Zegalogue® (dasiglucagon) injection is now available for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes 6 years of age and older.
Zegalogue is a glucagon analogue that is formulated in a ready-to-use aqueous solution for subcutaneous administration. The approval was based on data from 3 double-blind, placebo-controlled phase 3 trials in adult and pediatric patients with type 1 diabetes. Findings demonstrated that dasiglucagon was associated with a shorter median time to plasma glucose recovery compared with placebo.
As for safety, the most common adverse reactions reported in studies were nausea, vomiting, headache, diarrhea, and injection site pain. Zegalogue is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, and in those with insulinoma as administration may result in hypoglycemia.
Zegalogue is supplied as a 0.6mg/0.6mL single-dose autoinjector or prefilled syringe for subcutaneous injection. The product should be stored in a refrigerator but can be kept at room temperature for up to 12 months. Each device contains a single-dose of dasiglucagon and cannot be reused. An additional 0.6mg dose from a new device may be administered if there has been no response after 15 minutes.
The Company is providing a patient assistance program called Zealand Pharma ConnectedCare to support patients who receive Zegalogue.
- Zealand Pharma announces U.S. commercial availability of Zegalogue® (dasiglucagon) injection. [press release]. Copenhagen, Denmark and Boston, MA: Zealand Pharma A/S; June 24, 2021.
- Zegalogue [prescribing information]. Søborg, Denmark: Zealand Pharma A/S. 2021.