FDA Approves 2 New Indications for Rivaroxaban to Prevent, Treat Blood Clots in Children


The drug is available in both oral suspension and tablet dosage forms for use in individuals aged 18 years or younger.

The FDA has approved 2 additional pediatric indications for rivaroxaban (Xarelto, Janssen Pharmaceutical).

The first indication is for the treatment of venous thromboembolism (VTE) and risk reduction for recurrent VTE in patients aged 18 years or younger, following a minimum of 5 days of initial parenteral (injected or intravenous) anticoagulant treatment. The second indication is for thromboprophylaxis in children aged 2 years and older with congenital heart disease, following a Fontan procedure. The latter indication now makes rivaroxaban the only direct oral anticoagulant (DOAC) that is FDA-approved for thromboprophylaxis in pediatric patients following this procedure.

"Historically, there has been limited guidance and options for health care providers on how to help reduce potentially serious, even fatal, blood clots and related events in young children," Andrew Van Bergen, MD, pediatric cardiologist, Advocate Children's Hospital, said in a statement.

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

Although physicians are often recommended to adjust adult doses of standard anticoagulation therapies for pediatric patients, available data are limited on the efficacy and safety of these therapies in younger patients. Following this FDA approval, the oral suspension formulation is expected to become available for pediatric patients in the United States in mid-January 2022. Upon its availability, the oral suspension formulation can be administered to pediatric patients through a color-coded dosing device to minimize dosing errors. Only oral tablets are available for pediatric patients in the United States.

"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," Andrea Baer, MS, BCPA, executive director of Mended Hearts, said in the statement. "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."

Rivaroxaban has 11 FDA-approved indications in the United States. The latest approval is based on data from 2 phase 3 pediatric clinical trials, including the EINSTEIN-Jr study, which was the largest to date assessing rivaroxaban in pediatric patients from birth to aged 18 years with previously diagnosed VTE, and the UNIVERSE study, which was the first clinical trial to assess the use of a DOAC in the prevention of VTE in pediatric patients after undergoing a Fontan procedure.

"Today's FDA approval marks 2 new Xarelto indications for pediatric patients, an often underrecognized but especially important patient population," James List, MD, PhD, global therapeutic area head, cardiovascular, metabolism, and retina at Janssen Research & Development, said in the statement. "The approval of the 10th and 11th indications for Xarelto underscores its capability in reducing the risk of blood clots and cardiovascular events in patients from young to old and with a variety of conditions."


FDA approves two new Indications for Xarelto® (rivaroxaban) to help prevent and treat blood clots in pediatric patients. Janssen Pharmaceutical. News release. December 20, 2021. Accessed December 22, 2021. https://www.prnewswire.com/news-releases/fda-approves-two-new-indications-for-xarelto-rivaroxaban-to-help-prevent-and-treat-blood-clots-in-pediatric-patients-301448701.html

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