V-GO DISPOSABLE INSULIN DELIVERY DEVICE-

V-GO DISPOSABLE INSULIN DELIVERY DEVICE by

Drug Labeling and Warnings

V-GO DISPOSABLE INSULIN DELIVERY DEVICE by is a Other medication manufactured, distributed, or labeled by Valeritas, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IMPORTANT: A separate prescription for insulin is required for use with the V-Go. A U100 fast-acting insulin should be used to fill the V-Go. (See Section 3 for insulins tested with the V-Go.)
  • V-Go 20 requires two (2) vials of insulin
  • V-Go 30 and 40 require three (3) vials of insulin

IMPORTANT: Let your healthcare professional know how much insulin you actually take each day. Your healthcare professional will help select the correct V-Go option for you.
The correct V-Go option may lessen the risk of hypoglycemia.

IMPORTANT: A V-Go Disposable Insulin Delivery Device that has been properly prescribed and used will deliver your insulin needs. Wear each V-Go for a full 24-hour period, including while you sleep.

IMPORTANT: Do not use other insulin products while on V-Go therapy.

Valeritas Customer Care

If you have any questions about using the V-Go™ or EZ Fill, speak to a Valeritas Customer Care Representative 24/7 at 1-866-881-1209.

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

Liability Disclaimer

Valeritas does not give medical advice about insulin therapy. Discuss all medical therapies with your healthcare professional.

SECTION 1 (Part 2): BEFORE YOU BEGIN

Step 1: Remove the EZ Fill from the blister packaging

EZ Fill Blister Packaging

Step 2: Remove the V-Go from the blister packaging

V-Go Blister Packaging

NOTE: Only remove one (1) V-Go every 24 hours to fill, apply, and use. Leave the rest in their containers until you are ready to use them.

SECTION 2 (Part 1): V-Go OPERATING INSTRUCTIONS

IMPORTANT: Understanding the button names and locations is important for the successful use of the V-Go and EZ Fill.

V-Go Product Overview

Product Overview 1

Product Overview 2

Product Overview 3

EZ Fill Product Overview

EZ Fill Bottom

Aseptic Technique

Aseptic technique helps keep the V-Go and the EZ Fill devices clean during preparation, filling, and application. Following this technique requires hand-washing and wiping the application site with an alcohol swab. It may involve wiping the V-Go device with an alcohol swab if the device comes into contact with anything else.

Use aseptic technique when you are preparing, filling, and attaching a new V-Go.

SECTION 2 (Part 2): FILLING THE V-Go™ WITH INSULIN USING THE EZ FILL

IMPORTANT:
The EZ Fill is intended to fill one (1) V-Go each day.
Use the EZ Fill to fill 30 V-Go devices, one (1) V-Go each day. Then discard the EZ Fill after 30 fills.
A new EZ Fill will be included in each month’s supply of V-Go devices.
Do not fill and store V-Go devices ahead of time. That may result in the loss of insulin effectiveness.
Remove the EZ Fill from the refrigerator, allowing the insulin to reach room temperature (about 20 minutes) before filling the V-Go.

Step 1: Remove the plug from the EZ Fill drawer

NOTE: On day 1 when you remove the EZ Fill from the packaging, the plug will be separate from the EZ Fill; therefore, you can skip Step 1.

EZ Fill Drawer

    A. Place your thumb over the plug tab and your forefinger underneath the ribbed drawer handle. Pull the drawer out until it stops. The plug will pop up from the drawer.
    B. Lift the plug out of the EZ Fill using your thumb and forefinger. Set the plug aside. You will replace the plug into the EZ Fill after you fill the V-Go with insulin.

IMPORTANT: People should not touch the circular opening on the top of the plug. Touching the circular opening may compromise the sterility of the EZ Fill.

Step 2: Place the V-Go into the EZ Fill

EZ Fill Drawer

EZ Fill Drawer

EZ Fill Drawer

IMPORTANT: Shut the EZ Fill drawer only when the V-Go is completely inside the drawer. The drawer is shut when it cannot be pushed any further forward or in.

Step 3: Place the insulin vial into the EZ Fill insulin vial holder

NOTE: Before placing a new vial into the EZ Fill, check to make sure the insulin vial is not expired and that it will not expire during the time period that the vial will be used in the EZ Fill.

Insulin Vial

    A. Remove the protective cap from the insulin vial. Wipe the top with an alcohol swab.

Insulin Vial Holder

    B. Pull the EZ Fill cap out of the insulin vial holder and discard.

Insulin Vial and Insulin Vial Holder

    C. Turn the insulin vial upside down so the top of the vial faces downward.
    D. Place the insulin vial into the EZ Fill. Push the vial firmly straight down into the insulin vial holder until you feel it attach and you cannot push it further.
    E. Check the insulin supply window to make sure there is enough insulin to fill the V-Go™.

