Important Safety Information

As with many medical devices, you must be aware of safety-related issues to make sure that you are using V-Go correctly. Always consult with your doctor or healthcare professional if you have any questions regarding the functions and operation of V-Go.

Caution

Federal (United States) law restricts this device to sale by or on the order of a physician or properly licensed practitioner (prescription only).

Indication

V-Go 20:

The V-Go Wearable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 20 Units of insulin in one 24-hour time period (0.83 U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.

V-Go 30:

The V-Go Wearable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 30 Units of insulin in one 24-hour time period (1.25 U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.

V-Go 40:

The V-Go Wearable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 40 Units of insulin in one 24-hour time period (1.67 U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.

A U-100 fast-acting insulin should be used with V-Go. Humalog® (insulin lispro, rDNA origin) and NovoLog® (insulin aspart, rDNA origin) have been tested by Valeritas, Inc. and found to be safe for use in the V-Go Wearable Insulin Delivery Device.

Before using different insulin with V-Go, you should check the insulin label to make sure it can be used with this device.

Healthcare Professional Dosing Considerations

When selecting a V-Go 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.

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 should be considered when starting a patient on V-Go

Warnings

Insulin requirements

If you have to make regular adjustments or modifications to your 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

If you have a medical emergency while using V-Go, call 911, your doctor, or go directly to the hospital.

Precautions

General

The following are a number of general precautions you should consider when using the V-Go Wearable Insulin Delivery Device.

V-Go is magnetic resonance (MR) unsafe.

You 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.

You should monitor your blood glucose levels based on your doctor's or healthcare professional's recommendation. American Diabetes Association guidelines suggest that patients test blood glucose 3 or more times daily.

You should act quickly to respond to abnormal blood sugar levels.

  • Notify your doctor or healthcare professional of any serious hypoglycemia or hyperglycemia. Tell your doctor or healthcare professional of any increased frequency in abnormally high or low blood glucose test results

You should create a plan with your doctor or healthcare professional in case a problem occurs when you are unable to reach him or her for advice.

You should create a plan with your doctor or healthcare professional on how to manage your bolus (mealtime) dosing using V-Go, including what to do if you lose count while bolus dosing or if you forget to take a bolus dose.

You should carry an emergency kit of insulin supplies, if instructed by your doctor or healthcare professional, in case you develop a problem with V-Go that stops your insulin delivery. Tell a family member or friend where you keep your emergency kit items.

You should speak with your doctor or healthcare professional regarding what to have in the emergency kit, which often includes the following items:

  • Fast-acting glucose tablets
  • Blood glucose and urine ketone monitoring supplies
  • Back-up insulin, insulin syringe, and needles with directions from your doctor or healthcare professional regarding how much insulin to take
  • Dressing and adhesive

You should avoid exposing V-Go to direct sunlight.

You should avoid exposure to extremely hot temperatures. Remove V-Go prior to hot tub, whirlpool, or sauna use and replace with a new filled V-Go afterward.

You should check that V-Go is securely in place during and after periods of increased physical activity. Check that V-Go is securely in place 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.

You should follow these precautions to help prevent problems with V-Go placement:

  1. Never use insulin that appears cloudy. Cloudy insulin may be inactive. Do not use cloudy insulin with V-Go.
  2. Do not expose the insulin to extreme changes in temperature. Check the insulin package insert for temperature variation.
  3. Practice aseptic technique when preparing, filling, and attaching V-Go.
  4. Check the adhesive site for redness, irritation, and inflammation when you remove a used V-Go and before you attach a new V-Go.
  5. Change the application site each time you change V-Go. See Section 2 (Part 3) Step 3 of the Instructions for Patient Use manual. Changing the site will ensure proper absorption of insulin. The new site should be at least 1 inch away from the previous site.
  6. Do not apply V-Go to a site that has excess hair or is irritated, infected, or unhealthy for any reason. Consult with your doctor or healthcare professional about how to prepare and maintain these sites.
  7. Avoid attaching V-Go to sites that may interfere with your clothing, accessories, or car seatbelts.
  8. Do not attach V-Go to sites with rigorous movement and stretching due to exercise or job-related activities.

Hypoglycemia

Low blood sugar is the most common side effect associated with any insulin, including the insulin delivered using V-Go. Symptoms of low blood sugar may vary and can happen suddenly.

To help prevent hypoglycemic episodes, follow these precautionary steps:

  1. Know the symptoms of hypoglycemia. Do not ignore these symptoms, no matter how mild they may be.
  2. Always carry a fast-acting sugar replacement (such as candy, juice, or glucose tablets) in the event of a hypoglycemic episode.
  3. The V-Go delivery rate can vary by up to +/- 10% from device to device. Even though the chance of this happening is remote, you should monitor your glucose level at least 3 times per day or as recommended by your doctor. Your doctor or healthcare professional may recommend specific times for you to check your blood glucose.
  4. Check your blood glucose before driving or operating heavy machinery. Appropriate blood glucose levels are required to maintain alertness.

IMPORTANT: If your glucose level falls below 70 mg/dL, you may be hypoglycemic (low blood sugar) and you should take immediate action to raise your blood glucose level. This may be done by taking glucose tablets, eating candy, drinking juice, or doing as your doctor or healthcare professional instructs. 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.

Consult with your doctor or healthcare professional to understand how to best recognize and manage low blood glucose.

Hyperglycemia and Diabetic Ketoacidosis (DKA)

To help prevent serious hyperglycemia (high blood glucose) and the possibility of diabetic ketoacidosis (DKA), follow these precautions:

  1. Check your blood glucose frequently based on your doctor's or healthcare professional's recommendation. Your doctor or healthcare professional may recommend specific times for you to check your 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.
  2. Be sure you know when to test for ketones and when your doctor or healthcare professional expects you to call with results.
  3. Know your blood glucose target ranges and when your doctor or healthcare professional expects you to report trouble. When your blood glucose is high, be prepared to administer insulin. If you suspect that V-Go is not delivering insulin, refer to the Troubleshooting section of the Instructions for Patient Use manual.
  4. Keep yourself well hydrated, especially during illness or exercise.
  5. Do not treat DKA yourself. If you suspect DKA, contact your doctor or healthcare professional.

Adverse Reactions

Site Infection/Abscesses

Infections at the infusion site may occur. Proper site preparation and frequent site rotation (refer to Section 2 (Part 3) Step 3A to 3D of the Instructions for Patient Use manual) can minimize infections. Remove V-Go immediately if the area around V-Go becomes sore, red, or swollen. Apply a new V-Go to a new, clean site away from the suspected infected area. Do not discontinue therapy without the advice of your doctor or healthcare professional.

Skin Irritation

A more common problem than infection is skin irritation. Skin may become irritated by the adhesive pad on V-Go or by the way V-Go is positioned on your skin. Skin irritation can occur but does not lead to any further clinical complication.

NOTE: If you have sensitive skin or your skin becomes irritated, ask your doctor or healthcare professional about skin barrier products.

Humalog is a registered trademark of Eli Lilly and Company.
NovoLog is a registered trademark of Novo Nordisk A/S.

www.valeritas.com

 

Important Risk Information
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 the V-Go Wearable Insulin Delivery Device may result in hypoglycemia. The following conditions may occur during insulin therapy with V-Go: hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose). Other adverse reactions associated with V-Go use include skin irritation from the adhesive pad or infections at the infusion site. V-Go should be removed before any magnetic resonance imaging (MRI) testing.