Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 WARNINGS AND PRECAUTIONS • Substantial Increase in Blood Pressure in Patients with Pheochromocytoma : Contraindicated in patients with pheochromocytoma because Glucagon for Injection may stimulate the release of catecholamines from the tumor.
( 4 , 5.1 ) • Hypoglycemia in Patients with Insulinoma : In patients with insulinoma, glucagon administration may produce an initial increase in blood glucose;
however, Glucagon for Injection may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia.
If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously.
( 4 , 5.2 ) • Hypersensitivity and Allergic Reactions : Allergic reactions, which have been reported with glucagon, may occur and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension.
Like all medications, Glucagon can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: