1 INDICATIONS AND USAGE 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 ) 1.1 Severe Hypoglycemia Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus.

1.2 Diagnostic Aid Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

6 ADVERSE REACTIONS 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.

Glucagon adverse reactions include: injection site reactions, nausea, vomiting, headache, dizziness, asthenia, pallor, diarrhea, somnolence, and decreased blood pressure.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.