BYETTA 10 micrograms injectable solution in a prefilled pen

Introduction

Package Leaflet: Information for the User

Byetta 5micrograms solution for injection in pre-filled pen

Byetta 10micrograms solution for injection in pre-filled pen

Exenatide

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or diabetes nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or diabetes nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Byetta and what is it used for
2. What you need to know before you use Byetta
3. How to use Byetta
4. Possible side effects
5. Storing Byetta
6. Contents of the pack and other information

1. What is Byetta and what is it used for

Byetta contains the active substance exenatide. It is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus (non-insulin dependent).

Byetta is used with other diabetes medicines, such as metformin, sulfonylureas, thiazolidinediones, and basal or long-acting insulin. Your doctor has prescribed Byetta as an additional medicine to help control your blood sugar. Continue with your exercise and diet plan.

You have diabetes because your body does not produce enough insulin to control your blood sugar levels or because your body cannot use insulin properly. The medicine in Byetta helps your body increase insulin production when your blood sugar is high.

2. What you need to know before you use Byetta

Do not use Byetta

• If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or diabetes nurse before starting Byetta about the following:

• Using this medicine in combination with a sulfonylurea, as you may have low blood sugar (hypoglycemia). Ask your doctor, pharmacist, or diabetes nurse if you are not sure if any of your other medicines contain a sulfonylurea.
• If you have type 1 diabetes or diabetic ketoacidosis (a dangerous condition that can occur in diabetes), as you should not use this medicine.
• How to inject this medicine. It should be injected under the skin and not into a vein or muscle.
• If you have severe problems with stomach emptying or digestion, as the use of this medicine is not recommended. The active ingredient in this medicine slows down stomach emptying, so food passes more slowly through your stomach.
• If you have ever had pancreatitis (inflammation of the pancreas) (see section 4).
• Tell your doctor if you lose weight too quickly (more than 1.5 kg per week), as it may cause problems such as gallstones.
• If you have severe kidney disease or are on dialysis, as the use of this medicine is not recommended. There is limited experience with this medicine in patients with kidney problems.

Byetta is not insulin, so it should not be used as a substitute for insulin.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as there is no experience with this medicine in this age group.

Using Byetta with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, especially:

• Medicines used to treat type 2 diabetes that work like Byetta (e.g., liraglutide and extended-release exenatide), as it is not recommended to use these medicines with Byetta.
• Blood-thinning medicines (anticoagulants), such as warfarin, as you may need extra monitoring of changes in your INR (a measure of blood clotting) when starting treatment with this medicine.

Ask your doctor if you need to change the time you take any tablets you are using, as this medicine slows down stomach emptying and may affect medicines that need to pass through the stomach quickly, such as:

• Enteric-coated tablets or capsules (e.g., medicines that reduce stomach acid) that should not stay in the stomach for too long may need to be taken 1 hour before or 4 hours after injecting this medicine.
• Some antibiotics may need to be taken 1 hour before injecting Byetta.
• For tablets that need to be taken with food, the best option may be to take them with a meal when you are not injecting this medicine.

Using Byetta with food

Use this medicine at any time within 60 minutes (1 hour) beforeyour meal. (See section 3 "How to use Byetta"). Do not usethis medicine aftera meal.

Pregnancy and breastfeeding

It is not known if this medicine can have harmful effects on the fetus. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as it should not be used during pregnancy.

It is not known if exenatide passes into breast milk. This medicine should not be used if you are breastfeeding.

Driving and using machines

If you use this medicine in combination with a sulfonylurea or insulin, you may have low blood sugar (hypoglycemia). Hypoglycemia can reduce your ability to concentrate. Please be aware of this possible problem in situations where you may put yourself and others at risk (e.g., driving a car or using machines).

Byetta contains metacresol.

Metacresol may cause allergic reactions.

Byetta contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use Byetta

Follow the instructions for administering this medicine exactly as told by your doctor, pharmacist, or diabetes nurse. If you are unsure, consult your doctor, pharmacist, or diabetes nurse again.

There are two concentrations of Byetta available: Byetta 5 micrograms and Byetta 10 micrograms. Your doctor may tell you to start treatment using Byetta 5 micrograms twice a day. After using Byetta 5 micrograms twice a day for 30 days, your doctor may increase your dose to Byetta 10 micrograms twice a day.

If you are over 70 years old or have kidney problems, you may take longer than 30 days to tolerate the 5 microgram dose of Byetta, so your doctor may not increase your dose.

An injection from your pre-filled pen will give you your dose. Do not change your dose unless your doctor tells you to.

