Demonstrated efficacy profile¹

Adult Patients

Adult patients
Pediatric patients

99% (152/154) of adults had their glucose levels raised to safe levels across 2 clinical trials^1,*

*Blood glucose >70 mg/dL or an increase of blood glucose of ≥20 mg/dL from baseline.

Gvoke was evaluated in adult patients aged 18 to 74 years with type 1 diabetes in 2 multicenter, randomized, blinded, 2-way crossover clinical trials. 154 subects received an injection of Gvoke and 157 subjects received an injection of Glucagon Emergency Kit; 152 subjects received both products. The comparison between groups met the prespecified noninferiority margin.

Reference: 1. Gvoke [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc; 2021.

100% (30/30) of pediatric patients had their glucose levels raised to safe levels^1,†

Average change in plasma glucose at 30 minutes

2‐5 years (0.5 mg/0.1 mL dose)	6‐11 years (0.5 mg/0.1 mL dose)	12-17 years (0.5 mg/0.1 mL dose)	12-17 years (1 mg/0.2 mL dose)
+81 mg/dL	+84 mg/dL	+53 mg/dL	+55 mg/dL

^†Target glucose increase of ≥25 mg/dL at 30 minutes.

Gvoke was evaluated in a clinical trial in 31 pediatric patients with type 1 diabetes. Patients were administered insulin to induce a low normal glycemic state of <80mg/dL. Patients aged 2 to <12 years then received a 0.5 mg dose of Gvoke. Patients aged ≥12 years received a 0.5 mg or 1.0 mg dose of Gvoke.

Reference: 1. Gvoke [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc; 2021.

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PHARMACOKINETICS

99% (152/154) of adults had their glucose levels raised to safe levels across 2 clinical trials^1,*

*Blood glucose >70 mg/dL or an increase of blood glucose of ≥20 mg/dL from baseline.

Pediatric Patients

100% (30/30) of pediatric patients had their glucose levels raise to safe levels^1,†

Average change in
plasma glucose at
30 minutes

+81 mg/dL

2-5 years
(0.5 mg/0.1 mL dose)

+84 mg/dL

6-11 years
(0.5 mg/0.1 mL dose)

+53 mg/dL

12-17 years
(0.5 mg/0.1 mL dose)

+55 mg/dL

12-17 years
(1 mg/0.2 mL dose)

^†Target glucose increase of ≥25 mg/dL at 30 minutes.

Gvoke was evaluated in a clinical trial in 31 pediatric patients with type 1 diabetes. Patients were administered insulin to induce a low normal glycemic state of <80mg/dL. patients aged 2 to <12 years then received a 0.5 mg dose of Gvoke. Patients aged ≥12 years received a 0.5 mg or 1.0 mg dose of Gvoke.

Reference: 1. Gvoke [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc; 2021.

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PHARMACOKINETICS

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INDICATION AND IMPORTANT SAFETY INFORMATION

GVOKE is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 2 years and above.

IMPORTANT SAFETY INFORMATION

Contraindications

GVOKE is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of the risk of hypoglycemia, and known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

Warnings and Precautions

GVOKE is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, GVOKE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously.

Allergic reactions have been reported with glucagon. These include generalized rash, and in some cases, anaphylactic shock with breathing difficulties and hypotension. GVOKE is contraindicated in patients with a prior hypersensitivity reaction.

GVOKE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia, may not have adequate levels of hepatic glycogen for GVOKE administration to be effective. Patients with these conditions should be treated with glucose.

Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion. NME lesions may affect the face, groin, perineum and legs or be more widespread. In the reported cases NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

Adverse Reactions

Most common (≥5%) adverse reactions associated with GVOKE are nausea, vomiting, injection site edema (raised 1 mm or greater), and hypoglycemia.

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE. In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia. GVOKE may increase the anticoagulant effect of warfarin.

Demonstrated efficacy profile1

Adult Patients

99% (152/154) of adults had their glucose levels raised to safe levels across 2 clinical trials1,*

100% (30/30) of pediatric patients had their glucose levels raised to safe levels1,†

99% (152/154) of adults had their glucose levels raised to safe levels across 2 clinical trials1,*

Pediatric Patients

100% (30/30) of pediatric patients had their glucose levels raise to safe levels1,†

Demonstrated efficacy profile¹

99% (152/154) of adults had their glucose levels raised to safe levels across 2 clinical trials^1,*

100% (30/30) of pediatric patients had their glucose levels raised to safe levels^1,†

99% (152/154) of adults had their glucose levels raised to safe levels across 2 clinical trials^1,*

100% (30/30) of pediatric patients had their glucose levels raise to safe levels^1,†