BYDUREON 2 mg powder and solvent for prolonged-releasesuspension for injection

BYDUREON is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus.

BYDUREON is used in combination with the following diabetes medicines: metformin, sulphonylureas and thiazolidinediones. Your doctor is now prescribing BYDUREON as an additional medicine to help control your blood sugar. Continue to follow your food and exercise plan.

You have diabetes because your body does not make enough insulin to control the level of sugar in your blood or your body is not able to use the insulin properly. BYDUREON helps your body to increase the production of insulin when your blood sugar is high.

Do not use BYDUREON

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

Take special care with BYDUREON

• When using it in combination with a sulphonylurea, as low blood sugar (hypoglycaemia) can occur. Test your blood glucose levels regularly. Ask your doctor or pharmacist if you are not sure if any of your other medicines contain a sulphonylurea.
• BYDUREON should not be used if you have type 1 diabetes or diabetic ketoacidosis.
• BYDUREON should be injected into the skin and not into a vein or into the muscle.
• If you have severe problems with your stomach emptying (including gastroparesis) or food digestion, the use of BYDUREON is not recommended. BYDUREON slows stomach emptying so food passes more slowly through your stomach.
• Tell your doctor if you have ever had pancreatitis (see section 4).
• If you lose weight too quickly (more than 1.5 kg per week) talk to your doctor about it since this may not be good for you.
• There is little experience with BYDUREON in patients with kidney problems. The use of BYDUREON is not recommended if you have severe kidney disease or you are on dialysis.
• There is no experience with BYDUREON in children and adolescents less than 18 years and, therefore, use of BYDUREON is not recommended in this age group.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including warfarin and including medicines obtained without a prescription.

The use of BYDUREON with insulins, and other medicines that are used to treat type 2 diabetes that work like BYDUREON (for example:liraglutide and Byetta [exenatide twice daily]), is not recommended.

Using BYDUREON with food and drink

Use BYDUREON at any time of day, with or without meals.

Pregnancy and breast-feeding

Women of childbearing potential should use contraception during treatment with BYDUREON. It is not known if BYDUREON may harm your unborn child. Tell your doctor if you are, you think you might be, or are planning to become pregnant as BYDUREON should not be used during pregnancy and for at least three months before a pregnancy.

It is not known if BYDUREON passes into your milk. BYDUREON should not be used if breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you use BYDUREON in combination with a sulphonylurea, low blood sugar (hypoglycaemia) can occur. Hypoglycaemia may reduce your ability to concentrate. Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or operating machines).

Important information about some of the ingredients of BYDUREON

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ?sodium-free?.

Always use BYDUREON exactly as your doctor or diabetes nurse has told you. You should check with your doctor, diabetes nurse or pharmacist if you are unsure.

BYDUREON 2 mg should be injected once a week, at any time of day, with or without meals.

BYDUREON is injected into the skin (subcutaneous injection) of your stomach area (abdomen), upper leg (thigh), or the back of your upper arm.
Each week you can use the same area of your body. But be sure to choose a different injection site in that area.

Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.

Follow the Instructions for the User provided in the carton to inject BYDUREON

Your health care professional should teach you how to inject BYDUREON before you use it for the first time.

Check that the liquid in the syringe is clear and free of particles before you begin. After mixing use the suspension only if the mixture is white to off white and cloudy. If you see clumps of dry powder on the sides or bottom of the vial, the medicine is NOT mixed well. Shake vigorously again until well mixed.

BYDUREON should be injected immediately after mixing the powder and the solvent.

Use a new injection needle for each injection and dispose of it after each use.
If you are not sure you have taken the full dose of BYDUREON:

If you are not sure if you have taken all your dose, do not inject another dose of BYDUREON, just take it next week as planned.

If you use more BYDUREON than you should

If you use too much BYDUREON you may need medical treatment. Too much BYDUREON can cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).

If you forget to use BYDUREON

You might like to choose a day that you always plan to make your BYDUREON injection. If you miss your injection that day, take your injection as soon as possible after you notice. For your next injection you can return to your chosen injection day as long as the next injection is at least one day (24 hours) later. You can also change your chosen injection day. Do not take two injections on the same day.

If you stop using BYDUREON

If you feel you should stop using BYDUREON please consult your doctor first. If you stop using BYDUREON this can affect your blood sugar levels.
If you have any further questions on the use of this medicine, ask your doctor, diabetes nurse or pharmacist.

Like all medicines, BYDUREON can have side effects although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).

Severe allergic reactions (anaphylaxis) have been reported very rarely in patients receiving a product that has the same active ingredient as BYDUREON.