You should inject this medicine at any time within 60 minutes (1 hour) beforeyour breakfast and dinner, or before your two main meals of the day, which should be at least 6 hours apart. Do not usethis medicine aftermeals.

You should inject this medicine under the skin (subcutaneously) in the upper leg (thigh), stomach area (abdomen), or upper arm. If you are using Byetta and insulin, you should inject them separately.

To establish your dose of Byetta, you do notneed to check your blood sugar levels daily. However, if you are also using a sulfonylurea or insulin, your doctor may tell you to check your blood sugar levels to adjust the dose of sulfonylurea or insulin. If you are receiving insulin, your doctor will tell you how to reduce your insulin dose and recommend that you monitor your blood sugar levels more frequently to avoid high blood sugar (hyperglycemia) and diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough insulin).

In the User Manual for the Pen that comes with this leaflet, you can find instructions on how to use the Byetta pen.

Your doctor or nurse should teach you how to inject Byetta before you use it for the first time.

Becton, Dickinson and Company needles are suitable for use with the Byetta pen. The needles for injection are not included.

Use a new needle for each injection and discard it after each use. This medicine is for you; never share the Byetta pen with others.

If you use more Byetta than you should

If you use more of this medicine than you should, talk to your doctor or go to a hospital immediately. Using too much of this medicine can cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).

If you forget to use Byetta

If you forget a dose of this medicine, skip that dose and give your next dose when it is due. Do notgive a double dose or increase the amount of your next dose to make up for the forgotten dose.

If you stop using Byetta

If you think you need to stop using this medicine, consult your doctor first. If you stop using this medicine, it may affect your blood sugar levels.

If you have any other questions about using this medicine, ask your doctor, pharmacist, or diabetes nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rarely (may affect up to 1 in 1,000 people), severe allergic reactions(anaphylaxis) have been reported.

You should talk to your doctor immediately if you get symptoms such as:

• Swelling of the face, tongue, or throat (angioedema)
• Rash, itching, and rapid swelling of the tissues of the neck, face, mouth, or throat
• Difficulty swallowing
• Hives and difficulty breathing

Cases of pancreatitis(inflammation of the pancreas) have been reported (frequency not known) in patients taking this medicine. Pancreatitis can be a serious and potentially life-threatening medical condition.

• Talk to your doctor if you have had pancreatitis, gallstones, alcoholism, or very high triglycerides. These medical conditions may increase the risk of pancreatitis or make it more likely to happen again, whether or not you are taking this medicine.

• Stop takingthis medicine and contact your doctor immediately if you have severe and persistentstomach pain, with or without vomiting, as you may have pancreatitis.

Very common side effects(may affect more than 1 in 10 people):

• nausea (nausea is the most common side effect when starting treatment with this medicine, but it decreases over time in most patients)
• vomiting
• diarrhea
• low blood sugar (hypoglycemia)

When using this medicine with another medicine that contains a sulfonylurea or insulin, low blood sugar (hypoglycemia) may occur very commonly. You may need to reduce the dose of your sulfonylurea or insulin while using this medicine. The signs and symptoms of low blood sugar can include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, rapid heartbeat, sweating, and a feeling of nervousness. Your doctor should tell you how to treat low blood sugar.

Common side effects(may affect up to 1 in 10 people):

• dizziness
• headache
• feeling nervous
• constipation
• stomach pain
• swelling
• indigestion
• itching (with or without a rash)
• flatulence (gas)
• increased sweating
• loss of energy and strength
• heartburn
• loss of appetite

This medicine may reduce your appetite, the amount of food you eat, and your weight.

Tell your doctor if you lose weight too quickly (more than 1.5 kg per week), as it may cause problems such as gallstones.

Uncommon side effects(may affect up to 1 in 100 people):

• decreased kidney function
• dehydration, usually associated with nausea, vomiting, and/or diarrhea
• unusual taste in the mouth
• belching
• reactions at the injection site (redness)
• drowsiness
• hair loss
• weight loss
• delayed stomach emptying
• inflamed gallbladder
• gallstones

Rare side effects(may affect up to 1 in 1,000 people):

• intestinal obstruction (blockage in the intestine)

Unknown frequency(cannot be estimated from the available data).

Additionally, the following other side effectshave been reported:

• bleeding or bruising more easily than normal due to a low platelet count in the blood.
• changes in INR (a measure of blood clotting) have been reported when used with warfarin.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or diabetes nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Byetta

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Once in use, store your pen below 25°C for 30 days. Discard the Byetta pen after 30 days, even if there is still medicine left in the pen.

