Gvoke

GVOKE®

GVOKE HypoPen® (pronounced Gee-voke) (glucagon injection) is the first FDA-approved autoinjector for very low blood sugar that is premixed and ready-to-use. It is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in adults and children ages 2 years and above with diabetes. It is available in both pediatric (0.5 mg/0.1 mL) and adult (1.0 mg/0.2 mL) doses.1

GVOKE reduces the steps to prepare and administer glucagon in the event of severe hypoglycemia. This innovative technology helps provide the reliability of a ready-to-use liquid glucagon while making it simple for patients or caregivers to administer.

Studies demonstrated 100% (30/30) treatment success in children* and 99% (152/154) treatment success in adults.1† Usability research evaluating GVOKE HypoPen demonstrated 99% (74/75) success rates in administering a full dose of glucagon using the simple, two-step (pull red, push yellow) administration process.2,3

*Treatment success was defined in the pediatric study as a plasma glucose increase of at least 25 mg/dL at 30 minutes following glucagon administration.1
†Treatment success was defined in the adult studies as plasma glucose increase from mean value at time of glucagon administration to absolute value greater than 70 mg/dL or relative increase of 20 mg/dL or greater, at 30 minutes after glucagon administration.1

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
    • Insulinoma 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 the Full Prescribing Information .

 Please see Patient Package Insert.

1 GVOKE {prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc.
2 Valentine V, Newswanger B, Prestrelski S, Andre AD, Garibaldi M. Human factors usability and validation studies of a glucagon autoinjector in a simulated severe hypoglycemia rescue situation. Diabetes Technol Ther. 2019; 21(9):522–530.
3 Gvoke HypoPen [instructions for use]. Chicago, IL: Xeris Pharmaceuticals, Inc.