INDICATION AND SAFETY SUMMARY
GVOKE is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in adults and kids with diabetes ages 2 years and above. It is not known if GVOKE is safe and effective in children under 2 years of age.
Do not use GVOKE if:
- you have a tumor in the gland on top of your kidneys (adrenal gland), called a pheochromocytoma.
- you have a tumor in your pancreas, called either an insulinoma or a glucagonoma.
- you are allergic to glucagon or any other inactive ingredient in GVOKE.
GVOKE MAY CAUSE SERIOUS SIDE EFFECTS, INCLUDING:
High blood pressure. GVOKE can cause high blood pressure in certain people with tumors in their adrenal glands.
Low blood sugar. GVOKE can cause low blood sugar in certain people with tumors in their pancreas.
Serious skin rash. GVOKE can cause a serious skin rash in certain people with a tumor in their pancreas called a glucagonoma.
Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:
- difficulty breathing
- low blood pressure
COMMON SIDE EFFECTS
The most common side effects of GVOKE include:
- swelling at the injection site
These are not all the possible side effects of GVOKE. For more information, ask your doctor. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Before using GVOKE, tell your doctor about all your medical conditions, including if you:
- have a tumor in your pancreas
- have not had food or water for a long time (prolonged fasting or starvation)
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
HOW TO USE
- Read the detailed Instructions For Use that come with GVOKE.
- Make sure your caregiver knows where you keep your GVOKE and how to use GVOKE correctly before you need their help.
- Your doctor will tell you how and when to use GVOKE.
- GVOKE contains only 1 dose of medicine and cannot be reused.
- After administering GVOKE, the caregiver should call for emergency medical help right away.
- If the person does not respond after 15 minutes, another dose may be given.
- Tell your doctor each time you use GVOKE.
- Store GVOKE at temperatures between 68°F and 77°F. Do not keep it in the refrigerator or let it freeze.
- Keep GVOKE in the foil pouch until you are ready to use it.
Keep GVOKE and all medicines out of the reach of children.
For more information, call 1-877-937-4737 or go to www.GvokeGlucagon.com.
Please see the Important Facts about Gvoke.