GlucaGen HypoKit (Page 4 of 5)

12.3 Pharmacokinetics

Absorption

Intramuscular injection of 1 mg GlucaGen resulted in a mean Cmax (CV%) of 1686 pg/mL (43%) and median Tmax of 12.5 minutes.

Elimination

The mean apparent half-life of 45 minutes after intramuscular injection probably reflects prolonged absorption from the injection site.

Metabolism

Glucagon is degraded in the liver, kidney, and plasma.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long term studies in animals to evaluate carcinogenic potential have not been performed.

Mutagenesis

The mutagenic potential tested in the Ames and human lymphocyte assays, was borderline positive under certain conditions for both glucagon (pancreatic) and glucagon (rDNA) origin. Doses of 100 and 200 mg/kg of glucagon of both pancreatic and recombinant origins gave slightly higher incidences of micronucleus formation in male mice but there was no effect in females. The weight of evidence indicates that synthetic and recombinant glucagon are not different and do not pose a genotoxic risk to humans.

Impairment of Fertility
Glucagon was not tested in animal fertility studies. Studies in rats have shown that pancreatic glucagon does not cause impaired fertility.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

GlucaGen for injection is supplied as a lyophilized white powder available as follows:

Presentation

NDC

Strength

Description

Treatment of Severe Hypoglycemia

GlucaGen HypoKit

0169-7065-15

1 mg per vial

1 mL single-dose vial of GlucaGen with 1 mL single-dose syringe of Sterile Water for Injection, USP for reconstitution

Use as a Diagnostic Aid

GlucaGen 10-pack: 10 Single-dose vials

0597-0053-45

1 mg per vial

1 mL single-dose vial of GlucaGen

GlucaGen Diagnostic Kit

0597-0260-10

1 mg per vial

1 mL single-dose vial of GlucaGen with 1 mL single-dose vial of Sterile Water for Injection, USP for reconstitution

16.2 Recommended Storage

Before Reconstitution:

The GlucaGen package may be stored up to 24 months at controlled room temperature 20o to 25o C (68o to 77o F) prior to reconstitution. Do not freeze. Keep in the original package to protect from light.

After Reconstitution:

Use the reconstituted GlucaGen solution immediately. Discard any unused portion [see Dosage and Administration (2)].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved (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 GlucaGen. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3)].

Manufactured by:

Novo Nordisk A/S

2880 Bagsvaerd, Denmark

GlucaGen® and HypoKit® are registered trademarks of Novo Nordisk A/S

© 1998-2021 Novo Nordisk

For information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536, USA

1-800-727-6500

www.novonordisk-us.com

INFORMATION FOR PATIENTS

PATIENT INFORMATION

GlucaGen® (Glū-ka-Gen)

(glucagon) injection,

for subcutaneous, intramuscular, or intravenous use

What is GlucaGen?

GlucaGen is a prescription medicine used:

to treat very low blood sugar (severe hypoglycemia) in people with diabetes.
as diagnostic aid during certain radiologic tests to temporarily stop stomach movement in adults.

It is not known if GlucaGen is safe and effective for use in children, to temporarily stop stomach movement during radiologic tests.

Who should not use GlucaGen?

Do not use GlucaGen if:

you have a tumor in the gland on top of your kidneys (adrenal gland) called a pheochromocytoma.
you have a tumor in your pancreas called an insulinoma.
you are allergic to glucagon or any of the ingredients in GlucaGen. See the end of this Patient Information leaflet for a complete list of ingredients in GlucaGen.
you have a tumor in your pancreas called a glucagonoma because it could cause low blood sugar when used for your radiology tests.

What should I tell my doctor before using GlucaGen?

Before using GlucaGen, tell your doctor about all of your medical conditions, including if you:

have kidney problems.
have adrenal gland problems (adrenal insufficiency).
have pancreas problems. Tumors in your pancreas called insulinomas or glucagonomas.
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 GlucaGen will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if GlucaGen passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. GlucaGen may affect the way other medicines work, and other medicines may affect how GlucaGen works. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use GlucaGen?

Read the detailed Instructions for Use that come with GlucaGen.
Use GlucaGen exactly as your doctor tells you to.
Make sure that you and your family know how to use GlucaGen the right way before you need it.
Act quickly. Having very low blood sugar for a period of time may be harmful.
Call for emergency medical help right after you use GlucaGen.
Eat sugar or a sugar-sweetened product such as a regular soft drink or fruit juice as soon as you are able to swallow.
Tell your doctor each time you use GlucaGen. Your doctor may need to change the dose of your diabetes medicines.

What are the possible side effects of GlucaGen?

