Gvoke
Pronunciation: Gee-voke
Generic name: glucagon
Other brand names of glucagon include: Gvoke HypoPen, Gvoke PFS, Gvoke Kit, Gvoke VialDx
Dosage form: single-dose prefilled autoinjector (0.5 mg/0.1 mL, 1 mg/0.2 mL), single-dose prefilled syringe (1 mg/0.2 mL), single-dose vial and syringe kit (1 mg/0.2 mL), intravenous injection (1 mg/0.2 mL)
Drug class: Glucose elevating agents
What is Gvoke?
Gvoke is used to treat very low blood sugar (severe hypoglycemia) in people with diabetes aged 2 years and older. Gvoke VialDx is a gastrointestinal mobility inhibitor (stops stomach movements) used intravenously as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adults.
Gvoke in the HypoPen auto-injector, pre-filled syringe, and the vial and syringe kit is given by subcutaneous (under the skin) injection. Gvoke VialDx is given intravenously.
- In this guide, Gvoke applies to the Gvoke Auto-Injector, Gvoke Prefilled Syringes (PFS), and Gvoke Vial and Syringe Kit.
- Gvoke VialDx applies to the diagnostic aid.
Glucagon raises blood sugar levels by binding to liver receptors, triggering glycogen breakdown and glucose release. This requires adequate liver glycogen stores to work effectively. Glucagon also relaxes smooth muscle in the digestive tract, slowing down the function and movement of the stomach, small intestine, and colon.
Gvoke gained FDA approval on September 10, 2019, as a new dosage form. Glucagon has been approved since 1960.
Side effects
Get emergency medical help if you have signs of an allergic reaction to Gvoke: hives; difficulty breathing; fast or slow heartbeat; swelling of your face, lips, tongue, or throat.
The most common side effects of Gvoke in adults are:
- nausea
- swelling at the injection site
- vomiting
- headache.
The most common side effects of Gvoke in children are:
- nausea
- high blood sugar
- abdominal pain
- pain or redness at the injection site
- low blood sugar
- vomiting
- headache
- itching.
The most common side effects of Gvoke VialDx are:
- nausea
- change in the way foods taste or loss of taste (dysgeusia)
- headache
- dizziness
- hot flush.
Serious side effects
Gvoke and Gvoke VialDx may cause serious side effects, including:
- High blood pressure. Gvoke and Gvoke VialDx can cause high blood pressure in certain people with tumors in their adrenal glands
- Low blood sugar. Gvoke and Gvoke VialDx can cause low blood sugar in people with certain tumors in their pancreas called insulinomas, by making too much insulin in their bodies. Gvoke VialDx can also cause low blood sugar in people with certain tumors called glucagonomas. Signs and symptoms of low blood sugar may include:
- sweating
- blurred vision
- personality changes, abnormal behavior, inability to concentrate, or irritability
- drowsiness
- hunger
- lightheadedness or dizziness
- slurred speech
- unsteady movement
- sleep disturbances
- restlessness
- irregular heartbeat
- depressed mood or anxiety
- tingling in the hands, feet, lips, or tongue
- headache
- tremor
- Serious allergic reactions. Serious allergic reactions have happened in some people using products with glucagon, the active ingredient in Gvoke and Gvoke VialDx. Stop using Gvoke and call your healthcare provider or get medical help right away if you have a serious allergic reaction. If you are receiving Gvoke VialDx for a radiology exam and have a serious allergic reaction, your healthcare provider will stop the IV infusion. Symptoms of a serious allergic reaction include rash, difficulty breathing, or low blood pressure
- High blood sugar with Gvoke VialDx. If you have diabetes and receive Gvoke VialDx before your radiology exam, it can cause high blood sugar. Your healthcare provider will check your blood sugar levels during treatment with Gvoke VialDx.
- Heart problems with Gvoke VialDx. If you have heart problems and receive Gvoke VialDx before your radiology exam, you may have an increase in your blood pressure and pulse while receiving Gvoke VialDx. This could be life-threatening. Your healthcare provider will monitor your heart during treatment with Gvoke VialDx.
You should not use Gvoke if you are allergic to glucagon or lactose, or if you have a tumor of the pancreas (insulinoma) or adrenal gland (pheochromocytoma).
It is not known if Gvoke is safe and effective in children under 2 years of age. It is not known if Gvoke VialDx is safe and effective in children.
These are not all the possible side effects of Gvoke and Gvoke VialDx. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Before taking this medicine
Do not use Gvoke or receive Gvoke VialDx if you:
- have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma
- have a tumor in your pancreas called an insulinoma
- have had an allergic reaction to glucagon or any of the ingredients in Gvoke or Gvoke VialDx, such as lactose (see the end of this guide for a list of ingredients)
Do not receive Gvoke VialDx if you:
- have tumors in your pancreas called Glucagonomas.
