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Indications and Usage

What is GlucaGen

®

 (glucagon) for 

injection 1mg/mL?

GlucaGen

®

 is a prescription medicine 

used to treat very low blood sugar (severe 

hypoglycemia) in people with diabetes who 

use insulin.

Important Safety Information

Who should not use GlucaGen

®

?

Do not use GlucaGen

®

 if:

 you are allergic to glucagon or lactose or any 

of the ingredients in GlucaGen

®

 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

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 pancreas problems. Tumors in your 

pancreas called 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 heart problems

 are pregnant or plan to become pregnant

 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. 

Please see additional Important 

Safety Information on next page, and 

Prescribing Information on following 

pages.

Summary of 

Instructions for Use 

This is only a summary of the Instructions for Use. Please see the full Instructions for Use on the following pages.

–––––––––––––––    Preparing the GlucaGen

®

 dose    ––––––––––––––––

   See instructions for giving the injection on the next page

 

u

Step 1.

 Check that the orange plastic cap 

on your vial of GlucaGen

®

 is firmly attached. 

Do not 

use if the cap is loose or missing. 

With your thumb, flip the cap off the 

GlucaGen

®

 vial. 

Pull Straight Off

Step 2.

 Pick up the prefilled syringe 

containing sterile water. 

Do not use any 

other liquid to mix the medicine.

 Hold the 

syringe with 1 hand. With your other hand, 

pull the needle cover off the syringe. 

Do not

 

remove the plastic backstop from the syringe.

Step 3.

 Pick up the GlucaGen

®

 vial of dry 

powder. Hold the vial with 1 hand. With your 

other hand, push the needle of the prefilled 

syringe through the center of the rubber 

stopper.

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

. Do not take the 

syringe out of the vial.

Step 5.

 Firmly hold both the vial and syringe 

together in one hand, and gently shake until 

the powder is completely dissolved. 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.

Step 6.

 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. Do not pull the plunger 

out of the syringe.

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. Gently push on the 

plunger to move only the air bubbles back 

into the vial.

1 mL

0.5 mL

Step 8. 

Hold the vial and syringe as shown.

 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 ensure 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).

Summary of Contents for HypoKit

Page 1: ...ght Off Step 2 Pick up the prefilled syringe containing sterile water Do not use any other liquid to mix the medicine Hold the syringe with 1 hand With your other hand pull the needle cover off the syringe Do not remove the plastic backstop from the syringe Step 3 Pick up the GlucaGen vial of dry powder Hold the vial with 1 hand With your other hand push the needle of the prefilled syringe through...

Page 2: ...or call 1 800 FDA 1088 If you need assistance with prescription costs help may be available Visit pparx org or call 1 888 4PPA NOW Back Front Step 9 Choose the injection site Common injection sites for GlucaGen are upper arms thighs or buttocks 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 plunger down until the ...

Page 3: ...AGE 1 1 Treatment of severe hypoglycemia 1 2 Use as a diagnostic aid 2 DOSAGE AND ADMINISTRATION 2 1 Treatment of severe hypoglycemia 2 2 Use as a diagnostic aid 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5 1 Pheochromocytoma 5 2 Insulinoma and Glucagonoma 5 3 Hypersensitivity and Allergic Reactions 5 4 Glycogen Stores and Hypoglycemia 5 5 Necrolytic Migratory Eryt...

Page 4: ...echolamines from the tumor If the patient develops a dramatic increase in blood pressure 5 to 10 mg of phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed 5 2 Insulinoma and Glucagonoma GlucaGen should not be administered to patients suspected of having insulinoma In patients with insulinoma intravenous administration of g...

Page 5: ... IV 0 25 0 5 mg 5 20 minutes 45 seconds 9 17 minutes 2 mg 5 20 minutes 45 seconds 22 25 minutes IM 1 mg 30 minutes 8 10 minutes 12 27 minutes 2 mg 30 minutes 4 7 minutes 21 32 minutes The usual diagnostic dose for relaxation of the stomach duodenal bulb duodenum and small bowel is 0 2 0 5 mg given intravenously or 1 mg given intramuscularly the usual dose to relax the colon is 0 5 0 75 mg intraven...

Page 6: ... HypoKit are registered trademarks of Novo Nordisk A S Manufactured by Novo Nordisk A S 2880 Bagsvaerd Denmark For information contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro New Jersey 08536 1 800 727 6500 www novonordisk us com 1998 2018 Novo Nordisk US18GLGN00013 7 2018 ...

Page 7: ...mful 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 should I avoid while using GlucaGen While using GlucaGen do not drive or operate machinery until you...

Page 8: ...u 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 and sterile water for reconstitution This Patient Information has been approved by the U S Food and Drug Administration Revised April 18 2018 GlucaGen and HypoKit are registe...

Page 9: ... 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 Figure B 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 Straight Off Figure C Step 3 Pick...

Page 10: ... 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 ...

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