Step 4: Fill the V-Go with insulin

NOTE: Keep the EZ Fill in a vertical, fully upright position during filling.
Keep the viewing window at eye level. Direct the backside of the EZ Fill toward a brightly lit area when you fill the V-Go. This makes it easier to see the flow of insulin. Seeing the flow of insulin helps you fill the V-Go properly and completely.

Plunger

    B. Slowly pull the plunger up to its full upright position with your free hand and wait 5 seconds.

IMPORTANT: Make sure you slowly pull the plunger up as far as it can go.

Viewing Window

    C. Make sure the viewing window is at eye level so you can watch the V-Go fill with insulin.

Insulin Vial and Insulin Vial Holder

    D. Slowly and steadily push the plunger down over a minimum of 25 seconds to fill the V-Go™ with insulin.
    • The V-Go should be filled with insulin in a continuous flow of droplets, not in a solid, steady stream. Make sure you don't fill the V-Go with a steady stream of insulin. If you push too fast or too hard the insulin will become foamy. Foamy insulin may lead to an incomplete fill. If the insulin turns foamy, push the plunger more slowly.

IMPORTANT: Watch the insulin fill the V-Go to make sure you get a complete fill.

    E. Push the plunger until it is all the way down.
    • When the position of the plunger is all the way down, the V-Go should be full.

IMPORTANT: Make sure the V-Go fills with insulin in a continuous flow of droplets, not in a solid, steady stream. Make sure the insulin is not foamy. Foam will not damage the V-Go or the insulin, but may lead to an incomplete fill of the V-Go.
Count to about 25 seconds when you push the plunger down to make sure the V-Go is filled with insulin.

    F. Check that the V-Go is filled properly. Ideally you should see only fluid and no air space. You may see tiny air bubbles smaller than a grain of rice.
    • If the V-Go is not filled fully, check to see if you still have insulin in your vial.
      • – If you do not, replace vial (Step 3) and repeat Step 4A to 4F.
      • – If you do, repeat Step 4A to 4F.

IMPORTANT: Make sure the V-Go is completely full of insulin before removing from the EZ Fill. If the V-Go does not appear completely full, repeat Step 4A to 4F.

Step 5: Remove the V-Go from the EZ Fill

EZ Fill

EZ Fill

REMINDER: Fill only one (1) V-Go each day. Fill the V-Go on the day you use it, and attach the V-Go to your skin immediately after filling it with insulin.

EZ Fill

Step 6: Store the EZ Fill and unfilled V-Go™ devices after each day's V-Go filling session

EZ Fill

EZ Fill

NOTE: Do not remove the insulin vial from the EZ Fill. The insulin vial should be removed only when the vial is empty.

IMPORTANT: To make sure the EZ Fill remains sterile:
  • Replace the plug after each fill.
  • Wipe the circular opening on top of the plug with an alcohol swab before placing the plug back into the EZ Fill.

    B. Store the EZ Fill with the insulin vial and plug attached in a clean, dry area of the refrigerator between each fill. Store unfilled, unused V-Go devices in a dry, safe place until your next fill. Please refer to Section 4 for additional storage information.

Additional Steps

Step 7: Remove an empty vial of insulin from the insulin vial holder and place a new vial of insulin into the insulin vial holder

NOTE: Before placing a new vial into the EZ Fill, check to make sure the insulin vial is not expired and that it will not expire during the time period that the vial will be used in the EZ Fill.

EZ Fill

    A. Grasp the vial along the finger and thumb grooves. Pull up the vial to remove it from the EZ Fill.

EZ Fill

    B. To place a new vial of insulin into the EZ Fill, follow filling Step 3A to 3E.

Step 8: Dispose of the EZ Fill

EZ Fill

IMPORTANT: The EZ Fill is only intended to fill a 30-day supply of V-Go devices (1 V-Go per day). A new EZ Fill will be provided with each monthly prescription of the V-Go.
Do not use the same EZ Fill for more than 30 fills.

SECTION 2 (Part 3): APPLYING AND USING THE V-Go™

Step 1: Inspect the V-Go before you attach it to your body

Viewing Window

IMPORTANT: If you see air bubbles larger than a grain of rice, the V-Go may not be filled completely. Repeat Step 4A to 4F in Section 2 (Part 2) to ensure a complete fill.
Having a few small bubbles is normal and harmless.
As discussed in Section 2 (Part 2), you should slowly and steadily push the plunger down for about 25 seconds to reduce air bubbles as you fill the V-Go.

    C. When the insulin is full in the viewing window, you are ready to attach the V-Go to your body.

IMPORTANT: To receive your total 24-hour dose of insulin, always start with a V-Go that has been completely filled with insulin.
Do not attach a partially filled or empty V-Go to your body. If the V-Go is not filled completely with insulin, repeat Step 4A to 4F in Section 2 (Part 2).

Step 2: Wash your hands

Always wash your hands thoroughly before preparing the V-Go for use. Use aseptic technique when you are preparing and applying a new V-Go. See the end of Section 2 (Part 1) for a description of aseptic technique.

