Gvoke

What is Gvoke?

Gvoke is a prescription medicine that is used to treat low blood sugar.

Description

GVOKE contains glucagon, an antihypoglycemic agent used to treat severe hypoglycemia. Glucagon is a single chain containing 29 amino acid residues and has a molecular weight of 3483 and is identical to human glucagon. Glucagon is produced by solid phase synthesis with subsequent purification.

Its molecular formula is C 153H 225N 43O 49S with the following structure:

GVOKE is a clear, colorless to pale yellow, sterile solution for subcutaneous injection available in 0.5 mg per 0.1 mL or 1 mg per 0.2 mL auto-injector or pre-filled syringe, and in 1 mg per 0.2 mL vial and syringe kit.

GVOKE Auto-Injector (HypoPen) and GVOKE Pre-Filled Syringe

Each 0.2 mL of GVOKE contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, and 1.2 mg of 1N sulfuric acid NF, in dimethyl sulfoxide diluent.

Each 0.1 mL of GVOKE contains 0.5 mg of glucagon, 5.6 mg of trehalose dihydrate NF, and 0.6 mg of 1N sulfuric acid NF, in dimethyl sulfoxide diluent.

GVOKE Vial and Syringe Kit

Each 0.2 mL of GVOKE contains 1 mg of glucagon, 11.1 mg of trehalose dihydrate NF, 5.8 mg of mannitol USP, and 1.32 mg of 1N sulfuric acid NF, and NF in dimethyl sulfoxide diluent.

 Mechanism of Action

Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect.

Before taking GVOKE, tell your doctor:

• If you are allergic to GVOKE; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an adrenal gland tumor called pheochromocytoma.
• If you have certain types of pancreas tumors (glucagonoma, insulinoma).
• If you have a weak adrenal gland, have not had food or water for a long time, or have low blood sugar often.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take GVOKE with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take GVOKE?

• Tell all of your health care providers that you take GVOKE. This includes your doctors, nurses, pharmacists, and dentists.
• Check your blood sugar as you have been told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you have eaten sugar or a product that has sugar in it like a regular soft drink or fruit juice. Avoid these tasks or actions until you feel fully alert.
• Low blood sugar can happen with GVOKE in people who have certain types of pancreas tumors (glucagonoma, insulinoma). Very low blood sugar can lead to seizures, confusion, passing out, and sometimes death. If signs of low blood sugar happen after using GVOKE, get medical help right away.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is GVOKE best taken?

Use GVOKE as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Be sure you know how to use before an emergency happens. Read the package insert and instructions for use that come with GVOKE. If you have any questions about how to use GVOKE, talk with the doctor or pharmacist.
• Someone else may have to give GVOKE. Be sure others know where GVOKE is stored and how to give it if needed.
• Get medical help right away after using GVOKE.
• After using GVOKE, eat and drink as soon as you can. This includes having a product that has sugar in it like juice. Follow what your doctor has told you to do.
• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Do not mix GVOKE until you are ready to use it.
• Do not use if the solution is cloudy, leaking, or has particles.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• Each container is for one use only. Use right after opening. Throw away any part of the opened container after the dose is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• This medicine is taken on an as needed basis. Do not take more often than told by the doctor.

What are the side effects of GVOKE that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• A fast heartbeat.
• Blisters; scaly, red, itchy, or painful skin; or if the skin starts to break down.

What are some other side effects of GVOKE?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Headache.
• Redness or swelling where the shot is given.
• Feeling tired or weak.
• Pale skin.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out GVOKE?

• Store at room temperature. Do not refrigerate or freeze.
• Store in original container.
• Store in foil pouch until ready for use.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.