What is it and how is it used?

BYETTA is an injectable medicine used to improve blood sugar control in adults with type 2 (non insulin dependent) diabetes mellitus.

BYETTA is used with other diabetic medicines called metformin, sulphonylureas or thiazolidinediones. Your doctor is now prescribing BYETTA 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 if your body is not able to use the insulin properly. BYETTA helps your body to increase the production of insulin when your blood sugar is high.

What do you have to consider before using it?

Do not use BYETTA:

  • If you are allergic (hypersensitive) to exenatide or any of the other ingredients of BYETTA, listed at the end of this leaflet.
Take special care with BYETTA:

  • When using it in combination with a sulphonylurea, as low blood sugar (hypoglycaemia) can occur. Ask your doctor or pharmacist if you are not sure if any of your other medicines contain a sulphonylurea.
  • BYETTA should be injected under 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 BYETTA is not recommended. BYETTA slows stomach emptying so food passes more slowly through your stomach.
  • The use of BYETTA with insulins is not recommended.
  • There is little experience with BYETTA in patients with kidney problems. The use of BYETTA is not recommended if you have severe kidney disease or you are on dialysis.
  • There is no experience with BYETTA in children and adolescents less than 18 years and, therefore, use of BYETTA is not recommended in this age group.
Using other medicines:

BYETTA slows stomach emptying and can affect medicines that need to pass through the stomach quickly.

Ask your doctor if the time at which you take any tablets (for example, antibiotics) should be changed. For tablets that you need to take with food, it may be best if they are taken at a meal at a time when BYETTA is not being administered.

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

Using BYETTA with food and drink:

Use BYETTA at any time within the 60 minutes (1 hour) before your meal. (See 3 ?How to use BYETTA?). Do not use BYETTA after your meal.

Pregnancy and breast-feeding:

It is not known if BYETTA may harm your unborn child. Tell your doctor if you are, you think you might be, or are planning to become pregnant as BYETTA should not be used during pregnancy.

It is not known if BYETTA passes into your milk. BYETTA 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 BYETTA 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 machinery).

Important information about some of the ingredients of BYETTA:

This medicine contains less than 1mmol sodium per dose, i.e. essentially ?sodium-free?. This medicine contains metacresol which may cause allergic reactions.

How is it used?

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

Two presentations of BYETTA are available: BYETTA 5 micrograms(µg) and BYETTA 10 micrograms(µg). Your doctor may tell you to use BYETTA 5 µg twice a day to start with. After using BYETTA 5 µg twice a day for 30 days the doctor may increase your dose to BYETTA 10 µg twice a day. One injection of your pre-filled pen will give you your dose. Do not change your dose unless your doctor has told you to.

BYETTA should be injected at any time within the 60 minutes (1 hour) before your morning and evening meals, or before your two main meals of the day, which should be about 6 hours or more apart. Do not use BYETTA after your meal.

BYETTA is injected under the skin (subcutaneous injection) of your upper leg (thigh), stomach area (abdomen), or upper arm.

You will not need to test your sugar levels on a day-by-day basis to set the dose of BYETTA. However, if you are also using a sulphonylurea your doctor may tell you to check your blood sugar levels to adjust the dose of sulphonylurea.

See the accompanying Pen User Manual for instructions for using the BYETTA Pen.

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

Injection needles are not included. The following are examples of disposable needles that can be used with your BYETTA pen:

  • 29 (thin), 30 or 31 (thinner) gauge (diameter 0.25 - 0.33mm) and
  • 12.7, 8 or 5mm length. Ask your doctor or nurse, which needle gauge and length is best for you. Use a new injection needle for each injection and dispose of it after each use. This medicine is for you; never share a BYETTA pen with others.
If you use more BYETTA than you should:

If you use too much BYETTA you may need medical treatment right away. Too much BYETTA can cause nausea, vomiting, dizziness, or symptoms of low blood sugar.

If you forget to use BYETTA:

If you miss a dose of BYETTA, skip that dose and take your next dose at the next prescribed time. Do not take an extra dose or increase the amount of your next dose to make up for the one you missed.

If you stop using BYETTA:

If you feel you should stop using BYETTA consult your doctor. If you stop using BYETTA 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.

What are possible side effects?

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

Very common, more than 1 in 10 patients experienced: nausea, (nausea is most common when first starting BYETTA, but decreases over time in most patients), vomiting or diarrhoea.