Step 3: Select and prepare the infusion site

IMPORTANT: The place on your body where you attach the V-Go is important for the success of your therapy. Choose a location that remains flat when you are sitting down, standing up, or lying down. Discuss the best location for you with your doctor or healthcare professional.

Abdomen

Backside of the Arm

    A. The V-Go can be worn any place that insulin can be injected or infused. Insulin is injected or infused into the subcutaneous tissue.
    • You may wish to attach the V-Go:
    • – On the abdomen. The abdomen has ample flat surface area, and is an accessible and comfortable location. Insulin absorption is fast, predictable, and less affected by exercise when administered through the abdomen.
      • If the V-Go is worn on the abdomen, keep it horizontal above the belt line.
    • – On the backside of the arm, not on the muscle.
      • If the V-Go is worn on the backside of the arm, keep it in the up and down direction. Make sure you can see the grey indicator in the viewing window directly by rotating your arm, or indirectly through the use of a mirror. Attach the V-Go in the up and down position as your arm hangs down.
B. When choosing the location for the V-Go™, consider the following:
  • Make sure you are able to view the grey indicator in the viewing window, either directly or indirectly through the use of a mirror.
  • That you can comfortably reach the V-Go and all of the buttons, for easy operation and removal.
  • That you apply the V-Go to a flat area of skin, not on a fold of the skin, muscle, or bone.
  • That the site is flat when you are in any of the following positions: sitting down, standing up, or lying down.

Avoid Beltline or Waistline

    C. When choosing the location for the V-Go, avoid the following:
    • The belt line or waistline, or other areas where clothing may rub or constrict.
    • Areas with excessive hair. You may shave the area to help the V-Go attach to your skin.
    • Areas that are curved or rigid due to muscle or bone.
    • Areas within a 1-inch circle around the belly button or surgical scars.
    • Skin that is tender, bruised, red, or hard or has any skin disease or infection.

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

NOTE: Change the location of the V-Go slightly every 24 hours. Needle insertion sites should be at least 1 inch away from the last site.
This may mean moving it from the right to the left side of the abdomen. It does not require attaching the V-Go on the abdomen one day then on the arm the next.

Clean area with alcohol swab

    D. Clean the area where you will attach the V-Go with an alcohol swab.
    • The alcohol swab will remove all lotions and oils. Let the area dry. This helps the adhesive stick properly to the skin.
    • Practice aseptic technique as described in Section 2 (Part 1).

Step 4: Attach the V-Go

Actions in this step describe how to attach the V-Go to your abdomen. As noted in Section 2 (Part 3) Step 3, there are a couple of places you can attach the V-Go.

Now you are ready to attach the V-Go.

IMPORTANT: Be careful not to press any buttons when you practice attaching the V-Go.

Button Cover

    B. Remove the button cover.
      1. Hold the V-Go™ with one hand and pull the button cover with the other hand. Pull the button cover in a quick, straight direction up and away from the V-Go.

Cover Pin

    2. Check to see if the cover pin came off with the button cover.
    • If the cover pin is not attached and has remained inside the V-Go, try to remove the pin manually; otherwise discard this V-Go and start over with a new V-Go.

IMPORTANT: If you bend the button cover backwards, as you would a soda pop can top, you could damage the V-Go.

Adhesive Tab

    C. Lift the adhesive tab and completely peel off the adhesive liner from the bottom of the V-Go. Removing the liner exposes the adhesive.
      1. Do not touch the adhesive surface. Touching the adhesive surface can reduce the strength of the adhesive.
      2. Keep the adhesive pad intact and clean before you place it on the infusion site.

Hold in Place

    D. Without touching the adhesive pad, press the V-Go against the skin at the cleaned needle infusion site.
    E. Hold the V-Go in place for 5-10 seconds. Run your finger around the entire edge of the adhesive pad to make sure it is attached to your body. Do not accidentally press any of the buttons.

NOTE: When you apply the V-Go to the abdomen, attach the V-Go horizontally at a slight downward angle. This allows any tiny air bubbles to travel away from the needle.

Step 5: Start the 24-hour flow of insulin with the V-Go

Press down on raised bump

Locked Needle Button

Press down on the raised bump of the needle button with one firm quick motion. Needle button needs to be pressed completely into the V-Go until you hear a click or button locks in place. This begins the flow of insulin. The V-Go delivers a continuous preset basal rate of insulin over 24 hours.

NOTE: Grasp the side of the V-Go as you press the raised bump of the needle button to keep the V-Go in place.
Be careful not to press any other buttons during this process.

IMPORTANT: Needle button must lock in place to begin the flow of insulin.

IMPORTANT: Avoid exposing the V-Go™ to direct sunlight. Avoid extremely hot temperatures. Remove the V-Go prior to hot tub, whirlpool, or sauna use and replace with a new filled V-Go afterward.