GlucaGen may cause serious side effects, including:

high blood pressure. GlucaGen can cause high blood pressure in certain people with tumors in their adrenal glands called pheochromocytoma.
low blood sugar. GlucaGen can cause low blood sugar in people with tumors in their pancreas called insulinomas and glucagonomas by making too much insulin in their bodies. Signs and symptoms of low blood sugar may include:
sweating
blurred vision
abnormal behavior
drowsiness
hunger
lightheadedness
dizziness
slurred speech
unsteady movement
sleep disturbances
restlessness
inability to concentrate
irregular heartbeat
depressed mood
personality changes
anxiety
tingling in the hands, feet, lips or tongue
headache
tremor
irritability

Very low blood sugar can cause passing out (loss of consciousness), confusion, seizures, and death. Talk to your doctor about how to tell if you have low blood sugar and what to do if this happens while using GlucaGen for injection. Know your symptoms of low blood sugar. Follow your doctor’s instructions to treat low blood sugar.

serious allergic reactions. Symptoms of a serious allergic reaction to GlucaGen may include rash, difficulty breathing, or low blood pressure (hypotension). If you have an allergic reaction, call your doctor and get emergency help right away.
high blood sugar. If you receive GlucaGen before your radiology test, it can cause high blood sugar in people with diabetes mellitus. Your doctor will check your blood glucose levels during treatment with GlucaGen.
heart problems. If you have heart problems and receive GlucaGen before your radiology test, you may have an increase in your blood pressure and pulse. Your doctor will monitor your heart when using GlucaGen during treatment.

The most common side effects of GlucaGen may include:

injection site reactions
vomiting
dizziness
pale skin
feeling sleepy or drowsy
nausea
headache
lack of energy
diarrhea
lower blood pressure

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GlucaGen. For more information, ask your doctor or pharmacist. 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 GlucaGen?

Before you mix the GlucaGen powder and liquid:

Store GlucaGen at room temperature between 68°F to 77°F (20°C to 25°C) for up to 24 months (2 years).
Check the expiration date on your vial of GlucaGen. Do not use GlucaGen if the expiration date has passed.
Do not freeze GlucaGen.
Keep GlucaGen in its original package and keep GlucaGen out of light.

After you mix the GlucaGen powder and liquid:

Use GlucaGen right away.
Throw away any unused GlucaGen.
Do not use GlucaGen if a gel has formed, or if you see particles in the solution.

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

General information about the safe and effective use of GlucaGen.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GlucaGen for a condition for which it was not prescribed. Do not give GlucaGen 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 GlucaGen that is written for health professionals.

What are the ingredients in GlucaGen?

Active Ingredient: glucagon.

Inactive ingredients: lactose monohydrate, hydrochloric acid, sodium hydroxide, and sterile water for reconstitution.

Manufactured by: Novo Nordisk A/S, 2880 Bagsvaerd, Denmark.

GlucaGen® and HypoKit® are registered trademarks of Novo Nordisk A/S; © 1998-2021 Novo Nordisk.

For more information, go to www.novonordisk-us.com or call 1-800-727-6500.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 03/2021

Instructions for Use

GlucaGen® (Glū-ka-Gen)

(glucagon) for injection

HypoKit®

Read this Instructions for Use before you start using GlucaGen and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor or pharmacist if you have any questions about how to use GlucaGen.

Important:

Read and become familiar with this Instructions for Use before an emergency happens.
Show your family members and others where you keep your GlucaGen HypoKit and how to use it the right way.
Call for emergency medical help right after you use GlucaGen.
Do not share your GlucaGen syringes or needles with another person. You may give other people a serious infection or other people may get a serious infection from you.
The prefilled syringe that comes with your GlucaGen HypoKit is meant for use with GlucaGen only. Do not use GlucaGen syringes to inject other medicines.

How should I store GlucaGen?

Before you mix the GlucaGen powder and liquid:

Store GlucaGen at room temperature between 68°F to 77°F (20°C to 25°C) for up to 24 months (2 years).
Check the expiration date on your vial of GlucaGen. Do not use GlucaGen if the expiration date has passed.
Do not freeze GlucaGen.
Keep GlucaGen in its original package, and keep GlucaGen out of light.

After you mix the GlucaGen powder and liquid:

Use GlucaGen right away.
Throw away any unused GlucaGen.
Do not use GlucaGen if a gel has formed, or if you see particles in the solution.

Supplies you will need for your GlucaGen injection (See Figure A):

1 GlucaGen HypoKit that contains:
o
1 single-dose vial that contains 1 mg of GlucaGen powder (glucagon) for injection and 1 prefilled syringe with attached needle that contains 1 mL of sterile water.
Content of GlucaGen Hypokit
(click image for full-size original)
1 puncture-resistant container for throwing away used needles and syringes. See “How should I dispose of (throw away) used GlucaGen prefilled syringes” at the end of these instructions.

Preparing the GlucaGen dose:

The GlucaGen medicine comes as a dry powder. Before you use GlucaGen, you must mix the dry powder with the syringe of sterile water that comes in the GlucaGen Hypokit. Do not use any other liquid to mix the medicine.
Check that the orange plastic cap on your vial of GlucaGen is firmly attached. Do not use the vial of GlucaGen if the orange plastic cap is loose or missing.

Step 1. Using your thumb, flip the orange plastic cap off the GlucaGen vial (See Figure B).

