The FDA approved two new pediatric indications for rivaroxaban (Xarelto), a factor Xa anticoagulant with multiple indications in adults:
- the treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment, and
- thromboprophylaxis in patients 2 years of age and older with congenital heart disease who have undergone the Fontan procedure.
Rivaroxaban is the only direct oral anticoagulant approved for primary prevention of clots in pediatric patients following the Fontan procedure.
The FDA also approved a new oral suspension formulation of rivaroxaban. The new oral suspension offers flexible, body weight–adjusted dosing options for pediatric patients, an alternative to injectable anticoagulants that have been the standard of care for children, according to the manufacturer, Janssen Pharmaceuticals. The oral suspension formulation will be administered through a color-coded dosing device designed to help minimize dosing errors.
Consult product labeling for important prescribing instructions and precautions.
