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Drug overview for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl):
Generic name: dasiglucagon HCl (DAS-i-GLOO-ka-gon)
Drug class: Glucagon and Analogs
Therapeutic class: Endocrine
Dasiglucagon, an antihypoglycemic agent, is a glucagon analog that increases blood glucose concentration by stimulating hepatic glycogenolysis.
No enhanced Uses information available for this drug.
Generic name: dasiglucagon HCl (DAS-i-GLOO-ka-gon)
Drug class: Glucagon and Analogs
Therapeutic class: Endocrine
Dasiglucagon, an antihypoglycemic agent, is a glucagon analog that increases blood glucose concentration by stimulating hepatic glycogenolysis.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl) have been approved by the FDA:
Indications:
Hypoglycemic disorder
Professional Synonyms:
Hypoglycemia
Indications:
Hypoglycemic disorder
Professional Synonyms:
Hypoglycemia
The following dosing information is available for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl):
Dosage of dasiglucagon hydrochloride is expressed in terms of dasiglucagon.
Dasiglucagon is administered by sub-Q injection only. Injection sites include the lower abdomen, buttocks, thigh, and outer upper arm. Dasiglucagon is supplied in single-use auto-injectors and prefilled syringes.
Dasiglucagon injection should be inspected visually prior to administration. The solution should appear clear, colorless, and free from particles and should be discarded if it is discolored or contains particulate matter. Dasiglucagon should be administered as soon as possible after severe hypoglycemia is recognized.
Immediately following administration, emergency assistance should be summoned. If the patient has not responded within 15 minutes after the initial dose, an additional dose may be administered using a new auto-injector or prefilled syringe while awaiting emergency assistance. Once the patient has responded to treatment, oral carbohydrates should be administered to restore liver glycogen stores and to prevent recurrence of hypoglycemia.
Dasiglucagon injection should be inspected visually prior to administration. The solution should appear clear, colorless, and free from particles and should be discarded if it is discolored or contains particulate matter. Dasiglucagon should be administered as soon as possible after severe hypoglycemia is recognized.
Immediately following administration, emergency assistance should be summoned. If the patient has not responded within 15 minutes after the initial dose, an additional dose may be administered using a new auto-injector or prefilled syringe while awaiting emergency assistance. Once the patient has responded to treatment, oral carbohydrates should be administered to restore liver glycogen stores and to prevent recurrence of hypoglycemia.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ZEGALOGUE 0.6 MG/0.6ML AUTOINJ | Maintenance | Adults inject 0.6 mg by subcutaneous route once may repeat dose in 15 minutes if inadequate response for a total of 2 doses |
No generic dosing information available.
The following drug interaction information is available for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Coumarin Anticoagulants/Glucagon, Dasiglucagon SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Not defined. CLINICAL EFFECTS: Excess hypoprothrombinemia and possible bleeding complications. PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. thrombocytopenia). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). PATIENT MANAGEMENT: If the duration of glucagon/dasiglucagon therapy is one day, a clinically important interaction is unlikely. Avoid using multiple doses of glucagon/dasiglucagon in anticoagulated patients. If this combination is necessary, decrease the warfarin dose prior to glucagon/dasiglucagon dosing. Monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin and/or hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. When applicable, perform INR to monitor efficacy and safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug. DISCUSSION: If the duration of glucagon/dasiglucagon therapy is one day, a clinically important interaction is unlikely. However, the potentiation effects of glucagon/dasiglucagon on the anticoagulant effect of warfarin seems to occur rapidly and can reverse within one day of stopping glucagon. |
ANISINDIONE, DICUMAROL, JANTOVEN, WARFARIN SODIUM |
The following contraindication information is available for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl):
Drug contraindication overview.
Dasiglucagon is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure and in those with insulinoma because of the risk of hypoglycemia.
Dasiglucagon is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure and in those with insulinoma because of the risk of hypoglycemia.
There are 0 contraindications.
There are 0 severe contraindications.
There are 0 moderate contraindications.
The following adverse reaction information is available for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl):
Adverse reaction overview.
Adverse effects reported in 2% or more of adults or pediatric patients receiving dasiglucagon include nausea, vomiting, headache, and injection site pain. Diarrhea also has been reported in 2% or more of adults receiving the drug.
Adverse effects reported in 2% or more of adults or pediatric patients receiving dasiglucagon include nausea, vomiting, headache, and injection site pain. Diarrhea also has been reported in 2% or more of adults receiving the drug.
There are 4 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Hypertension |
| Rare/Very Rare |
|---|
|
Bradycardia Hypersensitivity drug reaction Hypotension |
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Headache disorder Injection site sequelae Nausea Vomiting |
None. |
| Rare/Very Rare |
|---|
|
Orthostatic hypotension Palpitations Presyncope |
The following precautions are available for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl):
Safety and efficacy of dasiglucagon for the treatment of severe hypoglycemia in pediatric patients 6 years of age and older with diabetes mellitus are supported by evidence from a controlled study in 42 pediatric patients with type 1 diabetes mellitus. (See Hypoglycemia under Uses.) Safety and efficacy of the drug have not been established in pediatric patients younger than 6 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no available data regarding use of dasiglucagon in pregnant women by which to establish a drug-associated risk of major birth defects, spontaneous abortion, or adverse maternal or fetal outcomes. Untreated hypoglycemia during pregnancy can cause complications and can be fatal. In animal reproduction studies, daily sub-Q administration of dasiglucagon to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at exposure levels of 7 and 709 times, respectively, the recommended human dose of 0.6 mg; in rabbits at dosages of 20 or more times the recommended human dose, dasiglucagon caused fetal skeletal and visceral malformations.
It is not known whether dasiglucagon is distributed into human or animal milk, affects breast-fed infants, or affects milk production. Because dasiglucagon is a peptide and would be expected to be broken down to its constituent amino acids in an infant's digestive tract, the drug is unlikely to harm breast-fed infants.
Clinical studies of dasiglucagon did not include sufficient numbers of patients 65 years of age and older to determine whether geriatric patients respond differently than younger adults.
The following prioritized warning is available for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ZEGALOGUE AUTOINJECTOR (dasiglucagon hcl)'s list of indications:
| Hypoglycemic disorder | |
| E08.64 | Diabetes mellitus due to underlying condition with hypoglycemia |
| E08.649 | Diabetes mellitus due to underlying condition with hypoglycemia without coma |
| E09.64 | Drug or chemical induced diabetes mellitus with hypoglycemia |
| E09.649 | Drug or chemical induced diabetes mellitus with hypoglycemia without coma |
| E10.64 | Type 1 diabetes mellitus with hypoglycemia |
| E10.649 | Type 1 diabetes mellitus with hypoglycemia without coma |
| E11.64 | Type 2 diabetes mellitus with hypoglycemia |
| E11.649 | Type 2 diabetes mellitus with hypoglycemia without coma |
| E13.64 | Other specified diabetes mellitus with hypoglycemia |
| E13.649 | Other specified diabetes mellitus with hypoglycemia without coma |
| E16.0 | Drug-induced hypoglycemia without coma |
| E16.1 | Other hypoglycemia |
| E16.2 | Hypoglycemia, unspecified |
| P70.3 | Iatrogenic neonatal hypoglycemia |
| P70.4 | Other neonatal hypoglycemia |
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