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glucagon

Glucagon

Published evidence · coverage incomplete
Anatomical contextAnatomy connections are not mapped yet.

No body region is highlighted until this profile has a supported anatomical connection. This does not mean the peptide has no biological effects.

Read published mechanism findings ↓

At a glance

What is it—and why does it matter?

This product contains synthetic-origin glucagon that is structurally identical to endogenous human glucagon (a polypeptide hormone). Glucagon receptor activation initiates intracellular signaling that culminates in activation of phosphorylase A. Glucagon has a hyperglycemic pharmacodynamic effect, increasing circulating blood glucose concentration. Reported adverse reactions include gastrointestinal symptoms, specifically nausea and vomiting.

Sources for this introduction: [1] [2] [3] [4]

This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.

What is it?

A molecule, not a product name.

Identity

This product contains synthetic-origin glucagon that is structurally identical to endogenous human glucagon (a polypeptide hormone).

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection (synthetic origin) is a polypeptide hormone identical to human glucagon

    dailymed-lead-31105257 · DESCRIPTION

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

How does it work?

Target, response, and disposition.

Mechanism

Mechanistically, glucagon’s glycemic action is described as acting on hepatic glycogen stores to generate glucose.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon acts only on liver glycogen, converting it to glucose.

    dailymed-lead-31105257 · CLINICAL PHARMACOLOGY

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

Mechanism

Glucagon’s hepatic action promotes glycogenolysis, converting glycogen stores into glucose.

Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon acts in the liver resulting in the conversion of glycogen stores to glucose.

    IUPHAR ligand commentary · Mechanism of action

    iuphar-comments:1136:d5e2476f1902:d5e2476f1902

Mechanism

By agonizing hepatic glucagon receptors, glucagon promotes hepatic glycogenolysis and hepatic glucose output, increasing circulating glucose.

Source records
2
Regulatory records
2

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 12.1 Mechanism of Action

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6
  2. supports · Source-backed record
    Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960 · 12.1 Mechanism of Action

    dailymed:e4be1c0e-0fe6-45a0-9229-5cde98434b84:b646e2b671b3:b646e2b671b3

Mechanism

The stated extrahepatic mechanism includes smooth-muscle relaxation in multiple GI segments (stomach, small bowel, colon), consistent with reduced GI motility during imaging procedures.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Extra hepatic effects of glucagon include relaxation of the smooth muscle of the stomach, small bowel, and colon.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 12.1 Mechanism of Action

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Mechanism

Phosphorylase A catalyzes glycogen breakdown by releasing glucose-1-phosphate from glycogen polymers.

Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    the enzyme responsible for the release of glucose-1-phosphate from glycogen polymers.

    IUPHAR ligand commentary · Mechanism of action

    iuphar-comments:1136:d5e2476f1902:d5e2476f1902

Mechanism

A HEK293 cell-based luciferase reporter assay measuring cAMP stimulation at GLP1R reported CHEMBL5314341 EC50 of 3.3 nM.

Reported result
EC50 = 3.3 nM
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Molecule: CHEMBL5314341 Target: Glucagon-like peptide 1 receptor (CHEMBL1784) Assay: Agonist activity at GLP1R expressed in HEK293 cells assessed as stimulation of cAMP production by luciferase reporter gene assay Assay format: cell-based format Standard result: EC50 = 3.3 nM pChEMBL value: 8.48 Document: CHEMBL1221226

    ChEMBL activities for CHEMBL5314341 · Activity 3421667

    chembl-activities:chembl5314341:9bceb24dded1:9bceb24dded1

Mechanism

Mechanism: glucagon binds hepatic glucagon receptors, promoting glycogenolysis and hepatic glucose output, increasing blood glucose concentration.

Source records
2
Regulatory records
2

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 12.1 Mechanism of Action

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87
  2. supports · Source-backed record
    Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver.

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 12 CLINICAL PHARMACOLOGY

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Mechanism

Mechanistically, glucagon initiates its hepatic effect by activating the glucagon receptor.

Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The first step of the process is glucagon-induced activation of the glucagon receptor,

    IUPHAR ligand commentary · Mechanism of action

    iuphar-comments:1136:d5e2476f1902:d5e2476f1902

Mechanism

A cell-based HTRF assay in HEK293 cells expressing the human glucagon receptor measured cAMP accumulation after 30 mins and reported an EC50 of 0.0004 nM for CHEMBL5314341.

Reported result
EC50 = 0.0004 nM
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Molecule: CHEMBL5314341 Target: Glucagon receptor (CHEMBL1985) Assay: Agonist activity at human glucagon receptor expressed in HEK293 cells assessed as cAMP accumulation after 30 mins by HTRF assay Assay format: cell-based format Standard result: EC50 = 0.0004 nM Document: CHEMBL4049452

    ChEMBL activities for CHEMBL5314341 · Activity 18240493

    chembl-activities:chembl5314341:9bceb24dded1:9bceb24dded1

Mechanism

A single-protein competitive binding assay at the glucagon receptor reported that CHEMBL5314341 displaced radiolabeled [125I]glucagon with IC50 1.5 nM, indicating high-affinity binding in this setup.

Reported result
IC50 = 1.5 nM
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Molecule: CHEMBL5314341 Target: Glucagon receptor (CHEMBL4720) Assay: Compound was tested for its ability to displace [125I]glucagon from the glucagon receptor Assay format: single protein format Standard result: IC50 = 1.5 nM pChEMBL value: 8.82 Document: CHEMBL1150501

    ChEMBL activities for CHEMBL5314341 · Activity 518642

    chembl-activities:chembl5314341:9bceb24dded1:9bceb24dded1

Mechanism

Glucagon receptor activation initiates intracellular signaling that culminates in activation of phosphorylase A.

Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    triggering a signalling cascade which culminates in the activation of phosphorylase A,

    IUPHAR ligand commentary · Mechanism of action

    iuphar-comments:1136:d5e2476f1902:d5e2476f1902

Pharmacokinetics

Across the studied IV dose range, systemic exposure metrics are described as dose-proportional for glucagon in adult volunteers.

Reported result
dose proportionality between 0.25 and 2.0 mg
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Administration of the intravenous glucagon showed dose proportionality of the pharmacokinetics between 0.25 and 2.0 mg.

    dailymed-lead-31105257 · Pharmacokinetics

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

Pharmacokinetics

Pharmacokinetics: the elimination half-life reported for subcutaneous GVOKE (glucagon) is 32 minutes.

Reported result
Half-life 32 minutes
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The half-life of GVOKE was determined to be 32 minutes.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 12.3 Pharmacokinetics

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Pharmacokinetics

Absorption profile: following 1 mg subcutaneous GVOKE in adults with type 1 diabetes, reported exposure metrics include Cmax 2481.3 pg/mL, tmax 50 minutes, and AUC0‑240min 3454.6 pg*min/mL.

Reported result
Cmax 2481.3 pg/mL; tmax 50 minutes; AUC0‑240min 3454.6 pg*min/mL
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Subcutaneous injection of 1 mg GVOKE in adult type 1 diabetes mellitus patients resulted in a mean glucagon Cmaxof 2481.3 pg/mL, tmaxof 50 minutes and AUC0‑240minof 3454.6 pg*min/mL.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 12.3 Pharmacokinetics

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Pharmacokinetics

Glucagon is described as having a mean elimination half-life ranging from 8 to 18 minutes.

Reported result
8 to 18 minutes
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The mean half-life ranged from 8 to 18 minutes.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 12.3 Pharmacokinetics

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6

Pharmacokinetics

PK calculations reported for a 1 mg dose include a small mean Vd (0.25 L/kg), moderate mean clearance (13.5 mL/min/kg), and a short half-life (8–18 minutes).

Reported result
mean Vd 0.25 L/kg; mean clearance 13.5 mL/min/kg; half-life 8 to 18 minutes
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Calculations from a 1 mg dose showed a small volume of distribution (mean, 0.25 L/kg) and a moderate clearance (mean, 13.5 mL/min/kg). The half-life was short, ranging from 8 to 18 minutes.

    dailymed-lead-31105257 · Pharmacokinetics

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

What has been studied?

What the evidence says.

