Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke® Kit for the Treatment of Severe Hypoglycemia
First ready-to-use liquid glucagon available in a single-dose vial and syringe kit for rescue
Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit – three different administration options to accommodate patients’ preferences
Gvoke Kit eliminates the need for reconstitution
Gvoke Kit availability anticipated in early Q1 2022
“Offering three different administration options - Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit, allows for greater patient choice in a ready-to-use rescue product for the approximately 6.8 million people in the
The sNDA approval was supported by a pharmacokinetic study demonstrating bioequivalence of a 1 mg Gvoke dose administered via a vial and syringe kit (Gvoke Kit) to that of 1 mg Gvoke administered as a pre-filled syringe (Gvoke PFS).
ABOUT Gvoke® (US) /Ogluo® (EU)
Gvoke® PFS and Gvoke HypoPen® (glucagon injection), the first prescription, ready-to-use, pre-mixed, pre-measured glucagon injection, were approved by the FDA in
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
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.
Most common (≥5%) adverse reactions associated with GVOKE are nausea, vomiting, injection site edema (raised 1 mm or greater), and hypoglycemia.
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.
Please see full Prescribing Information for GVOKE on www.xerispharma.com. Manufactured for
Xeris (Nasdaq: XERS) is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world.
With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable and infusible therapies, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the
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