INDICATIONS AND USAGE For the treatment of severe hypoglycemia: Glucagon is indicated as a treatment for severe hypoglycemia (low blood sugar) which may occur in patients with diabetes mellitus.

Because patients with type 1 diabetes may have less of an increase in blood glucose levels compared with a stable type 2 patient, supplementary carbohydrate should be given as soon as possible, especially to a pediatric patient.

For use as a diagnostic aid: Glucagon is indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous.

Glucagon is as effective for this examination as are the anticholinergic drugs.

However, as use of glucagon in combination with anticholinergic drugs may result in increased side effects, the use of glucagon in combination with anticholinergic drugs is not recommended.

INDICATIONS FOR USE Use glucagon to treat insulin coma or insulin reaction resulting from severe hypoglycemia (very low blood sugar).

Symptoms of severe hypoglycemia include disorientation, unconsciousness, and seizures or convulsions.

Give glucagon if (1) the patient is unconscious (2) the patient is unable to eat sugar or a sugar-sweetened product (3) the patient is having a seizure, or (4) repeated administration of sugar or a sugar-sweetened product such as a regular soft drink or fruit juice does not improve the patient’s condition.

Milder cases of hypoglycemia should be treated promptly by eating sugar or a sugar-sweetened product.

(See INFORMATION ON HYPOGLYCEMIA below for more information on the symptoms of hypoglycemia.) Glucagon is not active when taken orally.

DIRECTIONS FOR USE TO PREPARE GLUCAGON FOR INJECTION 1.Remove the flip-off seal from the bottle of glucagon.

Wipe rubber stopper on bottle with alcohol swab.

2.Remove the needle protector from the syringe, and inject the entire contents of the syringe into the bottle of glucagon.

DO NOT REMOVE THE PLASTIC CLIP FROM THE SYRINGE.

Remove syringe from the bottle.

3.Swirl bottle gently until glucagon dissolves completely.

GLUCAGON SHOULD NOT BE USED UNLESS THE SOLUTION IS CLEAR AND OF A WATER-LIKE CONSISTENCY.

TO INJECT GLUCAGON Use Same Technique as for Injecting Insulin 4.Using the same syringe, hold bottle upside down and, making sure the needle tip remains in solution, gently withdraw all of the solution (1 mg mark on syringe) from bottle.

The plastic clip on the syringe will prevent the rubber stopper from being pulled out of the syringe; however, if the plastic 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 children, withdraw 1/2 of the solution from the bottle (0.5 mg mark on syringe).

DISCARD UNUSED PORTION.

USING THE FOLLOWING DIRECTIONS, INJECT GLUCAGON IMMEDIATELY AFTER MIXING.

5.Cleanse injection site on buttock, arm, or thigh with alcohol swab.

6.Insert the needle into the loose tissue under the cleansed injection site, and inject all (or 1/2 for children weighing less than 44 lb) of the glucagon solution.

Apply light pressure at the injection site, and withdraw the needle.

Press an alcohol swab against the injection site.

7.Turn the patient on his/her side.

When an unconscious person awakens, he/she may vomit.

Turning the patient on his/her side will prevent him/her from choking.

8.FEED THE PATIENT AS SOON AS HE/SHE AWAKENS AND IS ABLE TO SWALLOW.

Give the patient 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 patient does not awaken within 15 minutes, give another dose of glucagon and INFORM A DOCTOR OR EMERGENCY SERVICES IMMEDIATELY.

9.Even if the glucagon revives the patient, his/her doctor should be promptly notified.

A doctor should be notified whenever severe hypoglycemic reactions occur.

Instructions 1 Instructions 2 Instructions 3 Instructions 4

WARNINGS Glucagon should be administered cautiously to patients with a history suggestive of insulinoma, pheochromocytoma, or both.

In patients with insulinoma, intravenous administration of glucagon may produce an initial increase in blood glucose; however, because of glucagon’s hyperglycemic effect the insulinoma may release insulin and cause subsequent hypoglycemia.

A patient developing symptoms of hypoglycemia after a dose of glucagon should be given glucose orally, intravenously, or by gavage, whichever is most appropriate.

Exogenous glucagon also stimulates the release of catecholamines.

In the presence of pheochromocytoma, glucagon can cause the tumor to release catecholamines, which may result in a sudden and marked increase in blood pressure.

If a patient develops a sudden increase in blood pressure, 5 to 10 mg of phentolamine mesylate may be administered intravenously in an attempt to control the blood pressure.

Generalized allergic reactions, including urticaria, respiratory distress, and hypotension, have been reported in patients who received glucagon by injection.

Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion.

NME lesions may affect the face, groin, perineum and legs or be more widespread.

In the reported cases NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective.

Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

ADVERSE REACTIONS Side effects may include nausea and vomiting.

These reactions may also occur with hypoglycemia.

Generalized allergic reactions have been reported (see WARNINGS ).

In a three month controlled study of 75 volunteers comparing animal-sourced glucagon with glucagon manufactured through rDNA technology, no glucagon-specific antibodies were detected in either treatment group.

Necrolytic migratory erythema (NME) cases have been reported postmarketing in patients receiving continuous infusions of glucagon (see WARNINGS ).