Study findings

Glucagon given by parenteral routes is described to relax gastrointestinal smooth muscle (stomach, duodenum, small bowel, colon).

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon administered through a parenteral route relaxes smooth muscle of the stomach, duodenum, small bowel, and colon.

    dailymed-lead-31105257 · CLINICAL PHARMACOLOGY

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

Study findings

Glucagon has a hyperglycemic pharmacodynamic effect, increasing circulating blood glucose concentration.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon increases blood glucose concentration

    dailymed-lead-31105257 · CLINICAL PHARMACOLOGY

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

Studied populations

In pediatric patients with diabetes, safety and effectiveness of glucagon for injection for treatment of severe hypoglycemia are established.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The safety and effectiveness of glucagon for injection for the treatment of severe hypoglycemia in pediatric patients with diabetes have been established.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 8.4 Pediatric Use

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6

Risks and interactions

Risks, organized for scanning.

Contraindications

Insulinoma is a labeled contraindication due to risk of hypoglycemia following glucagon administration.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Insulinoma [see Warnings and Precautions (5-5.2)] because of the risk of hypoglycemia

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 4 CONTRAINDICATIONS

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Contraindications

Label-listed contraindications include pheochromocytoma, insulinoma, prior hypersensitivity to glucagon or excipients, and glucagonoma when glucagon is used as a diagnostic aid.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for injection is contraindicated in patients with:Pheochromocytoma because of the risk of substantial increase in blood pressure[see Warnings and Precautions (5.1)]Insulinoma because of the risk of hypoglycemia[see Warnings and Precautions (5.2)]Known hypersensitivity to glucagon or any of the excipients in glucagon for injection. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension[see Warnings and Precautions (5.3)]Glucagonoma when used as a diagnostic aid because of the risk of hypoglycemia[see Warnings and Precautions (5.8)]

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 4 CONTRAINDICATIONS

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6

Contraindications

The product labeling lists pheochromocytoma as a contraindication for Glucagon for Injection.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is contraindicated in patients with:Pheochromocytoma

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 4 CONTRAINDICATIONS

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Contraindications

The contraindications listed are known hypersensitivity to glucagon and known pheochromocytoma.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon is contraindicated in patients with known hypersensitivity to it or in patients with known pheochromocytoma.

    dailymed-lead-31105257 · CONTRAINDICATIONS

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

Contraindications

Contraindication: glucagon (GVOKE/GVOKE VialDx) should not be used in pheochromocytoma due to risk of substantial blood pressure increase.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    GVOKE and GVOKE VialDx are contraindicated in patients with:Pheochromocytoma because of the risk of substantial increase in blood pressure

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 4 CONTRAINDICATIONS

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Contraindications

The product labeling lists pheochromocytoma as a contraindication for Glucagon for Injection.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is contraindicated in patients with:Pheochromocytoma

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960 · 4 CONTRAINDICATIONS

    dailymed:e4be1c0e-0fe6-45a0-9229-5cde98434b84:b646e2b671b3:b646e2b671b3

Contraindications

The label lists pheochromocytoma as a contraindication for Glucagon for Injection.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is contraindicated in patients with:Pheochromocytoma

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 4 CONTRAINDICATIONS

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Interactions

A clinically significant interaction is described where beta-blocker coadministration is associated with transient increases in heart rate (pulse) and blood pressure after glucagon administration.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given Glucagon for Injection.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960 · 7.1

    dailymed:e4be1c0e-0fe6-45a0-9229-5cde98434b84:b646e2b671b3:b646e2b671b3

Safety findings

Clinical safety experience described includes a randomized, single-blind study in which healthy subjects received 1 mg IM Glucagon for Injection as a single dose.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    In a randomized single-blind clinical study of Glucagon for Injection, 29 healthy subjects received a single dose of 1 mg Glucagon for Injection intramuscularly.

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 6 ADVERSE REACTIONS

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Safety findings

The labeling reports that intravenous bolus dosing above 1 mg has been associated with nausea and vomiting, and such dosing is not recommended.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Bolus doses above 1 mg administered intravenously have caused nausea and vomiting and are not recommended

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 2.1 Recommended Dose

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Safety findings

Reported adverse reactions include gastrointestinal symptoms, specifically nausea and vomiting.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Side effects may include nausea and vomiting.

    dailymed-lead-31105257 · ADVERSE REACTIONS

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

Products and regulatory status

Same ingredient. Different records.