Put the pen cap back on the pen to protect it from light. Do not freeze. Discard any Byetta pen that has been frozen.

Do not use this medicine if you notice particles in the solution or if it is cloudy or colored.

Do not store the pen with the needle attached. If you leave the needle attached, the medicine may leak from the pen or air bubbles may form in the cartridge.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Byetta

• The active ingredient is exenatide.
• Two pre-filled pens are available. One for the administration of a 5 microgram dose and another for a 10 microgram dose.
• Each dose of the Byetta 5 microgram injection solution contains 5 micrograms of exenatide in 20 microliters.
• Each dose of the Byetta 10 microgram injection solution contains 10 micrograms of exenatide in 40 microliters.
• Each milliliter (ml) of injection solution contains 0.25 milligrams (mg) of exenatide.
• The other components are metacresol (44 micrograms/dose in the Byetta 5 microgram injection solution and 88 micrograms/dose in the Byetta 10 microgram injection solution), mannitol, glacial acetic acid, sodium acetate trihydrate, and water for injectable preparations (see section 2).

Appearance of the Product and Container Contents

Byetta is a clear and colorless liquid (injection solution) found in a glass cartridge within a pen. When the pen is empty, it cannot be reused. Each pen contains 60 doses to provide two injections per day for 30 days.

Byetta is available in packages of 1 and 3 pre-filled pens. Only some package sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

AstraZeneca AB

Global External Sourcing (GES)

Astraallén

Gärtunaporten (B 674:5)

SE-151 85 Södertälje

Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

This project has been approved in:

Detailed information on this medication is available on the European Medicines Agency website http://www.ema.europa.eu.

USER MANUAL FOR THE PEN

Byetta 5 micrograms solution for injection in a pre-filled pen

(exenatide)

CONTENTS OF THE USER MANUAL

Section 1 – WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN

Section 2 – STARTING TO USE YOUR PEN: FOR NEW USERS OR NEW PENS

Section 3 – ROUTINE USE: FOR PATIENTS WHO HAVE PREPARED THEIR PEN

Section 4 – FREQUENTLY ASKED QUESTIONS: QUESTIONS RELATED TO THE PEN

Section 1. WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN

Read this section completely before starting. Then go to Section 2 – starting to use your pen.

Read these instructions carefully BEFORE using your Byetta pen. Also, read the Byetta leaflet included in the pen package.

You must use the pen correctly to get the most benefit from Byetta. If you do not follow these instructions exactly, the result may be, for example, that an incorrect dose is administered, the pen breaks, or an infection occurs.

These instructions do not replace talking to your healthcare professional about your illness or treatment. If you are having problems using the Byetta pen, contact your healthcare professional.

IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

• Byetta is injected twice a day and the pen contains enough medication for 30 days. You do not need to measure the dose; the pen sets each dose for you.
• DO NOT TRANSFER THE MEDICATION FROM THE BYETTA PEN TO A SYRINGE.
• Do not use the pen if any part of it is broken or damaged.
• Do not share your pen or needles as this can pose a risk of infection transmission.
• The use of this pen is not recommended for blind or visually impaired persons. The assistance of a person trained in the use of the pen will be necessary.
• Healthcare professionals or other caregivers must follow institutional or local guidelines for needle handling.
• Follow the instructions recommended by your healthcare professional for a hygienic injection technique.
• Follow the instructions included in Section 2 only for the preparation of a new pen before the first use.
• For each injection, follow the instructions included in Section 3 of this user manual.

INFORMATION ABOUT INJECTION NEEDLES

Your Byetta pen is suitable for use with Becton, Dickinson and Company injection needles.

Should I use a new needle for each injection?

• Yes. Do not reuse needles.
• Remove the needle immediately after each injection. This will help prevent Byetta loss, avoid air bubbles, reduce needle blockages, and decrease the risk of infection.
• Do not press the injection button unless a needle is attached to the pen.

How do I dispose of my needles?

• Dispose of used needles in a puncture-resistant container or as instructed by your healthcare professional.
• Do not throw away the pen with the needle attached.

STORAGE OF YOUR BYETTA PEN

How should I store my Byetta pen?

• Store in the refrigerator (between 2°C and 8°C).
• Do not freeze. Discard any Byetta pen that has been frozen.
• Once in use, your Byetta pen must be stored below 25°C.
• Put the cap on the pen to protect it from light.
• Do not store the Byetta pen with the needle attached. If you leave the needle attached, medication loss from the Byetta pen or air bubbles may form in the cartridge.

Keep the pen and needles out of the sight and reach of children.

How long can I use a Byetta pen?

