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Indication

GVOKE (glucagon) is a prescription medicine used to treat very low blood sugar in adults and children ages 2 years and above with diabetes.

Important Safety Information 

• Do not use GVOKE if you:

• • Have a tumor in the gland on top of your kidneys, called a pheochromocytoma because of the risk of a substantial increase in blood pressure
  • Have a tumor in your pancreas called an insulinoma because of the risk of low blood sugar
  • Are allergic to glucagon or any inactive ingredient in GVOKE. Stop using GVOKE and seek immediate medical attention if you experience any symptoms of a serious allergic reaction such as rash, difficulty breathing, or low blood pressure

• Before using GVOKE, tell your doctor about all the medicines you take and your medical conditions, including if you have not had food or water for a long time (prolonged fasting or starvation), have low blood sugar that does not go away (chronic hypoglycemia), or have a history of a skin rash called necrolytic migratory erythema (commonly associated with glucagon-producing tumors)
• The most common side effects reported in adults are nausea, vomiting, swelling at the injection site, and headache
• The most common side effects reported in children are nausea, low blood sugar, vomiting, headache, abdominal pain, high blood sugar, pain or redness at injection site, and hives
• Inform caregivers on the Instructions for Use of GVOKE, and symptoms of severe hypoglycemia, which include unconsciousness and seizures or convulsions
• Store in original container until time of use, and at room temperature between 68°F to 77°F (20° C to 25° C)
• You are encouraged to report side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088

Please talk to your doctor and see full Prescribing Information and Patient Information Guide for GVOKE.