Gvoke VialDx 1 mg/.2mL
glucagon injection · INJECTION, SOLUTION · American Regent, Inc.
Gvoke VialDx is a injection, solution containing glucagon injection at 1 mg/.2mL, taken intravenous. Manufactured by American Regent, Inc..
Key Facts
- Brand Name
- Gvoke VialDx
- Generic Name
- glucagon injection
- NDC Code (Product)
0517-2901- Manufacturer
- American Regent, Inc.
- Strength
- 1 mg/.2mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA212097
- Drug Class
- Antihypoglycemic Agent [EPC]; Gastrointestinal Motility Inhibitor [EPC]
- Marketing Start
- 08/19/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE GVOKE is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes ( 1.1 ) 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 ( 1.2 ) 1.1 Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes GVOKE is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two and older with diabetes. 1.2 Diagnostic Aid in Adults 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosage and Administration of GVOKE for Subcutaneous Use to Treat Severe Hypoglycemia in Adult and Pediatric Patients Aged 2 Years and Older with Diabetes ( 2.1 ) Important Administration Instructions Administer GVOKE HypoPen, GVOKE PFS, or GVOKE Kit subcutaneously. These three presentations are referred to as GVOKE in this labeling Administer GVOKE according to the printed instructions on the foil pouch label, carton, or the Instructions for Use. Visually inspect GVOKE prior to administration. The solution should appear clear and colorless to pale yellow. Administer GVOKE subcutaneously in the lower abdomen, outer thigh, or outer upper arm. Call for emergency assistance immediately after administering the dose. If there has been no response after 15 minutes, may administer an additional dose from a new HypoPen, GVOKE PFS, or GVOKE Kit while waiting for emergency assistance. When the patient has responded to GVOKE, give oral carbohydrates. Do not attempt to reuse GVOKE. Each GVOKE device or vial contains a single dose of glucagon. Do not reuse and discard any unused portion. Recommended Dosage Recommended dose for adult and pediatric patients aged 12 year…
Contraindications
4 CONTRAINDICATIONS GVOKE and GVOKE VialDx are 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 )] Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE or GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions ( 5.3 )] . GVOKE VialDx for use as a diagnostic aid is also contraindicated in patients with glucagonoma because of risk of hypoglycemia [see Warnings and Precautions ( 5.8 )] Pheochromocytoma ( 4 ) Insulinoma ( 4 ) Prior hypersensitivity reaction to glucagon or to any of the excipients ( 4 ) Glucagonoma when used as a diagnostic aid ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 4: Clinically Significant Drug Interaction with GVOKE and GVOKE VialDx Beta-Blockers Clincial Impact: Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE or GVOKE VialDx. Intervention The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. Insulin Clincial Impact: Insulin acts antagonistically to glucagon. Intervention Monitor blood glucose when GVOKE VialDx is used as a diagnostic aid in patients receiving insulin. Indomethacin Clincial Impact: In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia. Intervention Monitor blood glucose levels during glucagon treatment of patients taking indomethacin. Anticholinergic Drugs Clincial Impact: 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. Intervention Concomitant use of anticholinergic drugs with GVOKE VialDx is not recommended. Warfarin Clincial Impact: GVOKE and GVOKE Vial Dx may increase the anticoagulant ef…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions ( 5.1 )] . Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions ( 5.2 )] . Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Lack of Efficacy With Subcutaneous Use for Severe Hypoglycemia in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions ( 5.4 )] Necrolytic Migratory Erythema [see Warnings and Precautions ( 5.5 )] . Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus [see Warnings and Precautions ( 5.6 )] Blood Pressure and Heart Rate Increases with Intravenous Use as a Diagnostic Aid in Patients with Cardiac Disease [see Warnings and Precautions ( 5.7 )] Hypoglycemia in Patients with Glucagonoma with Intravenous Use as a Diagnostic Aid [see Warnings and Precautions ( 5.8 )] Most common adverse reactions (incidence 2% or greater) reported for GVOKE were: Adults—nausea, vomiting, injection site edema raised 1 mm or greater, and headache ( 6.1 ) Pediatric Patients—nausea, hypog…
Frequently Asked Questions
What is Gvoke VialDx used for?
Gvoke VialDx contains glucagon injection. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Gvoke VialDx a controlled substance?
Gvoke VialDx is not classified as a controlled substance by the DEA.
What is the generic name for Gvoke VialDx?
The generic name for Gvoke VialDx is glucagon injection. There are 4 other brand versions of glucagon injection.
What is the NDC code for Gvoke VialDx 1 mg/.2mL?
The NDC (National Drug Code) for Gvoke VialDx 1 mg/.2mL is 0517-2901, listed by American Regent, Inc..