Gvoke is a hormone that increases blood sugar levels.

Gvoke is used to treat hypoglycemia (low blood sugar). Gvoke in the HypoPen auto-injector, pre-filled syringe (PFS), and the vial and syringe kit is given by subcutaneous (under the skin) injection.

Gvoke is for use in adults and children (aged 2 years and above) with diabetes.

Gvoke should be used to treat hypoglycemia only if the person cannot eat, passes out, or is having a seizure. Be sure you know how to give a this medicine before you need to use it. Hypoglycemia should be treated as quickly as possible. Having low blood sugar for too long can cause seizure, coma, or death.

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).

Gvoke is injected under the skin (subcutaneous injection). You will be shown how to use this injection in an emergency for severe hypoglycemia. Call your doctor after each time you use a this medicine.

Gvoke is available as a single-dose auto-injector, single-dose pre-filled syringe (PFS), or vial and syringe kit.

Hypoglycemia should be treated as quickly as possible. Having low blood sugar for too long can cause seizure, coma, or death.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Be sure you know how to give a Gvoke before you need to use it. The correct dose for a child is lower than an adult dose. A child's dose may also be based on how much the child weighs. Follow your doctor's dosing instructions very carefully.

After the injection, you should eat a fast-acting source of sugar (fruit juice, glucose gel, hard candy, raisins, or non-diet soda) and then eat a snack or small meal such as cheese and crackers or a meat sandwich.

If you are a caregiver, get emergency medical help after giving a Gvoke. If the patient does not improve within 15 minutes, you may need to mix a new dose and give a second injection.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

To keep from having severe hypoglycemia, follow your diet, medication, and exercise routines very closely.

Store Gvoke at room temperature, away from moisture, heat, and light. Do not refrigerate or freeze. Throw away any mixed medicine you have not used right away. Do not use Gvoke after the expiration date on the label has passed.

Store the injector, prefilled syringe, or vial and syringe kit in the foil pouch and use the medicine right away after opening.

Usual Adult Dose for Hypoglycemia:

Gvoke Auto-Injector, Prefilled Syringes, and Vial and Syringe Kit: 1 mg subcutaneously once.

Usual Pediatric Dose for Hypoglycemia:

Gvoke Auto-Injector, Prefilled Syringes, and Vial and Syringe Kit
2 to 12 years (weight less than 45 kg): 0.5 mg subcutaneously once
2 to 12 years (weight 45 kg or greater): 1 mg subcutaneously once
12 years or older: 1 mg subcutaneously once

REPEAT DOSE: An unconscious patient will usually awaken within 15 minutes following treatment; if response is delayed, may repeat dose while waiting for emergency assistance
Comments:
-After patient has responded to treatment, supplemental carbohydrates should be given to restore liver glycogen and prevent recurrence of hypoglycemia.
-Patients who do not respond should receive IV glucose.

Uses: For the treatment of severe hypoglycemia in patients 2 years or older.

You should not use Gvoke if you are allergic to glucagon or lactose, or if you have:

• a tumor of the pancreas (insulinoma); or

• a tumor of the adrenal gland (pheochromocytoma).

Gvoke should be used to treat hypoglycemia only if the person is unable to eat, or is unconscious or having a seizure.

To make sure Gvoke is safe for you, tell your doctor if:

• you have any tumor of the pancreas;

• you have not recently eaten on a regular basis; or

• you have chronic low blood sugar.

Glucagon is not expected to harm an unborn baby, but quickly treating hypoglycemia would outweigh any risks posed by using this medicine.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast-feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medicine.

Since Gvoke is used as needed, it does not have a daily dosing schedule.

Call your doctor promptly if symptoms do not improve after using Gvoke.

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).

Avoid drinking alcohol. It can lower your blood sugar.

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.

Call your doctor at once if you have any of the following skin changes on your face, legs, groin, or genital area:

• redness;

• itching;

• blistering;

• crusting, scaling; or

• other skin sores or lesions.

Common Gvoke side effects may include:

• nausea, vomiting; or

• swelling where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of medicines used to treat diabetes. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.