• Use a Byetta pen only for the 30 days following the preparation of a new pen for its first use.

After 30 days, discard the used Byetta pen, even if there is still medication in the pen.

• Mark the date you first used your pen and the date 30 days later in the space below:

Date of first day of use

Date of pen disposal

• Do not use Byetta after the expiration date shown on the label and on the packaging after "EXP". The expiration date is the last day of the month indicated.

How can I clean my Byetta pen?

• If necessary, clean the outside of the pen with a clean, damp cloth.
• During routine use, white particles may appear on the external end of the cartridge. You can remove them with a cotton swab or gauze soaked in alcohol.

Please also read the Byetta leaflet included in the pen package. For additional information, consult your healthcare professional.

Section 2. STARTING TO USE YOUR PEN

Read and follow the instructions in this section once you have read Section 1 – what you need to know about your Byetta pen.

Prepare your new pen just before using it for the first time. Follow the instructions for Preparing the New Penonly once. Do not repeatthe Preparation of the New Pen for each routine use. If you do, you will run out of Byetta before 30 days of use.

PREPARING THE NEW PEN – DO THIS ONLY ONCE

STEP A. Check the Pen

• Wash your hands before starting.
• Check the pen label to ensure it is your 5 microgram pen.
• Remove the blue pen cap.

Check the appearance of Byetta in the cartridge. The liquid should be clear and colorless and without particles. If it is not, do not use it.

Note:A small air bubble in the cartridge is normal.

STEP B. Attach the Needle

• Remove the paper tab from the outer needle cap.
• Pressthe outer needle cap, which contains the needle, directlyonto the pen, then screwthe needle until it is secure.

• Remove the outer needle cap. Do not throw it away.The outer needle cap will be used when you remove the needle from the pen after injection.

• Remove the inner needle protector and throw it away. A small drop of liquid may appear. This is normal.

STEP C. Set the Dose

• Check that 5appears in the dose window. If it does not, turn the dose button clockwise until it stopsand 5appears in the dose window.

• Pull the dose button until it stopsand 5appears in the dose window.

• Turn the dose button clockwise until it stopsand 5appears. Make sure the 5with the line below is in the center of the dose window.

Note:If you cannot turn the dose button clockwise to 5, see question 9 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP D. Prepare the Pen

• Hold the pen with the needle pointing upwards and away from you.

PRESS AND HOLD

• Use your thumb to press the injection button firmly until it stops, then hold the injection button firmly pressed and count slowly to 5.
• If you do not see a small flow or a few drops coming out of the needle tip, repeat Steps C and D.

• The pen preparation is complete when 5appears in the center of the dose window ANDyou have seen a small flow or a few drops coming out of the needle tip.

Note:If you do not see liquid after repeating this operation 4 times, see question 3 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP E. Complete the Preparation of the New Pen

• Turn the dose button clockwise until it stopsand 5appears in the dose window.
• The preparation of the new pen is complete. Do not repeat the instructions included in Section 2 for each routine use; if you do, you will run out of Byetta before 30 days of use.
• You are now ready to inject your first dose of Byetta.
• Go to Section 3, step 3, where you will find the instructions for injecting your first routine dose.

Note:If you cannot turn the dose button, see question 9 in the Frequently Asked Questionssection of Section 4 of this user manual.

Section 3. ROUTINE USE

Now that you have prepared the new pen, follow the instructions included in this section for allyour injections.

STEP 1. Check the Pen

• Wash your hands before using it.
• Check the pen label to ensure it is your 5 microgram pen.
• Remove the blue pen cap.

• Check the appearance of Byetta in the cartridge.
• The liquid should be transparent and colorless and free of particles. If it is not, do not use it.

Note: A small air bubble will not harm you or affect your dose.

STEP 2. Attach the Needle

• Remove the paper tab from the outer needle cap.
• Pressthe outer needle cap, which contains the needle, directlyonto the pen. Screwthe needle on until it is secure.

• Remove the outer needle cap. Do not throw it away. The outer needle cap will be used when you remove the needle from the pen after injection.

• Remove the inner needle shield and throw it away. A small drop of liquid may appear. This is normal.

Note:If the needle is not secure, you may not receive your full dose.

STEP 3. Dial the Dose

• Check that appears in the dose window. If it does not, turn the dose button clockwise until it stopsand appears in the dose window.

• Pull the dose button until it stopsand appears in the dose window.

• Turn the dose button clockwise until it stopson . Make sure the 5 with the line below is in the center of the dose window.

