What is the Fontan procedure?

Some children are born with a heart condition that prevents normal amounts of oxygen from circulating through the body. The Fontan procedure reroutes the blood flow from the lower body to the lungs to help increase the levels of oxygen in the blood. Because the Fontan procedure is an open-heart surgery, the risk of blood clots increases after the procedure.

What is XARELTO®?

XARELTO® is used to help prevent blood clots in children 2 years and older with congenital heart disease after the Fontan procedure. XARELTO® belongs to a group of medicines called direct oral anticoagulants, or DOACs for short. Like other DOACs, XARELTO® has no known dietary restrictions, no requirements for routine blood tests, and few drug interactions.

XARELTO® is the only DOAC indicated to help prevent blood clots in children with congenital heart disease after the Fontan procedure.

XARELTO® has flexible administration options

XARELTO® provides flexible oral administration of a liquid or tablet based on a child’s weight with:

no injection

No injections (after at least 5 days of initial blood thinner)

No routine blood test monitoring

Color-coded guidance to help with liquid administration

The dose of XARELTO® depends on your child’s body weight and will be calculated by your child’s doctor. Your child’s doctor will tell you if XARELTO® can be given to your child with or without food. If your child is taking the tablet, do not split the tablet in an attempt to give part of a XARELTO® tablet dose.

If your child is taking the oral suspension, use the syringes provided in the original carton. The suspension will be prepared by the pharmacy. Talk to your child’s doctor about proper administration and any questions you may have about XARELTO®.

Do not switch between the XARELTO® oral suspension or tablet without first talking to your child’s doctor.

XARELTO® may cause an increased risk of bleeding

XARELTO® can cause bleeding, which can be serious, and may lead to death. This is because XARELTO® is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO® your child is likely to bruise more easily, and it may take longer for bleeding to stop. Your child may be at higher risk of bleeding if your child takes XARELTO® and has certain other medical problems.

The risk of bleeding increases if you take XARELTO® with other medicines that also increase your risk of bleeding, such as:

    • Aspirin or aspirin-containing products
    • Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
    • Warfarin sodium (Coumadin®, Jantoven®)
    • Any medicine that contains heparin
    • Clopidogrel (Plavix®)
    • Selective serotonin reuptake inhibitors (SSRIs)
    • Serotonin norepinephrine reuptake inhibitors (SNRIs)
    • Other medicines to prevent or treat blood clots

Always tell your healthcare professional if your child experiences any side effects while taking XARELTO®—keeping an open and honest conversation going with your child’s healthcare professional will help you get your child the best care.