Patient information: uses, side effects, how to take - Gvoke VialDx

INSTRUCTIONS FOR USE

GVOKE® PFS

[GEE-voke P-F-S ]

(glucagon injection)

pre-filled syringe

for subcutaneous use

This “Instructions for Use” contains information on how to inject GVOKE® PFS

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1. GVOKE® PFS VISUAL

Understanding GVOKE PFS

GVOKE PFS contains a 1 mg dose of glucagon and is in a foil pouch. Below is a picture of the pouch. See the GVOKE PFS package for a full view of the Quick-Use Guide.

GVOKE PFS (1 mg dose)

PFS Device

Note: GVOKE PFS should be used one time and then thrown away (discarded).

2. IMPORTANT INFORMATION YOU NEED TO KNOW BEFORE INJECTING GVOKE® PFS

Become familiar with the following instructions before an emergency happens.
Do not use this product past the expiration date printed on the device. Replace GVOKE PFS before the expiration date on the box.
If you have questions regarding the use of this product, talk to a healthcare provider or pharmacist.

Make sure that relatives, close friends, or caregivers know that if you become unconscious, they should call for emergency medical help right away. GVOKE PFS may have been prescribed so that relatives, close friends, and caregivers can give the injection if you become hypoglycemic (severe low blood sugar) and are unable to take sugar by mouth. If you are unconscious, GVOKE PFS can be given while awaiting medical assistance.

Show your relatives, close friends, or caregivers where you store GVOKE PFS and how to use it. They need to know how to use GVOKE PFS before an emergency situation happens.

Indications for Use

GVOKE PFS is for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. Symptoms of severe hypoglycemia include unconsciousness, and seizures or convulsions.

Give GVOKE PFS if:

1. the patient is unconscious,
2. the patient is unable to eat sugar or a sugar-sweetened product,
3. the patient is having a seizure, or
4. you have tried to give the patient sugar or drinks that are high in sugar such as a regular soft drink (soda) or fruit juice and the patient does not get better.

Milder cases of hypoglycemia should be treated promptly by eating sugar or a sugar sweetened product. (See Information on Hypoglycemia for more information on the symptoms of low blood sugar.) GVOKE PFS will not work when taken by mouth (orally).

Information on Hypoglycemia

Early symptoms of hypoglycemia (low blood sugar) include:

sweating
drowsiness
dizziness
sleep disturbances
palpitation
anxiety
tremor
light-headedness
abnormal behavior
inability to concentrate

blurred vision
hunger
slurred speech
depressed mood
tingling in the hands, feet, lips, or tongue
irritability
unsteady movement
headache
personality changes

If not treated, the patient may progress to severe hypoglycemia which can include:

confusion
seizures
unconsciousness
death

The occurrence of early symptoms calls for quick and, if necessary, repeated administration of some form of carbohydrate. Patients should always carry a quick source of sugar, such as candy mints or glucose tablets. The prompt treatment of mild hypoglycemic symptoms can prevent severe hypoglycemic reactions. If the patient does not improve or if administration of carbohydrate is impossible, GVOKE® PFS should be given or the patient should be treated with intravenous glucose by a medical professional.

Possible Problems with GVOKE PFS Treatment

Common side effects in adults and pediatric patients are nausea and vomiting. The product may cause serious side effects including serious allergic reactions, fast heart beat and high blood pressure.

People may be allergic to glucagon or to one of the inactive ingredients in GVOKE PFS, or may experience fast heart-beat for a short while.

If you experience any other reactions that may have been caused by GVOKE PFS, please contact your healthcare provider.

Important:

Act quickly. Prolonged unconsciousness may be harmful.
After the injection is complete, turn the unconscious patient on his or her side to prevent them from choking in case they throw up (vomit).
Carefully read and follow these instructions. Have a healthcare provider show you the right way to use GVOKE PFS.

Important Warnings

Do not open pouch until time of use.
Do not use after the expiration date has passed.
Do not use if the needle cap has been removed or is damaged.
Do not remove the needle cap until you are ready to inject.
Do not remove the finger flange from the syringe.
Call a healthcare provider as soon as GVOKE® PFS has been injected.
If the patient does not wake up within 15 minutes, give another dose of GVOKE PFS and call for emergency medical help right away.
Feed the patient as soon as he or she wakes up and is able to swallow.

Read and become familiar with the following instructions before an emergency happens. If you have questions about using GVOKE PFS, talk with your healthcare provider or pharmacist.

3. PREPARING TO INJECT GVOKE® PFS

Step 1. Remove GVOKE PFS from Foil Pouch

Tear open pouch at the dotted line and carefully remove GVOKE PFS (see Figure 1).

Figure 1

Step 2. Check the Expiration Date

Check the expiration date printed on the label of GVOKE PFS (see Figure 2).
Important: Do not use GVOKE PFS if the expiration date has passed. If GVOKE PFS is expired, throw it away in an FDA cleared sharps container and use a new GVOKE PFS.

