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

CONTRAINDICATIONS

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.

WARNINGS

A separate prescription for insulin is required for use with V-Go. A U100 fast-acting insulin should be used to fill V-Go. V-Go 20 requires two (2) vials of insulin. V-Go 30 and 40 require three (3) vials of insulin. 36 Units of insulin are available for on-demand bolus dosing in all V-Go options. Bolus doses are delivered in 2-Unit increments. Patients can only click the Bolus Delivery Button 18 times. Each click delivers 2 Units of insulin (1 click = 2 Units). Patients should not use other insulin products while on V-Go therapy unless instructed by their healthcare professional. Patients wear each V-Go for a full 24-hour period, including when they sleep. Patients should only fill V-Go with insulin using the EZ Fill accessory. EZ Fill is only intended to fill a 30-day supply of V-Go devices (1 V-Go per day).

Risks Related to Insulin Administration and Device Use

If regular adjustments or modifications to the basal rate of insulin are required in 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
• Hyperglycemia and diabetic ketoacidosis (DKA)

PRECAUTIONS

Risks Related to Device Use

General risks related to device use may include:

• Site infections / Abscesses
• Skin Irritation

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 that should be included in an emergency kit.
• 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.
• Patients should check that V-Go is securely in place during and after periods of increased physical activity.
• 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.
• Patients should practice aseptic technique when preparing, filling, and attaching V-Go.
• 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 change the application site on their body each time they change V-Go. Changing the site will ensure proper absorption of insulin. The new site should be at least 1 inch away from the previous site.
• Instruct patients to avoid placing V-Go on a site that has excess hair or is irritated, infected, or unhealthy for any reason.
• Consult with your patient about how to prepare and maintain these sites.
• Instruct patients to avoid attaching V-Go to sites that may interfere with their clothing, accessories, car seatbelts or that undergo rigorous movement or stretching due to exercise or job-related activities.
• Please see Full Instructions for Patient Use.