FDA Approves Xarelto (rivaroxaban) for Thromboprophylaxis in Pediatric Patients After Fontan Procedure

FDA Published March 31, 2026 DOI ↗

Key Takeaway

Consider rivaroxaban for thromboprophylaxis in pediatric patients ≥2 years old post-Fontan procedure.

The FDA has approved a new indication for the factor Xa inhibitor rivaroxaban (Xarelto) for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure. This approval, dated December 20, 2021, addresses a specific thromboembolic risk in a vulnerable pediatric cardiac population. The label indicates the drug is also approved for the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years, following initial parenteral anticoagulation. This expands the clinical utility of an established oral anticoagulant into carefully defined pediatric settings.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

XARELTO is a factor Xa inhibitor.

Indication & Patient Population

The FDA-approved indication is for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure. The label also lists indications for: reducing stroke/systemic embolism risk in nonvalvular atrial fibrillation; treatment of DVT; treatment of PE; reduction in risk of recurrence of DVT/PE; prophylaxis of DVT following hip/knee replacement; prophylaxis of VTE in acutely ill medical patients not at high bleeding risk; reduction of major cardiovascular events in CAD (with aspirin); reduction of major thrombotic vascular events in PAD (with aspirin); and treatment/reduction of recurrent VTE in pediatric patients from birth to <18 years.

Dosing & Administration

For the newly approved pediatric Fontan thromboprophylaxis indication, the label states: 'Pediatric Patients: See dosing recommendations in the Full Prescribing Information (2.2).' For adult indications, dosages vary: Nonvalvular AF: 15 or 20 mg once daily with food; DVT/PE treatment: 15 mg twice daily with food for 21 days, then 20 mg once daily with food; Recurrence risk reduction of DVT/PE: 10 mg once daily; DVT prophylaxis post-orthopedic surgery: 10 mg once daily; VTE prophylaxis in acutely ill medical patients: 10 mg once daily for 31-39 days; CAD or PAD: 2.5 mg twice daily with aspirin.

Key Clinical Trial Data

Trial data not available in label for the pediatric Fontan procedure indication. For the nonvalvular atrial fibrillation indication, the label notes: 'There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled.'

Warnings & Contraindications

Not reported in label for the specific pediatric Fontan indication. General warnings from other sections note that for prophylaxis in acutely ill medical patients, it is indicated for those 'not at high risk of bleeding.'

Place in Therapy

Xarelto is indicated as thromboprophylaxis specifically for pediatric patients 2 years and older with congenital heart disease status post Fontan procedure. It is also indicated for the treatment and secondary prevention of VTE in the broader pediatric population from birth to less than 18 years.

The U.S. Food and Drug Administration (FDA) has approved a new use for the prescription drug rivaroxaban, known by the brand name Xarelto. It is now approved to help prevent dangerous blood clots in children aged 2 years and older who were born with a heart defect and have had a specific open-heart surgery called the Fontan procedure. These children have a higher risk of blood clots forming, which can travel to the lungs or brain and cause serious problems. Xarelto is a type of medicine known as a blood thinner, or anticoagulant, which helps reduce this risk.

This approval means that doctors now have an oral (taken by mouth) medication option for these young patients. Previously, Xarelto was already approved for adults and for treating blood clots in children. This new approval specifically addresses the long-term need to prevent clots from forming in the first place in this unique group. It is important to understand that this is for a very specific situation and is not a general treatment for all children with heart problems.

As with all medications, there are important considerations. All blood thinners carry a risk of bleeding. The decision to use this medicine involves carefully weighing the benefit of preventing a clot against the risk of bleeding for each individual child. The FDA's approval is based on a review of evidence showing the drug's benefit for this specific use.

One important note for families is that this approval does not change the fundamental need for close care from a specialist. If you are a parent or caregiver of a child with congenital heart disease, this news means there is a potential new option to discuss with your child's cardiology team. They are the best people to determine if this treatment is appropriate for your child's specific health situation.

What this means for you: A new option exists to discuss with your child's heart specialist for preventing blood clots.

View Original Abstract ↓

1 INDICATIONS AND USAGE XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients ( 1.6 ) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD) ( 1.7 ) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD ( 1.8 ) for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years ( 1.9 ) for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure ( 1.10 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation XARELTO is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of XARELTO and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled [see Clinical Studies (14.1) ]. 1.2 Treatment of Deep Vein Thrombosis XARELTO is indicated for the treatment of deep vein thrombosis (DVT). 1.3 Treatment of Pulmonary Embolism XARELTO is indicated for the treatment of pulmonary embolism (PE). 1.4 Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism XARELTO is indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months. 1.5 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery. 1.6 Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding XARELTO is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding [see Warnings and Precautions (5.2) and Clinical Studies (14.5) ] . 1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) XARELTO, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. 1.8 Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD XARELTO, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. 1.9 Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients XARELTO is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment. 1.10 Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure XARELTO is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.