Zegalogue

About Dasiglucagon

• Zegalogue, containing the active ingredient Dasiglucagon, received FDA approval on March 22, 2021.
• Dasiglucagon injection is used to treat severe hypoglycemia in patients aged 6 years and older with diabetes mellitus. Severe hypoglycemia, characterized by a drastic drop in blood glucose levels, typically occurs with insulin therapy. 
• Dasiglucagon acts by activating hepatic glucagon receptors, prompting the breakdown of glycogen in the liver and the subsequent release of glucose into the bloodstream. 
• This mechanism facilitates the restoration of blood glucose levels in individuals experiencing severe hypoglycemia.

Strength: 

• 0.6 mg/0.6 mL single-dose autoinjector 
• 0.6 mg/0.6 mL single-dose prefilled syringe

Recommended Dosage:

Zegalogue autoinjector and prefilled syringe are for subcutaneous injection only. Patients and caregivers should know the signs of severe hypoglycemia and how to use the medicine. Upon recognizing severe hypoglycemia, administer the medicine promptly and seek emergency assistance. Inject into the lower abdomen, buttocks, thigh, or outer upper arm.Once the patient responds, provide oral carbohydrates. Do not reuse the medicine, as each device contains a single dose of dasiglucagon.

• The suggested dosage of Zegalogue for adults and children aged 6 years and above is 0.6 mg given via subcutaneous injection into the lower abdomen, buttocks, thigh, or outer upper arm. If there is no response within 15 minutes, an extra 0.6 mg dose of medicine from a new device can be administered.

Important:

Your healthcare provider may adjust your Zegalogue treatment in response to severe side effects, possibly suspending or delaying treatment or altering the dosage. Regular blood tests will monitor for potential side effects, and the duration of treatment will be based on your individual response. Before starting treatment, inform your doctor about pregnancy status, plans, or breastfeeding, along with current medications and medical conditions, to tailor the treatment plan accordingly.

Warnings & Precautions

• Zegalogue is not recommended for patients with pheochromocytoma due to the potential stimulation of catecholamine release from the tumor. If a substantial increase in blood pressure occurs and pheochromocytoma is suspected, intravenous administration of 5 to 10 mg of phentolamine mesylate can effectively lower blood pressure. 
• Additionally, in patients with insulinoma, this medicine may lead to hypoglycemia by stimulating insulin release. 
• Therefore, it is contraindicated in these patients. Symptoms of hypoglycemia following Zegalogue administration should be treated with oral or intravenous glucose. 
• Allergic reactions, such as rash or anaphylactic shock, have been reported with glucagon products. 
• Patients should seek immediate medical attention if they experience symptoms of serious hypersensitivity reactions. 
• This medicine may not be effective in patients with decreased hepatic glycogen levels, such as those in a state of starvation or with adrenal insufficiency. These patients should be treated with glucose instead.

Common Zegalogue Side Effects:

For adults:

• Nausea
• Vomiting
• Headache
• Diarrhea
• Injection site pain

For pediatrics:

• Nausea
• Vomiting
• Headache
• Injection site pain

Use in Specific Population

• Data regarding the use of dasiglucagon in pregnant women are not available to assess the potential risk of major birth defects, miscarriage, or adverse outcomes for both the mother and fetus. Similarly, there is insufficient information about the presence of dasiglucagon in human or animal milk and its effects on breastfeeding infants or milk production. Dasiglucagon, being a peptide, is expected to undergo breakdown into amino acids in the infant’s digestive system, thereby posing minimal risk to the infant. 
• The safety and efficacy of Zegalogue in treating severe hypoglycemia in pediatric patients aged 6 years and older have been established. However, its safety and efficacy have not been confirmed in pediatric patients under 6 years of age. 
• Regarding geriatric use, clinical trials involving this medicine included too few patients aged 65 years and older to determine whether they respond differently compared to younger adults.

Storage and Handling

• Store Zegalogue in a refrigerator (2°C to 8°C) but keep away from the cooling element and do not freeze. It can also be stored at room temperature (20°C to 25°C) for up to 12 months. 
• Once removed from the refrigerator, record the date on the protective case. 
• Discard after the 12-month period or upon expiration. The gray cap inside the autoinjector and the gray needle cover in the prefilled syringe contain dry natural rubber.
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.