Note: If you cannot turn the dose button clockwise to , see question 9 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP 4. Inject the Dose

• Hold the pen firmly in your hand.
• Avoid pinching your skin too hard before injection. Insert the needle into your skin following the injection technique recommended by your healthcare professional for a hygienicinjection.

PRESS AND HOLD

• Use your thumb to press the injection button firmly until it stops, then hold the injection button firmly and count slowly to 5to administer the full dose.
• Hold the injection button while removing the needle from your skin, this keeps the medicine in the cartridge. See question 4 in Frequently Asked Questions.

• The injection is complete when appears in the center of the dose window.
• The pen is now ready to reset.

Note: If you see several drops of Byetta coming out of the needle after you have finished your injection, it means you did not press the injection button completely. See question 5 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP 5. Reset the Pen

• Turn the dose button clockwise until it stopsand appears in the dose window.

Note:This must be repeated after each injection.

Note: If you cannot turn the dose button or your pen is leaking, it means you have not injected your full dose. See questions 5 and 9 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP 6. Remove and Dispose of the Needle

• Carefully replace the outer needle cap.
• Remove the needle after each injection.This helps prevent leakage.

• Unscrew the needle.
• Replace the blue pen cap before storing it.

• Dispose of used needles in a puncture-resistant container or as directed by your healthcare professional.

STEP 7. Storing the Pen for the Next Dose

• Store your Byetta pen properly. (For more information, see Storing Your Byetta Penin Section 1 of this user manual).
• When it is time for your next routine dose, repeat steps 1 through 7 included in Section3.

SECTION4. FREQUENTLY ASKED QUESTIONS

1. Do I need to follow the preparation instructions for a new pen before each dose?
   • No. Preparation of the new pen is only done once, just before each new pen is used for the first time.
   • The purpose of preparation is to ensure that your Byetta pen is ready for use during the next 30 days.
   • If you repeat the New Pen Preparation before each routine dose, you will not have enough Byetta for 30 days.The small amount of Byetta used in the new pen preparation will not affect the Byetta content for 30 days.

1. Why are there air bubbles in the cartridge?
   • A small air bubble is normal. It will not harm you or affect your dose.
   • If you store the pen with the needle attached, air bubbles may form in the cartridge. Do notstore the pen with the needle attached.

1. What should I do if Byetta does not come out of the needle tip after four attempts during new pen preparation?
   • Carefully replace the outer needle cap and remove the needle. Unscrew it and dispose of it properly.
   • Put on a new needle and repeat steps B through Eof the New Pen Preparationsection of Section 2 of this user manual. Once you see a small stream or a few drops coming out of the needle tip, preparation is complete.

1. Why do I see particles in the cartridge after I finish my injection?

Particles or discoloration may appear in the cartridge after injection. This can occur if you pinched your skin too hard or if you released the injection button before the needle was removed from your skin.

1. Why do I see Byetta still dripping from my needle after I have finished my injection?

It is normal for a single drop to remain on the needle tip after completing the injection. If you see more than one drop:

• You may not have injected a full dose. Do notinject another dose. Consult your healthcare professional about what to do if you have injected an incomplete dose.
• To prevent this, for your next dose, make sure to press the injection button firmly, hold it down, and count slowly to 5(see Step 4: Inject the Dosein Section3).

1. What do the arrows mean?

The arrows mean you are ready for the next step. These arrows show the direction to pull or turn the dose button for the next step. This symbol means the dose button is pressed and the pen is ready to reset.

1. How do I know when the injection is complete?

The injection is complete when:

• You have pressed the injection button firmly until it stops

and

• You have counted slowly to 5while still holding the injection button down and the needle is still in your skin

and

• appears in the center of the dose window.

1. Where should I inject Byetta?

Byetta should be injected into your abdomen, thigh, or upper arm using the injection technique recommended by your healthcare professional.

Front Back

1. What should I do if I cannot pull, turn, or press the dose button?

Check which symbol appears in the dose window. Follow the steps indicated next to that symbol.

Ifappears in the dose window:

• Pull the dose button until appears.

Ifappears in the dose window and the dose button does not turn:

• The cartridge in your Byetta pen may not have enough liquid to deliver a full dose. If the cartridge contains a small amount or appears to be empty, get a new Byetta pen.

Ifand part ofappear in the window and the dose button cannot be pressed:

• The dose button has not been turned all the way. Continue turning it clockwise until appears in the center of the dose window.

If part ofand part ofappear in the dose window, and the dose button cannot be pressed:

• The needle may be clogged, bent, or not properly attached.
• Put on a new needle. Make sure the needle is straight and fully screwed on.
• Press the injection button all the way down. Byetta should come out of the needle tip.

