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What is V-Go?

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.

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.

WARNINGS

IMPORTANT: Hypoglycemia may occur during the insulin therapy with V-Go, 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.

IMPORTANT: Hypoglycemia or hyperglycemia and diabetic ketoacidosis (DKA) may occur during insulin therapy with V-Go. If you have a medical emergency while using V-Go, call 911, your healthcare professional, or go directly to the emergency room.

IMPORTANT: If your glucose level falls below 70 mg/dL, you may be having a hypoglycemic (low blood sugar) episode and you should take immediate action to raise your blood glucose level as directed by your healthcare provider. You should retest your blood glucose after 15 minutes and if it is still below 70 mg/dL continue to take steps to increase your blood glucose level until it reaches your normal level, as directed by your healthcare provider. Follow your healthcare professional’s recommendations or Consult with your healthcare professional to understand how to best recognize and manage low blood glucose.

IMPORTANT: Nausea and vomiting are often the first signs of DKA. To avoid DKA, be prepared and act quickly. Don’t assume your blood glucose is high because you are under stress, have the flu, or miscalculated your last meal bolus.

PRECAUTIONS

General Precautions

• Adverse Reactions associated with V-Go include site infections at the infusion site or skin irritation from the adhesive pad. If you have sensitive skin or your skin becomes irritated, ask your healthcare professional about skin barrier or adhesive removal products.
• V-Go is magnetic resonance unsafe. Remove V-Go before having an X-ray, MRI or CT scan and replace it with a new V-Go after the test is completed.
• Monitor your blood glucose levels based on your healthcare professional’s recommendation. Act quickly to respond to abnormal blood sugar levels. Notify your healthcare professional of any serious hypoglycemia or hyperglycemia.
• Create a plan with your healthcare professional on how to manage your bolus (mealtime) dosing with V-Go, including what to do if you lose count while bolus dosing or if you forget to take a bolus dose.
• If the Bolus Ready Button or Bolus Delivery Button does not press in or does not click when pressed, you may have used all of the 18 available bolus doses.
• Carry an emergency kit of insulin supplies, if instructed by your healthcare professional, in case you develop a problem with V-Go that stops your insulin delivery.
• Avoid exposing V-Go to direct sunlight and avoid exposure of the device to extremely hot temperatures. Remove V-Go prior to hot tub, whirlpool or sauna use and replace with a newly filled V-Go afterward.
• Check that V-Go is securely in place during and after increased physical activity or if it has been exposed to water or gone under water to the depth of 3 feet, 3 inches (1 meter). V-Go can go under water and will continue to work safely.
• Never use insulin that appears cloudy. Cloudy insulin may be inactive.
• Do not expose insulin to extreme changes in temperature. Check the insulin package insert for temperature variation.
• Practice aseptic technique when preparing, filling, and attaching V-Go. Wash your hands, wipe the application site with an alcohol swab, and avoid V-Go coming in contact with anything. You may wipe V-Go if with an alcohol swab if V-Go comes in contact with anything prior to applying it to the site.
• Check the adhesive site for redness, irritation, and inflammation when removing a used V-Go and before attaching a new V-Go.
• Change the application site on your body each time you 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.
• Do not apply V-Go to a site that has excess hair or is irritated, infected, or unhealthy for any reason.
• Avoid attaching V-Go to sites that may interfere with your clothing, accessories, or car seatbelts. Do not attach V-Go to sites with rigorous movement and stretching due to exercise or job-related activities.
• If the Start Button does not fully depress or does not remain in the down position, V-Go cannot function. You will not receive the present basal rate of insulin. Do not use V-Go if the Start Button does not stay down. Remove and discard that V-Go. Start over with a new V-Go.
• Check to make sure the needle is retracted prior to disposal of V-Go.

Please see Full Instructions For Patient Use (IFU) for additional details, including precautions to follow to help prevent problems with the V-Go and its placement.