INDICATION
INDICATION AND IMPORTANT SAFETY INFORMATION

ZEGALOGUE (dasiglucagon) injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

IMPORTANT SAFETY INFORMATION
Contraindications

ZEGALOGUE is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure and in patients with insulinoma because of the risk of hypoglycemia.

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INDICATION

ZEGALOGUE (dasiglucagon) injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

IMPORTANT SAFETY INFORMATION

Contraindications

ZEGALOGUE is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure and in patients with insulinoma because of the risk of hypoglycemia.

Warnings and Precautions

ZEGALOGUE is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon products may produce an initial increase in blood glucose; however, ZEGALOGUE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. ZEGALOGUE is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon products; these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions.

ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE administration to be effective. Patients with these conditions should be treated with glucose.

Adverse Reactions 

The most common adverse reactions (≥2%) associated with ZEGALOGUE in adults were nausea, vomiting, headache, diarrhea and injection site pain; in pediatrics: nausea, vomiting, headache and injection site pain.

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given ZEGALOGUE. In patients taking indomethacin, ZEGALOGUE may lose its ability to raise blood glucose or may produce hypoglycemia. ZEGALOGUE may increase the anticoagulant effect of warfarin.

Please see Full Prescribing Information.

References: 1. Zegalogue (dasiglucagon). Prescribing information. Zealand Pharma A/S; April 2021. 2. Hövelmann U, Bysted BV, Mouritzen U, et al. Pharmacokinetic and pharmacodynamic characteristics of dasiglucagon, a novel soluble and stable glucagon analog. Diabetes Care. 2018;41(3):531-537. doi:10.2337/dc17-1402

References: 1. International Hypoglycaemia Study Group. Minimizing hypoglycemia in diabetes. Diabetes Care. 2015;38(8):1583-1591. doi:10.2337/dc15-0279 2. Edridge CL, Dunkley AJ, Bodicoat DH, et al. Prevalence and incidence of hypoglycaemia in 532,542 people with type 2 diabetes on oral therapies and insulin: a systematic review and meta-analysis of population based studies. PLoS One. 2015;10(6):e0126427. doi:10.1371/journal.pone.0126427 3. American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2021. Diabetes Care. 2021;44(suppl 1):S73-S84. doi:10.2337/dc21-S006 4. American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2020. Diabetes Care. 2020;43(suppl 1):S66-S76. doi:10.2337/dc20-S006

References: 1. American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2021. Diabetes Care. 2021;44(suppl 1):S73-S84. doi:10.2337/dc21-S006 2. Cobb E, Watson N, Wardian J, Morrow C, Sauerwein T. Glucagon kits: are your patients prepared for a hypoglycemic emergency? AADE in Practice. 2017;5(1):12-17. doi:10.1177/2325160316677575 3. International Hypoglycaemia Study Group. Minimizing hypoglycemia in diabetes. Diabetes Care. 2015;38(8):1583-1591. doi:10.2337/dc15-0279 4. Zegalogue (dasiglucagon). Prescribing information. Zealand Pharma A/S; April 2021.

References: 1. Zegalogue (dasiglucagon). Prescribing information. Zealand Pharma A/S; April 2021. 2. Pieber TR, Aronson R, Hövelmann U, et al. Dasiglucagon: a next-generation glucagon analog for rapid and effective treatment of severe hypoglycemia: results of phase 3 randomized double-blind clinical trial. Diabetes Care. Preprint posted online April 21, 2021. doi:10.2337/DC20-2995 3. Data on file. Zealand Pharma A/S; 2021.

References: 1. Zegalogue (dasiglucagon). Prescribing information. Zealand Pharma A/S; April 2021. 2. Battelino T, Tehranchi R, Bailey T, et al. Dasiglucagon, a next-generation ready-to-use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: results of a phase 3, randomized controlled trial. Pediatr Diabetes. Preprint posted online May 2, 2021. doi:10.1111/pedi.13220

Reference: Zegalogue (dasiglucagon). Prescribing information. Zealand Pharma A/S; April 2021.

References: 1. Zegalogue (dasiglucagon). Prescribing information. Zealand Pharma A/S; April 2021. 2. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. ZEGALOGUE NDA 214231 approval letter, March 22, 2021. Accessed March 26, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214231Orig1s000ltr.pdf

References: 1. Zegalogue (dasiglucagon). Prescribing information. Zealand Pharma A/S; April 2021. 2. Hövelmann U, Bysted BV, Mouritzen U, et al. Pharmacokinetic and pharmacodynamic characteristics of dasiglucagon, a novel soluble and stable glucagon analog. Diabetes Care. 2018;41(3):531-537. doi:10.2337/dc17-1402 3. Macchi F, Wenander C, Lundholt BK. Dasiglucagon is a novel stable glucagon analog with fast glucose response following subcutaneous injection in hypoglycemic rats. Poster presented at: Virtual European Association for the Study of Diabetes Annual Meeting 2020; September 21-25, 2020.

Reference: Zealand Pharma A/S. About us. Accessed March 23, 2021. https://www.zealandpharma.com/about-us

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