Most common adverse reactions in adults, adolescents, and children

ADULT

Adverse reactions occurring ≥2% and more frequently than with placebo in ZEGALOGUE^® (dasiglucagon) injection-treated adult patients within 12 hours of treatment in 2 placebo-controlled trials

PEDIATRIC

Adverse reactions occurring ≥2% and more frequently than with placebo in ZEGALOGUE^®-treated pediatric patients within 12 hours of treatment in a placebo-controlled trial

Immunogenicity

In all clinical trials, 4/498 (<1%) ZEGALOGUE^®-treated patients had treatment-emergent antidrug antibodies (ADAs).

Although no safety or efficacy concerns were noted for these ADA-positive patients, due to the low incidence of ADAs observed, it is unknown whether ADAs may affect pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of the drug

With ZEGALOGUE^®, patients and caregivers should have confidence in being prepared to treat severe hypoglycemia

ABOUT THE DEVICES

Indication and Usage for ZEGALOGUE^® (dasiglucagon) injection 0.6 mg/0.6 mL

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 click here for ZEGALOGUE^® Prescribing Information.

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