Regulatory status

This indicates glucagon (GVOKE) for subcutaneous rescue treatment of severe hypoglycemia in adults and children ≥2 years with diabetes.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 1.1 Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Regulatory status

Glucagon for injection has an approved diagnostic-aid indication to temporarily inhibit gastrointestinal tract movement during radiologic examinations in adults.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 1.2 Diagnostic Aid

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6

Regulatory status

The labeled indication includes treating severe hypoglycemia in both pediatric and adult patients who have diabetes.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 1 INDICATIONS & USAGE

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Regulatory status

The product’s labeled indication includes treating severe hypoglycemia in both pediatric and adult patients with diabetes.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960 · 1.1 Severe Hypoglycemia

    dailymed:e4be1c0e-0fe6-45a0-9229-5cde98434b84:b646e2b671b3:b646e2b671b3

Regulatory status

This indication positions IV glucagon (GVOKE VialDx) as a diagnostic aid to transiently inhibit gastrointestinal motility in adult radiologic examinations.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    GVOKE VialDx is indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 1.2 Diagnostic Aid in Adults

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Regulatory status

The labeled diagnostic-use indication is temporary inhibition of gastrointestinal tract movement during radiologic examinations in adults.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 1 INDICATIONS & USAGE

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Regulatory status

In radiologic procedures, glucagon can be used diagnostically to temporarily inhibit gastrointestinal tract motility.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is indicated for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 1 INDICATIONS AND USAGE

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Regulatory status

Glucagon for injection has an approved indication for treating severe hypoglycemia in pediatric and adult patients with diabetes mellitus.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 1.1 Severe Hypoglycemia

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6

Regulatory status

This product’s labeling excludes emergency hypoglycemia treatment due to packaging that lacks syringe and diluent needed for rapid preparation and administration in out-of-facility emergencies.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is not indicated for the emergency treatment of hypoglycemia because it is not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 1 INDICATIONS AND USAGE

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Regulatory status

The labeled diagnostic indication is temporary inhibition of gastrointestinal motility during radiologic examinations in adult patients.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960 · 1.2 Diagnostic Aid

    dailymed:e4be1c0e-0fe6-45a0-9229-5cde98434b84:b646e2b671b3:b646e2b671b3

Administration context

The practical clinical context.

Administration

The dosing instruction specifies 1 mg glucagon for severe hypoglycemia, administered subcutaneously, intramuscularly, or intravenously in adults and pediatric patients >44 lb (20 kg).

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    For adults and for pediatric patients weighing more than 44 lb (20 kg), give 1 mg by subcutaneous, intramuscular, or intravenous injection.

    dailymed-lead-31105257 · DOSAGE AND ADMINISTRATION

    dailymed:31105257-4af6-417e-9fb9-58a9b4e87092:7d4929d61d0e:7d4929d61d0e

Administration

Permitted routes include SC, IM, and IV; IV administration is restricted to medical supervision.

Source records
2
Regulatory records
2

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 2.1 Important Administration Instructions for Using Glucagon for Injection to Treat Severe Hypoglycemia

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6
  2. supports · Source-backed record
    Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960 · 2.1 Important Administration Instructions for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe Hypoglycemia

    dailymed:e4be1c0e-0fe6-45a0-9229-5cde98434b84:b646e2b671b3:b646e2b671b3

Administration

Because it is supplied as a lyophilized powder, glucagon must be reconstituted using 1 mL Sterile Water for Injection before parenteral (IV or IM) administration.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Using a syringe, withdraw 1 mL of Sterile Water for Injection and inject into the vial containing Glucagon for Injection lyophilized powder.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 2.2 Reconstitution of the Lyophilized Powder

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Administration

For intravenous administration, the product labeling specifies bolus delivery over 1 minute, which defines the administration rate.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    If given intravenously, administer Glucagon for Injection as a bolus over a time period of 1 minute.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 2.3 Important Administration Instructions

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Administration

The labeled routes of administration are SC, IM, or IV; IV administration is restricted to situations with medical supervision.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 2 DOSAGE & ADMINISTRATION

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Administration

Preparation requirement: IV glucagon (GVOKE VialDx) is diluted in 0.9% sodium chloride before use to yield a 0.45 mg/mL glucagon solution for administration.

