RARITAN, NJ - The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral (injected or intravenous) anticoagulant treatment; and thromboprophylaxis (prevention of blood clots and blood-clot related events) in children aged two years and older with congenital heart disease who have undergone the Fontan procedure. XARELTO is the only direct oral anticoagulant (DOAC) FDA-approved for primary prevention of clots in pediatric patients following the Fontan procedure and the only DOAC in the U.S. to offer an oral suspension formulation for flexible, body weight-adjusted dosing options for pediatric patients.
While VTE more commonly occurs in adults, blood clots can still be a serious problem in children, affecting approximately 58 per 10,000 of those hospitalized in the U.S., with rates increasing. Children may be at greater risk of blood clots when suffering from other conditions, such as infectious diseases, active cancer, or after undergoing surgery, like the Fontan procedure, which is performed in children who have a single functioning heart ventricle to redirect blood flow from the lower body to the lungs.2,3
Current medical guidelines are limited and recommend that young patients with or at risk for developing blood clots be treated with standard anticoagulation therapy, such as warfarin or heparin.4 Often times, physicians have to adjust adult doses, based on limited data for these therapies for younger patients.4 Additionally, for some of these treatment options, that can mean painful injections, dietary restrictions and regular laboratory monitoring - all things that can be especially challenging for younger patients and their caregivers.4,5,6
'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. '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.'
The oral suspension formulation will be administered through a color-coded dosing device that was designed to help minimize dosing errors and is expected to become available in the U.S. for pediatric patients in mid-January 2022. The oral tablets are currently available in the U.S. for appropriate pediatric patients.
'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.'
XARELTO now has 11 indications in the U.S. - the most of any DOAC - and is the most studied oral Factor Xa inhibitor in its class. This latest approval is based on two Phase 3 pediatric studies from the industry-leading EXPLORER clinical research program, EINSTEIN-Jr, the largest study to date evaluating pediatric patients from birth to
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