When BYETTA is used with a medicine that contains a sulphonylurea, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur very commonly. The dose of your sulphonylurea medicine may need to be reduced while you use BYETTA. 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, less than 1 in 10 but more than 1 in 100 patients experienced: dizziness, headache, reduced appetite, weight decreased, feeling jittery, pain in the stomach area, bloating, indigestion, increased sweating, loss of energy and strength or heartburn, injection site reactions (redness).

In addition some other side effects have been reported: angiodema, 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, unusual taste in the mouth, drowsiness, constipation, burping, flatulence, hair loss (rarely). Changes in INR (measurement of blood thinning) have been reported when used together with warfarin.

Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving BYETTA. 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 BYETTA.
  • Call your doctor if you experience severe and persistent stomach pain, with or without vomiting, because you could have pancreatitis.

Some severe allergic reactions (anaphylaxis) have been reported very rarely.

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

  • Swollen face, tongue or throat
  • Difficulty to swallow
  • Hives and difficulties to breathe

BYETTA may reduce your appetite, the amount of food you eat, and your weight. Take care if you lose weight too quickly as this may not be good for you (for example, it can cause dehydration, dizziness upon standing, and gallstones).

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.

How should it be stored?

Keep out of the reach and sight of children.

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

Store in a refrigerator (2 °C ? 8 ºC). Once in use, your BYETTA pen should be kept below 25 ºC.

Replace the cap on the pen in order to protect from light. Do not freeze. Throw away any BYETTA pen that has been frozen.

Use a BYETTA pen for only 30 days. Dispose of a used BYETTA pen after 30 days, even if some medicine remains in the pen.

Do not use BYETTA if you notice particles in the solution, or if it is cloudy or coloured.

Do not store the BYETTA pen with the needle attached. If the needle is left on, medicine may leak from the BYETTA pen or air bubbles may form in the cartridge.

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.

Further information

What BYETTA contains:

  • The active substance is exenatide.
  • Two pre-filled pens are available one to deliver doses of 5 micrograms (µg) and one 10 micrograms (µg).
  • Each dose of BYETTA 5 micrograms solution for injection contains 5 micrograms exenatide in 20 microlitre.
  • Each dose of BYETTA 10 micrograms solution for injection contains 10 micrograms exenatide in 40 microlitre.
  • Each millilitre (ml) of the solution for injection contains 0.25 milligrams (mg) of exenatide.
  • The other ingredients are metacresol (44 micrograms/dose in BYETTA 5 micrograms solution for injection and 88 micrograms/dose in BYETTA 10 micrograms solution for injection),mannitol, glacial acetic acid, sodium acetate trihydrate and water for injections.
What BYETTA looks like and contents of the pack

BYETTA is a clear and colourless liquid (solution for injection) filled in a glass cartridge within a pen. When the pen is empty, you cannot use it again. Each pen has 60 doses to provide 30 days of twice?a?day injections.
It is available in pack sizes of 1 and 3 pens. 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 medicinal product, 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 3726441100 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 S.A. 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 XXX.

PEN USER MANUAL

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

Read this section completely before you begin. Then, move on to Section 2 ? Getting Started.

BYETTA 5 micrograms solution for injection, pre-filled pen
(exenatide)

Read these instructions carefully BEFORE using your BYETTApen. Also read the BYETTA Package leaflet that comes with the BYETTA pen carton.

You need to use the pen correctly in order to get the most benefit from BYETTA. Failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.

These instructions do not take the place of talking with your healthcare professional about your medical condition or your treatment. If you are having problems using your BYETTA pen, contact your healthcare professional.

IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

  • BYETTA is injected twice a day, the pen contains enough medicine for 30 days. You do not have to measure any doses, the pen measures each dose for you.
  • DO NOT TRANSFER THE MEDICINE IN THE BYETTA PEN TO A SYRINGE.
  • If any part of your pen appears broken or damaged, do not use the pen.
  • This pen is not recommended for use by people who are blind or who cannot see well enough. Help will be needed by a person trained to use the pen.
  • Healthcare professionals or other caregivers should follow local or institutional policies regarding needle handling.
  • Follow the instructions for hygienic injection technique recommended by your healthcare professional.
  • Follow Section 2 only to set up a new pen before first use.
  • Section 3 of this manual should be used for every injection.
ABOUT INJECTION NEEDLES

What kinds of needles can be used with my BYETTA pen?

