CONTENTS

Section 1 (Part 1): Introduction and V-Go Overview
    Healthcare professional prescribing considerations
    Valeritas customer care
    Liability disclaimer

Section 1 (Part 2): Before You Begin

Section 2 (Part 1): V-Go Operating Instructions
    V-Go product overview
    EZ Fill product overview
    Aseptic technique

Section 2 (Part 2): Filling the V-Go with Insulin Using the EZ Fill
    Step 1: Remove the plug from the EZ Fill drawer
    Step 2: Place the V-Go into the EZ Fill
    Step 3: Place the insulin vial into the EZ Fill insulin vial holder
    Step 4: Fill the V-Go with insulin
    Step 5: Remove the V-Go from the EZ Fill
    Step 6: Store the EZ Fill and unfilled V-Go devices after each day's V-Go filling session
    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
    Step 8: Dispose of the EZ Fill

Section 2 (Part 3): Applying and Using the V-Go
    Step 1: Inspect the V-Go before you attach it to your body
    Step 2: Wash your hands
    Step 3: Select and prepare the infusion site
    Step 4: Attach the V-Go
    Step 5: Start the 24-hour flow of insulin with the V-Go
    Step 6: Bolus dose with the V-Go at mealtimes
    Step 7: Monitor V-Go progress
    Step 8: Remove the V-Go
    Step 9: Dispose of the V-Go

Section 3: V-Go Safety Information
    Caution
    Indication
    Healthcare professional dosing considerations
    Warnings
    Precautions
    Adverse reactions

Section 4: Product Specifications
    EZ Fill
    V-Go
    Delivery accuracy test results

Section 5: V-Go User Assistance Information

Section 6: Troubleshooting/Frequently Asked Questions

Section 7: Glossary and Packaging Symbols

The V-Go Disposable Insulin Delivery Device should be used only by people who have been prescribed the device, and only for intended use.

Terms in bold and italic are explained in the glossary.

SECTION 1 (Part 1): INTRODUCTION AND V-Go™ OVERVIEW

The V-Go provides a continuous subcutaneous insulin infusion over 24 hours. It uses a preset basal rate for between-meal and nighttime insulin. The V-Go provides on-demand bolus dosing to cover glucose intake at meals. The V-Go device is convenient and easy to operate (see Section 3 for indication).

Here is how to use the V-Go:

• Fill the V-Go with insulin using the EZ Fill
• Attach the V-Go to a selected site (skin area)
• Push in the needle button to deliver the preset basal rate
• Wear the V-Go for one (1) 24-hour period
• Bolus dose at meals as prescribed by your doctor or healthcare professional
• At the end of the 24-hour period, retract the needle and remove the V-Go from your body
• Discard the device after use (the V-Go is 100% disposable)
• Repeat these steps for the next 24-hour period using a new V-Go

SECTION 1 (Part 2): BEFORE YOU BEGIN

Step 1: Remove the EZ Fill from the blister packaging

A.

Turn the packaging over so you can read the text.

B.

Peel back on the lower right corner.

C.

Remove the EZ Fill.

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

A.

Turn the packaging over so you can read the text.

B.

Peel back on the lower left corner on one of the V-Go containers.

C.

Remove the V-Go. Do not pull on the adhesive tab while removing the V-Go from the container.

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

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

SECTION 2 (Part 3): APPLYING AND USING 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.

SECTION 4: PRODUCT SPECIFICATIONS

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:

1.

The insulin vial is not completely pushed down into the insulin vial holder.

• If this is the case, push the vial firmly straight down into the insulin vial holder until you feel it attach and cannot push it further.

2.

You have run out of insulin in your vial. You have to switch vials before you can fill the rest of the V-Go.

• If this is the case, keep the V-Go in the EZ Fill drawer. Remove the insulin vial from the EZ Fill insulin vial holder, replace with a new vial, and refill the V-Go.

3.

You did not completely pull the plunger to its full upright position.

• If this is the case, slowly pull the plunger up completely and repeat the filling process for the V-Go.

4.

You have pushed down the plunger too quickly, which turned the insulin foamy. The foam could become an air bubble larger than a grain of rice.

• If this is the case, the EZ Fill cannot correct this error at this time. Set the V-Go aside for use on the next day and start over with a new V-Go.

  –

  The V-Go with the foamy insulin should be stored with the insulin port up. Before using this V-Go, refill it completely with insulin. See Section 2 (Part 2) Step 4A to 4F. Refer to the V-Go storage conditions in Section 4.

5.

The EZ Fill drawer may not be completely closed.

• If this is the case, check again to ensure the drawer is pushed all the way closed.

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.

1.

You have run out of insulin in your vial. You have to switch vials before you can fill the rest of the V-Go.

• If this is the case, keep the V-Go in the EZ Fill drawer. Remove the insulin vial from the EZ Fill insulin vial holder, replace with a new vial, and refill the V-Go.

2.

You did not completely shut the EZ Fill drawer.

• Grip the ribbed drawer handle and push the drawer completely into the EZ Fill. The ribbed drawer handle should not stick out past the bottom of the EZ Fill.

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:

• Water activities below 3 feet, 3 inches (1 meter), such as scuba diving.
• Extremely hot water temperatures, such as hot tubs or whirlpools.

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:

 

Type 1 diabetes: In Type 1 diabetes, the body does not produce enough insulin. People with Type 1 diabetes must use insulin to regulate their blood glucose levels.

 

Type 2 diabetes: In Type 2 diabetes, the body does not produce enough insulin or use it properly. People with Type 2 diabetes can usually regulate their blood glucose levels by following an individual meal plan, exercising, and taking certain medicines, including insulin, if needed. It usually occurs in people 40 years or older.

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

Store at

Unless opened or damaged, contents are sterile

Do not reuse

Dispose of after 30 fills

Use by

Before using contents, read the Instructions for Patient Use

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.