Indication

GVOKE (glucagon) is an antihypoglycemic agent indicated for subcutaneous use for the treatment of severe hypoglycemia in adult and pediatric patients aged 2 years and older with diabetes.

Important Safety Information

• GVOKE is contraindicated in patients with:

• • Pheochromocytoma because of the risk of substantial increase in blood pressure
  • lnsulinoma because of the risk of hypoglycemia
  • Prior hypersensitivity reaction to glucagon or to any of the excipients. Serious hypersensitivity reactions have been reported with glucagon, including generalized rash, and anaphylactic shock with breathing difficulties and hypotension

• GVOKE may stimulate the release of catecholamines from the tumor. If patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate intravenously has been shown to be effective in lowering blood pressure
• In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, administration may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously
• Patients with insufficient hepatic stores of glycogen may not respond to GVOKE for treatment of severe hypoglycemia. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation, or in patients with adrenal insufficiency or chronic hypoglycemia
• A skin rash called necrolytic migratory erythema (NME), has been reported post-marketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. GVOKE is not approved for continuous infusion. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks
• Most common adverse reactions reported in adult patients were nausea, vomiting, injection site edema raised 1 mm or greater, and headache
• Most common adverse reactions reported in pediatric patients were nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria
• Patients taking concomitant beta-blockers may have a transient increase in pulse and blood pressure. In patients taking concomitant indomethacin, GVOKE may lose its ability to raise glucose or may produce hypoglycemia. GVOKE may increase the anticoagulant effect of warfarin

Please see full Prescribing Information for GVOKE.