Dasiglucagon
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kosar Doraghi, M.D.[2]
Kosar Doraghi, M.D.
Current Position
Associate Editor-in-Chief, Beth Israel Deaconess Medical Center by Harvard Medical School, Boston, Massachusetts, USA, WikiDoc Scholar
Pages Authored/Co-authored/Collaborated
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Black Box Warning
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Allergic reactions
See full prescribing information for complete Boxed Warning.
increase in blood pressure in Patients with Pheochromocytoma due to its potential to stimulate catecholamine release from the tumor.
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Overview
Dasiglucagon is an anti-hypoglycemic that is FDA approved for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and older. There is a Black Box Warning for this drug as shown here. Common adverse reactions include nausea, vomiting, headache, diarrhea, and injection site pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
ZEGALOGUE autoinjector and prefilled syringe are meant for subcutaneous injection only, with a standard dose of 0.6 mg for adults and pediatric patients aged 6 years and older.
- Administration should follow the printed instructions on the protective case label and the Instructions For Use.
- Prior to administration, visually inspect ZEGALOGUE for clarity, colorlessness, and absence of particles; do not use if the solution is discolored or contains particulate matter.
- Inject into the lower abdomen, buttocks, thigh, or outer upper arm, and seek emergency assistance immediately afterward. If there's no response after 15 minutes, another dose from a new device may be administered while awaiting emergency assistance. Once the patient responds to treatment, provide oral carbohydrates. *ZEGALOGUE devices are single-use only and should not be reused.
- 0.6 mg/0.6 mL single-dose autoinjector
- 0.6 mg/0.6 mL single-dose prefilled syringe
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Dasiglucagon FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
- Pheochromocytoma
- Insulinoma
Warnings
|
Allergic reactions
See full prescribing information for complete Boxed Warning.
increase in blood pressure in Patients with Pheochromocytoma due to its potential to stimulate catecholamine release from the tumor.
|
- Substantial Increase in Blood Pressure in Patients with Pheochromocytoma:
ZEGALOGUE is contraindicated in 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, administer 5 to 10 mg of phentolamine mesylate intravenously to lower blood pressure.
- Hypoglycemia in Patients with Insulinoma:
In patients with insulinoma, ZEGALOGUE administration may initially increase blood glucose levels but could subsequently stimulate excessive insulin release, leading to hypoglycemia. ZEGALOGUE is contraindicated in patients with insulinoma. If hypoglycemia symptoms occur after ZEGALOGUE administration, administer glucose orally or intravenously.
- Hypersensitivity and Allergic Reactions:
Allergic reactions, including rash and anaphylactic shock with breathing difficulties and hypotension, have been reported with glucagon products. Advise patients to seek immediate medical attention if they experience symptoms of serious hypersensitivity reactions.
- Lack of Efficacy in Patients with Decreased Hepatic Glycogen:
ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients with conditions such as starvation, adrenal insufficiency, or chronic hypoglycemia may lack adequate hepatic glycogen for ZEGALOGUE to be effective; treat these patients with glucose instead.
Adverse Reactions
Clinical Trials Experience
- nausea
- vomiting
- headache
- diarrhea
- injection site pain
Postmarketing Experience
There is limited information regarding Dasiglucagon Postmarketing Experience in the drug label.
Drug Interactions
- Beta-blockers: Patients taking beta-blockers may experience a temporary increase in pulse and blood pressure.
- Indomethacin: ZEGALOGUE's ability to raise blood glucose may be compromised or result in hypoglycemia in patients taking indomethacin.
- Warfarin: ZEGALOGUE may augment the anticoagulant effect of warfarin.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Dasiglucagon in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dasiglucagon in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Dasiglucagon during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Dasiglucagon in women who are nursing.
Pediatric Use
The safety and effectiveness of ZEGALOGUE have not been established in pediatric patients younger than 6 years of age.
Geriatic Use
There is no FDA guidance on the use of Dasiglucagon in geriatric settings.
Gender
There is no FDA guidance on the use of Dasiglucagon with respect to specific gender populations.
Race
There is no FDA guidance on the use of Dasiglucagon with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Dasiglucagon in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Dasiglucagon in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dasiglucagon in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Dasiglucagon in patients who are immunocompromised.
Administration and Monitoring
Administration
ZEGALOGUE autoinjector and prefilled syringe are designated for subcutaneous injection exclusively. Educate patients and caregivers on recognizing signs and symptoms of severe hypoglycemia. As recovery from severe hypoglycemia typically necessitates external assistance, advise patients to inform those around them about ZEGALOGUE and its proper usage.
- Administer ZEGALOGUE promptly upon recognizing severe hypoglycemia.
Ensure patients or caregivers read the Instructions For Use upon receiving a ZEGALOGUE prescription. Highlight the following instructions:
- Follow the printed instructions on the protective case label and the Instructions For Use while administering ZEGALOGUE.
- Before administration, visually inspect ZEGALOGUE to ensure the solution is clear, colorless, and devoid of particles. If discolored or containing particulate matter, do not use.
- Administer the injection into the lower abdomen, buttocks, thigh, or outer upper arm.
Immediately call for emergency assistance after administering the dose. If no response is observed after 15 minutes, consider administering an additional dose of ZEGALOGUE while awaiting emergency assistance.
- Following treatment response, provide oral carbohydrates to replenish liver glycogen and prevent hypoglycemia recurrence.
- Do not attempt to reuse ZEGALOGUE, as each device contains a single dose of dasiglucagon and is not reusable.
- Recommended Dosage:
The recommended dose of ZEGALOGUE for adults and pediatric patients aged 6 years and older is 0.6 mg administered via subcutaneous injection into the lower abdomen, buttocks, thigh, or outer upper arm.
Monitoring
- If there is no response after 15 minutes, an additional 0.6 mg dose of ZEGALOGUE from a new device may be administered.
IV Compatibility
There is limited information regarding the compatibility of Dasiglucagon and IV administrations.
Overdosage
In case of overdosage, patients may exhibit symptoms including nausea, vomiting, gastrointestinal motility inhibition, and elevated blood pressure and heart rate. Monitor serum potassium levels and correct if necessary. If there's a significant increase in blood pressure, short-term administration of phentolamine mesylate can effectively lower it. Initiate appropriate supportive treatment based on the patient's clinical presentation.
Pharmacology
There is limited information regarding Dasiglucagon Pharmacology in the drug label.
Mechanism of Action
Dasiglucagon, a glucagon receptor agonist, raises blood glucose levels by activating hepatic glucagon receptors. This activation stimulates the breakdown of glycogen in the liver, releasing glucose into the bloodstream. Adequate hepatic glycogen stores are essential for dasiglucagon to exert its antihypoglycemic effect.
Structure
ZEGALOGUE contains dasiglucagon hydrochloride, which is a glucagon analog and an antihypoglycemic agent. Dasiglucagon is comprised of 29 amino acids. The molecular formula of dasiglucagon (anhydrous, free-base) is C152H222N38O50, and its molecular mass is 3382 g/mol (anhydrous, free-base). Dasiglucagon hydrochloride has the following chemical structure:
ZEGALOGUE injection is a preservative free, sterile, aqueous, clear, and colorless solution for subcutaneous use in a single-dose prefilled syringe and an autoinjector. Each prefilled syringe and autoinjector contains 0.63 mg of dasiglucagon provided as dasiglucagon hydrochloride, which is a salt with 3 - 5 equivalents of hydrochloride, and contains the following inactive ingredients: 3.82 mg tromethamine, 6.44 mg sodium chloride, and water for injection. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH to 6.5.
Pharmacodynamics
After administration of ZEGALOGUE in adult patients with type 1 diabetes, the mean glucose increase from baseline at 90 minutes was 168 mg/dL
Pharmacokinetics
- The half-life was approximately 30 minutes.
