Gvoke VialDx™ Clinical Highlights

Gvoke VialDx is a gastrointestinal motility inhibitor indicated for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.¹

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Recommended Dosing and Administration¹

The recommended diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg administered IV. The recommended dose to relax the colon is 0.5 mg to 0.75 mg administered IV.

Each 1-count package contains a single-dose glass vial of concentrated glucagon solution.

Gvoke VialDx is only for intravenous use under medical supervision.

Gvoke VialDx must be diluted with 0.9% sodium chloride injection prior to administration. Using a syringe, draw 0.2 mL from the Gvoke VialDx vial and dispense into a separate sterile container containing 2 mL of 0.9% sodium chloride injection.

The final concentration of the diluted solution is 0.45 mg/mL of glucagon. Draw the required dose from the container into a syringe for administration.

Safety¹

Most common adverse reactions (incidence 5% or greater) reported for Gvoke VialDx were nausea, dyspepsia, headache, hot flush, and dizziness.

Bioequivalence²

Gvoke VialDx was shown to have bioequivalence to Fresenius Kabi^® when 0.75 mg glucagon was administered intravenously.

Baseline-Corrected Plasma Glucagon Concentration-Time Profile
(Linear Scale, PK Population)

Baseline-corrected plasma glucagon concentration chart

Baseline-Corrected Plasma Glucagon Concentration-Time Profile
(Semi-Log Scale, PK Population) Observed plasma glucagon concentration chart

Image Description

The 2-sided 90% CIs for the baseline-corrected glucagon geometric least squares mean ratios for Cmax, AUC0-t, and AUC0-inf were within the pre-specified range of 80% to 125%.

AUC0-inf=area under the curve from time 0 to time infinity; AUC0-t=area under the curve from time 0 to time t; CI=confidence interval; Cmax=maximum concentration; IV=intravenous; PK=pharmacokinetic; SD=standard deviation.

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Important Safety Information

CONTRAINDICATIONS

GVOKE VialDx is contraindicated in patients with:

Pheochromocytoma because of the risk of substantial increase in blood pressure

Pheochromocytoma because of the risk of substantial increase in blood pressure
Insulinoma because of the risk of hypoglycemia
Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension
Glucagonoma because of risk of hypoglycemia.

Insulinoma because of the risk of hypoglycemia
Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension
Glucagonoma because of risk of hypoglycemia.

WARNINGS AND PRECAUTIONS

Substantial Increase in Blood Pressure in Patients With Pheochromocytoma

GVOKE VialDx is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a substantial 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.

Hypoglycemia in Patients With Insulinoma

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

Serious Hypersensitivity Reactions

Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. These reactions are more likely to occur in patients who have a hypersensitivity reaction to glucagon or who have an allergic reaction to glycoproteins. Patients who have a serious hypersensitivity reaction should seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. GVOKE VialDx is contraindicated in patients with a prior hypersensitivity reaction to glucagon, or any of the excipients in GVOKE VialDx.

Necrotizing Migratory Erythema (NME)

NME, a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported post marketing following continuous glucagon infusion. GVOKE VialDx cannot be given as an 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.

Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus

GVOKE VialDx in patients with diabetes mellitus may cause hyperglycemia. Monitor patients with diabetes for changes in blood glucose levels during treatment with GVOKE VialDx and treat hyperglycemia, if indicated.

Blood Pressure and Heart Rate Increase in Patients With Cardiac Disease When Used as a Diagnostic Aid

GVOKE VialDx may increase myocardial oxygen demand, blood pressure, and pulse rate, which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of GVOKE VialDx as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy.

Hypoglycemia in Patients With Glucagonoma

GVOKE VialDx administered to patients with glucagonoma may cause secondary hypoglycemia. GVOKE VialDx is contraindicated in patients with glucagonoma when used as a diagnostic agent or as treatment. If a patient is suspected of having glucagonoma for blood glucose from this treatment, and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of GVOKE VialDx, give glucose orally or intravenously.

ADVERSE REACTIONS

Clinical Trials Experience

The most common adverse reactions occurring in ≥5% of adult healthy volunteers who received 0.75 mg GVOKE VialDx intravenously were nausea, dysgeusia, headache, hot flush, and dizziness.

Postmarketing Experience

The following reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Necrotizing migratory erythema (NME): See Warnings and Precautions for postmarketing in patients receiving continuous infusion of glucagon
Hypoglycemia and hypoglycemic coma: Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration

DRUG INTERACTIONS

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE VialDx.

Insulin acts antagonistically to glucagon.

The concomitant use of anticholinergic drugs and GVOKE VialDx increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility.

GVOKE VialDx may increase the anticoagulant effect of warfarin.

USE IN SPECIFIC POPULATIONS

Pediatric Use

Safety and effectiveness of GVOKE VialDx for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established.

Geriatric Use

Clinical studies of GVOKE VialDx did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients.

OVERDOSAGE

If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure, and pulse rate. In case of suspected overdosing, serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.

INDICATIONS AND USAGE

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.

Please see Full Prescribing Information.

You are encouraged to report Adverse Drug Events to Xeris Pharmaceuticals, Inc. at 1-877-937-4737, or to the FDA by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

References: 1. Data on File, American Regent, Inc. 2. Gvoke VialDx [prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc. 3. Glucagon for injection [prescribing information]. Rancho Cucamonga, CA: Amphastar Pharmaceuticals, Inc. 4. Glucagon for injection [prescribing information]. Lake Zurich, IL: Fresenius Kabi.