Gvoke HypoPen 0.5 mg Auto-Injector glucagon injection, solution

Brand Name: Gvoke HypoPen 0.5 mg Auto-Injector

Generic Name: GLUCAGON INJECTION, SOLUTION

Drug Type: HUMAN PRESCRIPTION DRUG

Route: SUBCUTANEOUS

Dosage Form: INJECTION, SOLUTION

Packager: Xeris Pharmaceuticals, Inc.

Data Current As Of: 2021-10-18

7.1 Beta-Blockers

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE.

7.2 Indomethacin

In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia.

7.3 Warfarin

GVOKE may increase the anticoagulant effect of warfarin.

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GVOKE.

7.2 Indomethacin

In patients taking indomethacin, GVOKE may lose its ability to raise blood glucose or may even produce hypoglycemia.

7.3 Warfarin

GVOKE may increase the anticoagulant effect of warfarin.

Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Recognition of Severe Hypoglycemia

Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.

Administration

Review the Patient Information and Instructions for Use with the patient and family members or caregivers.

Serious Hypersensitivity

Inform patients that allergic reactions can occur with GVOKE. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [ see Warnings and Precautions ( 5.3) ].

Gvoke HypoPen® (glucagon injection) | Instructions for Use

• Become familiar with the following instructions before an emergency happens.
• Do not use this auto-injector past the expiration date printed on the device. Replace GVOKE HypoPen 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 HypoPen 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 HypoPen can be given while awaiting medical assistance.

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

Indications for Use

GVOKE HypoPen 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 HypoPen if:

• the patient is unconscious,
• the patient is unable to eat sugar or a sugar-sweetened product,
• the patient is having a seizure, or
• 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 HypoPen will not work when taken by mouth (orally).

Understanding GVOKE HypoPen

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

Adult GVOKE HypoPen (1 mg dose)

Pediatric GVOKE HypoPen contains a 0.5 mg dose of glucagon and is in a foil pouch. Below is a picture of the pouch. Below is a picture of the pouch. See the GVOKE HypoPen package for a full view of the Quick-Use guide.

Pediatric GVOKE HypoPen (0.5 mg dose)

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

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.

Information on Hypoglycemia

Early symptoms of hypoglycemia (low blood sugar) include:

• sweating
• drowsiness
• dizziness
• sleep disturbances
• palpitation
• anxiety
• tremor
• blurred vision
• hunger
• slurred speech
• depressed mood
• tingling in the hands, feet, lips, or tongue
• irritability
• light-headedness
• abnormal behavior
• inability to concentrate
• 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 HypoPen should be given or the patient should be treated with intravenous glucose by a medical professional.

Possible Problems with GVOKE HypoPen 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 HypoPen or may experience fast heart-beat for a short while.

If you experience any other reactions that may have been caused by GVOKE HypoPen, 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 HypoPen.

Important Warnings

• Do not open pouch until time of use.
• Do not use after the expiration date has passed.
• Do not use if the red needle cap has been removed or is damaged.
• Do not remove the red cap until you are ready to inject.
• Do not put or press thumb, fingers, or hand over the yellow needle guard.
• Call a healthcare provider as soon as glucagon has been injected.
• If the patient does not awaken within 15 minutes, give another dose of GVOKE HypoPen and call for emergency medical help right away.
• Feed the patient as soon as he or she awakens and is able to swallow.

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

Remove GVOKE HypoPen from Pouch

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

Check the Expiration Date

• Check the expiration date printed on the label of GVOKE HypoPen (see Figure 2).

Important:

Do not use GVOKE HypoPen if the expiration date has passed. If GVOKE HypoPen is expired, throw it away in an FDA cleared sharps container and use a new GVOKE HypoPen.

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).

Important:

Do not use GVOKE HypoPen 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 HypoPen to use, call for emergency medical help right away.

Pull off Red Cap

• Pull the red needle cap straight off of the device (see Figure 4).

