FDA Approves Two New Indications for XARELTO® (rivaroxaban) to Help Prevent and Treat VTE in Pediatric Patients

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that the U.S. Food and Drug Administration (FDA) has proved two pediatric indications for XARELTO® (rivaroxaban) for the treatment of venous thromboembolism (VTE)in patients from birth to less than 18 years after at least five days of parenteral anticoagulant treatment.

XARELTO® stands as the only direct oral anticoagulant (DOAC) FDA-approved for the primary prevention of clots in pediatric patients following the Fontan procedure and the only U.S. treatment to offer an oral suspension formulation.

According to the company, the oral suspension formulation will be administered through a color-coded dosing device developed to help minimize dosing errors. The device is expected and is expected to become available in the U.S. for pediatric patients in mid-January of this year. The oral tablets are currently available in the U.S. for appropriate pediatric patients.

“Historically, there has been limited guidance and options for healthcare providers on how to help reduce potentially serious, even fatal, blood clots and related events in young children,” said Andrew Van Bergen, M.D., Pediatric Cardiologist, Advocate Children’s Hospital via a press release. * “We have had to adjust adult doses of standard anticoagulation therapies, which are both burdensome and uncomfortable for patients, and require frequent monitoring. Now that XARELTO® is FDA-approved with weight-based dosing options, either as tablets or liquid formulation, a convenient option is available allowing flexibility to tailor the treatment for my patients. This is a major advancement in antithrombotic care for those patients under the age of 18.”

“When a child is experiencing health challenges, learning that they are also at risk for a blood clot can feel overwhelming for the patient, and also their parents or caregivers,” said Andrea Baer, MS, BCPA, Executive Director of The Mended Hearts, Inc., a patient advocacy organization whose program Mended Little Hearts serves patients and families with congenital heart disease.** “Knowing that there is now an FDA-approved oral treatment option to reduce the risk of blood clots that’s easy and may be more comfortable than injections to administer may help ease that burden.”