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GlucaGen

®

 (glucagon) for injection HypoKit

®

  Patient Information

5

PATIENT INFORMATION

GlucaGen

®

 (Gl

ū

-ka-Gen) 

(glucagon) for injection 

HypoKit

®

What is GlucaGen

®

?

GlucaGen

®

 is a prescription medicine used:

• to treat very low blood sugar (severe hypoglycemia) in people with diabetes who use insulin.

Who should not use GlucaGen

®

?

Do not use GlucaGen

®

 if:

• you are allergic to glucagon or lactose 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 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. 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 should I avoid while using GlucaGen

®

?

While using GlucaGen

®

 do not:

• drive or operate machinery until you have eaten sugar or a sugar-sweetened product such as a regular soft drink or fruit juice.

What are the possible side effects of GlucaGen

®

?

GlucaGen

®

 may cause serious side effects, including:

• 

High blood pressure. 

High blood pressure is common after taking GlucaGen

®

 and can be severe.

• 

Low blood sugar.

 GlucaGen

®

 can cause low blood sugar in patients with tumors in their pancreas called insulinomas and glucagonomas by making too 

much insulin in their bodies.

• 

Allergic reactions.

 Symptoms of a serious allergic reaction to GlucaGen

®

 may include rash, difficulty breathing, or low blood pressure (hypotension).

The most common side effects of GlucaGen

®

 include:

• nausea
• vomiting
• temporary fast heartbeat or pounding in your chest (tachycardia).

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.

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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