For the treatment of hypoglycemia.

GlucaGen® is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes treated with insulin Because GlucaGen® depletes glycogen stores, the patient should be given supplemental carbohydrates as soon as he/she awakens and is able to swallow, especially children or adolescents. Medical evaluation is recommended for all patients who experience severe hypoglycemia.

For use as a diagnostic aid

GlucaGen® is indicated for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. Glucagon is as effective for this examination as are the anticholinergic drugs. However, the addition of the anticholinergic agent may result in increased side effects. Because GlucaGen® depletes glycogen stores, the patient should be given oral carbohydrates as soon as the procedure is completed.

Directions for treatment of severe hypoglycemia

Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing GlucaGen® powder and inject all the liquid from the syringe into the vial. Roll the vial gently until powder is completely dissolved and no particles remain in the fluid The reconstituted fluid should be clear and of water-like consistency. The reconstituted GlucaGen'8 gives a concentration of approximately 1 mg/ml glucagon. The reconstituted GlucaGen should be used immediately after reconstitute. Discard any unused portion. Inject 1 ml (adults and children, weighing more than 55 lbs) or ½ ml (children weighing less than 55 lbs) subcutaneously (s.c), intramuscularly (i.m), or intravenously (i.v). If the weight is not known: Children younger than 6 to 8 years should be given half dose (=½ ml) and children older than 6 to 8 should be given the adult dose (1 ml).^l,2,3,4,5,6 Emergency assistance should be sought if the patient fails to respond within 15 minutes after subcutaneous or intramuscular inaction of glucagon. The glucagon injection may be repeated while waiting for emergency assistance.¹ Intravenous glucose MUST be administered if the patient fails to respond to glucagon. When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent recurrence of hypoglycemia.

Directions for use as a diagnostic aid

GlucaGen® should be reconstituted with the supplied 1 ml of Sterile Water for Reconstitution (if supplied) or 1 ml Sterile Water for Injection, USP. Using a syringe, withdraw all of the Sterile Water for Reconstitution (if supplied) or 1 ml Sterile Water for Injection, USP and inject into the GlucaGen® vial. Roll the vial gently until powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency. The reconstituted GlucaGen gives a concentration of approximately 1 mg/ml glucagon. The reconstituted GlucaGen® should be used immediately after reconstitution. Discard any unused portion. When the diagnostic procedure is over, give oral carbohydrate to restore the liver glycogen and prevent occurrence of secondary hypoglycemia.

References for diagnostic aid use only

Stability And Storage

Before Reconstitution

The GlucaGen® package may be stored up to 24 months at controlled room temperature 20° to 25° C (68° to 77° F) prior to reconstitution. Avoid freezing and protect from light. GlucaGen should not be used after the expiry date on the vials.

After Reconstitution:

Reconstituted GlucaGen® should be used immediately. Discard any unused portion. If the solution shows any sign of gel formation or particles, it should be discarded

GlucaGen HypoKit includes

1 vial containing 1 mg (1 unit) GlucaGen® (glucagon [rDNA origin] for injection)

1 disposable syringe containing 1 ml Sterile Water for Reconstitution
NDC 0169-7065-15

OR

GlucaGen® Diagnostic Kit includes

1 vial containing 1 mg (1 unit) GlucaGen® (glucagon [rDNA origin] for injection)

1 vial containing 1ml Sterile Water for Reconstitution
NDC 55390-004-01

OR

The GlucaGen® 10-pack includes

10x1 vial containing 1 mg (1 unit) GlucaGen® (glucagon [rDNA origin] for injection)
NDC 55390-004-10

REFERENCES

1. Drug Information for the Health Care Professional. 17th ed. Rockville, Maryland: The United States Pharmacopeial Convention, Inc; 1997; Vol. 1, IA: 1516-1518.

2. Gibbs et al: Use of Glucagon to terminate insulin reactions in diabetic children. Nebr Med 1958;43:56-57.

3. Carson MJ, Koch R, Clinical studies with glucagon in children. J Pediatr 1955; 47:161-170.

4.   Shipp JC, et al: Treatment of insulin hypoglycemia in diabetic campers. Diabetes 1964; 13:645-648.

5. Aman J, Wranne L: Hypoglycemia in childhood diabetes II: Effect of subcutaneous or intramuscular injection of different doses of glucagon. Acta Pediatr Scand 1988; 77:548-553.

6. Aynsley-Green AS, Eyre JA, and Soltesz G, Hypoglycaemia in diabetic children. In: Frier BM and Fisher BM, eds Hypoglycaemia and Diabetes, Edward Arnold, 1993; 237-238

Edition: December 2004. Novo Norilsk® and GlucaGen9 are registered trademarks of Novo Nordisk A/5. For information contact: Novo Nordisk Inc. Princeton, New Jersey 08540. 1-800-727-6500. www.novonordisk-us.com. Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd. Denmark. FDA Rev date: 11/14/2005

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