IMPORTANT: If the needle button does not fully depress or does not remain in the down position, the V-Go cannot function. You will not receive the preset basal rate of insulin. Do not use the V-Go if the needle button does not stay down. Remove and discard that V-Go. Start over with a new V-Go.
Once the needle button is pushed down and locks into place, insulin is now flowing into your body. The needle within the V-Go remains in your body for the entire 24-hour use of the V-Go. The V-Go design helps to minimize discomfort.

IMPORTANT: Stop all your previous insulin injections and do not use any other insulin in conjunction with the V-Go Disposable Insulin Delivery Device.

NOTE: You should check the area around the V-Go at regular intervals for redness, irritation, and inflammation.

Step 6: Bolus dose with the V-Go at mealtimes

Your doctor or healthcare professional should have instructed you on how and when to use the V-Go and how many bolus doses to administer at mealtimes. Consult your doctor or healthcare professional if you have questions regarding your specific bolus dosing needs.

IMPORTANT: Each V-Go has a total of 36 Units of insulin available for on-demand bolus dosing per 24-hour period. The 36 Units of insulin can only be delivered in 2-Unit increments (1 push = 2 Units). You can only push the bolus delivery button 18 times in every 24-hour period. After 18 uses, the bolus delivery button will pop out and lock, preventing further bolus doses. Plan your day so that you have enough insulin for each meal.

Slide with pressure

Pop out

    A. To administer 2 Units of insulin at mealtime:
      1. Slide your finger with pressure to locate and press the bolus ready button on the long edge of the V-Go.
      • The bolus delivery button located at the end of the V-Go will pop out. You will hear a click.

Needle Release Button

    2. Push the bolus delivery button all the way into the V-Go until it stops. You will hear another click.
    • You have just delivered 2 Units of insulin (1 push = 2 Units).

IMPORTANT: Do not touch the needle release button (button with ridges) while giving yourself bolus doses. This may cause you to retract the needle before the end of its 24-hour use and stop the delivery of insulin to your body. If this occurs and the needle button pops out, remove the V-Go and replace it with a new one.

    B. Repeat Step 6A until you reach the number of bolus doses prescribed by your doctor or healthcare professional for that specified time.

NOTE: Each push of the bolus delivery button delivers 2 Units of insulin (1 push = 2 Units).

IMPORTANT: If you do not know the number of insulin units you have just delivered or if you lose count, STOP bolus dosing, monitor your blood glucose, and follow the plan agreed upon with your doctor or healthcare professional. If you have not agreed upon a plan already, consult your doctor or healthcare professional for guidance.

IMPORTANT: 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 available bolus doses. If you require additional bolus doses, do not continue to use this V-Go™. Replace it with a new filled V-Go.

Step 7: Monitor V-Go progress

Grey Indicator

IMPORTANT: The indicator moves very slowly over the 24-hour period. It will take time to notice the change in the indicator location.
Monitoring the V-Go progress is important to make sure the V-Go is delivering insulin. If the indicator does not appear to be moving after several hours of wearing the V-Go, consider checking your blood glucose levels. If your levels are abnormally high after normal V-Go use as prescribed by your doctor or healthcare professional, you should remove the V-Go and replace it with a new one.

Step 8: Remove the V-Go

IMPORTANT: After 24 hours of use it is time to replace the current V-Go with a new filled V-Go. Remember to fill the V-Go with insulin using the EZ Fill, and attach the V-Go to your skin immediately after filling.
The V-Go is meant to be worn for 24 hours only. Establishing a daily routine will help remind you to change the V-Go every 24 hours.

    A. Start by filling a new V-Go with insulin. Follow previous instructions in Section 2 (Part 2) Steps 1 to 6.
    • Make sure the V-Go is completely filled with insulin before you attach.
    B. Set the new filled V-Go aside until you remove the used V-Go from your skin.

NOTE: Do not block the needle button with your finger or any part of your hand or clothing while releasing the needle via the needle release button.

Slide

Press

    C. To remove the used V-Go™, place thumb on the ridged section of the needle release button. Slide the needle release button along the side of the V-Go. In a continuous motion, press the needle release button directly into the V-Go until you hear a click. This motion retracts the needle.

Pop Out

    D. At this point the needle button will pop out automatically.

Lift

    E. To remove the V-Go from your skin, run a finger under an edge of the adhesive pad.

Peel

    F. Press lightly on the skin adjacent to the V-Go with one hand and peel the V-Go away from your skin with the other hand.

NOTE: After you remove the V-Go, the adhesive may leave behind a sticky residue. Use warm soapy water and roll your finger around the attachment site. This motion will remove the sticky adhesive residue.
You could use a medical adhesive remover instead. Ask your doctor or healthcare professional to recommend an adhesive remover.

Step 9: Dispose of the V-Go

Discard the used V-Go according to local disposal requirements.

Discard

NOTE: When used as directed, the V-Go needle is never exposed. It comes out only when the device is attached to the skin. After use, the needle is retracted back into the V-Go and locked. Once retracted, the V-Go needle is completely contained/covered.
Check to make sure the needle is retracted. If it is not, repeat Step 8C prior to disposal of the V-Go.

