Gvoke

Gvoke

Gvoke HypoPen®(pronounced G-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 (0.5mg/0.1mL) and adult (1.0mg/0.2mL) doses.1

Gvoke reduces the steps to prepare and administer glucagon in the event of severe hypoglycemia (i.e., dangerously low blood sugar levels). This innovation is designed to provide the reliability of a ready-to-use liquid glucagon while making it easier for patients or caregivers to administer quickly and simply. Studies demonstrated 100% treatment success* in children and 99% treatment success in adults. Usability research evaluating the Gvoke PFS and Gvoke HypoPen demonstrated 99% success rates in administering a full dose of glucagon using the simple two-step administration process.2,3

Severe hypoglycemia occurs when your blood sugar gets so low that you need help bringing it back up. Sometimes people with very low blood sugar may have a hard time thinking straight or controlling their body, get very tired, refuse to eat, pass out, or even have a seizure. It is an emergency situation that must be treated immediately.4

Indication and Important Safety Information

Gvoke is indicated for the treatment of severe hypoglycemia in adult and pediatric patients with diabetes ages 2 years and above.

Important Safety Information

Contraindications

Gvoke is contraindicated in patients with pheochromocytoma because of the risk of substantial increase in blood pressure, insulinoma because of the risk of hypoglycemia, and known hypersensitivity to glucagon or to any of the excipients in Gvoke. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension.

Warnings and Precautions

Gvoke is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor. If the patient develops a dramatic increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered 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, Gvoke administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. Gvoke is contraindicated in patients with insulinoma. If a patient develops symptoms of hypoglycemia after a dose of Gvoke, give glucose orally or intravenously. Allergic reactions have been reported with glucagon. These include generalized rash, and in some cases, anaphylactic shock with breathing difficulties and hypotension. Gvoke is contraindicated in patients with a prior hypersensitivity reaction.

Gvoke is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia, may not have adequate levels of hepatic glycogen for Gvoke administration to be effective. Patients with these conditions should be treated with glucose.

Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion. NME lesions may affect the face, groin, perineum and legs or be more widespread. In the reported cases NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

Adverse Reactions

Most common (≥5%) adverse reactions associated with Gvoke are nausea, vomiting, injection site edema (raised 1 mm or greater), and hypoglycemia.

Drug Interactions

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given Gvoke. In patients taking indomethacin, Gvoke may lose its ability to raise blood glucose or may even produce hypoglycemia. Gvoke may increase the anticoagulant effect of warfarin.

For more information, call 1-877-937-4737 or go to www.GvokeGlucagon.com

Please see the Important Facts about Gvoke.

1 Gvoke {prescribing information]. Chicago, IL: Xeris Pharmaceuticals, Inc; 2021.
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 Newswanger B, Prestreleski S, Andre AD. Human factor studies of a prefilled syringe with stable liquid glucagon in a simulated severe hypoglycemia rescue situation. Expert Opin Drug Deliv. 2019; 16(9):1015–1025.
4 National Institute of Diabetes and Digestive and Kidney Diseases. Hypoglycemia. https://www.niddk.nih.gov/-/media/Files/Diabetes/hypoglycemia_508.pdf. July 2021.

US-GVK-21-00142 2/22