FDA approves two paediatric venous thromboembolism indications for Janssen’s Xarelto

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Xarelto liquid suspension contents

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced that the US Food and Drug Administration (FDA) has approved two paediatric indications for Xarelto (rivaroxaban): 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 five days of initial parenteral anticoagulant treatment; and thromboprophylaxis in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.

According to Janssen, Xarelto is the only direct oral anticoagulant (DOAC) FDA approved for primary prevention of clots in paediatric patients following the Fontan procedure and the only DOAC in the US to offer an oral suspension formulation for flexible, body weight-adjusted dosing options for paediatric 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, paediatric Cardiologist at Advocate Children’s Hospital (Oak Lawn and Park Ridge, USA). “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 colour-coded dosing device that was designed to help minimise dosing errors and is expected to become available in the USA for paediatric patients in mid-January 2022. The oral tablets are currently available in the USA for appropriate paediatric 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, executive Director of The Mended Hearts, a patient advocacy organisation whose programme 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 is easy and may be more comfortable than injections to administer may help ease that burden.”


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