SECTION 3: V-Go™ SAFETY INFORMATION

The V-Go is a safe and reliable device. As with many medical devices, you must be aware of safety-related issues to make sure that you are using the V-Go correctly. Always consult with your doctor or healthcare professional if you have any questions regarding the functions and operation of the 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 Disposable 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 Disposable 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 Disposable 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 U100 fast-acting insulin should be used with the 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 Disposable Insulin Delivery Device.

Before using different insulin with the 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 the 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 the V-Go may result in hypoglycemia.

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

If you have a medical emergency while using the 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™ Disposable Insulin Delivery Device.

The V-Go is magnetic resonance (MR) unsafe.

You should remove the 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 the 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 the 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 the V-Go to direct sunlight.

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

You should check that the V-Go is securely in place during and after periods of increased physical activity. Check that the 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). The V-Go can go under water and will continue to work safely.

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

    1. Never use insulin that appears cloudy. Cloudy insulin may be inactive. Do not use cloudy insulin with the 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 the 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 the V-Go. See Section 2 (Part 3) Step 3. 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 the 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 the V-Go to sites that may interfere with your clothing, accessories, or car seatbelts.
    8. Do not attach the 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 the 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 sugar) 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 the V-Go is not delivering insulin, refer to the Troubleshooting section of this manual on page 41.
    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) can minimize infections. Remove the 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. 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 the V-Go or by the way the 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.

SECTION 4: PRODUCT SPECIFICATIONS

EZ Fill
Storage Conditions –
Unused Device Only		-4°F (-20°C) to +140°F (+60°C)
20% to 90% relative humidity
Operating Conditions+40°F (+5°C) to +99°F (+37°C)
20% to 90% relative humidity
Warm to room temperature to optimize fill quality
InsulinEach time before placing a new vial into the EZ Fill, check to make sure the insulin vial is not expired and that it will not expire during the time period that the vial will be used in the EZ Fill
Duration of Use30 fills
DisposalLocal disposal requirements
V-Go™
Basal Delivery,
Continuous Subcutaneous		20 Units/24 hr (0.83 U/hr)
30 Units/24 hr (1.25 U/hr)
40 Units/24 hr (1.67 U/hr)
Bolus Delivery, On-DemandEach push of the bolus delivery button provides 2 Units
Each V-Go contains 18 uses for a maximum of 36 Units per V-Go
V-Go Minimum Capacity Reservoir0.56 mL V-Go 20
0.66 mL V-Go 30
0.76 mL V-Go 40
V-Go Size2.4 x 1.3 x 0.5 inches
(6.1 cm x 3.3 cm x 1.3 cm)
V-Go Weight0.7 to 1.8 ounces
(20 to 50 grams)
Storage Conditions –
Device Only		+10°F (-12°C) to +140°F (+60°C)
20% to 90% relative humidity
Avoid prolonged exposure to the extremes of the storage temperature range
Storage Conditions –
Filled with Humalog®		The V-Go may be filled with Humalog for up to 24 hours prior to use if refrigerated or if left at room temperature
Storage Conditions –
Filled with NovoLog®		The V-Go may be filled with NovoLog for up to 5 days prior to use if refrigerated
The V-Go may be filled with NovoLog for up to 3 days prior to use if left at room temperature
Operating Conditions+40°F (+5°C) to +99°F (+37°C)
20% to 90% relative humidity
Do not expose the V-Go to temperatures over 99°F for prolonged periods of time (beyond 14 hours) as this may lead to degradation of the insulin (check the insulin manufacturer's instructions for use for temperature details) and may cause the V-Go to run at a basal rate slightly greater than the specified range
Operating Atmospheric Pressure697 hPa to 1,013 hPa
(Equivalent to altitudes up to 10,000 feet [3,048 meters])
Duration of Use24 hr
Bolus Delivery Accuracy
(For all 3 V-Go options)		+/-10%
Basal Delivery Accuracy
(For all 3 V-Go options)		+/-10%
V-Go Power SourceMechanical
Enclosure ProtectionProtects against the effects of submersion at depths up to 3 feet, 3 inches (1 meter) for 24 hours.
(IPX8)
Needle4.6-mm, 30-gauge needle with sharps injury prevention features and floating needle technology
DisposalLocal disposal requirements

Delivery Accuracy Test Results

The following graphs show the basal flow rate accuracy for all 3 V-Go™ options (20/30/40) for the given time periods.

The bolus accuracy is +/-10% for all 3 V-Go options.

Flow Rate Start-up Graphs

V-Go 20/Day - Start-up Graph

V-Go 30/Day - Start-up Graph

V-Go 40/Day - Start-up Graph

Flow Rate Test Period Graphs

V-Go 20/Day - Trumpet Curve

V-Go 30/Day - Trumpet Curve

V-Go 40/Day - Trumpet Curve

SECTION 5: V-Go™ USER ASSISTANCE INFORMATION

Valeritas Customer Care

You may have questions or concerns when you use a new product. Please contact us for advice or assistance. A trained staff member will help you with any questions on how to fill, apply, or use the V-Go.

