FDA approves Xarelto for treatment, prevention of VTE in subsets of children
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FDA approved rivaroxaban in tablet form and as an oral suspension to treat and reduce the risk for recurrence of venous thromboembolism among certain populations of children.
The approval applies to patients aged younger than 18 years who received 5 or more days of injectable or IV treatment for blood clots.
The agency also approved rivaroxaban (Xarelto, Janssen) to prevent blood clots in children aged 2 years and older with congenital heart disease who underwent the Fontan procedure, a type of open-heart surgery.
The oral suspension represents a new FDA-approved dosage form of rivaroxaban, a direct factor Xa inhibitor.
Researchers studied the effectiveness of rivaroxaban to treat and lower the risk for recurrent VTE among 500 children with confirmed VTE. They randomly assigned patients to receive rivaroxaban or standard-of-care treatments for 3 months, or 1 month for children aged younger than 2 years with a central venous catheter related-VTE.
Results showed 1.2% of patients in the rivaroxaban group had signs or symptoms of recurrent VTE at the end of the study, compared with 3% of patients in the standard-of-care group.
A separate study evaluated the effectiveness of rivaroxaban for blood clot prevention after the Fontan procedure among children aged 2 to 8 years with congenital heart disease. Children in Part A of the study received rivaroxaban for 1 year, and those in part B underwent random assignment to rivaroxaban or aspirin for 1 year. Results showed 8.3% of patients in Part A, all of whom received rivaroxaban, had a blood clot at the end of the study. In Part B, 1.6% of patients in the rivaroxaban group had a blood clot compared with 8.8% of those assigned aspirin.
The most common adverse events experienced by children who received rivaroxaban included bleeding, cough, vomiting and gastroenteritis.
Rivaroxaban has not been studied and is not recommended for children aged younger than 6 months who were born before 37 weeks, have been mouth-fed for less than 10 days, or weigh less than 5.7 pounds.
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