- Metabolism
Metabolism data indicated that dasiglucagon is cleared like native glucagon through proteolytic degradation pathways in blood, liver, and kidney
Nonclinical Toxicology
In a study assessing fertility and early embryofetal development in rats, dasiglucagon administered via subcutaneous injection at doses of 0.5, 2, and 8 mg/kg/day did not affect fertility in male and female rats. These doses corresponded to exposures approximately 179 and 269 times higher than the human dose of 0.6 mg, based on the area under the curve (AUC).
Clinical Studies
Three randomized, double-blind, placebo-controlled, multicenter trials were conducted in patients with type 1 diabetes. Two trials (Trial A and Trial B) were conducted in adult patients, while one trial (Trial C) was conducted in pediatric patients aged 6 to 17 years. In all trials, patients were randomly assigned to receive ZEGALOGUE 0.6 mg, placebo, or (in Trials A and C) glucagon for injection 1.0 mg. These treatments were administered as single subcutaneous injections following controlled induction of hypoglycemia using intravenous insulin.
- The primary efficacy endpoint for all trials was the time to plasma glucose recovery (treatment success), defined as an increase in blood glucose of at least 20 mg/dL within 45 minutes without additional intervention. In Trials A and B, plasma glucose values were assessed at various timepoints up to 90 minutes post-treatment, while Trial C assessed glucose levels up to 60 minutes post-treatment. The primary hypothesis tested the superiority of ZEGALOGUE over placebo, with no formal comparison between ZEGALOGUE and glucagon for injection.
- In Trial A, 170 adult patients were randomized, with ZEGALOGUE demonstrating a statistically significant shorter median time to plasma glucose recovery (10 minutes) compared to placebo (40 minutes). Trial B involved 45 adult patients, with ZEGALOGUE showing a significantly shorter median time to recovery (10 minutes) compared to placebo (35 minutes). The trials also found ZEGALOGUE to have a similar median time to recovery as glucagon for injection.
These findings highlight the effectiveness of ZEGALOGUE in rapidly restoring blood glucose levels in patients with type 1 diabetes experiencing hypoglycemia.
How Supplied
Storage
Store ZEGALOGUE in a refrigerator at temperatures of 2°C to 8°C (36°F to 46°F), ensuring it is kept away from the cooling element and not frozen.
- For short-term storage at room temperature (20°C to 25°C or 68°F to 77°F), ZEGALOGUE can be kept outside the refrigerator for up to 12 months. Note the removal date on the protective case provided and avoid returning the product to the refrigerator after storing at room temperature. Store ZEGALOGUE in its protective case and shield from light exposure.
- Dispose of ZEGALOGUE after the 12-month room temperature storage period or upon reaching the expiration date indicated on the product, whichever comes first.
- Note that the gray cap inside the ZEGALOGUE autoinjector and the gray needle cover inside the ZEGALOGUE prefilled syringe contain dry natural rubber, a derivative of latex.
Images
Drug Images
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Package and Label Display Panel
ZEGALOGUE® (ze' gah log)
(dasiglucagon) injection
0.6 mg/0.6 mL
Emergency Use for Very Low Blood Sugar
Single-Dose
Autoinjector
Injection, for subcutaneous use {{#ask: Label Page::Dasiglucagon |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
It's crucial to educate patients and their support system on recognizing the signs and symptoms of severe hypoglycemia and the potential risks associated with prolonged hypoglycemia.
- Before administration, thoroughly review the Patient Information and Instructions For Use with the patient, family members, or caregivers to ensure proper understanding of ZEGALOGUE usage.
- Patients should be aware of the possibility of serious allergic reactions with glucagon products like ZEGALOGUE. They should be instructed to promptly seek medical attention if they experience any symptoms indicative of serious hypersensitivity reactions.
Choose injection site and expose skin:
Outer upper arms
- Lower abdomen (at least 2 inches from the belly button)
- Front or back of thighs
- Buttocks
Roll back any clothing to expose bare skin. Do not inject through clothes.
Precautions with Alcohol
Alcohol-Dasiglucagon interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Dasiglucagon Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Dasiglucagon Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.