For specific treatment questions, information on insulin, or medical advice, call your doctor or healthcare professional.

If you have any questions regarding the operation of the V-Go or EZ Fill, speak to a Valeritas Customer Care Representative 24/7 at 1-866-881-1209.

Customers can visit the Valeritas website (www.valeritas.com) for additional information about disposable insulin delivery with the V-Go.

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

SECTION 6: TROUBLESHOOTING/FREQUENTLY ASKED QUESTIONS

How do I know how much insulin to put into the V-Go?

You always fill the V-Go completely. The V-Go comes in 3 options and your doctor or healthcare professional will select the option you need.

Why does insulin leak from the EZ Fill?

Check to make sure a V-Go is placed in the EZ Fill before a new insulin vial is placed into the insulin vial holder. This may reduce any insulin leak that can happen when extra pressure is built up in the vial upon initial puncture. Also, make sure the plug is properly inserted into the EZ Fill between fills.

It looks like the V-Go has not filled completely.

There are 5 reasons the V-Go may not fill completely:

In any of these situations follow Step 4A to 4F to make sure you have a complete fill.

I am looking in the viewing window while pushing the plunger down, but I don’t see the V-Go™ filling.

There are 2 reasons you may not see any insulin fill the V-Go.

If there is insulin in the vial and the drawer is completely shut, try to fill a new V-Go. If you are unable to fill a new V-Go, speak to a Valeritas Customer Care Representative at 1-866-881-1209.

There are bubbles in the insulin vial.

The most common reason for bubbles in the insulin vial is filling more than 1 V-Go at a time. The EZ Fill is designed to fill only 1 V-Go per day.

It is harder to push the plunger when it gets closer to the downward position.

This is normal. When the V-Go is full or close to full, you should expect to push a little harder. You may need a little extra pressure to push the plunger completely down.

What happens if I do not pull the plunger completely up when I fill the V-Go?

If the plunger is pulled only part of the way up during the fill process, you will get only a partial fill of the V-Go. You will see air bubbles in the V-Go viewing window. Keep the V-Go in the EZ Fill drawer and slowly pull the plunger up completely again. Make sure the plunger is completely up. Slowly and steadily push the plunger back down over about 25 seconds until it is in the complete down position.

I tried to pull the plunger up and it snapped back down. What should I do?

Try slowly pulling the plunger up again, but count the full 5 seconds before releasing or reversing the direction of the plunger. The plunger snaps back down if you try to pull the plunger up and release it in less than 5 seconds.

After I place the V-Go into the EZ Fill drawer, what happens if the plunger is already in the up position?

You can still fill the V-Go. Hold the EZ Fill upwards and slowly and steadily push the plunger down over about 25 seconds until it is in the complete down position. As you push the plunger down, check to make sure insulin enters the V-Go. Repeat the plunger cycle if no insulin entered the V-Go or if additional insulin is required to fill the V-Go. See Section 2 (Part 2) Step 4A to 4F.

I did not apply the V-Go directly after filling. Do I have to throw it away?

It is preferable to apply the V-Go immediately after filling. However, refer to the V-Go storage conditions in Section 4 and the specific insulin’s storage conditions for more information.

I believe an item is missing or appears to be damaged.

If you suspect an item is damaged, do not use the damaged piece. Replace this with a new one (V-Go or EZ Fill). EZ Fill replacements can be requested from a Valeritas Customer Care Representative at 1-866-881-1209.

I believe I have broken the EZ Fill. How do I get another one to fill the V-Go™?

EZ Fill replacements can be requested from a Valeritas Customer Care Representative at 1-866-881-1209. You will be asked to return the unusable EZ Fill. Valeritas Customer Care will provide you with further details.

The inner package for the V-Go is torn or damaged.

If you suspect the package containing the V-Go has been torn or damaged, do not use this V-Go. Replace with a new V-Go.

After I removed the button cover, the cover pin was not attached to the button cover and is still inside the V-Go.

If the cover pin is inside the V-Go, the V-Go will not work correctly. Try to remove the pin manually; otherwise discard this V-Go and start over with a new V-Go.

It is difficult to press down on the needle button.

Be sure you are pressing the raised bump of the needle button. If the needle button does not move when pressed, the needle button may have already been activated. Do not use this V-Go. Replace with a new V-Go.

The needle button will not stay in the down position.

The needle button must be pressed down fully to be locked into place. If you cannot get the button to stay down, do not use this V-Go. Replace with a new V-Go.

The V-Go won’t remain securely attached to my skin for the duration of use, which sometimes causes poking of the needle.

If the V-Go will not remain secure, replace with a new V-Go.

When replacing the V-Go, please review Section 2 (Part 3) Step 3A to 3D.

Do not touch the adhesive pad before you attach the V-Go to your skin. Thoroughly clean the site with an alcohol swab. Let the site dry before attaching the V-Go. Many lotions and ointments may keep the V-Go from sticking to your skin.