Ifappears in the dose window and the dose button does not turn:

• The injection button has not been pressed all the way down and a full dose has not been delivered. Consult your healthcare professional about what to do if you have injected an incomplete dose.
• Follow these steps to reset your pen for the next injection:

• Press the injection button all the way down. Hold the injection button down and count slowly to 5. Then, turn the dose button clockwise until appears in the dose window.
• If you cannot turn the dose button, the needle may be clogged. Change the needle and repeat the step above.
  • For your next dose, make sure to press the injection button firmly, hold it down, and count slowly to 5before removing the needle from your skin.

Please also read the Byetta package leaflet. For additional information, contact your healthcare professional.

BYETTA PEN USER MANUAL

Byetta 10micrograms solution for injection in pre-filled pen

(exenatide)

CONTENTS OF THEUSER MANUAL

Section 1 –WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN

Section 2 –GETTING STARTED WITH YOUR PEN: FOR NEW USERS OR NEW PENS

Section 3 – ROUTINE USE: FOR PATIENTS WHO HAVE PREPARED THEIR PEN

Section 4 –FREQUENTLY ASKED QUESTIONS: QUESTIONS RELATED TO THE PEN

Section1.WHAT YOU NEED TO KNOW ABOUT YOUR BYETTA PEN

Read this section completely before starting. Then go to Section2 – getting started with your pen.

Read these instructions carefully BEFORE using your Byetta pen. Also, read the Byetta package leaflet included in the Byetta pen package.

You must use the pen correctly to get the most benefit from Byetta. If you do not follow these instructions exactly, the result may be, for example, that you administer an incorrect dose, the pen breaks, or you get an infection.

These instructions do not replace talking to your healthcare professional about your condition or treatment. If you are having problems using the Byetta pen, contact your healthcare professional.

IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

• Byetta is injected twice a day and the pen contains enough medicine for 30 days. You do not need to measure the dose; the pen sets each dose for you.
• DO NOT TRANSFER THE MEDICINE FROM THE BYETTA PEN TO A SYRINGE.
• Do not use the pen if any part of it is broken or damaged.
• Do not share your pen or needles as this may pose a risk of infection transmission.
• The use of this pen is not recommended for blind or visually impaired individuals. Assistance from a trained person will be necessary for pen use.
• Healthcare professionals or other caregivers must follow institutional or local guidelines for needle handling.
• Follow the injection technique recommended by your healthcare professional for a hygienicinjection.

• Follow the instructions included in Section2 only for the preparation of a new pen before the first use.
• For each injection, follow the instructions included in Section 3 of this manual.

INFORMATION ABOUT INJECTION NEEDLES

Your Byetta pen is designed to be used with Becton, Dickinson and Company injection needles.

Should I use a new needle for each injection?

• Yes. Do not reuse needles.
• Remove the needle immediately after each injection. This will help prevent Byetta leakage, avoid air bubbles, reduce needle clogs, and decrease the risk of infection.
• Do not press the injection button unless a needle is attached to the pen.

How do I dispose of my needles?

• Dispose of used needles in a puncture-resistant container or as directed by your healthcare professional.
• Do not throw away the pen with the needle attached.

STORING YOUR BYETTA PEN

How should I store my Byetta pen?

• Store in the refrigerator (between 2°C and 8°C).
• Do not freeze. Discard any Byetta pen that has been frozen.
• Once in use, your Byetta pen must be stored below 25°C.
• Put the pen cap on to protect it from light.
• Do not store the Byetta pen with the needle attached. If you leave the needle attached, medication leakage from the Byetta pen or air bubbles in the cartridge may occur.

Keep the pen and needles out of sight and reach of children.

How long can I use a Byetta pen?

• Use a Byetta pen only for the 30 days following the preparation of a new pen for its first use.

After 30days, discard the used Byetta pen, even if there is still medicine in the pen.

• Mark the date you first used your pen and the date 30 days later in the space provided:

Date of first use

Date to discard pen

• Do not use Byetta after the expiration date on the label and packaging after "EXP". The expiration date is the last day of the month indicated.

How can I clean my Byetta pen?

• If necessary, clean the outside of the pen with a clean, damp cloth.
• During routine use, white particles may appear on the outside of the cartridge. You can wipe them off with a cotton ball or swab dipped in alcohol.

Please also read the Byetta package leaflet. For additional information, consult your healthcare professional.

Section2. GETTING STARTED WITH YOUR PEN

Read and follow the instructions in this section once you have read Section1 – what you need to know about your Byetta pen.