Reported result
Final concentration 0.45 mg/mL of glucagon
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The final concentration of the diluted solution is 0.45 mg/mL of glucagon.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 2.2 Dosage and Administration of GVOKE VialDx for Intravenous Use as a Diagnostic Aid in Adults

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Dose records

Weight-based pediatric dosing: subcutaneous glucagon (GVOKE) 0.5 mg for ages 2 to <12 years weighing <45 kg.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Less than 45 kg is 0.5 mg administered by subcutaneous injection into the lower abdomen, outer thigh, or outer upper arm.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 2.1 Dosage and Administration of GVOKE for Subcutaneous Use to Treat Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Dose records

For diagnostic inhibition of motility in the stomach and small bowel, labeled usual dosing is 0.2–0.5 mg intravenously or 1 mg intramuscularly.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The usual dose to inhibit movement of the:Stomach and small bowel is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 2.1 Recommended Dose

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Dose records

Adult diagnostic dosing for colonic relaxation includes IV dosing (0.5–0.75 mg) or IM dosing (1–2 mg).

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    the recommended dose to relax the colon is 0.5 mg to 0.75 mg administered intravenously or 1 mg to 2 mg administered intramuscularly

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960 · 2.4 Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid

    dailymed:e4be1c0e-0fe6-45a0-9229-5cde98434b84:b646e2b671b3:b646e2b671b3

Dose records

For severe hypoglycemia treatment in pediatric patients <20 kg, recommended dosing is 0.5 mg (0.5 mL) or 20–30 mcg/kg via SC/IM, with IV administration as an alternative by healthcare providers.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Pediatric Patients Weighing Less Than 20 kgThe recommended dosage is 0.5 mg (0.5 mL) or dose equivalent to 20 to 30 mcg/kg injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks. Alternatively, healthcare providers may administer the dose intravenously.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 2.2 Dosage for Treatment of Severe Hypoglycemia

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6

Dose records

Dose recommendation: subcutaneous glucagon (GVOKE) 1 mg for treatment of severe hypoglycemia in patients ≥12 years with diabetes.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The recommended dose is 1 mg administered by subcutaneous injection into lower abdomen, outer thigh, or outer upper arm.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 2.1 Dosage and Administration of GVOKE for Subcutaneous Use to Treat Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Dose records

In the emergency kit dosing scheme for severe hypoglycemia, patients >25 kg (or ≥6 years with unknown weight) receive 1 mg (1 mL) via SC/IM/IV routes.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The recommended dosage is 1 mg (1 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously.

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 2 DOSAGE & ADMINISTRATION

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Dose records

Adult diagnostic-aid dosing for upper GI smooth muscle relaxation is typically 0.25–0.5 mg IV or 1 mg IM; doses up to 2 mg IV/IM may be used when required.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The usual dose for relaxation of the stomach, duodenum and small bowel is 0.25 mg to 0.5 mg given intravenously or 1 mg given intramuscularly, but up to 2 mg intravenously or intramuscularly may be used if required (2 mg doses produce a higher rate of nausea and vomiting than lower doses)[see Adverse Reactions (6)].

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 2.4 Dosage in Adults for Use as a Diagnostic Aid

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6

Dose records

In the emergency kit dosing scheme for smaller/younger pediatric patients, the recommended dose is 0.5 mg (0.5 mL) via SC/IM/IV routes.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The recommended dosage is 0.5 mg (0.5 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously.

    GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR · 2 DOSAGE & ADMINISTRATION

    dailymed:a0845f53-edad-e28f-e053-2995a90a31cf:e75ddee3e61e:e75ddee3e61e

Dose records

For severe hypoglycemia treatment in patients ≥20 kg, the recommended glucagon for injection dose is 1 mg (1 mL) via SC/IM, with IV administration as an alternative by healthcare providers.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Adults and Pediatric Patients Weighing 20 kg or MoreThe recommended dosage is 1 mg (1 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks. Alternatively, healthcare providers may administer the dose intravenously.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960 · 2.2 Dosage for Treatment of Severe Hypoglycemia

    dailymed:6e80adb5-f45c-4f92-8dae-ee64217c676f:a64b811de5d6:a64b811de5d6

Dose records

For diagnostic inhibition of colonic motility, labeled usual dosing is 0.5–0.75 mg intravenously or 1–2 mg intramuscularly.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    Colon is 0.5 mg to 0.75 mg given intravenously or 1 mg to 2 mg given intramuscularly.

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998 · 2.1 Recommended Dose

    dailymed:8c8acad6-44cc-43aa-966b-027e053be8f5:1a3fe899d6b2:1a3fe899d6b2

Dose records

Weight-based pediatric dosing: subcutaneous glucagon (GVOKE) 1 mg for ages 2 to <12 years weighing ≥45 kg.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    45 kg or greater is 1 mg administered by subcutaneous injection into the lower abdomen, outer thigh, or outer upper arm.

    These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960 · 2.1 Dosage and Administration of GVOKE for Subcutaneous Use to Treat Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes

    dailymed:92385737-dbad-98c5-e053-2995a90a2805:3fab004d9b87:3fab004d9b87

Dose records

Adult diagnostic dosing for gastrointestinal smooth-muscle relaxation specifies IV dosing (0.2–0.5 mg) or IM dosing (1 mg) for the stomach, duodenal bulb, duodenum, and small bowel.

Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    The recommended diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg administered intravenously or 1 mg administered intramuscularly;

    These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960 · 2.4 Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid

    dailymed:e4be1c0e-0fe6-45a0-9229-5cde98434b84:b646e2b671b3:b646e2b671b3

Research status + gaps

What still needs better answers?

  • 74 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (46), assurance_score_below_0.72 (26), current_regulatory_source_required (16), extraction_ambiguity (39), high_risk_requires_regulatory_or_two_independent_sources (25), no_direct_support (71)

These are the limits of this profile, not an exhaustive list of scientific uncertainties.

References + discovery

Open the records yourself.

  1. ChEMBL activities for CHEMBL5314341

    chembl-activities · published 2026-08-26 · retrieved 2026-08-26T20:13:52Z

  2. dailymed-lead-31105257

    dailymed · published 2023-07-21 · retrieved 2026-09-04T19:33:50Z

  3. These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.Glucagon for Injection, for subcutaneous, intramuscular, or intravenous use.Initial U.S. Approval: 1960

    dailymed · published 2025-10-07 · retrieved 2026-09-04T19:33:46Z

  4. These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for intravenous or intramuscular useInitial U.S. Approval: 1998

    dailymed · published 2022-04-01 · retrieved 2026-09-04T19:33:52Z

  5. These highlights do not include all the information needed to use GVOKE and GVOKE VialDx safely and effectively. See full prescribing information for GVOKE and GVOKE VialDx.GVOKE (glucagon) injection, for subcutaneous useGVOKE VialDx (glucagon) injection, for intravenous useInitial U.S. Approval: 1960

    dailymed · published 2025-12-23 · retrieved 2026-09-04T19:33:47Z

  6. GLUCAGON EMERGENCY KIT FOR LOW BLOOD SUGAR

    dailymed · published 2024-02-22 · retrieved 2026-09-04T19:33:50Z

  7. These highlights do not include all the information needed to use GLUCAGON FOR INJECTION safely and effectively. See full prescribing information for GLUCAGON FOR INJECTION.GLUCAGON for injection, for subcutaneous, intramuscular or intravenous useInitial U.S. Approval: 1960

    dailymed · published 2020-09-16 · retrieved 2026-09-04T19:33:52Z

  8. IUPHAR ligand commentary

    iuphar-comments · published 2026-08-26 · retrieved 2026-08-26T20:13:52Z

Publication history and provenance

Version 7 · Automated assessment · 2026-09-04T19:33:52Z

4975dc079b3f8d71ac63cfcc3eb44be3e42d8258f91fb19d5b1a8db8f7119cb5