You should see your doctor immediately if you experience symptoms such as

• Swollen face, tongue or throat
• Difficulty with swallowing
• Hives and difficulty with breathing

Cases of inflammation of the pancreas (pancreatitis) have been reported rarely in patients receiving a product that has the same active ingredient as BYDUREON. Pancreatitis can be a serious, potentially life-threatening medical condition.

• Tell your doctor if you have had pancreatitis, gallstones, alcoholism or very high triglycerides. These medical conditions can increase your chance of getting pancreatitis, or getting it again, whether or not you are taking BYDUREON.
• Call your doctor if you experience severe and persistent stomach pain, with or without vomiting, because you could have pancreatitis.

Very common side effects of BYDUREON:

• nausea, (nausea is most common when first starting BYDUREON, but decreases over time in most patients)
• vomiting
• diarrhoea or constipation
• injection site reactions If you have an injection site reaction (redness, rash, or itching) you may like to ask your doctor for something to help relieve any signs or symptoms. You may see or feel a small bump under the skin after your injection; it should go away after 4 to 8 weeks. You should not need to stop your treatment.
• Hypoglycaemia When BYDUREON is used with a medicine that contains a sulphonylurea, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur. The dose of your sulphonylurea medicine may need to be reduced while you use BYDUREON. The signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery. Your doctor should tell you how to treat low blood sugar.

Common side effects of BYDUREON:

• dizziness
• headache
• tiredness (fatigue)
• sleepiness
• pain in the stomach area
• bloating
• indigestion
• burping
• flatulence
• heartburn
• reduced appetite BYDUREON may reduce your appetite, the amount of food you eat, and your weight. If you lose weight too quickly (more than 1.5 kg per week) talk to your doctor about it since this may not be good for you.

In addition, some other side effects have been seen in patients using a product that has the same active ingredient as BYDUREON:

Common:

• sweating Uncommon:
• unusual taste in the mouth Rare:
• angioedema (swelling of the face and throat)
• hypersensitivity (rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat)
• decrease in kidney function
• dehydration, sometimes with a decrease in kidney function
• hair loss
• Changes in INR (measurement of blood thinning) have been reported when used together with warfarin.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use BYDUREON after the expiry date, which is stated on the label and the carton after EXP.

Store in a refrigerator. Do not freeze.
However, the kit may be kept for up to 4 weeks below 30 ºC prior to use.
Store in the original package in order to protect from light.
Throw away any BYDUREON kit that has been frozen.

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

What BYDUREON contains:

• The active substance is exenatide. Each vial contains 2 mg of exenatide.
• The other ingredients are:
• In the powder: poly (D,L-lactide-co-glycolide) and sucrose.
• In the solvent: carmellose sodium, sodium chloride, polysorbate 20, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate and water for injections.

What BYDUREON looks like and contents of the pack:

Powder and solvent for prolonged-release suspension for injection.

The powder is white to off-white and the solvent is a clear, colourless to pale yellow to pale brown solution.

Each single-dose kit consists of one vial containing 2 mg exenatide powder, one pre-filled syringe containing 0.65 ml solvent, one vial connector, and two injection needles. One needle is a spare.

It is available in pack sizes of 4 single dose kits and 3 packs of 4 single-dose kits. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten, The Netherlands.

Manufacturer:

Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Teichweg 3, D - 35396 Giessen, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiqueBelgiëBelgien Eli Lilly Benelux S.AN.V. TélTel 32-0 2 548 84 84 LuxembourgLuxemburg Eli Lilly Benelux S.AN.V. TélTel 32-0 2 548 84 84

.. - . 359 2 491 41 40 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100

eská republika Eli Lilly R, s.r.o. Tel 420 234 664 111 Malta Charles de Giorgio Ltd. Tel 356 25600 500

Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Nederland Eli Lilly Nederland B.V. Tel 31-0 30 60 25 800

Deutschland Lilly Deutschland GmbH Tel. 49-0 6172 273 2222 Norge Eli Lilly Norge A.S Tlf 47 22 88 18 00

Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 372 6 817 280 Österreich Eli Lilly Ges.m.b.H Tel 43-0 1 711 780

- ... 30 210 629 4600 Polska Eli Lilly Polska Sp. z o.o. Tel. 48 0 22 440 33 00

España Lilly S.A. Tel 34 91 663 50 00 Portugal Lilly Portugal - Produtos Farmacêuticos, Lda Tel 351 21 4126600

France Lilly France SAS Tél. 33-01 55 49 34 34 România Eli Lilly România S.R.L. Tel 40 21 4023000

Ireland Eli Lilly and Co. Ireland Limited, Tel 353-0 1 661 4377 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10

Ísland Icepharma hf. Sími 354 540 8000 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111

Italia Eli Lilly Italia S.p.A. Tel 39-055 42571 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358-0 9 85 45 250

Phadisco Ltd 357 22 715000 Sverige Eli Lilly Sweden AB Tel 46 0 8 737 88 00

Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 67364000 United Kingdom Eli Lilly and Company Limited Tel 44-0 1256 315000

Lietuva
Eli Lilly Holdings Limited atstovyb-
Tel. +370 (5) 2649600

This leaflet was last approved in

INSTRUCTIONS FOR THE USER

Your Step by Step Guide

BYDUREON 2 mg powder and solvent for prolonged-release suspension for injection

If you have questions about taking BYDUREON

• Refer to the Common Questions and Answers

Helpful Hints

• Take your time.
• Follow these instructions step by step.
• You will need enough time to complete all the steps without stopping.
• You will probably need less time as you get used to giving yourself injections.