Prepare your new pen just before using it for the first time. Follow the New Pen Preparationinstructions only once. Do not repeatthe New Pen Preparation.

Use the Byetta pen for each routine use. If you do, you will run out of Byetta before 30 days of use.

PREPARING A NEW PEN – DO THIS ONLY ONCE

STEP A. Check the Pen

• Wash your hands before starting.
• Check the pen label to make sure it is your 10 microgram pen.
• Remove the blue pen cap.

Check the appearance of Byetta in the cartridge. The liquid should be clear and colorless and free of particles. If it is not, do not use it.

Note: A small air bubble in the cartridge is normal.

STEP B. Attach the Needle

• Remove the paper tab from the outer needle cap.
• Pressthe outer needle cap, which contains the needle, directlyonto the pen, then screwthe needle on until it is secure.

• Remove the outer needle cap. Do notthrow it away. The outer needle cap will be used when you remove the needle from the pen after injection.

• Remove the inner needle protector and throw it away. A small drop of liquid may appear. This is normal.

STEP C. Set the Dose

• Check that 10appears in the dose window. If it does not, turn the dose button clockwise until it stopsand 10appears in the dose window.

• Pullthe dose button until it stopsand 10appears in the dose window.

• Turnthe dose button clockwise until it stopsand 10appears. Make sure the 10with the line below it is in the center of the dose window.

Note: If you cannot turn the dose button clockwise to 10, see question 9 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP D. Prepare the Pen

• Hold the pen with the needle pointing up and away from you.

PRESS AND HOLD

• Use your thumb to press the injection button firmly until it stops, then hold the injection button firmly pressed and count slowly to 5.
• If you do not see a small stream or a few drops coming out of the needle tip, repeat Steps C and D.

• The pen preparation is complete when 10appears in the center of the dose window andyou have seen a small stream or a few drops coming out of the needle tip.

Note: If you do not see liquid after repeating this operation 4 times, see question 3 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP E. Complete the New Pen Preparation

• Turnthe dose button clockwise until it stopsand 10appears in the dose window.
• The new pen preparation is complete. Do not repeat the instructions in Section 2 for each routine use, if you do, you will run out of Byetta before 30 days of use.
• You are now ready to inject your first dose of Byetta.
• Go to Section 3, Step 3, where you will find the instructions to inject your first routine dose.

Note: If you cannot turn the dose button, see question 9 in the Frequently Asked Questionssection of Section 4 of this user manual.

SECTION 3. ROUTINE USE

Now that you have prepared the new pen, follow the instructions in this section for allyour injections.

STEP 1. Check the Pen

• Wash your hands before using it.
• Check the pen label to make sure it is your 10 microgram pen.
• Remove the blue pen cap.

• Check the appearance of Byetta in the cartridge.
• The liquid should be clear and colorless and free of particles. If it is not, do not use it.

Note: A small air bubble will not harm you or affect your dose.

STEP 2. Attach the Needle

• Remove the paper tab from the outer needle cap.
• Pressthe outer needle cap, which contains the needle, directlyonto the pen. Screwthe needle on until it is secure.

• Remove the outer needle cap. Do notthrow it away. The outer needle cap will be used when you remove the needle from the pen after injection.

• Remove the inner needle protector and throw it away. A small drop of liquid may appear. This is normal.

Note: If the needle is not secure, you may not receive your full dose.

STEP 3. Set the Dose

• Check that 10appears in the dose window. If it does not, turn the dose button clockwise until it stopsand 10appears in the dose window.

• Pullthe dose button until it stopsand 10appears in the dose window.

• Turnthe dose button clockwise until it stopsand 10appears. Make sure the 10with the line below it is in the center of the dose window.

Note: If you cannot turn the dose button clockwise to 10, see question 9 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP 4. Inject the Dose

• Hold the pen firmly in your hand.
• Avoid pinching your skin too hard before injection. Insert the needle into your skin following the injection technique recommended by your healthcare professional for a hygienicinjection.

PRESS AND HOLD

• Use your thumb to press the injection button firmly until it stops, then hold the injection button firmly pressed and count slowly to 5to administer the full dose.
• Hold the injection button pressed while removing the needle from your skin, this keeps the medication in the cartridge clear. See question 4 in Frequently Asked Questions.

• The injection is complete when 10appears in the center of the dose window.
• The pen is now ready to restart.

Note: If you see several drops of Byetta coming out of the needle, it means you did not press the injection button completely. See question 5 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP 5. Restart the Pen

• Turnthe dose button clockwise until it stopsand 10appears in the dose window.

Note: This must be repeated after each injection.