Important:

Do not put your thumb, fingers, or hand on or near the needle guard or needle opening to help prevent accidental needle sticks.

Choose Injection Site and Expose Bare Skin

• Choose the lower abdomen, outer thigh, or outer upper arm for your injection site (see Figure 5).
• Remove any clothing covering the injection site (see Figure 6). The injection must be performed straight into the skin.

Important:

• Do not inject through clothing.

Push and Hold to Start Injection

• Push and hold GVOKE HypoPen straight Down against the injection site. Listen for a “Click”
• Continue to hold the device down and count slowly to 5 (see Figure 7).
• When the injection is complete, the viewing window will be red (see Figure 8).

Important:

Do not lift up GVOKE HypoPen until the injection is complete.

Lift Away from Skin

• Lift the device straight up from the injection site (see Figure 9).
• The yellow needle guard will lock over the needle.

Turn Patient onto Side

• When an unconscious person wakes up, he or she may throw up (vomit).
• Turn the patient on their side to prevent choking (see Figure 10).

Make Sure Patient Receives Immediate Medical Attention After Use

• Call for emergeny medical help right after GVOKE HypoPen has been injected.
• Even if GVOKE HypoPen helps the patient to wake up, you should still call for emergency medical help right away.
• The patients’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 HypoPen. The patient’s diabetes medication 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 and notify emergency medical services right away.

Re-Cap and Dispose of GVOKE HypoPen in a FDA Cleared Sharps Disposal Container

If a puncture-resistant sharps container is not available, carefully re-cap and store GVOKE HypoPen in a safe place until it can be disposed of into a FDA cleared sharps container (see Figure 11). 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 HypoPen.

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

Manufactured for:
Xeris Pharmaceuticals, Inc.
Chicago, IL 60601

Manufactured by:
Pyramid Laboratories, Inc.
Costa Mesa, CA 92626

Revised 08/2020

©2020 by Xeris Pharmaceuticals, Inc.

Gvoke® PFS (glucagon injection) | Instructions for Use

• 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:

• the patient is unconscious,
• the patient is unable to eat sugar or a sugar-sweetened product,
• the patient is having a seizure, or
• 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).

Understanding GVOKE PFS

Adult 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.

Adult GVOKE PFS (1 mg dose)

Pediatric GVOKE PFS contains a 0.5 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.

Pediatric GVOKE PFS (0.5 mg dose)

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

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.

Information on Hypoglycemia

Early symptoms of hypoglycemia (low blood sugar) include:

• sweating
• drowsiness
• dizziness
• sleep disturbances
• palpitation
• anxiety
• tremor
• blurred vision
• hunger
• slurred speech
• depressed mood
• tingling in the hands, feet, lips, or tongue
• irritability
• light-headedness
• abnormal behavior
• inability to concentrate
• 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 red needle cap has been removed or is damaged.
• Do not remove the red 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 awaken within 15 minutes, give another dose of glucagon and call for emergency medical help right away.
• Feed the patient as soon as he or she awakens 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.

Remove GVOKE PFS from Pouch

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

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.

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 medical help right away.

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

Pull off the Needle Cap

• Pull the needle cap straight off of the syringe (see Figure 6).

Important:

Do not put your thumb, fingers, or hand on or near the needle guard or needle opening to help prevent accidental needle sticks.

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.

Lift Away from Skin

• Lift the syringe straight up from the injection site (see Figure 10).

Important:

Do not re-cap the syringe.

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).

Make Sure Patient Receives Immediate Medical Attention After Use

• Call for emergeny 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 patients’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 medication 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 and notify emergency medical services right away.

Dispose of GVOKE PFS in a 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.

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

Manufactured for:
Xeris Pharmaceuticals, Inc.
Chicago, IL 60601

Manufactured by:
Pyramid Laboratories, Inc.
Costa Mesa, CA 92626

Revised 08/2020

©2020 by Xeris Pharmaceuticals, Inc.

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.