Be sure that you have properly attached the V-Go to a flat surface on your body.

If the site is covered with hair, this could also affect whether the V-Go sticks. You may shave the area to help the V-Go attach to your skin.

When I went to give myself a bolus dose of insulin, the bolus delivery button was already popped out.

If the bolus delivery button was already popped out, the bolus ready button was already activated. Press the bolus delivery button to deliver 2 Units of insulin when the next bolus dose is needed.

The bolus delivery button will not pop out.

First check that you are pressing the bolus ready button fully. If the bolus delivery button fails to pop out after you activate the bolus ready button, you have used all of the available insulin for bolus dosing (36 Units or 18 uses per 24 hours). Replace this V-Go with a new V-Go before your next meal. Plan your day so that you have enough insulin for each meal.

What should I do if I forget the number of Units I have delivered when bolus dosing or if I forget to take a bolus dose?

Follow the plan you created with your doctor or healthcare professional for such situations. If you have not created a plan already, consult your doctor or healthcare professional for guidance.

The area of skin around the V-Go is red and sore to the touch.

Skin may be irritated by the adhesive pad on the V-Go. There are a number of skin barrier products available to help prevent irritation and treat sensitivity problems. Contact your doctor or healthcare professional for specific products and recommendations.

Infections at the site may also occur. If you experience redness, irritation, or inflammation around the V-Go (specifically the end closest to the needle), immediately replace the V-Go with a new V-Go on a new body site. Contact your doctor or healthcare professional for the best way to treat infection and irritation, especially if the inflamed site appears bigger than a dime.

I dropped the V-Go™.

Check to see if there is any damage to the V-Go. If you suspect that the V-Go was damaged or became dirty as a result of the fall, do not use this one. Replace with a new V-Go.

I dropped the EZ Fill.

Check to see if there is any damage to the EZ Fill or the insulin vial, if it was attached. If the insulin vial came out of the EZ Fill, wipe the top of the vial with an alcohol swab and watch closely for leaks when you place the vial back into the EZ Fill. If insulin is leaking, replace the insulin vial with a new one. If you suspect that the EZ Fill was damaged, speak to a Valeritas Customer Care Representative at 1-866-881-1209.

The V-Go was exposed to water. Is this a problem?

The V-Go can go under water up to 3 feet, 3 inches (1 meter), and will continue to work safely. You should check to see that it stays in place. Depending on the cleanliness of the water, you may be at an increased risk for an infection at the needle infusion site.

Can I swim, scuba dive, shower, or bathe while wearing the V-Go?

The V-Go has been successfully tested in water to depths of 3 feet, 3 inches (1 meter) for 24 hours, and therefore can be worn during normal daily activities, such as showering and bathing as well as activities near the surface of the water, such as swimming.

The V-Go has not been tested and therefore should not be used in the following conditions:

Remove the V-Go prior to scuba diving, hot tub use, or whirlpool use, and replace with a new filled V-Go afterward.

Can I wear the V-Go for longer than 24 hours – for example, if I sleep an extra hour on the weekend?

The V-Go has been designed for 24-hour wear. You should change it at the same time each day. After 24 hours, the V-Go may no longer deliver a continuous preset basal rate of insulin.

How do I travel with the V-Go?

Use the same precautions that you would when traveling with other insulin supplies. Speak with your doctor or healthcare professional about extra precautions you may need to take while traveling.

When traveling with the EZ Fill, with an insulin vial attached, it should be refrigerated at all times. Empty V-Go devices do not require refrigeration. They should be stored according to the storage conditions in Section 4. For information on storing filled V-Go devices refer to the V-Go storage conditions in Section 4.

Can I wear the V-Go on an airplane?

Yes, the V-Go can safely be worn on an airplane.

Should I wear the V-Go to bed?

Yes, you should wear the V-Go for a full 24 hours, even while you sleep.

The needle will not retract back into the V-Go.

Try to slide and press the needle release button again. See Section 2 (Part 3) Step 8C. If the needle still will not retract into the V-Go, dispose of the V-Go in a sharps container.

SECTION 7: GLOSSARY AND PACKAGING SYMBOLS

Aseptic technique: This process helps keep the V-Go™ and EZ Fill devices clean during preparation, filling, and application. Following this technique requires handwashing and wiping the application site with an alcohol swab. It may involve wiping the V-Go device with an alcohol swab if the device comes into contact with anything else.

Basal rate: The basal rate is the amount of insulin delivered at a preset rate by the V-Go over 24 hours. Your basal rate is the amount of insulin required to maintain your target glucose values when you are not eating. Basal rate may also be referred to as background, continuous, or long-acting insulin.

Blood glucose levels: Blood glucose levels are the measure of how much sugar is in the blood.

Bolus: A bolus is an amount of insulin delivered at one time. A bolus is usually taken before a meal to cover your body's insulin needs. A bolus of insulin can also be taken when blood glucose levels are abnormally high. Bolus may also be referred to as mealtime, prandial, short-acting, or rapid-acting insulin.