Take the orange plastic cap off the vial
(click image for full-size original)

Step 2. Pick up the prefilled syringe containing sterile water. Hold the syringe with 1 hand and with your other hand, pull the needle cover off the syringe (See Figure C).

Do not remove the plastic backstop from the syringe.
Pull off
(click image for full-size original)

Step 3. Pick up the GlucaGen vial. Hold the vial of dry powder with 1 hand and with your other hand, push the needle of the prefilled syringe through the center of the rubber stopper (See Figure D).

Push the syringe needle through the rubber stopper
(click image for full-size original)

Step 4. Hold the vial and syringe together, with the needle still inserted into the vial. Carefully turn the vial and syringe together right side up. Slowly push the plunger down until the syringe is empty (See Figure E).

Do not take the syringe out of the vial.
Slowly push the plunger until the syringe is empty
(click image for full-size original)

Step 5. Hold the entire unit (the vial and syringe) in one hand and gently shake the vial until the powder is completely dissolved (See Figure F).

Do not use if a gel has formed, or if you see particles in the solution.
Do not take the syringe out of the vial.
Gently shake the vial
(click image for full-size original)

Step 6. Firmly hold the vial and syringe together, with the needle still inserted into the vial. Carefully turn the vial and syringe together upside down. Gently pull down on the plunger and slowly withdraw all of the liquid into the syringe (See Figure G).

Do not pull the plunger out of the syringe.
Gently pull down on the plunger
(click image for full-size original)

Step 7. Keep the needle inside the vial. Check the syringe for air bubbles. If you see bubbles, tap the syringe until the bubbles rise to the top of the syringe (See Figure H). Gently push on the plunger to move only the air bubbles back into the vial.

Check the syringe for air bubbles
(click image for full-size original)

Step 8. Hold the vial and syringe as shown (See Figure I).

Hold the vial and syringe as shown
(click image for full-size original)
The usual dose for adults and children who weigh more than 55 pounds (25 kg) is 1 mg
(1 mL). Use the content of the full syringe (1 mL).
The usual dose for children who weigh less than 55 pounds (25 kg) is 0.5 mg (0.5 mL). Gently push the plunger until it is at the 0.5 mL mark on the syringe to make sure there is 0.5 mL liquid left in the syringe.

Take the syringe and needle out of the vial when the correct dose of GlucaGen is in the syringe.

If you do not know how much the child weighs:

Give a child under 6 years of age 0.5 mg (0.5 mL).
Give a child 6 years of age and older 1 mg (1 mL).

Giving the GlucaGen injection:

Step 9. Choose the injection site (See Figure J).

Common injection sites for GlucaGen are upper arms, thighs, or buttocks.

Injection site
(click image for full-size original)

Step 10. With one hand gently pinch the skin at the injection site. With your other hand insert the needle into the skin and push the syringe plunger down until the syringe is empty (See Figure K).

Gently pinch the skin
(click image for full-size original)

After Giving the GlucaGen injection:

Step 11. Pull the needle out of the skin and press on the injection site (See Figure L).

Press on the injection site
(click image for full-size original)

Throw away your used syringe with the needle attached and any GlucaGen you did not use. See “How should I dispose of (throw away) used GlucaGen prefilled syringes ” at the end of these instructions.

Step 12. Turn the person on their side. When an unconscious person awakens, they may vomit. Turning the person on their side will lessen the chance of choking.

Step 13. Call for emergency medical help right away.

Step 14. Feed the person as soon as they are awake and able to swallow.

Give the person 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).

Step 15. If the patient does not awaken within 15 minutes, give another dose of GlucaGen. Call your doctor and get emergency help right away.

Step 16. Even if the GlucaGen treatment wakes the person, tell their doctor right away. The doctor should be told whenever a severe drop in blood sugar (hypoglycemia reaction) happens. The person’s dose of diabetes medicine may need to be changed.

Hypoglycemia may happen again after receiving GlucaGen treatment.

Early symptoms of hypoglycemia may include:

sweating
drowsiness
dizziness
sleep disturbances
irregular heartbeat (palpitation)
anxiety
tremor
blurred vision
hunger
slurred speech
restlessness
depressed mood
tingling in the hands, feet, lips, or tongue
irritability
abnormal behavior
lightheadedness
unsteady movement
inability to concentrate
personality changes
headache

If not treated early, hypoglycemia may worsen and the person may have severe hypoglycemia. Signs of severe hypoglycemia include:

confusion
unconsciousness
seizures
death

How should I dispose of (throw away) GlucaGen pre-filled syringes?

Put used syringes in a FDA-cleared sharps disposal container right away after use. 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:
o
made of a heavy-duty plastic,
o
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
o
upright and stable during use,
o
leak-resistant, and
o
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.

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

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

Manufactured by:

Novo Nordisk A/S

2880 Bagsvaerd, Denmark

GlucaGen® and HypoKit® are registered trademarks of Novo Nordisk A/S

© 1998-2021 Novo Nordisk

For information contact:

Novo Nordisk Inc.

800 Scudders Mill Road

Plainsboro, NJ 08536

1-800-727-6500

www.novonordisk-us.com

Revised: 03/2021

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