  • Injection needles are not included. The following are examples of disposable needles that can be used with your BYETTA pen:
  • 29 (thin), 30 or 31 (thinner) gauge (diameter 0.25-0.33mm) and
  • 12.7, 8 or 5mm length.Ask your healthcare professional which needle gauge and length is best for you.
Do I use a new needle for each injection?

  • Yes. Do not reuse needles.
  • Remove the needle immediately after each injection. This will help prevent leakage of BYETTA, keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
  • Never push the injection button on the pen unless a needle is attached.
How do I throw away my needles?

  • Throw away used needles in a puncture-resistant container or as recommended by your healthcare professional.
  • Do not throw away the pen with a needle attached. Do not share your pen or needles.
STORING YOUR BYETTA PEN

How do I store my BYETTA pen?

  • Store in a refrigerator (2° to 8°C).
  • Do not freeze. Throw away any BYETTA pen that has been frozen.
  • Once in use, your BYETTA pen should be kept below 25°C.
  • Replace the cap on the pen in order to protect from light.
  • Do not store the BYETTA pen with the needle attached. If the needle is left on, medicine may leak from the BYETTA pen or air bubbles may form in the cartridge. Keep your pen and needles out of the reach and sight of children.
How long can I use a BYETTA pen?

  • Use a BYETTA pen for only 30 days after setting up a new pen for first use. Dispose of a used BYETTA pen after 30 days, even if some medicine remains in the pen.
  • Mark the date when you first used your pen and the date 30 days later in the spaces below:

Date of First Use
Date to Throw Away Pen

  • Do not use BYETTA after the expiry date, which is stated on the label and the carton.
How do I clean my BYETTA pen?

  • If needed, wipe the outside of the pen with a clean, damp cloth.
  • White particles may appear on the outside tip of the cartridge during normal use. You may remove them with an alcohol wipe or alcohol swab.
Please see the accompanying BYETTA Package Leaflet. For additional information, contact your healthcare professional.

Section 2. GETTING STARTED

Read and follow the directions in this section only after you?ve read Section 1-What You Need To Know About Your BYETTA Pen.

Set up your new pen just before you use it for the first time. Follow the New Pen Setup only once. For routine use, do not repeat the New Pen Setup. If you do, you will run out of BYETTA before 30 days of use.

BYETTA PEN PARTS Blue Pen Cap Cartridge Label BYETTA Liquid Dose Window Dose Knob Injection Button

DOSE WINDOW SYMBOLS NEEDLE PARTS Needles Not Included ready to pull dose knob out ready to turn to dose position ready to inject 5 g Needle Paper Tab dose knob pushed in and ready to reset Outer Needle Shield Inner Needle Shield

NEW PEN SETUP ? DO THIS ONE TIME ONLY

STEP A Check the Pen

  • Wash hands prior to use.
  • Check pen label to make sure it is your 5 µg pen.
  • Pull off the blue pen cap.

Check BYETTA in the cartridge. The liquid should be clear, colourless, and free of particles. If it is not, do not use.
Note: A small air bubble in the cartridge is normal

STEP B Attach the Needle

  • Remove paper tab from outer needle shield.
  • Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure.
  • Pull off outer needle shield. Do not throw away. The outer needle shield will be used when you are removing the needle from the pen after the injection.
  • Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal.
STEP C Dial the Dose

Check that the is in the dose window. If not, turn dose knob clockwise until it stops and the is in the dose window.

  • Pull dose knob out until itstops and the is in the dose window.
  • Turn dose knob clockwise until it stops at . Make sure that the 5 with the line under it is in the centre of the dose window.

, see Commonly Asked Questions, Note If you cannot turn the dose knob clockwise to the number 8, in Section 4 of this user manual.

STEP D Prepare the Pen

  • Point the needle of the pen up and away from you.
PUSH & HOLD

  • Use thumb to firmly push the injection button in until it stops, then continue holding the injection button in while slowly counting to 5.
  • If you do not see a stream or several drops come from the needle tip, repeat Steps C & D.
  • Pen preparation is complete when the is in the centre of the dose window AND you have seen a stream or several drops come from the needle tip.

Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.

