Dasiglucagon

What is Dasiglucagon?

• Dasiglucagon (ZEGALOGUE) is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.

What are the uses of this medicine?

• This medicine is medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes aged 6 years and older.
• It is not known if ZEGALOGUE is safe and effective in children under 6 years of age.

How does this medicine work?

• Dasiglucagon is a glucagon receptor agonist, which increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver.
• Hepatic stores of glycogen are necessary for dasiglucagon to produce an antihypoglycemic effect.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Pheochromocytoma because of the risk of substantial increase in blood pressure
• Insulinoma because of the risk of hypoglycemia

What drug interactions can this medicine cause?

Avoid coadministrartion with:

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

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

Recommended dosage

• The recommended dose of ZEGALOGUE in adults and pediatric patients aged 6 years and older is 0.6 mg administered by subcutaneous injection into the lower abdomen, buttocks, thigh, or outer upper arm.
• If there has been no response after 15 minutes, an additional 0.6 mg dose of ZEGALOGUE from a new device may be administered.

Administration

• Read the detailed Instructions For Use that come with ZEGALOGUE.
• Use ZEGALOGUE exactly how your healthcare provider tells you to use it.
• Make sure your caregiver knows where you keep your ZEGALOGUE and how to use ZEGALOGUE the right way before you need it.
• Your caregiver must act quickly. Having very low blood sugar for a period of time may be harmful.
• Your healthcare provider will tell you how and when to use ZEGALOGUE.
• After giving ZEGALOGUE, your caregiver should call for emergency medical help right away.
• Once you are able to safely consume food or drink, your caregiver should give you a fast-acting source of sugar (such as fruit juice) and a long-acting source of sugar (such as crackers with cheese or peanut butter).
• If you do not respond to treatment after 15 minutes, your caregiver may give you another dose, if available.
• Tell your healthcare provider each time you use ZEGALOGUE. Your healthcare provider may need to change the dose of your other diabetes medicines.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

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

This medicine is available in fallowing brand namesː

• ZEGALOGUE

What side effects can this medication cause?

The most common side effects of this medicine include: In Adults:

• nausea
• vomiting
• headache
• diarrhea
• injection site pain

In Children:

• nausea
• vomiting
• headache
• injection site pain

ZEGALOGUE may cause serious side effects, including:

• high blood pressure
• low blood sugar
• serious allergic reaction

What special precautions should I follow?

• Contraindicated in patients with pheochromocytoma because ZEGALOGUE may stimulate the release of catecholamines from the tumor.
• In patients with insulinoma, administration may produce an initial increase in blood glucose, but ZEGALOGUE may stimulate exaggerated insulin release from an insulinoma and cause subsequent hypoglycemia. 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 and may include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension.
• 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 to be effective. Patients with these conditions should be treated with glucose.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• vomiting
• inhibition of GI tract motility
• increases in blood pressure and heart rate

Management of Overdose

• In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed.
• If the patient develops a marked increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.
• Appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.

Can this medicine be used in pregnancy?

• There are no available data on dasiglucagon use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of ZEGALOGUE for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 6 years and above.
• The safety and effectiveness of ZEGALOGUE have not been established in pediatric patients younger than 6 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dasiglucagon, provided as dasiglucagon hydrochloride
• Inactive ingredients: tromethamine, sodium chloride and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

Who manufactures and distributes this medicine?

• Marketed by: Zealand Pharma A/S, 2860 Søborg, Denmark

What should I know about storage and disposal of this medication?

• Store ZEGALOGUE in a refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze ZEGALOGUE.
• ZEGALOGUE can also be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 12 months. See example in the Instructions For Use for how to keep track of this 12-month period.
• Do not return ZEGALOGUE to the refrigerator after storing at room temperature.
• Throw away ZEGALOGUE if it has been stored at room temperature for more than 12 months.
• Replace ZEGALOGUE before the expiration date printed on the red protective case.
• Store ZEGALOGUE in the red protective case it comes in.

• Dailymed label info on Dasiglucagon
• FDA Dasiglucagon

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