glucagon injection, solution

FDA Drug Profile — Gvoke HypoPen 0.5 mg Auto-Injector, Gvoke HypoPen 1 mg Auto-Injector, Gvoke PFS 1 mg Pre-filled Syringe, Gvoke Kit

Drug Details

Generic Name
glucagon injection, solution
Brand Names
Gvoke HypoPen 0.5 mg Auto-Injector, Gvoke HypoPen 1 mg Auto-Injector, Gvoke PFS 1 mg Pre-filled Syringe, Gvoke Kit
Application Number
NDA212097
Sponsor
Xeris Pharmaceuticals, Inc.
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients
GLUCAGON

Indications and 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.