2.1 Important Administration Instructions

GVOKE auto-injector, pre-filled syringe, and vial and syringe kit 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:

• For the HypoPen or pre-filled syringe: Do not open foil pouch until ready to administer.
• For the vial and syringe kit: Store in original carton until ready to administer.
• 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.
• Withdraw the correct dose.
• Call for emergency assistance immediately after administering the dose.
• If there has been no response after 15 minutes, an additional dose from a new device or vial and syringe kit may be administered while waiting for emergency assistance.
• 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 or vial contains a single dose of glucagon and cannot be reused. Discard any unused portion.

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 or vial and syringe kit 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 or vial and syringe kit may be administered while waiting for emergency assistance.