New Mealtime Insulin Option Approved for Children With Diabetes

The US Food and Drug Administration (FDA) has approved Fiasp (insulin aspart injection) 100 u/mL for use at mealtime in children with diabetes. It is the first and only fast-acting mealtime insulin injection that does not have a pre-dosing recommendation.

After first approving Fiasp for use in adults in 2017, the FDA approved its use in children following a review of data from the 26-week onset 7 clinical trial (N = 777), which demonstrated the safety and efficacy of Fiasp in children.

FDA Expands Label of Insulin Aspart Injection
FDA Expands Diabetes Drug Indication

Three different dosing options for Fiasp are available for use in children and adults: multiple daily injections, continuous subcutaneous insulin infusion pumps, and intravenous infusion under the supervision of a health care professional.

The most commonly reported adverse effects of Fiasp include eczema, pruritus, dermatitis, injection site reactions, injection site lipodystrophy, and weight gain.

Potential serious adverse effects associated with the use of Fiasp may include hypoglycemia, hypokalemia, and serious allergic reactions. Heart failure may also occur with Fiasp among patients who are taking thiazolidinediones.

—Christina Vogt

FDA approves Fiasp® for treatment of children with diabetes [press release]. Plainsboro, NJ. Novo Nordisk. January 6, 2020. Accessed January 7, 2020.