Dalteparin sodium (Fragmin) was approved in 1994 as an anticoagulant for adults. It is a low-molecular-weight form of heparin that inhibits clotting Factor Xa and thrombin but has a minimal effect on activated partial thromboplastin time. The Food and Drug Administration has approved its use in children as young as one month of age to treat symptomatic venous thromboembolism (VTE) (including deep vein thrombosis and pulmonary embolism) and reduce the risk of its recurrence. Dalteparin sodium is the first anticoagulant approved for use in children with VTE, which can be fatal. It is administered subcutaneously.
The most likely risk factor for VTE is the presence of a central venous catheter (CVC), which is typically placed in children with chronic illnesses such as cancer, congenital heart disease, severe infections, or sickle cell disease.
Efficacy was determined in a single-arm, open-label, multicenter trial of 38 pediatric cancer patients who had symptomatic deep vein thrombosis and/or pulmonary embolism. Patients received dalteparin sodium for up to three months. At study completion, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, and one patient experienced recurrence of VTE. No patients experienced VTE progression.
Other than updating the label to include the use of dalteparin sodium in children, the labeling information for the drug hasn't changed. Its most common adverse effects (seen in more than 1% of patients) remain bleeding and thrombocytopenia.
Dalteparin sodium comes in prefilled syringes and in multidose vials containing benzyl alcohol. Nurses who care for infants requiring dalteparin sodium should confirm that these patients only receive the formulation in the syringes. Exposure to the benzyl alcohol preservative can induce fatal "gasping syndrome," as well as gradual neurologic deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Pregnant women should also not receive the benzyl alcohol formulation as it can cross the placenta and harm the fetus.
For complete prescribing information for dalteparin sodium, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020287s072lbl.pdf.