GVOKE KIT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for GVOKE KIT (GVOKE KIT).
Glucagon acts as a hormone that raises blood glucose by promoting hepatic glycogenolysis and gluconeogenesis, and reducing glycogen synthesis. It also relaxes smooth muscle of the gastrointestinal tract.
| Metabolism | Primarily hepatic via proteolysis; also renal and plasma degradation. |
| Excretion | Primarily hepatic metabolism; renal excretion of metabolites; <10% unchanged in urine. Biliary excretion of metabolites is minimal. |
| Half-life | Terminal elimination half-life: 8-15 minutes; clinical context: due to rapid clearance, continuous infusion or repeated dosing is required for sustained effect. |
| Protein binding | 30-40% bound; primarily to albumin. |
| Volume of Distribution | 0.11-0.97 L/kg; large variation indicating extensive distribution into tissues including skeletal muscle and liver. |
| Bioavailability | Subcutaneous: 85-100%; Intranasal (via GVOKE): 65-75% relative to intravenous. |
| Onset of Action | Intravenous: <1 minute; Subcutaneous: 2-5 minutes; Intranasal (via GVOKE): 2-5 minutes. |
| Duration of Action | Intravenous: 10-20 minutes; Subcutaneous: 15-30 minutes; Intranasal (via GVOKE): 20-40 minutes. Duration is short; clinical effect wanes rapidly. |
1 mg subcutaneously or intramuscularly as a single dose; may repeat once after 15 minutes if no response.
| Dosage form | SOLUTION |
| Renal impairment | No dose adjustment required for renal impairment. Safety and efficacy not established in end-stage renal disease. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Body weight ≥25 kg: 1 mg subcutaneously or intramuscularly; body weight <25 kg: 0.5 mg subcutaneously or intramuscularly. May repeat once after 15 minutes. |
| Geriatric use | No specific dose adjustment; use with caution due to potential for cardiovascular effects (e.g., hypertension, arrhythmias) and consider lower initial doses if frail. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for GVOKE KIT (GVOKE KIT).
| Breastfeeding | Glucagon is not orally bioavailable in infants due to gastrointestinal degradation. Excretion into breast milk is negligible; M/P ratio is not established. Considered compatible with breastfeeding if used for acute hypoglycemia. |
| Teratogenic Risk | Glucagon (GVOKE KIT) is a polypeptide hormone with no known teratogenic risk. Animal studies have not shown fetal harm, and there are no adequate human studies in pregnancy. Use only if clearly needed for severe hypoglycemia. Risk cannot be ruled out for any trimester, but benefits of treating maternal hypoglycemia outweigh potential risks. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Known hypersensitivity to glucagon or any component of the formulation","Pheochromocytoma (risk of hypertensive crisis)","Insulinoma (risk of hypoglycemia)"]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis) have been reported","May cause nausea and vomiting","Use with caution in patients with suspected pheochromocytoma or insulinoma","May cause hypoglycemia in patients with insulinoma or glucagonoma","Cardiovascular effects such as hypertension and tachycardia may occur"] |
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| Fetal Monitoring | Monitor maternal blood glucose levels before and after administration. Fetal heart rate monitoring is not required but may be considered if maternal hypoglycemia is prolonged. Observe for maternal nausea, vomiting, or tachycardia as adverse effects. |
| Fertility Effects | No known effects on fertility. Glucagon is used acutely and does not impact reproductive function in animal studies. |