FDA Approves Two Additional Indications for Rivaroxaban in Children

The US Food and Drug Administration has green-lighted two new indications for rivaroxaban (Xarelto; Bayer/Janssen) in pediatric populations.

The first allows the direct oral anticoagulant (DOAC) to be given as tablets or oral suspension for the treatment of venous thromboembolism (VTE), and as prophylaxis for recurrent VTE, in children under age 18, provided they have had at least 5 days of injectable or IV VTE treatment. This approval is supported by data from the EINSTEIN-Jr trial, in which signs or symptoms of recurrent VTE occurred in 1.2% of children treated with body weight-adjusted rivaroxaban versus 3% of children given heparin or vitamin K antagonists.

The second indication applies to children ages 2 and older with congenital cardiac disease who have undergone a Fontan procedure to improve blood flow to the lungs. In this group, rivaroxaban can be given as prophylaxis to prevent thromboembolism. As the two-part UNIVERSE trial showed, patients receiving rivaroxaban had fewer thrombotic events compared with those who received aspirin (1.6% vs. 8.8%).

In a press release, pediatric cardiologist Andrew Van Bergen, MD (Advocate Children’s Hospital, Park Ridge, IL), said the new indications represent “a major advancement in antithrombotic care for those patients under the age of 18.” Historically, guidance and options for reducing the risk of blood clots in young children have been limited, he added.

“We have had to adjust adult doses of standard anticoagulation therapies, which are both burdensome and uncomfortable for patients, and require frequent monitoring,” Van Bergen said.

According to Janssen, a new color-coded dosing device designed to help minimize errors will be used to administer the oral suspension. It is expected to be available next month.