Figure 2

Step 3. Inspect the Solution

Look at the liquid medicine through the viewing window. It must be clear and colorless, or a pale yellow (see Figure 3).
It is normal to see air bubbles in the medicine.
Important: Do not try to remove air bubbles before injecting.
Do not use GVOKE® PFS or inject if the liquid contains lumps, flakes, or particles.
Do not inject if solution is not visible in the viewing window.
If you do not have another GVOKE PFS to use, call for emergency help right away.

Figure 3

4. INJECTING GVOKE® PFS

Step 4. Choose Injection Site and Expose Bare Skin

Choose the lower abdomen, outer thigh, or outer upper arm for your injection site (see Figure 4).
Remove any clothing covering the injection site (see Figure 5). The injection must be performed straight into the skin.
Important: Do not inject through clothing

Figure 4

Figure 5

Step 5. Pull off the Needle Cap

Pull the needle cap straight off the syringe (see Figure 6).
Important: Do not put your thumb, fingers, or hand on or near the needle to help prevent accidental needle sticks.

Figure 6

Step 6. Pinch, Insert and Push to Start Injection

Pinch the skin directly around the chosen injection site and keep pinching for the entire injection (see Figure 7). This is recommended to make sure a subcutaneous (under the skin) injection is given and to prevent injection into the muscle.
Without touching the plunger, insert the needle into the skin at the injection site at a 90-degree angle (see Figure 8).
Push the plunger down as far as it will go to inject all of the liquid medicine into the skin (see Figure 9). You want to inject the medicine very fast to help decrease the pain.
Important: Do not aspirate (pull back on plunger rod) after inserting the needle. Push the plunger down as far as it will go. Do not lift up GVOKE® PFS until the injection is complete.

Figure 7

Figure 8

Figure 9

Step 7. Lift Away from Skin

Lift the syringe straight up from the injection site (see Figure 10).
Important: Do not re-cap the syringe.

Figure 10

Step 8. Turn Patient onto Side

When an unconscious person wakes up, he or she may throw up (vomit).
Turn the unconscious patient on their side to prevent choking (see Figure 11).

Figure 11

Step 9. Make Sure Patient Receives Immediate Medical Attention After Use

Call for emergency medical help right after GVOKE® PFS has been injected.
Even if GVOKE PFS helps the patient to wake up, you should still call for emergency medical help right away.
The patient’s healthcare provider should also be notified whenever a severe drop in blood sugar (hypoglycemic reactions) happens. Hypoglycemia may happen again after receiving an injection from GVOKE PFS. The patient’s diabetes medicine may need to be changed.
Feed the patient as soon as he or she wakes up and is able to swallow. Give the patient 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 the patient does not wake up within 15 minutes, give another dose of glucagon if a second GVOKE PFS is available and notify emergency medical services right away.

5. STORING GVOKE® PFS

Storage Information

Store in sealed original foil pouch until time of use.
Store at room temperature, 68° to 77°F (20° to 25°C).
Do not refrigerate or freeze.

6. DISPOSING OF GVOKE® PFS

Dispose of GVOKE PFS in an FDA Cleared Sharps Disposal Container

To prevent injury caused from contact with the used needle, put the used syringe in a safe place until it can be disposed of into a FDA cleared sharps container right away after use (see Figure 12). Do not throw away (dispose of) loose needles and syringes in your household trash.

If you do not have a FDA cleared sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic
can be closed with a tight-fitting puncture-resistant lid, without sharps being able to come out
upright and stable during use
leak-resistant
properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.

Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Always keep the sharps container out of the reach of children. If needed, make sure to get a refill of GVOKE PFS.

Figure 12

7. ADDITIONAL INFORMATION

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed by:

Xeris Pharmaceuticals, Inc.

Chicago, IL 60607

Revised 04/2023

INSTRUCTIONS FOR USE

GVOKE KIT

[GEE-voke k-it]

glucagon injection

Subcutaneous Injection

This Instructions for Use contains information on how to inject GVOKE^®KIT.

GVOKE ^®KIT VISUAL

Understanding GVOKE KIT

GVOKE KIT contains one (1) single-dose sterile syringe (29 G x ½” needle) with markings for 0.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose vial containing 0.2 mL of solution.

STORING GVOKE KIT

Storage Information

Store vial and pouched syringe together in original carton until time of use. Do not remove syringe from pouch until time of use.
Store at room temperature, 68°F to 77°F (20°C to 25°C).
Do not refrigerate or freeze.
Protect vial from light exposure.

IMPORTANT INFORMATION YOU NEED TO KNOW BEFORE INJECTING GVOKE KIT

Become familiar with the following instructions before an emergency happens.
Do not use this product past the expiration date printed on the vial. Replace GVOKE^®KIT before the expiration date on the box.
If you have questions regarding the use of this product, talk to a healthcare provider or pharmacist.

Make sure that relatives, close friends, or caregivers know that if you become unconscious, they should call for emergency medical help right away. GVOKE KIT may have been prescribed so that relatives, close friends, and caregivers can give the injection if you become hypoglycemic (severe low blood sugar) and are unable to take sugar by mouth. If you are unconscious, GVOKE KIT can be given while awaiting medical assistance.

Show your relatives, close friends, or caregivers where you store GVOKE KIT and how to use it. They need to know how to use GVOKE KIT before an emergency happens.