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

Placebo (n=53)
% of patients
ZEGALOGUE (n=116)
% of patients
Nausea457
Vomiting225
Headache411
Diarrhea05
Injection site pain02

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

Placebo (n=11)
% of patients
ZEGALOGUE (n=20)
% of patients
Nausea065
Vomiting050
Headache010
Injection site pain05

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

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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TERMS AND CONDITIONS
Patient Instructions: The ZEGALOGUE® (dasiglucagon) injection Co-Pay Savings Card Program is ONLY valid for patients with commercial (private) insurance. In order to redeem this offer, you must have a valid prescription for ZEGALOGUE and you may not be enrolled in a state or federally funded prescription benefit program, including, but not limited to, Medicare (Parts A, B, C, or D), Medicaid (including Managed Medicaid), Veterans Affairs (VA), Department of Defense (DOD), or TRICARE. You are responsible for the first $25 and the card pays the remainder per prescription, up to a maximum of 12 fills per calendar year. Follow instructions provided by your doctor. This offer may not be redeemed for cash. By using this offer, you are certifying that you meet the eligibility criteria and will comply with the terms and conditions described in the Restrictions section below, including that you will not seek reimbursement for any part of the benefit received through this offer from any third-party payer, including any health savings, flexible spending, or other healthcare reimbursement account. Patients with questions about the offer should call 1-877-501-ZEGA (9342). THIS OFFER IS NOT INSURANCE.

Pharmacist: As a condition of payment, when you apply this offer, you are certifying that you have not submitted a claim for reimbursement under any federal, state, or other governmental programs including, without limitation, Medicare, Medicaid, VA, DOD, TRICARE, for this prescription and will not seek reimbursement from health insurance or any third party for any part of the benefit the patient receives through this program. Participation in this program must comply with all applicable laws and regulations as a pharmacy provider. By participating in this program, you are certifying that you will comply with the terms and conditions described in the Restrictions section below.

Pharmacist Instructions for a Patient With an Eligible Third-Party Payer: Submit the claim to the primary Third-Party Payer first, then submit the balance due to CHANGE HEALTHCARE as a Secondary Payer COB (coordination of benefits) with patient responsibility amount and a valid Other Coverage Code, (e.g., 8). The patient is responsible for the first $25 and the card pays the remainder per prescription, up to 12 fills per calendar year. Reimbursement will be received from CHANGE HEALTHCARE.

A valid Other Coverage Code is required. For any questions regarding CHANGE HEALTHCARE online processing, please call the Help Desk at 1-800-422-5604.

Restrictions: This offer is valid in the United States. This offer is not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan, VA, DOD, or TRICARE, or other federal or state health programs (such as medical assistance programs). If the patient is eligible for drug benefits under any such program or is Medicare-eligible and enrolled in employer-sponsored group waiver health plans or government-subsidized prescription drug benefit programs for retirees, the patient cannot use this offer. By using this offer, the patient and pharmacist certify that they will comply with any terms or requirements imposed on patients or providers by the health insurance to notify the health insurance plan of the existence and/or value of this offer. This offer is not valid for patients under 6 years of age. It is illegal to (or offer to) sell, purchase, or trade this offer. This offer is not transferable and is limited to one offer per person. Not valid if reproduced. Void where prohibited by law. This is not insurance. Program managed by ConnectiveRx on behalf of Zealand Pharma. The parties reserve the right to rescind, revoke, or amend this offer without notice at any time.

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