FDA Approves Dalteparin Sodium for VTE in Pediatric Patients


On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium (Fragmin) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients.

“Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease. Not only are they fighting a serious illness, having a condition like VTE can then lead to significant complications and even death,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Prior to this approval, there had been no FDA-approved therapies to treat VTE in pediatric patients. Given the unmet need, we granted the application priority review and…are approving it as the first anticoagulant indicated for pediatric patients. We remain committed to advancing treatments for children with unmet medical needs.”

Basis for Approval

Approval was based on evidence from two prospective, single-arm, multicenter clinical trials in 52 pediatric patients with or without cancer who had symptomatic deep vein thrombosis and/or pulmonary embolism. Patients were treated with dalteparin sodium subcutaneously twice daily for up to 3 months, with starting doses determined by age and weight. The starting dose of dalteparin sodium was based on population pharmacokinetic analysis of anti-Xa levels.

Efficacy was based on the achievement of therapeutic anti-Xa levels (0.5–1.0 IU/ml) and supported by the number of patients with lack of VTE progression or recurrent VTE.

A total of 48 patients (92%) achieved a therapeutic anti-Xa level. Upon study completion, no patients experienced progression of the qualifying VTE, and one patient (2%) had recurrence of VTE.  

In pediatric patients with symptomatic VTE, the most common (greater than 10%) adverse reactions were injection site bruising (30%), contusion (12%), and epistaxis (10%).

Prescribing information for daletparin sodium contains a Boxed Warning alerting health-care professionals and patients about the risk of epidural or spinal hematomas in patients who are anticoagulated with low–molecular-weight heparins or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture.

The recommended dalteparin sodium dose in pediatric patients is based on age and weight.

View the full prescribing information for dalteparin sodium.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.