Fill, Wear & Go with V-Go^®

INDICATION

Indication for Use

The V-Go series of Wearable Insulin Delivery Devices are indicated for continuous subcutaneous infusion of either 20 Units of Insulin (0.83 U/hr), 30 Units of insulin (1.25 U/hr), or 40 Units of insulin (1.67 U/hr) in one 24-hour time period and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period) in adults requiring insulin. A U100 fast-acting insulin should be used with V-Go. EZ Fill accessory to V-Go is required to fill the V-Go with Insulin. EZ Fill is only intended to fill a 30-day supply of V-Go devices (1 V-Go per day).

IMPORTANT SAFETY INFORMATION

V-Go is magnetic resonance (MR) unsafe. Remove V-Go before X-ray, MRI or CT scan and replace it with a new V-Go after the test is completed. Do not use other insulin products while on V-Go therapy unless instructed by your healthcare professional.

HEALTHCARE PROFESSIONAL DOSING CONSIDERATIONS
When selecting a V-Go basal dose option, healthcare professionals should refer to their own experience when initiating continuous subcutaneous insulin infusion therapy with a patient. If unfamiliar, the healthcare professional should refer to insulin therapy guidelines from diabetes associations and prescribing information.

The following should be considered when initially prescribing V-Go:

• Understand the total daily dose of insulin your patient is actually taking with their current insulin regimen versus what is being prescribed. Selecting the correct V-Go option may lessen the risk of hypoglycemia.
• It is common practice to reduce the total daily insulin dose when starting a patient on continuous subcutaneous insulin infusion therapy and this reduction should be considered when starting a patient on V-Go.

Other prescribing considerations

• A separate prescription of a U100 fast-acting insulin is required for use with V-Go.
  • Two (2) vials of insulin are required for the V-Go 20 option.
  • Three (3) vials of insulin are required for the V-Go 30 and 40 options.

WARNINGS
Insulin requirements

If regular adjustments or modifications are needed to patient’s basal rate during a 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-Unit increments, use of V-Go may result in hypoglycemia.

The following conditions may occur during insulin therapy with V-Go

• Hypoglycemia: Intensive management of diabetes with too much insulin has been associated with an increase in the incidence of hypoglycemia (low blood sugar).
• Hyperglycemia and diabetic ketoacidosis (DKA): Any insulin delivery interruption may result in hyperglycemia (high blood sugar) or the onset of diabetic ketoacidosis.

PRECAUTIONS
General Precautions

• V-Go is magnetic resonance (MR) unsafe. Patients should remove V-Go before having an X-ray, MRI or CT scan (or any similar test or procedure). Replace with a new V-Go after the test or procedure is completed.
• Blood glucose levels should be monitored based on the healthcare professional’s recommendation. American Diabetes Association guidelines suggest that patients test blood glucose 3 or more times daily.
• Plan with your patients in case of a problem and they are unable to reach you. Plan with your patients on how to manage bolus dosing with V-Go and what to do if your patients lose count of the bolus dosing or forget to take it.
• Reinforce the importance of carrying an emergency kit of insulin supplies, including what should be included in an emergency kit.
• Patients should practice aseptic technique when preparing, filling, and attaching V-Go.
• To function properly, V-Go must be completely filled with insulin before use. A partially filled V-Go should not be attached to the body.
• Patients should never use insulin that appears cloudy. Cloudy insulin may be inactive.
• Patients should not expose insulin to extreme changes in temperature. Check the insulin package insert for temperature variation.
• V-Go can be worn any place that insulin can be injected or infused. V-Go should be applied to a flat area of skin, not on a fold of the skin, muscle, or bone.
• Instruct patients when choosing the location for V-Go to avoid the following: the belt line or waistline, areas with excessive hair, areas that are curved or rigid due to muscle or bone, areas within a 1-inch circle around the belly button or surgical scars and areas of skin that are tender, bruised, red or hard or have any skin disease or infection.
• Consult with your patient about how to prepare and maintain application sites and to change the location of V-Go slightly every 24 hours. Needle insertion sites should be at least 1 inch away from the previous site.
• Reinforce the Start Button must lock in place to begin the flow of insulin and if it does not fully depress or does not remain in the down position, V-Go cannot function.
• Reinforce if the Bolus Ready Button or Bolus Delivery Button does not press in or click when pressed, the patient may have used all of the 18 available bolus doses.
• Monitoring V-Go progress is important to make sure V-Go is delivering insulin. Instruct patients to consider checking their blood glucose levels if the grey indicator in the viewing window has not slightly moved toward the Start Button after several hours.
• Patients should check that V-Go is securely in place during and after periods of increased physical activity and if it has been exposed to water or gone under water to the depth of 3 feet, 3 inches.
• V-Go should not be exposed to direct sunlight or to extremely hot temperatures. Patients should remove V-Go before using a hot tub, whirlpool, or sauna and replace with a newly filled V-Go afterward.
• Instruct patients to check the adhesive site for redness, irritation, and inflammation when removing a used V-Go and before attaching a new V-Go.
• Patients should check to make sure the needle is retracted prior to disposal of V-Go.

ADVERSE REACTIONS

General reactions related to device use may include:

• Site infections / Abscesses: Infections at the infusion site may occur. Proper site preparation and frequent site rotation can minimize infections. Remove V-Go immediately if the area around the V-Go becomes sore, red, or swollen. Apply a new V-Go to a new, clean site away from the suspected infected area.
• Skin Irritation: A more common problem than infection is skin irritation. Skin may become irritated by the adhesive pad on the V-Go or by the way V-Go is positioned on the skin.

Please see Full Instructions for Patient Use.