GlucaGen for Injection, 1 mg/Vial

Glucagen is a a human prescription drug product labeled by Boehringer Ingelheim Pharmaceuticals, Inc.. The generic name of Glucagen is glucagon hydrochloride. The product's dosage form is injection, powder, for solution and is administered via intramuscular; intravenous; subcutaneous form.

Indications

Treatment of severe hypoglycemia

GlucaGen is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes mellitus 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.

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. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied.

For GlucaGen HypoKit:

Treatment of severe hypoglycemia

1. 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.
2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency.
3. The reconstituted GlucaGen gives a concentration of approximately 1 mg/mL glucagon.
4. The reconstituted GlucaGen should be used immediately after reconstitution.
5. Inject 1 mL (adults and children, weighing more than 55 lbs (25 kg)) or 0.5 mL (children weighing less than 55 lbs (25 kg)) subcutaneously, intramuscularly, or intravenously. Common injection sites for GlucaGen are upper arms, thighs, or buttocks. If the weight is not known: children younger than 6 years should be given a 0.5 mL and children 6 years and older should be given 1 mL.
6. Discard any unused portion.
7. Emergency assistance should be sought immediately after subcutaneous or intramuscular injection of glucagon.
8. The glucagon injection may be repeated using a new kit while waiting for emergency assistance.
9. Intravenous glucose MUST be administered if the patient fails to respond to glucagon.
10. When the patient has responded to the treatment, give fast-acting and long-acting oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia.

For GlucaGen Diagnostic Kit and the GlucaGen 10-pack:

Use as a diagnostic aid

1. GlucaGen should be reconstituted with 1 mL of Sterile Water for Reconstitution (if supplied) or 1 mL of 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.
2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency.
3. The reconstituted GlucaGen gives a concentration of approximately 1 mg/mL glucagon.
4. The reconstituted GlucaGen should be used immediately after reconstitution.
5. GlucaGen must be administered by medical personnel.
6. Discard any unused portion.
7. Onset of action after an injection will depend on the organ under examination and route of administration [see Pharmacodynamics (12.2)].
8. The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly; the usual dose to relax the colon is 0.5 mg to 0.75 mg intravenously and 1 mg to 2 mg intramuscularly [see Pharmacodynamics (12.2)].
9. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied.

The GlucaGen Diagnostic Kit and the GlucaGen presentations are intended only for use by healthcare providers as a diagnostic aid. The GlucaGen Diagnostic Kit and the GlucaGen presentations are not intended for use by patients to treat severe hypoglycemia because they are not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.