Glucagon

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

• Single-dose vial containing 1 mg Glucagon for Injection with a pre-filled syringe containing 1 mL of diluent for Glucagon.

Glucagon for Injection is contraindicated in patients with:

• Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warning and Precautions (5.1)]
• Insulinoma because of the risk of hypoglycemia [see Warning and Precautions (5.2)]
• 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 Warning and Precautions (5.3)]
• Glucagonoma when used as a diagnostic aid because of the risk of hypoglycemia [see Warnings and Precautions (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)]

The following adverse reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Injection site reactions including erythema and swelling
• Nausea
• Vomiting
• Headache
• Dizziness
• Asthenia
• Pallor
• Diarrhea
• Somnolence
• Generalized allergic reactions including anaphylactic shock with breathing difficulties and hypotension
• Hypertension and tachycardia
• Decreased blood pressure. Hypotension has been reported up to 2 hours after administration in patients receiving glucagon as premedication for upper gastrointestinal endoscopy procedures.
• Hypoglycemia and hypoglycemic coma. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration [see Drug Interactions (7)].
• Necrolytic Migratory Erythema (NME) cases have been reported post marketing in patients receiving continuous infusion of glucagon.

If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, the serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.

Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is synthesized in a laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for glucagon. The chemical structure of the glucagon is identical to human glucagon. Glucagon is a single-chain polypeptide that contains 29 amino acid residues and has a molecular weight of 3483 Daltons.

The empirical formula is C₁₅₃H₂₂₅N₄₃O₄₉S. The primary sequence of glucagon is shown below.

Crystalline glucagon is a white to off-white powder. It is relatively insoluble in water but is soluble at a pH of less than 3 or more than 9.5.

Glucagon for Injection is a sterile lyophilized white to off white powder in a vial and a syringe of sterile diluent for intravenous, intramuscular, or subcutaneous use. The vial contains 1 mg of glucagon, 49 mg of lactose monohydrate. Hydrochloric acid may have been added during manufacture to adjust the pH of the glucagon to 2.5 to 3.0. One International Unit of glucagon is equivalent to 1 mg of glucagon. The 1-mL diluent syringe contains 12 mg of glycerin, 1 mg hydrochloric acid, and Water for Injection, at pH 1.8 to 2.2.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

INSTRUCTIONS FOR USE

Glucagon (GLOO-ka-gon) for injection

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 for Injection.
• Do not share your Glucagon syringes or needles with another person. You may give other people a serious infection or get a serious infection from them.
• The prefilled syringe that comes with your Glucagon Emergency Kit for Low Blood Sugar is for use with Glucagon for Injection only. Do not use Glucagon for Injection syringes to inject other medicines.

How should I store Glucagon for Injection?

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 the vial of Glucagon for Injection. Do not use Glucagon for Injection if the expiration date has passed.
• Do not freeze Glucagon.
• Keep Glucagon in its original package and away from light.

After you mix the Glucagon powder and liquid:

• Use Glucagon for Injection right away.
• Throw away unused Glucagon for Injection.

Supplies you will need for your Glucagon for Injection

• Glucagon Emergency Kit for Low Blood Sugar contains (see Figure A):
  • 1 single-dose vial containing 1 mg Glucagon for Injection (as a sterile, lyophilized white to off-white powder)
  • 1 prefilled syringe containing 1 mL of diluent for Glucagon

• 1 puncture resistant container for throwing away used needles and syringes. See “How should I dispose of (throw away) used Glucagon syringes?” at the end of these instructions.
• Alcohol swab (not included in kit)

Preparing to Inject Glucagon for Injection

• The Glucagon medicine comes as a dry powder. Before you use Glucagon for Injection, you must mix the dry powder with the syringe of diluent that comes in the Glucagon Emergency Kit for Low Blood Sugar. Do not use any other liquid to mix the medicine.

Step 1: Remove the flip-off seal from the vial of Glucagon. Wipe the rubber stopper on the vial with an alcohol swab (see Figure B).

Step 2: Remove the needle protector from the syringe. Inject all of the diluent in the prefilled syringe into the vial containing Glucagon powder (see Figure C). Do not remove the plastic clip from the syringe. Remove syringe from the vial.

Step 3: Swirl the vial gently until the Glucagon powder dissolves completely (see Figure D). Glucagon should not be used unless the solution is clear and of a water-like consistency.

Step 4: Using the same syringe, hold the vial upside down and, making sure the needle tip remains in the solution, gently withdraw all the solution (1 mg mark on syringe) from the vial (see Figure E). The backstop and plastic clip on the syringe will prevent the rubber stopper from being pulled out of the syringe; however, if the plunger rod separates from the rubber stopper, simply reinsert the rod by turning it clockwise. The usual adult dose is 1 mg. For children weighing less than 44 lb (20 kg), give 1/2 adult dose (0.5 mg). For these children, withdraw 1/2 of the solution from the vial (0.5 mg mark on syringe).

Injecting Glucagon for Injection

Step 5: Choose your injection site and clean with an alcohol wipe. Injection sites for Glucagon for Injection are the buttocks, upper arm, or thigh.

Step 6: Insert the needle into the loose tissue under the clean injection site and push the plunger to inject all (or 1/2 for children weighing less than 44 lbs.) of the Glucagon for Injection.

After injecting Glucagon for Injection

Step 7: Apply light pressure at the injection site and withdraw the needle. Press an alcohol swab against the injection site.

Throw away your used syringe with the needle attached and any Glucagon that you did not use in an FDA-cleared sharps disposal container right away after use. See “How should I dispose of (throw away) used Glucagon syringes?” at the end of these instructions.

Step 8: Turn the person on their side. When an unconscious person wakes up, they may vomit. Turning the person on their side will prevent them from choking.

Step 9: Call for emergency medical help right away.

Step 10: Feed the person as soon as they wake up and are 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 11: If the person does not awaken within 15 minutes, give another dose of Glucagon and inform a doctor or emergency services right away.

Step 12: Even if the Glucagon revives the person, their doctor should be notified right away. A doctor should be notified whenever severe hypoglycemia occurs.

Hypoglycemia may happen again after receiving Glucagon for Injection.

Early symptoms of hypoglycemia (low blood glucose) include:

If not treated early, the symptoms may progress to severe hypoglycemia. Signs include:

How should I dispose of (throw away) used Glucagon syringes?

• Put used syringes in an 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 an 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 labelled 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: 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 for Injection 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: 01/2021

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

Copyright © 2021, Eli Lilly and Company. All rights reserved.

GLU-0001-IFU-20210126

Lilly

Rx only

Glucagon Emergency Kit
for Low Blood Sugar

Glucagon for Injection, 1 mg per vial

Diluent for Glucagon, 1 mL syringe

NDC 0002-8031-01

Must reconstitute vial contents with diluent.