FDA Approves Rivaroxaban To Treat, Prevent Blood Clots In Pediatric Patients

The oral suspension for rivaroxaban prevents blood clots in patients aged ≥2 years with congenital heart disease following the Fontan procedure.

The US Food and Drug Administration (FDA) has approved rivaroxaban (Xarelto) as tablets and an oral suspension to treat venous thromboembolism (VTE) and reduce its recurring risk in pediatric patients from birth to younger than 18 years who have received ≥5 days of injectable or intravenous treatment for blood clots.

As of today, the FDA has also approved rivaroxaban to prevent blood clots in pediatric patients aged ≥2 years with congenital heart diseases, after the Fontan procedure, a type of open-heart surgery.

The approval of rivaroxaban in tablet form occurred in 2011, while the oral suspension is a new dosage approved today. Rivaroxaban was previously approved in the treatment, prevention, or reduction of the risks of various blood clotting conditions in certain patient populations.

If not treated, blood clots can restrict or block blood flow and oxygen, which can damage the body’s tissues or organs and ultimately result in death.

Rivaroxaban Data

The EINSTEIN Junior study tested the effectiveness of rivaroxaban to treat and reduce the risk of recurrent VTE in pediatric patients with confirmed VTE. A total of 500 pediatric patients were randomly assigned to receive either rivaroxaban or standard-of-care medication for 3 months or 1 month for children ≤2 years old with a central venous catheter related-VTE.

Following the end of the study, data show 1.2% of patients in the rivaroxaban group had signs or symptoms of recurrent VTE, compared to 3.0% of patients in the standard-of-care group.

Additionally, the UNIVERSE study investigated the effectiveness of rivaroxaban to prevent blood clots after the Fontan procedure in pediatric patients between 2 - 8 years old with congenital heart disease and a recent Fontan surgical procedure.

Part A of the study had patients receiving rivaroxaban for 1 year, while Part B had patients randomly assigned to receive rivaroxaban or aspirin for 1 year.

At the end of study, 8.3% of patients in Part A had a blood clot. Meanwhile in Part B, 1.6% of patients who received rivaroxaban had a blood clot compared to 8.8% of patients who received aspirin.

Safety Data

The agent was not studied or recommended for children <6 months old who were born prematurely, have fed by mouth for <10 days, or weigh <5.7 pounds.

The approval noted rivaroxaban should be used in patients with active major bleeding or serious allergic reactions to the medication. Additionally, patients with some serious conditions, or who take certain other drugs are at a higher bleeding risk when using rivaroxaban.

They noted the most common side effects of rivaroxaban in children included bleeding, cough, vomiting, and gastroenteritis.

The agent received priority review for the indication.