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.

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.

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

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.

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.