December 20, 2021
Xarelto® (rivaroxaban) has been approved for two new pediatric indications. The FDA also approved a new oral suspension dosage form of the drug.
- Xarelto is now indicated for use in pediatric patients under 18 years of age to treat venous thromboembolism (VTE) and reduce the risk of recurrent VTE following at least five days of initial parenteral (injected or intravenous) anticoagulant treatment.
- It is also indicated to prevent blood clots and blood-clot related events in children at least two years of age who have congenital heart disease and have undergone the Fontan procedure (a type of open-heart surgery).
- Recommended dosing for pediatric patients is based on the patient’s weight and diagnosis. The medication should be taken with food to increase absorption into the body.
- Xarelto first received FDA approval in 2011 as an oral tablet and holds nine additional indications to treat or prevent problems caused by blood clots such as pulmonary embolism, deep vein thrombosis, and strokes.