Note: If you cannot turn the dose button or your pen is leaking, see questions 5 and 9 in the Frequently Asked Questionssection of Section 4 of this user manual.

STEP 6. Remove and Dispose of the Needle

• Carefully replace the outer needle cap.
• Remove the needle after each injection.This prevents liquid from escaping.

• Unscrew the needle.
• Replace the blue pen cap before storing it.

• Dispose of used needles in a puncture-resistant container or as instructed by your healthcare professional.

STEP 7. Store the Pen for the Next Dose

• Store the Byetta pen properly. (For more information, see Storing Your Byetta Penin Section 1 of this user manual).
• When it is time to administer your next routine dose, repeat steps 1 to 7 in Section 3.

SECTION 4. FREQUENTLY ASKED QUESTIONS

1. Do I need to follow the new pen preparation instructions before each dose?
   • No. New pen preparation is only done once, just before each new pen is used for the first time.

• The purpose of the preparation is to ensure that your Byetta pen is ready to use for the next 30 days.
• If you repeat the New Pen Preparation before each routine dose, you will not have enough Byetta for 30 days.The small amount of Byetta used in the new pen preparation will not affect the Byetta content for the 30 days.

1. Why are there air bubbles in the cartridge?
   • A small air bubble is normal. It will not harm you or affect your dose.
   • If you store the pen with the needle attached, air bubbles may form in the cartridge. Do not store the pen with the needle attached.

1. What should I do if Byetta does not come out of the needle tip after four attempts during new pen preparation?
   • Carefully replace the outer needle cap and remove the needle. Unscrew and dispose of it properly.
   • Put on a new needle and repeat steps B to Ein the New Pen Preparationsection of Section 2 of this user manual. Once you see a small stream or a few drops coming out of the needle tip, the preparation is complete.

1. Why do I see particles in the cartridge after I finish my injection?

Particles or discoloration may appear in the cartridge after injection. This can happen if you pinched your skin too hard or if you released the injection button before the needle was removed from your skin.

1. Why do I see Byetta still dripping from my needle after I finish my injection?

It is normal for a single drop to remain on the tip of the needle after completing the injection. If you see more than one drop:

• You may not have injected the full dose. Do notinject another dose. Consult your healthcare professional about what to do if you have injected an incomplete dose.
• To prevent this, for your next dose, make sure to press the injection button firmly, hold it pressed, and count slowly to 5(see Step 4: Inject the Dosein Section 3).

1. What do the arrows mean?

The arrows mean you are ready for the next step. These arrows show the direction to pull or turn the dose button in the next step. This symbol means the dose button is pressed and the pen is ready to restart.

1. How do I know when the injection is complete?

The injection is complete when:

• You have pressed the injection button firmly until it stops

and

• You have counted slowly to 5while still holding the injection button pressed and the needle is still in your skin

and

• 10appears in the center of the dose window.

1. Where should I inject Byetta?

Byetta should be injected into your abdomen, thigh, or upper arm using the injection technique recommended by your healthcare professional.

Front Back

1. What should I do if I cannot pull, turn, or press the dose button?

Check which symbol appears in the dose window. Follow the steps indicated next to that symbol.

If10appears in the dose window:

• Pull the dose button until 10appears.

If10appears in the dose window and the dose button does not turn:

• The cartridge in your Byetta pen may not have enough liquid to deliver a full dose. There will always be a small amount of Byetta left in the cartridge. If the cartridge contains a small amount or appears to be empty, get a new Byetta pen.

If10and part of the symbol appear in the window and the injection button cannot be pressed:

• The dose button has not been turned all the way. Continue turning it clockwise until 10appears in the center of the dose window.

If part of the symbol and part of10appear in the dose window, and the injection button cannot be pressed:

• L
  • A needle may be clogged, bent, or not properly attached.
  • Put on a new needle. Make sure the needle is straight and fully screwed on.
  • Press the injection button completely with firmness. Byetta should come out of the needle tip.

  Ifit appears in the dose window and the dose button does not turn:

  • The injection button has not been pressed completely and a full dose has not been administered. Consult with your healthcare professionalon what to do in case of an incomplete dose.
  • Follow these steps to reset your pen for the next injection:
  • Press the injection button firmly until it stops. Hold the injection button pressed and count slowly to 5. Then, turn the dose button clockwise until it appears in the dose window.
  • If you cannot turn the dose button, the needle may be clogged. Change the needle and repeat the previous step.
    • For your next dose, make sure to press the injection button firmly, hold it pressed, and count slowly to 5before removing the needle from the skin.

  Please also read the leaflet included in the packaging. For additional information, contact your healthcare professional.