IMPORTANT:

Read and follow each step in these instructions carefullyevery timeyou take BYDUREON. Do not skip steps. Also read thePackage Leafletin your carton.

Your guide to the parts

• Single-dose kit

Lift here for a closer look at the parts

Keep this flap open so you can refer to it as you go through the steps

Plunger LiquidsolventinsideWhiteCapSyringe DoseLine Vial Vialconnector Greencap Papercover Thepowderinsideisyourmedicine Vialconnectorpackage OrangeconnectorNeedlemonojectThesingledosekithasaspareneedlenotshownincaseyouneedit. Bluecap Needle NeedleCove

Your guide to the parts

Single-dose kit

Syringe Needles2 Vial Vial connector vial connector

What?s inside

To take the correct dose, read each section so that you do every step in order.

This guide is divided into sections:

1 2 3 4 Getting started Connecting the parts Mixing the medicine and filling the syringe Injecting the medicine Common Questions and Answers.

1. Getting Started

1a Take a single-dose kit from the refrigerator.

Prepare to safely dispose of used needles and syringes. Have what you need ready in order to safely dispose of used needles and syringes.

1b Wash your hands.

1c 

Peel back the cover to open.

Remove the syringe. The liquid in the syringe should be clear and free of particles. It is okay if there are air bubbles.

Place the needle, vial connector package, vial, and syringe on a clean, flat surface.

1d 

Pick up the needle, and twist off the blue cap.

Put the covered needle down. The needle is now prepared. You will need it later.

There is a spare needle in case you need it.

1e 

Tap!

Pick up the vial.

Tap the vial several times against a hard surface to loosen the powder.

1f 

Use your thumb to remove the green cap.

Put the vial down.

2. Connecting the Parts

2a

Pick up the vial connector package and peel off the paper cover. Do not touch the orange connector inside.

2b 

Hold the vial connector package.

In your other hand, hold the vial.

2c

Press the top of the vial firmly into the orange connector.

2d

Lift the vial with the orange connector now attached out of its package.

2e

This is what the vial should now look like.

Put it down for later.

2f 

Pick up the syringe.

With your other hand, firmly hold the 2 grey squares on the white cap.

2gSnap Break off the cap

Be careful not to push in the plunger.

Just like you might break a stick, you are breaking off the cap.

2h 

This is what the broken-off cap looks like.

You will not need the cap and can throw it away.

2i

This is what the syringe should now look like.

2j 

Now, pick up the vial with the orange connector attached.

Twist the orange connector onto the syringe until snug. While twisting, be sure to hold the orange connector. Do not over tighten. Be careful not to push in the plunger.

2k

This is how the parts should now look when they are connected.

3.Mixing the Medicine and Filling the Syringe

IMPORTANT:

During these next steps, you will be mixing the medicine and filling the syringe. Once you mix the medicine, you must inject it immediately. You must not save the mixed medicine to inject at a later time.

3a 

With your thumb, push down the plunger until it stops and hold your thumb in place.

The plunger may feel like it is springing back a little.

3b 

Keep pushing down on the plunger with your thumb and shake vigorously. Keep shaking until the liquid and powder are mixed well.

Do not worry that the vial might come off. The orange connector will keep it attached to the syringe.

Shake vigorously like you would shake a bottle of oil-and-vinegar salad dressing.

3c

When the medicine is mixed well, it should look cloudy.

If you see clumps of dry powder on the sides or bottom of the vial, the medicine is NOT mixed well.

Shake vigorously again until well mixed.

Keep pushing on the plunger with your thumb while shaking.

3e 

Now, hold the vial so the syringe is pointing up. Keep pushing on the plunger with your thumb until it stops, and hold it in place.

3f 

Gently tap the vial with the other hand. Keep pushing on the plunger with your thumb to keep the plunger in place.

The tapping helps the medicine drip down along the sides of the vial. It is okay if there are air bubbles.

3g 

Pull the plunger down beyond the black dashed Dose Line.

This draws the medicine from the vial into the syringe. You may see air bubbles. This is normal.

A little bit of liquid may cling to the sides of the vial. This is also normal.