Before using Gvoke or receiving Gvoke VialDx, tell your healthcare provider about all of your medical conditions, including if you:
- have adrenal gland problems
- have a tumor in your pancreas
- 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)
- have diabetes mellitus
- have heart problems
- are pregnant or plan to become pregnant. It is not known if Gvoke or Gvoke VialDx will harm your unborn baby, but quickly treating hypoglycemia would outweigh any risks posed by using this medicine
- are breastfeeding or plan to breastfeed. It is not known if Gvoke passes into your breast milk. You and your healthcare provider should decide if you can use Gvoke while breastfeeding.
In an emergency, it may not be possible to tell your caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medicine.
How should I use Gvoke for low blood sugars?
Read the detailed Instructions for Use that comes with Gvoke. Use Gvoke exactly as your healthcare provider tells you to use it.
- Administer Gvoke subcutaneously (under the skin) in the lower abdomen, outer thigh, or outer upper arm.
Make sure your relatives, close friends, and caregivers know where you store Gvoke and how to use it the right way before you need their help.
- Act quickly. Having very low blood sugar for some time may be harmful.
- After giving Gvoke, your caregiver should call for emergency medical help right away.
- When you can safely swallow food or drink, your caregiver should give you a fast-acting source of sugar (such as a regular soft drink or fruit juice) and a long-acting source of sugar (such as crackers and cheese or a meat sandwich).
- If you do not respond to treatment after 15 minutes, your caregiver may give you another dose, if available.
Tell your healthcare provider each time you use Gvoke. Low blood sugar may happen again after receiving an injection of Gvoke. Your diabetes medicine may need to be changed.
How will I receive Gvoke VialDx as a diagnostic aid?
Gvoke VialDx will be given by a healthcare provider through a needle placed in your vein (IV infusion).
Dosing information
Gvoke Dose for Hypoglycemia (Adults)
- 1 mg (0.2 mL) subcutaneously once.
- This dose is the same for the Gvoke Auto-Injector, Prefilled Syringes, and Vial and Syringe Kit.
Gvoke Dose for Hypoglycemia (Pediatrics)
Gvoke can be self-administered or administered by a caregiver subcutaneously (SC, under the skin).
- Aged 2 to 12 years (weight less than 45 kg): 0.5 mg SC once
- Aged 2 to 12 years (weight 45 kg or greater): 1 mg SC once
- Aged 12 years or older: 1 mg SC once
This dose is the same for the Gvoke Auto-Injector, Prefilled Syringes, and Vial and Syringe Kit.
Repeat dosing of Gvoke
- If there has been no response after 15 minutes, administer an additional dose from a new Gvoke HypoPen, PFS, or Kit while waiting for emergency assistance.
- When the patient has responded to Gvoke, give oral carbohydrates.
- Do not attempt to reuse Gvoke. Each device or vial contains a single dose of glucagon. Do not reuse and discard any unused portion.
Gvoke VialDx for Intravenous Use as a Diagnostic Aid in Adults
Gvoke VialDx is only for intravenous (IV) use under medical supervision.
- Relaxation of the stomach, duodenal bulb, duodenum, and small bulb: 0.2 mg to 0.5 mg IV once.
- Relaxation of the colon: 0.5 mg to 0.75 mg IV once.
See the Full Prescribing Information for administration instructions for Gvoke VialDx.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include nausea, vomiting, diarrhea, rapid pulse, or high blood pressure (severe headache, blurred vision, pounding in your neck or ears).
What should I avoid after using Gvoke?
Avoid drinking alcohol. It can lower your blood sugar.
What other drugs will affect Gvoke?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Gvoke and Gvoke VialDx may affect the way other medicines work, and other medicines may affect how Gvoke and Gvoke VialDx works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I store Gvoke?
Store Gvoke in the original container at room temperature between 68°F to 77°F (20 °C to 25°C).
Do not refrigerate or freeze.
Keep out of the reach of children.
What are the ingredients in Gvoke and Gvoke VialDx?
Active ingredient: glucagon.
Inactive ingredients: trehalose dihydrate NF, sulfuric acid NF, mannitol USP (kit only), and dimethyl sulfoxide.
Company
Gvoke is distributed by Xeris Pharmaceuticals, Inc., Chicago, IL, and Gvoke VialDx is distributed by American Regent, Inc.
Popular FAQ
When should you use glucagon?
Glucagon is usually given in an emergency to people with insulin-dependent diabetes who develop very low blood sugar levels and pass out or are unable to take some form of sugar by mouth. Glucagon injection or nasal powder (Baqsimi) increases low blood sugar levels back to normal. Continue reading
How long does Baqsimi last?
One dose of Baqsimi lasts for at least 90 minutes. Baqsimi starts working within 7 to 8 minutes of administration, with peak levels being reached 30 minutes after administration.
Continue readingMore FAQ
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