Get your patient on Glucagon - Glucagon (Glucagon)

Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated:

• for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes (1.1 )
• as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients (1.2 )

Dosage in adults and pediatric patients using the glucagon emergency kit for low blood sugar to treat severe hypoglycemia (2.2 )

• Adults and Pediatric Patients Weighing More Than 25 kg or for Pediatric Patients with Unknown Weight 6 Years and Older:
  • The recommended dosage is 1 mg (1 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously.
  • If there has been no response after 15 minutes, an additional 1 mg dose (1 mL) of Glucagon for Injection may be administered using a new kit while waiting for emergency assistance.
• Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients with Unknown Weight Less Than 6 Years of Age:
  • The recommended dosage is 0.5 mg (0.5 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously.
  • If there has been no response after 15 minutes, an additional 0.5 mg dose (0.5 mL) of Glucagon for Injection may be administered using a new kit while waiting for emergency assistance.

Important Administration Instructions for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat

Severe Hypoglycemia (2.1 )

• Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.
• See the Full Prescribing Information for administration instructions

Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid (2.4 )

• The recommended diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg administered intravenously or 1 mg administered intramuscularly; the recommended dose to relax the colon is 0.5 mg to 0.75 mg administered intravenously or 1 mg to 2 mg administered intramuscularly.
• See the Full Prescribing Information for administration instructions (2.3 )

Glucagon for Injection is a white lyophilized powder supplied as follows:

Treatment of Severe Hypoglycemia

• 1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose syringe of Sterile Water for Injection, USP (Glucagon Emergency Kit for Low Blood Sugar)

Use as a Diagnostic Aid

• 1 mg single-dose vial of Glucagon for Injection
• 1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose vial of Sterile Water for Injection, USP (Diagnostic Kit)

Glucagon for Injection is contraindicated in patients with:

• Pheochromocytoma [see Warnings and Precautions (5.1 )]
• Insulinoma [see Warnings and Precautions (5.2 )] because of the risk of hypoglycemia
• Known hypersensitivity to glucagon or any of the excipients in Glucagon for Injection. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3 )]
• Glucagonoma [see Warnings and Precautions (5.8 )] because of risk of hypoglycemia when used as a diagnostic aid

• Catecholamine Release in Patients with Pheochromocytoma : Contraindicated in patients with pheochromocytoma because Glucagon for Injection may stimulate the release of catecholamines from the tumor. (4 , 5.1 )
• Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose; however, Glucagon for Injection may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously. (4 , 5.2 )
• Hypersensitivity and Allergic Reactions: Allergic reactions have been reported and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. (4 , 5.3 )
• Lack of Efficacy in Patients with Decreased Hepatic Glycogen: Glucagon for Injection is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for Glucagon for Injection to be effective. Patients with these conditions should be treated with glucose. (5.4 )
• Necrolytic Migratory Erythema (NME): a skin rash, has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. (5.5 )
• Hyperglycemia in Patients with Diabetes Mellitus when Used as a Diagnostic Aid: Treatment with Glucagon for Injection in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment and treat if indicated.(5.6 )
• Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease when Used as a Diagnostic Aid: Glucagon for Injection may increase myocardial oxygen demand, blood pressure, and pulse rate. Cardiac monitoring is recommended in patients with cardiac disease during use of Glucagon for Injection as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy. (5.7 )
• Hypoglycemia in Patients with Glucagonoma when Used as a Diagnostic Aid: Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment, and monitor blood glucose levels during treatment. If a patient develops hypoglycemia, give glucose orally or intravenously. (5.8 )

The following important adverse reactions are described below and elsewhere in the labeling:

• Hypersensitivity and Allergic Reactions [see Warnings and Precautions (5.3 )]
• Necrolytic Migratory Erythema [see Warnings and Precautions (5.5 )]
• Hyperglycemia in Patients with Diabetes Mellitus when Used as a Diagnostic Aid [see Warnings and Precautions (5.6 )]
• Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease when Used as a Diagnostic Aid [see Warnings and Precautions (5.7 )]

• Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. (7.1 )
• Indomethacin: In patients taking indomethacin Glucagon for Injection may lose its ability to raise glucose or may produce hypoglycemia. (7.2)
• Anticholinergic drugs: Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended. (7.3)
• Warfarin: Glucagon for Injection may increase the anticoagulant effect of warfarin. (7.4)
• Insulin: Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in patients receiving insulin. (7.5)

Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. It is produced by solid phase peptide synthesis. The chemical structure of the glucagon is identical to human glucagon. Glucagon is a single-chain polypeptide containing 29 amino acid residues. The structure of glucagon is:

Molecular Formula = C 153 H 225 N 43 O 49 S	Molecular Weight = 3483

Glucagon for Injection is a sterile, lyophilized white powder in a 3 mL vial for subcutaneous, intramuscular or intravenous use. The reconstituted solution contains glucagon as hydrochloride 1 mg per mL and lactose monohydrate (107 mg). Glucagon for Injection is supplied at pH 2.5 to 3.5 and is soluble in water.

Instructions for Use

Glucagon (GLOO-ka-gon)

for injection, for subcutaneous, intramuscular or intravenous use

Read this Instructions for Use before you start using Glucagon 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 Glucagon.

Important:

• Read and become familiar with this Instructions for Use before an emergency happens .
• Show your family members and others where you keep your Glucagon Emergency Kit for Low Blood Sugar and how to use it the right way.
• Call for emergency medical help right after you use Glucagon.
• Do not share your Glucagon 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 Glucagon Emergency Kit for Low Blood Sugar is meant for use with Glucagon only. Do not use Glucagon syringes to inject other medicines.

How should I store Glucagon?

Before you mix the Glucagon powder and liquid:

• Store Glucagon at room temperature between 68° to 77°F (20° to 25°C). Check the expiration date on your vial of Glucagon. Do not use Glucagon if the expiration date has passed.
• Do not freeze Glucagon.
• Keep Glucagon in its original package and Glucagon out of light.

After you mix the Glucagon powder and liquid:

• Use Glucagon right away.
• Throw away any unused Glucagon.
• Glucagon should be clear and colorless. Do not use Glucagon if it is cloudy or if you see particles in the solution.

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

• 1 Glucagon Emergency Kit for Low Blood Sugar that contains:
  • 1 vial that contains 1 mg of Glucagon for injection and 1 prefilled glass syringe with attached needle that contains 1 mL of Sterile Water for Injection.

Figure A

• 1 puncture resistant container for throwing away used needles and syringes. See “How should I dispose of (throw away) used Glucagon prefilled syringes” at the end of these instructions.
• Cotton ball or gauze pad (not included in kit)
• Preparing the Glucagon dose:
• The Glucagon medicine comes as a dry powder. Before you use Glucagon, you must mix the dry powder with the syringe of sterile water that comes in the Glucagon Emergency Kit for Low Blood Sugar. Do not use any other liquid to mix the medicine.
• Check that the orange plastic cap on your vial of Glucagon is firmly attached. Do not use the vial of Glucagon if the orange plastic cap is loose or missing.

Step 1 . Using your thumb, flip the orange plastic cap off the Glucagon 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.	Figure C
Step 3. Pick up the Glucagon 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 ).	Figure D
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.	Figure E
Step 5 . Hold the entire unit (the vial and syringe) in 1 hand and gently shake the vial until the powder is completely dissolved ( See Figure F ). Do not use if it is cloudy or if you see particles in the solution. Do not take the syringe out of the vial.	Figure F
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.	Figure G
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.	Figure H
Step 8 . Hold the vial and syringe as shown ( See Figure I )	Figure I
Giving the Glucagon for Injection:
Step 9. Choose the injection site ( See Figure J ). Common injection sites for Glucagon are upper arms, thighs, or buttocks. Patient does not need to be laying down to administer the medication as long as the common injection sites can be easily accessed.	Figure J
Step 10 . With 1 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 ).	Figure K
After Giving the Glucagon injection:
Step 11 . Pull the needle out of the skin and press on the injection site ( See Figure L ). Use a gauze pad or cotton ball (not included in the kit) if needed to press the injection site to make sure there is no direct contact with the skin.	Figure L

Throw away your used syringe with the needle attached and any Glucagon you did not use. See “ How should I dispose of (throw away) used Glucagon 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. If the person does not respond after 15 minutes,

another dose may be given, if available.

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. Even if the Glucagon for Injection 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 Glucagon for Injection 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:

How should I dispose of (throw away) Glucagon 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:
  • 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, and
  • 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 Glucagon and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 09/2019

The brand names mentioned in this document are the trademarks of their respective owners.

Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047

www.fresenius-kabi.com/us
451541

Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect. Extrahepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.