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
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