Indications for Use

GVOKE KIT 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 KIT if:

• the patient is unconscious,
• the patient is unable to eat sugar or a sugar-sweetened product,
• the patient is having a seizure, or
• 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 KIT will not work when taken by mouth (orally).

Information on Hypoglycemia

Early symptoms of hypoglycemia (low blood sugar) include:

• sweating
• drowsiness
• dizziness
• sleep disturbances
• palpitations
• anxiety
• tremor
• blurred vision
• hunger
• slurred speech
• depressed mood
• tingling in the hands, feet, lips, or tongue
• irritability
• light-headedness
• abnormal behavior
• inability to concentrate
• 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 of hypoglycemia 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 not possible, GVOKE KIT should be used or the patient should be treated with intravenous glucose by a medical professional.

Possible Problems with GVOKE KIT 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 KIT or may experience fast heartbeat for a short while.

If you experience any other reactions that may have been caused by GVOKE KIT, 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 KIT.

Important Warnings

• Do not remove syringe from 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.
• Draw the correct dose of Gvoke: 0.1 mL for pediatric patients aged 2 to under 12 years of age weighing less than 45 kg (100 lbs) and 0.2 mL for adults and pediatric patients aged 12 years and older or pediatric patients weighing 45 kg (100 lbs) or greater.
• There will be unused medicine in the vial after use. Do not save unused medicine for later use. Throw away (discard) unused portion
• Call a healthcare provider as soon as glucagon has been injected.
• If the patient does not wake up within 15 minutes, give another dose of GVOKE KIT 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 KIT, talk with your healthcare provider or pharmacist.

Preparing to Inject GVOKE KIT

Step 1. Remove GVOKE Vial and Syringe from Carton

• Open carton and carefully remove GVOKE vial and syringe (see Figure A ).

Step 2. Check the Expiration Date on GVOKE Vial

• Check the expiration date printed on the label of the GVOKE vial (see Figure B).

• Important: Do not use the GVOKE vial if the expiration date has passed. If the GVOKE vial is expired, discard and use a new GVOKE KIT. If you do not have another GVOKE KIT to use call for emergency medical help right away.

Step 3. Inspect the Solution in GVOKE Vial

• Look at the liquid medicine in the vial. It must be clear and colorless, or a pale yellow (see Figure C).

• Important: Do not use GVOKE or inject if the liquid contains lumps, flakes, or particles.

Step 4. Prepare

• Remove the blue cap from the vial to expose the rubber stopper (see Figure D).

• Tear Open Pouch at Dotted Line (see Figure E). Remove syringe.

• Pull the needle cap straight off the syringe (see Figure F).

• Important: Do not put your thumb, fingers, or hand on or near the needle to help prevent accidental needle sticks.
• Push the needle fully into the center of the rubber stopper (see Figure G). It is important to make sure the needle punctures within the raised circle of the stopper.

• Flip vial and syringe so vial is on top (see Figure H).

• Hold the vial upside down and pull the plunger out until the mark for 0.1 mL (0.5 mg pediatric dose) or 0.2 mL (1 mg adult dose) is lined up with the plunger and remove the syringe from the vial stopper (Figure I).

• GVOKE should be administered immediately.
• Important: Avoid drawing air into the syringe. If large air bubbles are drawn into the syringe, gently press the plunger to push air bubbles back into the vial and redraw the dose.
• There will be unused medicine in the vial after use. Do not save unused medicine for later use. Throw away (discard) unused portion.

Injecting GVOKE KIT

Step 5. Choose Injection Site and Expose Bare Skin

• Choose the lower abdomen, outer thigh, or outer upper arm for your injection site (see Figure J).

• Remove any clothing covering the injection site (see Figure K).The injection must be performed straight into the skin.

• Important: Do not inject through clothing.

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 L).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 M).

• Push the plunger down as far as it will go to inject all of the liquid medicine into the skin (see Figure N). You want to inject the medicine very fast to help decrease the pain.

