The Food and Drug Administration ( FDA ) has approved Fragmin ( Dalteparin sodium ) 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 venous thromboembolism in pediatric patients.
Approval was based on evidence from two prospective, single-arm, multi-center 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 three 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 venous thromboembolism.
A total of 48 patients ( 92% ) has achieved a therapeutic anti-Xa level.
Upon study completion, no patients experienced progression of the qualifying venous thromboembolism and one patient ( 2% ) had recurrence of VTE.
In pediatric patients with symptomatic venous thromboembolism, the most common ( greater than 10% ) adverse reactions were injection site bruising ( 30% ), contusion ( 12% ), and epistaxis ( 10% ).
Prescribing information 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. ( Xagena )
Source: FDA, 2019