Gvoke Approval History
Reviewed by J.Stewart BPharm Last updated on Sep 11, 2019.
FDA Approved: Yes (First approved September 10, 2019)
Brand name: Gvoke
Generic name: glucagon
Dosage form: Ready-to-Use 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) or auto-injector (Gvoke HypoPen).
- 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 side effects include nausea, vomiting, and hypoglycemia.
Development History and FDA Approval Process for Gvoke
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