Introduction
Gvoke HypoPen (glucagon injection) is a ready-to-use, shelf-stable glucagon emergency kit designed for the treatment of severe hypoglycemia in patients with diabetes. Unlike traditional glucagon emergency kits that require reconstitution, Gvoke HypoPen offers a simplified administration process with pre-mixed, auto-injector delivery, making it particularly valuable for use by caregivers or non-medical personnel during emergency situations.
Mechanism of Action
Glucagon is a polypeptide hormone that raises blood glucose levels through multiple mechanisms. It binds to glucagon receptors on hepatocytes, activating adenylate cyclase and increasing intracellular cyclic AMP. This leads to:
- Enhanced glycogenolysis (breakdown of glycogen to glucose)
- Stimulation of gluconeogenesis (production of glucose from non-carbohydrate sources)
- Inhibition of glycogen synthesis
- Mobilization of hepatic glucose stores
These actions result in a rapid increase in blood glucose concentrations, typically within 10-15 minutes of administration.
Indications
Gvoke HypoPen is indicated for the treatment of severe hypoglycemia in:
- Adults and pediatric patients aged 2 years and older with diabetes mellitus
- Patients who require assistance due to severely impaired mental status or unconsciousness during hypoglycemic episodes
Dosage and Administration
Standard dosing:- Adults and pediatric patients ≥45 kg (≥100 lb): 1 mg (entire contents of auto-injector)
- Pediatric patients 2 years to <45 kg (<100 lb): 0.5 mg (half the contents of auto-injector)
- Administer subcutaneously in the abdomen, thigh, or outer upper arm
- Remove safety cap and press firmly against skin until click is heard
- Hold in place for 10 seconds to ensure complete delivery
- No reconstitution required - ready-to-use formulation
- Use immediately after removal from foil pouch
- Hepatic impairment: No dosage adjustment required
- Renal impairment: No dosage adjustment required
- Geriatric patients: No specific dosage recommendations
Pharmacokinetics
Absorption: Rapidly absorbed following subcutaneous administration Distribution: Distributed throughout extracellular space; does not cross blood-brain barrier Metabolism: Primarily metabolized in liver, kidneys, and plasma Elimination: Half-life approximately 8-18 minutes; cleared by proteolytic enzymes Onset of action: Blood glucose typically begins to rise within 10-15 minutes Duration of effect: Glucose-elevating effects last approximately 60-90 minutesContraindications
- Hypersensitivity to glucagon or any component of the formulation
- Pheochromocytoma (due to risk of catecholamine release)
- Insulinoma (may cause initial hypoglycemia followed by reactive hypoglycemia)
- Glucagonoma (may exacerbate condition)
Warnings and Precautions
Hepatic impairment: Use with caution in patients with hepatic insufficiency as glucagon efficacy may be reduced Hypoglycemia recurrence: Monitor for recurrent hypoglycemia as effects are temporary Gastrointestinal effects: May cause nausea and vomiting; position unconscious patients on their side to prevent aspiration Cardiac effects: Use with caution in patients with cardiac disease; may increase myocardial oxygen demand Allergic reactions: Rare cases of hypersensitivity reactions including anaphylaxis reported Pregnancy: Category B - use only if clearly needed Breastfeeding: Glucagon is a large peptide unlikely to be excreted in breast milkDrug Interactions
- Beta-blockers: May blunt the hyperglycemic effect of glucagon
- Indomethacin: May inhibit glucagon-induced insulin secretion
- Anticholinergic agents: May potentiate gastrointestinal effects
- Warfarin: Glucagon may enhance anticoagulant effect
- Insulin: Antagonizes insulin effects (intended therapeutic interaction)
Adverse Effects
Common (≥10%):- Nausea (16%)
- Vomiting (9-15%)
- Headache (8-11%)
- Injection site reactions (5-10%)
- Dizziness
- Fatigue
- Diarrhea
- Constipation
- Hyperglycemia (following initial correction)
- Hypersensitivity reactions
- Tachycardia
- Hypertension
- Hypokalemia
Monitoring Parameters
- Blood glucose levels before and after administration (every 15 minutes until stable)
- Neurological status and level of consciousness
- Vital signs (blood pressure, heart rate)
- Signs of recurrent hypoglycemia
- Injection site for reactions
- Electrolyte levels in cases of prolonged or repeated use
Patient Education
- Train patients and caregivers on proper administration technique using trainer device
- Recognize signs of severe hypoglycemia (confusion, seizures, unconsciousness)
- Administer as soon as severe hypoglycemia is recognized
- Always call for emergency medical assistance after administration
- Consume a fast-acting carbohydrate source once conscious and able to swallow
- Follow with a snack or meal containing complex carbohydrates and protein
- Store at room temperature (20-25°C); do not freeze
- Check expiration date regularly and replace as needed
- Inform healthcare providers about all medications being taken
- Carry medical identification indicating diabetes diagnosis
References
1. FDA prescribing information: Gvoke (glucagon) injection 2. Seaquist ER, et al. Diabetes Care. 2013;36(5):1384-1395 3. Sherr JL, et al. Diabetes Technol Ther. 2016;18(2):100-103 4. Valentine V, et al. Curr Med Res Opin. 2021;37(2):233-240 5. Pontiroli AE, et al. Acta Diabetol. 2020;57(1):11-19 6. American Diabetes Association. Diabetes Care. 2023;46(Suppl 1):S1-S291 7. Castle JR, et al. J Diabetes Sci Technol. 2020;14(1):155-162 8. Pieber TR, et al. Lancet Diabetes Endocrinol. 2020;8(2):117-126
This monograph is for educational purposes only and does not replace professional medical advice. Healthcare providers should consult full prescribing information before administering Gvoke HypoPen.