3h 

With one hand, hold the plunger in place so it does not move.

3i 

With the other hand, twist the orange connector to remove.

After removing the connector be careful not to push in the plunger.

3j 

This is what the syringe should now look like.

4. Injecting the Medicine

IMPORTANT:

Read the next steps carefully and look closely at the pictures.
This helps you get the correct dose of medicine.

4a 

Twist the needle onto the syringe until snug. Do not remove the needle cover yet. Be careful not to push in the plunger.

4bSlowlypush Topofplunger

Slowly push in the plunger so the top of the plunger lines up with the black dashed Dose Line. Then, take your thumb off the plunger.

It is important to stop pushing at this point, or you will waste your medicine and you will not get the

correct dose.

4c

The top of the plunger must stay lined up with the black dashed Dose Line as you go through the next steps. This will help you get the correct dose of medicine.

IMPORTANT:

It is normal to see a few air bubbles in the mixture.
The air bubbles will not harm you or affect your dose.

4dBackofupperarm StomachThighFront Back Areasonbodyforinjection You can inject each dose of the medicine in your stomach area abdomen, your thigh, or the back of your upper arm.

Each week you can use the same area of your body. But be sure to choose a different injection site in that area.

4e

Hold the syringe near the black dashed Dose Line.

4f 

Pull

Pull the needle cover straight off.
Do not twist.

Be careful not to push in the plunger.

When you remove the cover, you may see 1 or 2 drops of liquid. This is normal.

4g 

Be sure to use the injection technique recommended by your healthcare professional. Remember: You must take your injection of BYDUREON immediately after mixing it

Insert the needle into your skin (subcutaneously). To inject your full dose, push down on the plunger with your thumb until it stops.

Withdraw the needle.

Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.

4h. Put the cover back on the needle. Dispose of the syringe with the covered needle still attached as instructed by your healthcare professional.
You do not have to save any parts. Each single-dose kit has everything you need for your weekly dose of BYDUREON.

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

When it is time for your next weekly dose, start again at step 1.

Common Questions and Answers

If your question is about How soon to inject after mixing Mixing the medicine Air bubbles in syringe Attaching the needle Removing the needle cover Plunger not lining up with black dashed Dose Line Being unable to push the plunger down when injecting See question number 1 2 3 4 5 6 7

Common Questions and Answers

1. After I mix the medicine, how long can I wait before taking the injection?

You must take your injection of BYDUREON immediately after mixing it. If you do not inject BYDUREON immediately, the medicine will start to form small clumps in the syringe. These clumps could clog the needle when you take the injection (see question 7).

2. How do I know that the medicine is mixed well?

When the medicine is mixed well, it should look cloudy. There should not be any dry powder on the sides or bottom of the vial. If you do see any dry powder, shake vigorously while continuing to push

down on the plunger with your thumb. (This question relates to the steps shown on page X, Section 3a to 3d).

3. I?m ready to take the injection. What should I do if I see air bubbles in the syringe?

It is normal for air bubbles to be in the syringe. The air bubbles will not harm you or affect your dose. BYDUREON is injected into your skin (subcutaneously). Air bubbles are not a problem with this type of injection.

4. What should I do if I have trouble attaching the needle?

First, be sure you have removed the blue cap. Then, twist the needle onto the syringe until snug. To prevent losing medicine, do not push in the plunger while attaching the needle. For more information on injection techniques talk with your health care professional.
(This question relates to step 4a.)

5. What should I do if I have trouble removing the needle cover?

With one hand, hold the syringe near the black dashed Dose Line. With your other hand, hold the needle cover. Pull the needle cover straight off. Do not twist it. (This question relates to step 4f page X.)

6. I am at step 4c. What should I do if the top of the plunger has been pushed past the black

dashed Dose Line?

The black dashed Dose Line shows the correct dose. If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection. Before your next injection in 1 week, carefully review the instructions for steps 3a to 4h.

7. When I inject, what should I do if I cannot push the plunger all the way down?

This means the needle has become clogged. Remove the needle and replace it with the spare needle from your kit. Then choose a different injection site and finish taking the injection.

To review how to:

• Remove the blue cap of the needle, see page X (step 1d)
• Attach the needle, see page X (step 4a)
• Remove the needle cover and give the injection, see page X (steps 4e to 4g)

If you still cannot push the plunger all the way down, withdraw the needle. Carefully put the needle cover back on the needle. Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.

To prevent a clogged needle, always mix the medicine very well, and inject immediately after mixing.

BYDUREON only needs to be taken once a week.

Make a note that you have taken your BYDUREON today and mark your calendar for when you are due for your next injection.

Where to learn more about BYDUREON

• Talk with your healthcare professional Read the Package Leaflet carefully

Instructions for the User was last approved in