Diabetes mellitus: Diabetes is a disease in which the body cannot maintain its own healthy blood glucose levels. Either the body cannot produce enough insulin or the body cannot properly use insulin. There are two main types of diabetes:

Diabetic ketoacidosis (DKA): DKA occurs when the blood glucose level is elevated and the insulin level is low. The body does not have enough insulin to help the glucose enter the cells. Glucose in the cells is used for energy. During this situation, the body begins to burn muscle and fat for energy. A waste product of fat burning is ketones. Ketones accumulate in the blood and are passed through the urine and lungs. This condition can be identified by urine and/or blood tests. DKA usually requires hospitalization and can lead to a life-threatening situation if not promptly treated.

Glucose: Glucose, a sugar, is a main way the body takes in carbohydrates. Glucose is the body’s most important source of energy. It is produced from digested food, by the normal action of the liver. Glucose is carried by the blood throughout the body.

Hyperglycemia: Hyperglycemia or high blood sugar occurs when blood glucose levels rise above normal (approximately 250 mg/dL). Hyperglycemia is the result of the body not having enough insulin or not being able to use insulin to process glucose.

Hypoglycemia: Hypoglycemia or low blood sugar occurs when blood glucose levels drop below normal (approximately 70 mg/dL). Hypoglycemia may result from too much insulin and/or exercising more than usual.

Infusion site: The infusion site is the place on the body where the V-Go is attached, specifically the end of the V-Go where the needle is inserted under the skin.

Insulin: Insulin is a hormone produced by the pancreas. Insulin is needed by the body to regulate the production and use of glucose.

Ketones: Ketones, or ketone bodies, are substances produced by normal liver activity, and used by muscle tissue. When blood glucose levels are elevated, the body's normal process is unbalanced and ketones can accumulate in the blood, pass through the urine, and ultimately result in diabetic ketoacidosis (DKA).

Subcutaneous: Subcutaneous means beneath the layer of the skin. The V-Go infusion needle delivers insulin subcutaneously. Subcutaneous injections are not the same thing as intravenous (IV) or intramuscular (IM) injections.

Packaging Symbols

Rx Only Rx Only

Store At Store at

Unless opened or damaged, contents are sterile Unless opened or damaged, contents are sterile

Do not reuse Do not reuse

Dispose of after 30 fills Dispose of after 30 fills

Use by Use by

Before using contents, read the Instructions for Patient Use Before using contents, read the Instructions for Patient Use

Lot code Lot code

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

V-Go
DISPOSABLE INSULIN DELIVERY
www.go-vgo.com

valeritas
www.valeritas.com

ART-037 Rev: H
09/2011
© 2011 Valeritas, Inc.

  • V-Go 20 Commercial Kit

    8560-9400-03

    V-Go™
    DISPOSABLE INSULIN DELIVERY

    20

    Kit Contents:

    Insulin is not included in this kit.

    Dispense as one (1) kit. Do not break apart.

    PHARMACIST

    Dispense two (2) vials of fast-acting insulin2 with the V-Go 20
    Patient counseling materials included in kit

    1-866-881-1209
    www.go-vgo.com

    valeritas

    V-Go 20 Commercial Kit
  • 2 See Instructions for Patient Use (Section 3) for insulins tested with the V-Go
  • V-Go 30 Commercial Kit

    8560-9400-02

    V-Go™
    DISPOSABLE INSULIN DELIVERY

    30

    Kit Contents:

    Insulin is not included in this kit.

    Dispense as one (1) kit. Do not break apart.

    PHARMACIST

    Dispense three (3) vials of fast-acting insulin3 with the V-Go 30
    Patient counseling materials included in kit

    1-866-881-1209
    www.go-vgo.com

    valeritas

    V-Go 30 Commercial Kit
  • 3 See Instructions for Patient Use (Section 3) for insulins tested with the V-Go
  • V-Go 40 Commercial Kit

    8560-9400-01

    V-Go™
    DISPOSABLE INSULIN DELIVERY

    40

    Kit Contents:

    Insulin is not included in this kit.

    Dispense as one (1) kit. Do not break apart.

    PHARMACIST

    Dispense three (3) vials of fast-acting insulin4 with the V-Go 40
    Patient counseling materials included in kit

    1-866-881-1209
    www.go-vgo.com

    valeritas

    V-Go 40 Commercial Kit
  • 4 See Instructions for Patient Use (Section 3) for insulins tested with the V-Go
  • INGREDIENTS AND APPEARANCE
    V-GO DISPOSABLE INSULIN DELIVERY DEVICE 
    pump, infusion, insulin
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:8560-9400
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:8560-9400-0330 in 1 BOX
    2NHRIC:8560-9400-0230 in 1 BOX
    3NHRIC:8560-9400-0130 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK10050402/06/2012
    Labeler - Valeritas, Inc (786236781)
    • © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.