Gvoke

Gvoke is a prescription medication used to treat very low blood sugar (severe hypoglycemia) in adults and children with diabetes. Glucagon, the active ingredient in Gvoke, belongs to a group of drugs called glycogenolytic agents. It is a hormone that works by causing the liver to release stored sugar to the blood.

This medication comes as a clear, colorless injectable solution to be injected subcutaneously (just under the skin). Gvoke is available in prefilled syringes and auto-injector devices.

Common side effects include nausea, vomiting, and reaction at the injection site.

Gvoke, a prescription medication, is a premixed liquid glucagon treatment for very low blood sugar in adults and kids with diabetes ages 2 and above.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects may occur. See "Gvoke Precautions" section.

The most common side effects include:

• nausea
• vomiting
• swelling at injection site
• headache

This is not a complete list of Gvoke side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

• anticholinergic medications such as benztropine (Cogentin), dicyclomine (Bentyl), or diphenhydramine (Benadryl)
• beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal, Innopran)
• indomethacin (Indocin)
• insulin
• warfarin (Coumadin, Jantoven)

This is not a complete list of Gvoke drug interactions. Ask your doctor or pharmacist for more information.

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:
  • rash
  • difficulty breathing
  • low blood pressure

Do not use Gvoke if you:

• have a tumor in the gland on top of your kidneys (adrenal gland), called a pheochromocytoma
• have a tumor in your pancreas, called either an insulinoma or glucagonoma
• are allergic to glucagon or any other ingredient in Gvoke

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Gvoke, there are no specific foods that you must exclude from your diet when receiving this medication.

Before using Gvoke, tell your doctor about all of your medical conditions. Especially tell your doctor 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 non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans taking Gvoke. There have been a small number of case studies and observational studies in which pregnant women were given glucagon (the active ingredient in Gvoke) and no major birth defects, miscarriages or adverse maternal or fetal outcomes were identified. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication. This medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known if Gvoke crosses into human milk. Glucagon, the active ingredient in Gvoke, is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant.

Talk to your doctor about breastfeeding and Gvoke.

Take Gvoke exactly as prescribed. Follow the directions on your prescription label carefully, and ask your pharmacist or doctor to explain any part you or your household members do not understand. Do not use more or less of it or use it more often than prescribed by your doctor.

• 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 can be used even before you or the person you're helping passes out or has a seizure. It's a good idea for you and the people in your life to know how to use it before you need it. This could include times that you or they:
  • have tried correcting with food or drink and it isn’t working
  • are unable to swallow safely
  • feel like you/they might pass out
  • experience loss of consciousness or a seizure
• Gvoke contains only 1 dose of medicine and cannot be reused.
• Do not open foil pouch until ready to administer Gvoke.
• Visually inspect Gvoke prior to administration. The solution should appear clear and colorless to pale yellow and be free of particles. If the solution is discolored or contains particulate matter, do not use.
• Do not attempt to reuse Gvoke. Each Gvoke device contains a single dose of glucagon and cannot be reused.

Injecting Gvoke in 2 Steps:

• Pull off needle cap.
• Pinch skin of lower abdomen, outer thigh, or outer upper arm. Insert needle at 90 degrees. Push plunger down to inject.

After using Gvoke PFS, turn person on his or her side and call for emergency help.

If the person does not respond after 15 minutes, another dose may be given.

Adults and Pediatric Patients Aged 12 and Older

• The recommended dose of Gvoke is 1 mg administered by subcutaneous injection into lower abdomen, outer thigh, or outer upper arm.
• If there has been no response after 15 minutes, an additional 1 mg dose of Gvoke from a new device may be administered while waiting for emergency assistance.

Pediatric Patients Aged 2 to Under 12 Years of Age

• The recommended dose for pediatric patients who weigh less than 45 kg is 0.5 mg Gvoke administered by subcutaneous injection into the lower abdomen, outer thigh, or outer upper arm.
• The recommended dose for pediatric patients who weigh 45 kg or greater is 1 mg Gvoke administered by subcutaneous injection into the lower abdomen, outer thigh, or outer upper arm.
• If there has been no response after 15 minutes, an additional weight appropriate dose of Gvoke from a new device may be administered while waiting for emergency assistance.

If you take too much Gvoke, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store in sealed original foil pouch until time of use.
• Store at room temperature, 68° to 77°F (20° to 25°C). 
• Do not refrigerate or freeze.
• Keep this and all medications out of the reach of children.