Gvoke PFS One Pack (injection)

Gvoke PFS One Pack is a hormone that raises blood sugar levels. It also slows down the involuntary muscle movements in the stomach and intestines that help with digestion.

Gvoke PFS One Pack is used to treat hypoglycemia (low blood sugar). This medicine is also used during a radiologic (x-ray) examination to assist in diagnosing certain issues with the stomach or intestines.

Gvoke PFS One Pack may also be used for reasons not mentioned in this medication guide.

Gvoke PFS One Pack is for treating hypoglycemia only when the person cannot eat, is unconscious, or is having a seizure. Make sure you know how to give this medicine before you need to use it. It is important to treat hypoglycemia as quickly as possible. Having low blood sugar for an extended time can lead to seizures, coma, or death.

Do not use Gvoke PFS One Pack if you are allergic to Gvoke PFS One Pack or lactose, or if you have a tumor of the pancreas (insulinoma) or adrenal gland (pheochromocytoma).

You should not use this medicine if you are allergic to Gvoke PFS One Pack or lactose, or if you have:

• a tumor of the pancreas (insulinoma); or
• a tumor of the adrenal gland (pheochromocytoma).

Gvoke PFS One Pack should be used to treat hypoglycemia only if the person cannot eat, is unconscious, or is having a seizure.

Tell your doctor if:

• you have any tumor of the pancreas;
• you have not recently eaten regularly; or
• you have chronic low blood sugar.

Do not give this medicine to a child without medical advice.

Gvoke PFS One Pack is not expected to harm an unborn baby, but quickly treating hypoglycemia would outweigh any risks from using this medicine.

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

In an emergency, you may not be able 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.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; fast or slow heartbeat; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you notice 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 side effects of Gvoke PFS One Pack may include:

• nausea, vomiting; or
• swelling at the injection site.

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

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

Gvoke PFS One Pack is injected under the skin, into a muscle, or into a vein. You will be shown how to use emergency this medicines for severe hypoglycemia. Call your doctor after each time you use a this medicine.

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 PFS One Pack 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.

You may need to mix Gvoke PFS One Pack with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

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 PFS One Pack. 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 PFS One Pack and any diluent 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 PFS One Pack after the expiration date on the label has passed.

Store the auto-injector or prefilled syringe in the foil pouch and use the medicine right away after opening.

Since Gvoke PFS One Pack is used as needed, there is no daily dosing schedule.

Call your doctor right away if symptoms do not improve after using Gvoke PFS One Pack.

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.

Many other medicines can change your blood sugar levels, and some can make diabetes treatments work better or worse. Certain drugs can also reduce the signs of hypoglycemia, making it harder to notice 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. Inform your doctor about any medicines you begin or stop taking.