentrations of rivaroxaban and pharmacodynamic activity similar to those observed in the ROCKET AF study. It is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with ESRD on dialysis, as was seen in ROCKET AF.²

*XARELTO^® is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. The use of XARELTO^® is not recommended in patients with prosthetic heart valves. While no longer using the "valvular" and "nonvalvular classifications of AF and concluding that those terms are obsolete, the 2023 Guideline for the Diagnosis and Management of Atrial Fibrillation notes that DOACs are currently recommended as first-line therapy over warfarin in patients with AF (except moderate to severe mitral stenosis or mechanical heart valve recipients).

ACC = American College of Cardiology; ACCP = American College of Clinical Pharmacy; AF = atrial fibrillation; AHA = American Heart Association; CrCl = creatinine clearance; DOAC = direct oral anticoagulant; ESRD = end-stage renal disease; HRS = Heart Rhythm Society; NVAF = nonvalvular atrial fibrillation.

References: 1. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024;83(1):109-279. 2. XARELTO^® [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.

XARELTO^® is licensed from Bayer HealthCare AG, 51368 Leverkusen, Germany.

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*XARELTO^® is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. The use of XARELTO^® is not recommended in patients with prosthetic heart valves. While no longer using the "valvular" and "nonvalvular" classifications of AF and concluding that those terms are obsolete, the 2023 Guideline for the Diagnosis and Management of Atrial Fibrillation notes that DOACs are currently recommended as first-line therapy over warfarin in patients with AF (except moderate to severe mitral stenosis or mechanical heart valve recipients).

ACC = American College of Cardiology; ACCP = American College of Clinical Pharmacy; AF = atrial fibrillation; AHA = American Heart Association; DOAC = direct oral anticoagulant; HRS = Heart Rhythm Society; NVAF = nonvalvular atrial fibrillation.

Reference: 1. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the diagnosis and management of atrial fibrillation: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024;83(1):109-279.

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