STEP E Complete New Pen Setup

  • Turn dose knob clockwise until it stops and the is in the dose window.
  • New Pen Setup is now done. Do not repeat Section 2 for routine use, if you do, you will run out of BYETTA before 30 days of use.
  • You are now ready for your first dose of BYETTA.
  • Go to Section 3, Step 3, for instructions on how to inject your first routine dose.

Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 8, Section 4 of this user manual.

Section 3. ROUTINE USE

Now that you have done the New Pen Setup, follow Section 3 for all of your injections.

STEP 1 Check the Pen

  • Wash hands prior to use.
  • Check pen label to make sure it is your 5 µg pen.
  • Pull off the blue pen cap.
  • Check BYETTA in the cartridge.
  • The liquid should be clear, colourless, and free of particles. If it is not, do not use.

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

STEP 2 Attach the Needle

  • Remove paper tab from outer needle shield.
  • Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure.
  • Pull off outer needle shield. Do not throw away. The outer needle shield will be used when you are removing the needle from the pen after the injection.
  • Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal.
STEP 3 Dial the Dose

Check that the is in the dose window. If not, turn dose knob clockwise until it stops and the is in the dose window.

  • Pull dose knob out until it stops and the is in the dose window.
  • Turn dose knob clockwise until it stops at . Make sure that the 5 with the line under it is in the centre of the dose window.

, see Commonly Asked Questions, Note If you cannot turn the dose knob clockwise to the number 8, in Section 4 of this user manual.

STEP 4 Inject the Dose

  • Grip pen firmly.
  • Insert needle into skin using hygienic injection technique recommended by your healthcare professional.
PUSH & HOLD

  • Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5 in order to get a full dose.
  • Remove needle from skin.
  • Injection is complete when the is in the centre of the dose window.
  • The pen is now ready to reset.

Note: If you see several drops of BYETTA leaking from the needle after the injection, the injection button was not pushed in all the way. See Commonly Asked Questions, number 4, in Section 4 of this user manual.

STEP 5 Reset the Pen

  • Turn dose knob clockwise until it stops and the is in the dose window.

Note: If you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered. See Commonly Asked Questions, numbers 4 and 8, in Section 4 of this user manual.

STEP 6 Remove and Dispose of the Needle

  • Remove the needle after each injection.
  • Carefully put the outer needle shield back over the needle.
  • Unscrew the needle.
  • Replace blue pen cap on pen before storage.
  • Throw away needles in a puncture-resistant container or as recommended by your healthcare professional.
STEP 7 Store Pen for Next Dose

  • Store your BYETTA pen properly. (See Storing Your BYETTA Pen in Section 1 of this user manual for more information.)
  • When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1 - 7.
Section 4. COMMONLY ASKED QUESTIONS

1. Do I need to do the New Pen Setup before every dose?
  • No. The New Pen Setup is done only once, just before each new pen is used for the first time.
  • The purpose of the setup is to make sure that your BYETTA pen is ready to use for the next 30 days.
  • If you repeat the New Pen Setup before each routine dose, you will not have enough BYETTA for 30 days. The small amount of BYETTA used in the New Pen Setup will not affect the 30-day supply of BYETTA.
2. Why are there air bubbles in the cartridge?
  • A small air bubble is normal. It will not harm you or affect your dose.
  • If the pen is stored with a needle attached, air bubbles may form in the cartridge. Do not store the pen with the needle attached.
3. What should I do if BYETTA does not come out of the needle tip after four tries during New
Pen Setup?

  • Remove the needle by carefully putting the outer needle shield back over the needle. Unscrew and dispose of properly.
  • Attach a new needle and repeat New Pen Setup, Steps B ? E, in Section 2 of this user manual. Once you see several drops or a stream of liquid coming out of the tip of the needle, the setup is complete.
4. Why do I see BYETTA leaking from my needle after I have finished my injection?

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

  • You may not have received your full dose. Do not inject another dose. Consult with your healthcare professional about how to handle a partial dose.
  • To prevent this, for your next dose, firmly push and hold the injection button in and slowly count to 5 (see Section 3, Step 4: Inject the Dose).
5. What do the arrows mean?

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

6. How can I tell when the injection is complete?

The injection is complete when:

  • You have firmly pushed the injection button in all the way until it stopsand
  • You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin and
  • The is in the centre of the dose window.
7. 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

8. What if I cannot pull, turn, or push the dose knob?

Check the symbol in the dose window. Follow the steps next to the matching symbol.

