Gvoke FDA Approval History
Last updated by Judith Stewart, BPharm on May 13, 2025.
FDA Approved: Yes (First approved September 10, 2019)
Brand name: Gvoke
Generic name: glucagon
Dosage form: Injection
Company: Xeris Pharmaceuticals, Inc.
Treatment for: Hypoglycemia, Diagnosis and Investigation
Gvoke (glucagon injection) is a ready-to-use, room-temperature stable, liquid glucagon for the treatment of hypoglycemia. Gvoke VialDx (glucagon injection) is used as a diagnostic aid.
- Gvoke is indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged two years and older with diabetes.
- Severe hypoglycemia is a serious condition that requires emergency assistance. Gvoke can be administered quickly and easily via a prefilled syringe (Gvoke PFS), auto-injector (Gvoke HypoPen), or single dose vial and syringe kit (Gvoke Kit).
- Gvoke is injected into the lower abdomen, outer thigh, or outer upper arm. Caregivers should call for emergency assistance immediately after administering the dose.
- Gvoke VialDx is indicated for intravenous use (under medical supervision) as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
- Gvoke and Gvoke VialDx can cause serious allergic reactions, and should not be used in patients who have had a prior hypersensitivity reaction to glucagon. Patients should seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions. Other warnings and precautions associated with Gvoke and Gvoke VialDx include substantial increase in blood pressure in patients with pheochromocytoma; hypoglycemia in patients with insulinoma; and necrolytic migratory erythema. Additional warnings and precautions associated with Gvoke VialDx administered intravenously as a diagnostic aid include hyperglycemia in patients with diabetes mellitus; increases in blood pressure and heart rate in patients with cardiac disease; and hypoglycemia in patients with glucagonoma.
- Common Gvoke adverse reactions (incidence 2% or greater) in adults include nausea, vomiting, injection site edema raised 1 mm or greater, and headache.
Common Gvoke adverse reactions (incidence 2% or greater) in pediatric patients include nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria.
Common Gvoke VialDx adverse reactions (incidence 5 % or greater) include nausea, dysgeusia, headache, dizziness and hot flush.
Development timeline for Gvoke
Further information
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