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Instructions For Emergency Use

GlucaGen®
(Glu-ka-Gen)
(glucagon [rDNA origin] for injection)
HypoKit®

1. GlucaGen® HypoKit® is for use in case of emergency for very low blood sugar (severe hypoglycemia) in people with diabetes who use insulin.
2. Read and become familiar with the following instructions before an emergency happens. If you have questions about using GlucaGen® HypoKit® talk with your doctor or pharmacist.

What is the most important information I should know about GlucaGen® HypoKit®?

1. Make sure that your family members, coworkers, or close friends know that if you become unconscious they should use this kit right away. They should call for emergency medical help immediately after using the kit.
2. Show your family members and others where you keep this kit and how to use it. They need to know how to use it before you need it. They can practice giving a shot by giving you your normal insulin shots. It is important that they practice. A person who has never given a shot may not be able to give one in an emergency.
3. It is important that your family member or friend:
   • Act quickly. Being unconscious for a period of time may be harmful. Follow these instructions to give GlucaGen® the right way.
   • Turn the unconscious person on their side to prevent choking.
   • Do not mix GlucaGen® until they are ready to use it.
   • Mix the GlucaGen®. The syringe does not have GlucaGen® in it. You must mix the contents of the syringe with GlucaGen® in the vial provided in GlucaGen® HypoKit® before giving the injection. (See Instructions for Use)
   • Throw away any mixed GlucaGen® that is not used.

The patient may be in a coma from very high blood sugar (severe hyperglycemia), rather than very low blood sugar. If this is the case, the unconscious person will not respond to GlucaGen®.

What is GlucaGen®?

GlucaGen® is a prescription medicine used to treat very low blood sugar that can happen in people who have diabetes and use insulin.

Symptoms of severe hypoglycemia include: confusion, loss of consciousness, and seizures.

You should only give GlucaGen® injection if:

1. the person is unconscious or
2. the person is having a seizure or
3. the person is confused and unable to eat sugar or a sugar-sweetened product.

GlucaGen® may have been prescribed so that your friends or family members can give the injection if you become hypoglycemic and are unable to take sugar by mouth.

Less severe cases of hypoglycemia should be treated right away by eating sugar or a sugar-sweetened product such as a regular soft drink or fruit juice.

GlucaGen® does not work if it is taken by mouth.

Who should not use GlucaGen®?

Do not use GlucaGen® if the person:

• is allergic to either glucagon or lactose
• has a tumor of the adrenal gland called a pheocromocytoma
• has a tumor of the pancreas called insulinoma

Instructions for Use:

To Prepare GlucaGen® For Injection:

GlucaGen® HypoKit® includes:

• 1 vial containing 1 mg GlucaGen® powder (glucagon [rDNA origin] for injection)
• 1 prefilled disposable syringe with attached needle containing 1 mL solvent (sterile water) for reconstitution

The vial with GlucaGen® in it has a protective plastic cap. You must remove the plastic cap to inject the water and mix the GlucaGen®. If the cap is loose or missing when you buy the package, return it to your local pharmacy.

Use the prefilled disposable syringe that comes in GlucaGen® HypoKit®, with the attached needle, to mix the GlucaGen® and sterile water before giving the injection.

Step 1. Take the orange plastic cap off the vial of GlucaGen®. see Figure A.

Figure A

Step 2. Pull the needle cover off the needle. See Figure B.

Figure B

Step 3. Insert the needle through the rubber stopper (within the marked circle) of the vial containing GlucaGen® and inject all the liquid from the syringe into the vial. See Figure C.

Figure C

Step 4. Without taking the syringe and needle out of the vial, gently shake the vial in your hand until the powder dissolves completely. See Figure D. The liquid should be clear. Do not use if the liquid has any particles in it or it is not clear.

Figure D

Step 5. Without taking the syringe and needle out of the vial, turn the vial upside down. Keep the needle in the liquid. Gently pull back on the plunger and slowly withdraw all the liquid into the syringe. See Figure E. Do not pull the plunger out of the syringe. This helps prevent the medicine from leaking out of the syringe.

Figure E

• The usual dose for adults and children who weigh more than 55 pounds (25 kg) is 1 mg (1 mL). Withdraw the liquid to 1 mL mark on the syringe. See Figure F.
• The usual dose for children who weigh less than 55 pounds (25 kg) is 0.5 mg (half of the adult dose). Withdraw the liquid to the 0.5 mL mark on the syringe for these children. See Figure F.

Figure F

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).

Step 6. Keep the needle in the liquid inside the vial. Remove any air bubbles in the syringe by flicking the syringe with your finger. See figure G. Gently push on the plunger to move any air bubbles out of the syringe and into the vial.

Figure G

Continue pushing the plunger until you have the correct dose as described in Step 5. If the plunger is pushed below the needed dose, pull back the plunger until you have the correct dose. When you have a correct amount of GlucaGen® in the syringe, take the syringe with the attached needle out of the vial.

To Inject GlucaGen®:

Step 7. See Figure H for commonly used injections site. Choose an area for injection.

Common injection sites

Figure H

Insert the needle into the loose tissue at the injection site, and inject the GlucaGen®. See Figure I.

Figure I

After Giving the GlucaGen® Injection:

Step 8. Withdraw the needle and press on the injection site. See Figure J.

Figure J

Place the used syringe with attached needle in a sharps container (such as a red biohazard container), a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Seal the container and throw it away the right way. There may be state and local laws about the right way to throw away used syringes and needles. Ask your doctor or pharmacist how to throw away used syringes and needles. Throw away any GlucaGen® you do not use.

Step 9. 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 10. Call for emergency medical help right away

Step 11. 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). If the person does not awaken within 15 minutes, give another dose of GlucaGen® using a new kit.

Step 12. Even if the GlucaGen® treatment awakens the person, tell their doctor right away. The doctor should be told whenever a severe 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:

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

Pregnancy

GlucaGen® is for use only during sudden, severe hypoglycemic attacks.

Nursing Mothers

It is not known if GlucaGen® passes into your breast milk. GlucaGen® does not stay in your body very long. Tell your doctor about all the medicines you take, including prescription and non-prescription 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.

What are the possible side effects of GlucaGen®?

GlucaGen® may cause serious side effects including:

• allergic reactions. Symptoms of a severe allergic reaction may include:
  • rash or itching
  • raised red patches on your skin (hives)
  • swelling of the face, lips, tongue or throat
  • problems breathing or swallowing
  • very high or very low blood pressure
  • fast or slow heart beat

The most common side effects of GlucaGen® include:

• nausea
• vomiting

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® HypoKit®?

Before mixing:

• Store GlucaGen® HypoKit® for up to 24 months at 68°F to 77° F (20°C to 25°C).
• Do not freeze GlucaGen® HypoKit®.
• Keep GlucaGen® HypoKit® in the original package to protect from light.
• Do not use GlucaGen® HypoKit® after the expiration date printed on the package.

After mixing:

• Mixed GlucaGen® should be used right away.
• GlucaGen® and the syringe with sterile water that comes in the kit, do not contain preservatives and should only be used one time. Throw away any unused medicine.

Keep GlucaGen® HypoKit®, all medicines, needles and syringes out of the reach of children.

What are the ingredients in the GlucaGen® HypoKit®

Active Ingredient: glucagon [rDNA origin] for injection

Inactive ingredients: lactose, sterile water for reconstitution

Last reviewed on RxList: 1/13/2012
This monograph has been modified to include the generic and brand name in many instances.