If is in the dose window

  • Pull the dose knob out until appears.

If is in the dose window and the dose knob will not turn The cartridge in your BYETTA pen may not have enough liquid to deliver a full dose. A small amount of BYETTA will always remain in the cartridge. If the cartridge contains a small amount or looks empty, obtain a new BYETTA pen.

If and part of the are in the dose window and the dose knob cannot be pushed in

  • The dose knob was not turned all the way. Continue turning the dose knob clockwise until is in the centre of the dose window.

If part of and part of are in the dose window and the dose knob cannot be pushed in The needle may be clogged, bent, or incorrectly attached. Attach a new needle. Make sure needle is on straight and screwed on all the way. Firmly push the injection button in all the way. BYETTA should come from needle tip.

If is in the dose window and the dose knob will not turn The injection button was not pushed in all the way and a complete dose was not delivered. Consult with your healthcare professional about how to handle a partial dose. Follow these steps to reset your pen for your next injection Firmly push the injection button in all the way until it stops. Keep holding the injection buttonin and slowly count to 5. Then turn the dose knob clockwise until appears in the dose window. If you cannot turn the dose knob, the needle may be clogged. Replace the needle and repeatthe step above. For your next dose, be sure to firmly push and hold the injection button in and slowly count to 5 before removing needle from skin.

Please see the accompanying Package Leaflet. For additional information contact your healthcare professional.

PEN USER MANUAL

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

Read this section completely before you begin. Then, move on to Section 2 ? Getting Started.

BYETTA 10 micrograms solution for injection, pre-filled pen
(exenatide)

Read these instructions carefully BEFORE using your BYETTApen. Also read the BYETTA Package leaflet that comes with the BYETTA pen carton.

You need to use the pen correctly in order to get the most benefit from BYETTA. Failure to follow these instructions completely may result in a wrong dose, a broken pen or an infection.

These instructions do not take the place of talking with your healthcare professional about your medical condition or your treatment. If you are having problems using your BYETTA pen, contact your healthcare professional.

IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN

  • BYETTA is injected twice a day, the pen contains enough medicine for 30 days. You do not have to measure any doses, the pen measures each dose for you.
  • DO NOT TRANSFER THE MEDICINE IN THE BYETTA PEN TO A SYRINGE.
  • If any part of your pen appears broken or damaged, do not use the pen.
  • This pen is not recommended for use by people who are blind or who cannot see well enough. Help will be needed by a person trained to use the pen.
  • Healthcare professionals or other caregivers should follow local or institutional policies regarding needle handling.
  • Follow the instructions for hygienic injection technique recommended by your healthcare professional.
  • Follow Section 2 only to set up a new pen before first use.
  • Section 3 of this manual should be used for every injection.
ABOUT INJECTION NEEDLES

What kinds of needles can be used with my BYETTA pen?

  • Injection needles are not included. The following are examples of disposable needles that can be used with your BYETTA pen:
  • 29 (thin), 30 or 31 (thinner) gauge (diameter 0.25-0.33mm) and
  • 12.7, 8 or 5mm length.Ask your healthcare professional which needle gauge and length is best for you.
Do I use a new needle for each injection?

  • Yes. Do not reuse needles.
  • Remove the needle immediately after each injection. This will help prevent leakage of BYETTA, keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
  • Never push the injection button on the pen unless a needle is attached.
How do I throw away my needles?

  • Throw away used needles in a puncture-resistant container or as recommended by your healthcare professional.
  • Do not throw away the pen with a needle attached. Do not share your pen or needles.
STORING YOUR BYETTA PEN

How do I store my BYETTA pen?

  • Store in a refrigerator (2° to 8°C).
  • Do not freeze. Throw away any BYETTA pen that has been frozen.
  • Once in use, your BYETTA pen should be kept below 25°C.
  • Replace the cap on the pen in order to protect from light.
  • Do not store the BYETTA pen with the needle attached. If the needle is left on, medicine may leak from the BYETTA pen or air bubbles may form in the cartridge. Keep your pen and needles out of the reach and sight of children.
How long can I use a BYETTA pen?

  • Use a BYETTA pen for only 30 days after setting up a new pen for first use. Dispose of a used BYETTA pen after 30 days, even if some medicine remains in the pen.
  • Mark the date when you first used your pen and the date 30 days later in the spaces below:

Date of First Use
Date to Throw Away Pen

  • Do not use BYETTA after the expiry date, which is stated on the label and the carton.
How do I clean my BYETTA pen?

