Gvoke®(glucagon injection) by Xeris Pharmaceuticals, Inc.


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Indications & Usage

INDICATIONS AND USAGE

 

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

 

 

Please see full Prescribing Information for Gvoke.

Dosage & Administration

DOSAGE AND ADMINISTRATION

 

·       GVOKE auto-injector and pre-filled syringe are for subcutaneous injection only

·       The recommended dose for adults and pediatric patients aged 12 years and older is 1 mg

·       The recommended dose for pediatric patients aged 2 to under 12 years of age is weight dependent:

·         For pediatric patients who weigh less than 45 kg, the recommended dose is 0.5 mg GVOKE

·         For pediatric patients who weigh 45 kg or greater, the recommended dose is 1 mg GVOKE

·       Administer GVOKE according to the printed instructions on the foil pouch label, carton, or the Instructions for Use

·       Visually inspect GVOKE prior to administration. The solution should appear clear and colorless to pale yellow and be free of particles. If the solution is discolored or contains particulate matter, do not use

·       Administer the injection in the lower abdomen, outer thigh, or outer upper arm

·       Call for emergency assistance immediately after administering the dose

·       When the patient has responded to treatment, give oral carbohydrates

·       Do not attempt to reuse GVOKE. Each GVOKE device contains a single dose of glucagon and cannot be reused

·       If there has been no response after 15 minutes, an additional weight appropriate dose of GVOKE from a new device may be administered while waiting for emergency assistance

 

DOSAGE FORMS AND STRENGTHS

 

Injection:

·         0.5 mg/0.1 mL single-dose pre-filled HypoPen auto-injector

·         1 mg/0.2 mL single-dose pre-filled HypoPen auto-injector

·         0.5 mg/0.1 mL single-dose pre-filled syringe

·         1 mg/0.2 mL single-dose pre-filled syringe

 

 

Please see full Prescribing Information for Gvoke.

Contraindications

CONTRAINDICATIONS

 

·         Pheochromocytoma

·         Insulinoma

·         Known hypersensitivity to glucagon or to any of the excipients

 

 

Please see full Prescribing Information for Gvoke.

Warnings & Precautions

WARNINGS AND PRECAUTIONS

 

·          Catecholamine Release in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because GVOKE may stimulate the release of catecholamines from the tumor.

·          Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose; however, GVOKE 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. 

·          Hypersensitivity and Allergic Reactions: Allergic reactions have been reported and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension.

·          Lack of Efficacy in Patients with Decreased Hepatic Glycogen: 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 to be effective. Patients with these conditions should be treated with glucose.

·          Necrolytic Migratory Erythema (NME): a skin rash, has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. 

·          Hypoglycemia in Patients with Glucagonoma: Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment, and monitor blood glucose levels during treatment. If a patient develops hypoglycemia, give glucose orally or intravenously.

 

 

Please see full Prescribing Information for Gvoke.

Adverse Reactions

ADVERSE REACTIONS

 

·       Most common adverse reactions (incidence 2% or greater) reported were:

·       Adults—nausea, vomiting, injection site edema raised 1 mm or greater, and headache

·       Pediatric Patients—nausea, hypoglycemia, vomiting, headache, abdominal pain, hyperglycemia, injection site discomfort and reaction, and urticaria

 

To report SUSPECTED ADVERSE REACTIONS, contact Xeris Pharmaceuticals at toll-free 1-877-937-4737 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  

 

Please see full Prescribing Information for Gvoke.

Drug Interactions

DRUG INTERACTIONS

 

·        Beta-blockers: Patients taking beta-blockers may have a transient increase in pulse and blood pressure. 

·        Indomethacin: In patients taking indomethacin GVOKE may lose its ability to raise glucose or may produce hypoglycemia.

·        Warfarin: GVOKE may increase the anticoagulant effect of warfarin.

 

 

Please see full Prescribing Information for Gvoke.

ICD Codes

Hypoglycemic disorder

E08.64      Diabetes mellitus due to underlying condition with hypoglycemia

E08.649    Diabetes mellitus due to underlying condition with hypoglycemia

                  without coma

E09.64      Drug or chemical induced diabetes mellitus with hypoglycemia

E09.649    Drug or chemical induced diabetes mellitus with hypoglycemia

                  without coma

E10.64      Type 1 diabetes mellitus with hypoglycemia

E10.649   Type 1 diabetes mellitus with hypoglycemia without coma

E11.64      Type 2 diabetes mellitus with hypoglycemia

E11.649    Type 2 diabetes mellitus with hypoglycemia without coma

E13.64      Other specified diabetes mellitus with hypoglycemia

E13.649    Other specified diabetes mellitus with hypoglycemia without coma

E16.0        Drug-induced hypoglycemia without coma

E16.1        Other hypoglycemia

E16.2        Hypoglycemia, unspecified

P70.3        Iatrogenic neonatal hypoglycemia

P70.4        Other neonatal hypoglycemia

US-GVK-20-00148 09/20

Please see full Prescribing Information

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

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, insulinoma, 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 has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia.

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.