Gvoke PFS 0.5 Mg Pre-filled Syringe

GVOKE PFS 0.5 MG PRE-FILLED SYRINGE- glucagon injection, solution
GVOKE PFS 1 MG PRE-FILLED SYRINGE- glucagon injection, solution
GVOKE HYPOPEN 1 MG AUTO-INJECTOR- glucagon injection, solution
GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR- glucagon injection, solution
Xeris Pharmaceuticals, Inc.

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

DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

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

Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about GVOKE and its Instructions for Use. Administer GVOKE as soon as possible when severe hypoglycemia is recognized.

Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for GVOKE. Emphasize the following instructions to the patient or caregiver:

  • Do not open foil pouch until ready to administer 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 to restore the liver glycogen and prevent recurrence of hypoglycemia.
  • Do not attempt to reuse GVOKE. Each GVOKE device contains a single dose of glucagon and cannot be reused.

2.2 Dosage in Adults and Pediatric Patients Aged 2 years and Above

Adults and Pediatric Patients Aged 12 and Older

  • The recommended dose of GVOKE is 1 mg administered by subcutaneous injection into lower abdomen, outer thigh, or outer upper arm.
  • If there has been no response after 15 minutes, an additional 1 mg dose of GVOKE from a new device may be administered while waiting for emergency assistance.

Pediatric Patients Aged 2 to Under 12 Years of Age

  • The recommended dose for pediatric patients who weigh less than 45 kg is 0.5 mg GVOKE administered by subcutaneous injection into the lower abdomen, outer thigh, or outer upper arm.
  • The recommended dose for pediatric patients who weigh 45 kg or greater is 1 mg GVOKE administered by subcutaneous injection into the lower abdomen, outer thigh, or outer upper arm.
  • 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

GVOKE injection is a clear, colorless to pale yellow solution available as follows:

  • 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

CONTRAINDICATIONS

GVOKE is contraindicated in patients with:

  • Pheochromocytoma [ see Warnings and Precautions ( 5.1) ]
  • Insulinoma [ see Warnings and Precautions ( 5.2) ] because of the risk of hypoglycemia
  • 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 [ see Warnings and Precautions ( 5.3) ].

WARNINGS AND PRECAUTIONS

5.1 Catecholamine Release in Patients with Pheochromocytoma

GVOKE is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor [ see Contraindications ( 4) ]. 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.

5.2 Hypoglycemia in Patients with Insulinoma

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, glucagon 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 [ see Contraindications ( 4) ]. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously.

5.3 Hypersensitivity and Allergic Reactions

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 [see Contraindications ( 4) ].

5.4 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 administration to be effective. Patients with these conditions should be treated with glucose.

5.5 Necrolytic Migratory Erythema

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.

5.6 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 for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously.

ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in labeling:

  • Hypersensitivity and Allergic Reactions [ see Warnings and Precautions ( 5.3) ].
  • Necrolytic Migratory Erythema [ see Warnings and Precautions ( 5.5) ].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of GVOKE cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.

Adverse Reactions in Adult Patients

The safety of GVOKE was evaluated in two randomized, blinded, 2-way crossover studies conducted in adults with type 1 diabetes mellitus. In total, 154 patients received an injection of GVOKE [ see Clinical Studies ( 14.1) ].

The most common adverse reactions occurring in 2% or more of adult subjects treated with GVOKE during clinical trials are listed in Table 1.

Table 1: Adverse Reactions Occurring ≥ 2% in Adult Patients with Type 1 Diabetes Mellitus Treated with GVOKE

GVOKE 1 mg dose

Nausea 30%
Vomiting 16%
Injection site edema raised 1 mm or greater 7%
Headache 5%

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