  • If needed, wipe the outside of the pen with a clean, damp cloth.
  • White particles may appear on the outside tip of the cartridge during normal use. You may remove them with an alcohol wipe or alcohol swab.
Please see the accompanying BYETTA Package Leaflet. For additional information, contact your healthcare professional.

Section 2. GETTING STARTED

Read and follow the directions in this section only after you?ve read Section 1-What You Need To Know About Your BYETTA Pen.

Set up your new pen just before you use it for the first time. Follow the New Pen Setup only once. For routine use, do not repeat the New Pen Setup. If you do, you will run out of BYETTA before 30 days of use.

BYETTA PEN PARTS Blue Pen Cap Cartridge Label BYETTA Liquid Dose Window Dose Knob Injection Button

DOSE WINDOW SYMBOLS NEEDLE PARTS Needles Not Included ready to pull dose knob out ready to turn to dose position ready to inject 10 g Needle Paper Tab dose knob pushed in and ready to reset Outer Needle Shield Inner Needle Shield

NEW PEN SETUP ? DO THIS ONE TIME ONLY

STEP A Check the Pen

  • Wash hands prior to use.
  • Check pen label to make sure it is your 10 µg pen.
  • Pull off the blue pen cap.

Check BYETTA in the cartridge. The liquid should be clear, colourless, and free of particles. If it is not, do not use.
Note: A small air bubble in the cartridge is normal

STEP B Attach the Needle

  • Remove paper tab from outer needle shield.
  • Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure.
  • Pull off outer needle shield. Do not throw away. The outer needle shield will be used when you are removing the needle from the pen after the injection.
  • Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal.
STEP C Dial the Dose

Check that the is in the dose window. If not, turn dose knob clockwise until it stops and the is in the dose window.

  • Pull dose knob out until itstops and the is in the dose window.
  • Turn dose knob clockwise until it stops at . Make sure that the 10 with the line under it is in the centre of the dose window.

, see Commonly Asked Questions, Note If you cannot turn the dose knob clockwise to the number 8, in Section 4 of this user manual.

STEP D Prepare the Pen

  • Point the needle of the pen up and away from you.
PUSH & HOLD

  • Use thumb to firmly push the injection button in until it stops, then continue holding the injection button in while slowly counting to 5.
  • If you do not see a stream or several drops come from the needle tip, repeat Steps C & D.
  • Pen preparation is complete when the is in the centre of the dose window AND you have seen a stream or several drops come from the needle tip.

Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.

STEP E Complete New Pen Setup

  • Turn dose knob clockwise until it stops and the is in the dose window.
  • New Pen Setup is now done. Do not repeat Section 2 for routine use, if you do, you will run out of BYETTA before 30 days of use.
  • You are now ready for your first dose of BYETTA.
  • Go to Section 3, Step 3, for instructions on how to inject your first routine dose.

Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 8, Section 4 of this user manual.

Section 3. ROUTINE USE

Now that you have done the New Pen Setup, follow Section 3 for all of your injections.

STEP 1 Check the Pen

  • Wash hands prior to use.
  • Check pen label to make sure it is your 10 µg pen.
  • Pull off the blue pen cap.
  • Check BYETTA in the cartridge.
  • The liquid should be clear, colourless, and free of particles. If it is not, do not use.

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

STEP 2 Attach the Needle

  • Remove paper tab from outer needle shield.
  • Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure.
  • Pull off outer needle shield. Do not throw away. The outer needle shield will be used when you are removing the needle from the pen after the injection.
  • Pull off inner needle shield and throw away. A small drop of liquid may appear. This is normal.
STEP 3 Dial the Dose

Check that the is in the dose window. If not, turn dose knob clockwise until it stops and the is in the dose window.

  • Pull dose knob out until it stops and the is in the dose window.
  • Turn dose knob clockwise until it stops at . Make sure that the 10 with the line under it is in the centre of the dose window.

, see Commonly Asked Questions, Note If you cannot turn the dose knob clockwise to the number 8, in Section 4 of this user manual.

STEP 4 Inject the Dose

  • Grip pen firmly.
  • Insert needle into skin using hygienic injection technique recommended by your healthcare professional.
PUSH & HOLD

  • Use thumb to firmly push injection button in until it stops, then continue holding the injection button in while slowly counting to 5 in order to get a full dose.
  • Remove needle from skin.
  • Injection is complete when the is in the centre of the dose window.
  • The pen is now ready to reset.