Important: aspirate (pull back on plunger rod) after inserting the needle. Do not lift up the syringe until the injection is complete.

Step 7. Lift Away from Skin

• Lift the syringe straight up from the injection site (Figure O).

• Important: Do not re-cap the syringe.

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 P).

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

• Call for emergency medical help right after GVOKE has been injected.
• Even if GVOKE KIT 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 KIT. 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 KIT is available and notify emergency medical services right away.

Disposing of GVOKE KIT

Disposing of GVOKE KIT

After the injection, discard vial with unused medicine and place the used syringe in a safe place until it can be disposed of in an FDA-cleared sharps container (see Figure Q). Do not throw away (dispose of) loose needles and syringes in your household trash.

If you do not have an 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. Do not recycle your used sharps disposal container.

Always keep the sharps container out of the reach of children.

If needed, make sure to get a refill of your GVOKE KIT.

Additional Information

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

Manufactured by:

Pyramid Laboratories, Inc.

Costa Mesa, CA 92626

Manufactured for:

Xeris Pharmaceuticals, Inc.

Chicago, IL 60601

Original Approval 08/2021

©2021 by Xeris Pharmaceuticals, Inc.

PATIENT INFORMATION

GVOKE® (Gee-voke)

(glucagon)

injection, for subcutaneous use

What is GVOKE?

GVOKE is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes aged 2 years and older.
It is not known if GVOKE is safe and effective in children under 2 years of age.

Do not use GVOKE if you:

have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
have a tumor in your pancreas called insulinoma.
are allergic to glucagon or any of the ingredients in GVOKE. See the end of this Patient Information leaflet for a complete list of ingredients in GVOKE.

Before using GVOKE, 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).

are pregnant or plan to become pregnant.

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. GVOKE may affect the way other medicines work, and other medicines may affect how GVOKE 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 use GVOKE?

Read the detailed Instructions for Use that comes with GVOKE.
Use GVOKE exactly how your healthcare provider tells you to use it.
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 a period of time may be harmful.
Your healthcare provider will tell you how and when to use GVOKE.
After giving GVOKE, your caregiver should call for emergency medical help right away.
When you are able to 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.

What are the possible side effects of GVOKE?

GVOKE may cause serious side effects, including:

High blood pressure. GVOKE can cause high blood pressure in certain people with tumors in their adrenal glands.
Low blood sugar. GVOKE can cause low blood sugar in people with certain tumors in their pancreas called insulinomas by making too much insulin in their bodies. Signs and symptoms of low blood sugar may include:

o sweating o blurred vision o abnormal behavior

o drowsiness o hunger o lightheadedness

o dizziness o slurred speech o unsteady movement

o sleep disturbances o restlessness o inability to concentrate

o irregular heartbeat o depressed mood o personality changes

o anxiety o tingling in the hands, feet, lips, or tongue o headache

o tremor o irritability

Serious allergic reaction. Call your healthcare provider or get medical help right away if you have a serious allergic reaction including:

rash difficulty breathing

low blood pressure

The most common side effects of GVOKE in adults include:

nausea swelling at the injection site
vomiting headache

The most common side effects of GVOKE in children include:

nausea high blood sugar abdominal pain pain or redness at the injection site
low blood sugar vomitting headache itching

These are not all the possible side effects of GVOKE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store GVOKE?

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

Keep GVOKE and all medicines out of the reach of children.

General information about the safe and effective use of GVOKE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GVOKE for a condition for which it was not prescribed. Do not give GVOKE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about GVOKE that is written for health professionals.

What are the ingredients in GVOKE?

Active ingredient: glucagon.

Inactive ingredients: trehalose dihydrate NF, sulfuric acid NF, mannitol USP (kit only), and dimethyl sulfoxide.

Distributed by: Xeris Pharmaceuticals, Inc., Chicago, IL

Manufactured by: Pyramid Laboratories, Inc., Costa Mesa, CA

For more information go to www.gvokeglucagon.com or call 1-877-937-4737.

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 08/2021