Gvoke FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 2, 2021.
FDA Approved: Yes (First approved September 10, 2019)
Brand name: Gvoke
Generic name: glucagon
Dosage form: Injection
Company: Xeris Pharmaceuticals, Inc.
Treatment for: Hypoglycemia
Gvoke (glucagon injection) is a ready-to-use, room-temperature stable, liquid glucagon for the treatment of severe hypoglycemia in diabetes patients ages 2 years and older.
- 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 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.
- Common adverse reactions in adults include nausea, vomiting, injection site edema raised 1 mm or greater, and headache. Common adverse reactions in pediatric patients include nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria.
Development timeline for Gvoke
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