Note: If you see several drops of BYETTA leaking from the needle after the injection, the injection button was not pushed in all the way. See Commonly Asked Questions, number 4, in Section 4 of this user manual.

STEP 5 Reset the Pen

  • Turn dose knob clockwise until it stops and the is in the dose window.

Note: If you cannot turn the dose knob, or if your pen leaks, your full dose has not been delivered. See Commonly Asked Questions, numbers 4 and 8, in Section 4 of this user manual.

STEP 6 Remove and Dispose of the Needle

  • Remove the needle after each injection.
  • Carefully put the outer needle shield back over the needle.
  • Unscrew the needle.
  • Replace blue pen cap on pen before storage.
  • Throw away needles in a puncture-resistant container or as recommended by your healthcare professional.
STEP 7 Store Pen for Next Dose

  • Store your BYETTA pen properly. (See Storing Your BYETTA Pen in Section 1 of this user manual for more information.)
  • When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1 - 7.
Section 4. COMMONLY ASKED QUESTIONS

1. Do I need to do the New Pen Setup before every dose?
  • No. The New Pen Setup is done only once, just before each new pen is used for the first time.
  • The purpose of the setup is to make sure that your BYETTA pen is ready to use for the next 30 days.
  • If you repeat the New Pen Setup before each routine dose, you will not have enough BYETTA for 30 days. The small amount of BYETTA used in the New Pen Setup will not affect the 30-day supply of BYETTA.
2. Why are there air bubbles in the cartridge?
  • A small air bubble is normal. It will not harm you or affect your dose.
  • If the pen is stored with a needle attached, air bubbles may form in the cartridge. Do not store the pen with the needle attached.
3. What should I do if BYETTA does not come out of the needle tip after four tries during New
Pen Setup?

  • Remove the needle by carefully putting the outer needle shield back over the needle. Unscrew and dispose of properly.
  • Attach a new needle and repeat New Pen Setup, Steps B ? E, in Section 2 of this user manual. Once you see several drops or a stream of liquid coming out of the tip of the needle, the setup is complete.
4. Why do I see BYETTA leaking from my needle after I have finished my injection?

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

  • You may not have received your full dose. Do not inject another dose. Consult with your healthcare professional about how to handle a partial dose.
  • To prevent this, for your next dose, firmly push and hold the injection button in and slowly count to 5 (see Section 3, Step 4: Inject the Dose).
5. What do the arrows mean?

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

6. How can I tell when the injection is complete?

The injection is complete when:

  • You have firmly pushed the injection button in all the way until it stopsand
  • You have slowly counted to 5 while you are still holding the injection button in and the needle is still in your skin and
  • The is in the centre of the dose window.
7. 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

8. What if I cannot pull, turn, or push the dose knob?

Check the symbol in the dose window. Follow the steps next to the matching symbol.

If is in the dose window

  • Pull the dose knob out until appears.

If is in the dose window and the dose knob will not turn The cartridge in your BYETTA pen may not have enough liquid to deliver a full dose. A small amount of BYETTA will always remain in the cartridge. If the cartridge contains a small amount or looks empty, obtain a new BYETTA pen.

If and part of the are in the dose window and the dose knob cannot be pushed in The dose knob was not turned all the way. Continue turning the dose knob clockwise until is in the centre of the dose window.

If part of and part of are in the dose window and the dose knob cannot be pushed in The needle may be clogged, bent, or incorrectly attached. Attach a new needle. Make sure needle is on straight and screwed on all the way. Firmly push the injection button in all the way. BYETTA should come from needle tip.

If is in the dose window and the dose knob will not turn The injection button was not pushed in all the way and a complete dose was not delivered. Consult with your healthcare professional about how to handle a partial dose. Follow these steps to reset your pen for your next injection Firmly push the injection button in all the way until it stops. Keep holding the injection buttonin and slowly count to 5. Then turn the dose knob clockwise until appears in the dose window. If you cannot turn the dose knob, the needle may be clogged. Replace the needle and repeatthe step above. For your next dose, be sure to firmly push and hold the injection button in and slowly count to 5 before removing needle from skin.

Please see the accompanying Package Leaflet. For additional information contact your healthcare professional.

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