Byetta

Package leaflet: Information for the user

Byetta 5 micrograms injectable solution in pre-filled pen, 10 micrograms injectable solution in pre-filled pen

(exenatide)
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse at the diabetes care centre.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse at the diabetes care centre. See section 4.

Contents of this leaflet:

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

1. What Byetta is and what it is used for

Byetta contains the active substance exenatide. It is an injectable medicine used to improve blood sugar (glycaemia) control in adults with type 2 diabetes mellitus (non-insulin-dependent).
Byetta is used in combination with other antidiabetic medicines called metformin, sulphonylureas, thiazolidinediones, basal or long-acting insulins. Your doctor is prescribing Byetta as an additional medicine to help control your blood sugar levels. Continue to follow your diet and exercise plan.
Your diabetes is caused by your body not producing enough insulin to control blood sugar levels, or because your body is unable to use insulin properly. The medicine in Byetta helps your body increase insulin production when blood sugar levels are high.

2. What you need to know before using Byetta

Do not use Byetta

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse at the diabetes centre before using Byetta in the following cases:

• If you are using this medicine in combination with a sulfonylurea, as this may cause a reduction in blood sugar levels (hypoglycaemia). If you are unsure whether any of the other medicines you are taking contain a sulfonylurea, ask your doctor, pharmacist or nurse at the diabetes centre.
• If you have type 1 diabetes or diabetic ketoacidosis (a serious condition that can occur in diabetic patients), as you must not use this medicine.
• How to inject this medicine. It must be injected under the skin and must not be injected into a vein or muscle.
• If you have a severe problem with delayed gastric emptying or digestion of food, as the use of this medicine is not recommended. The active substance in this medicine slows down stomach emptying, causing food to pass through the stomach more slowly.
• If you have previously had inflammation of the pancreas (pancreatitis) (see section 4). If you are losing weight too quickly (more than 1.5 kg per week), inform your doctor, as this may lead to 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 and therefore must 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.
Other medicines and Byetta
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• Medicines used to treat type 2 diabetes that work similarly to Byetta (e.g. liraglutide and prolonged-release exenatide), as taking these medicines together with Byetta is not recommended.
• Medicines used to thin the blood (anticoagulants), such as Warfarin, as you may need additional monitoring of changes in INR (a measure of blood thinning) when starting treatment with this medicine.

Ask your doctor whether you need to adjust the timing of other oral medications, as this medicine slows gastric emptying and may affect medicines that need to pass quickly through the stomach, for example:

• Enteric-coated tablets or capsules (e.g. medicines that reduce stomach acid (proton pump inhibitors)) that should not remain in the stomach for too long may need to be taken one hour before or four hours after this medicine.
• Some antibiotics may need to be taken one hour before the injection of Byetta.
• For tablets that must be taken with food, it may be better to take them during a meal when Byetta is not administered.

Byetta with food and drink
Take Byetta at any time within 60 minutes (1 hour) before a meal. (See section 3 “How to use Byetta”). Do not take Byetta after a meal.
Pregnancy and breastfeeding
It is not known whether this medicine could have harmful effects on the foetus. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine, as it must not be used during pregnancy.
It is not known whether exenatide passes into breast milk. This medicine must not be used during breastfeeding.
Driving and using machines
If you use this medicine in combination with a sulfonylurea or insulin, your blood sugar levels may decrease (hypoglycaemia). Hypoglycaemia may impair your ability to concentrate. Keep this in mind in any situation where you could be putting yourself or others at risk (e.g. driving a vehicle or operating machinery).
Byetta contains metacresol. Metacresol may cause allergic reactions.
Byetta contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is essentially sodium-free.

3. How to use Byetta

Use this medicine exactly as directed by your doctor, pharmacist, or nurse at the diabetes clinic. If you have any doubts, consult your doctor, pharmacist, or nurse at the diabetes clinic.
Byetta is available in two strengths: Byetta 5 micrograms and Byetta 10 micrograms. Initially, your doctor may instruct you to start with Byetta 5 micrograms twice daily. After using Byetta 5 micrograms twice daily for 30 days, your doctor may increase your dose to Byetta 10 micrograms twice daily.
If you are over 70 years of age or have kidney problems, it may take longer than 30 days to tolerate the 5 microgram dose of Byetta, and therefore your doctor may not increase the dose.
A single injection from the pre-filled pen will deliver your dose. Do not change the dose unless your doctor tells you to do so.
You must inject this medicine at any time within 60 minutes (1 hour) before your morning and evening meals, or before the two main meals of the day, which should be approximately 6 hours or more apart. Do not take this medicine after meals.
You must inject this medicine under the skin (subcutaneous injection) in the upper leg (thigh), the abdominal area (abdomen), or the upper arm. If you are using both Byetta and insulin, you must administer two separate injections.
You do not need to measure your blood glucose levels daily to adjust the dose of Byetta. However, if you are also using a sulfonylurea or insulin, your doctor may instruct you to monitor your blood sugar levels to adjust the dose of the sulfonylurea or insulin.
If you are using insulin, your doctor will advise you on how to reduce your insulin dose and will recommend more frequent blood glucose monitoring to prevent the onset of hyperglycaemia (high blood sugar levels) and diabetic ketoacidosis (a diabetes complication that occurs when the body cannot break down glucose due to insufficient insulin).
For instructions on how to use the Byetta pen, please read the user manual supplied with the pen.
Your doctor or nurse must teach you how to inject Byetta before you use it for the first time.
Becton Dickinson and Company needles are compatible for use with the Byetta pen. Injection needles are not included.
Use a new needle for each injection and discard it after each use. This medicine is for your use only; never share your Byetta pen with anyone else.
If you use more Byetta than you should
If you use more of this medicine than prescribed, speak to a doctor or go to a hospital immediately. Taking too high a dose of this medicine may cause nausea, vomiting, dizziness, or symptoms due to low blood sugar levels (see section 4).
If you forget to use Byetta
If you forget to take a dose of this medicine, skip the missed dose and take the next dose as prescribed by your doctor. Do not use an extra dose and do not increase the amount of the next dose to make up for the missed dose.
If you stop using Byetta
If you think you need to stop treatment with this medicine, consult your doctor first. Stopping treatment with this medicine may affect your blood sugar levels.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, or nurse at the diabetes clinic.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions (anaphylaxis) have been reported rarely (may affect up to 1
patient in 1,000).
You must contact your doctor immediately if you experience symptoms such as:

• Swelling of the face, tongue or throat (angioedema)
• Skin rash, itching and rapid swelling of the tissues of the neck, face, mouth or throat
• Difficulty swallowing
• Itching (urticaria) and breathing difficulties

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

• Inform your doctor if you have ever had pancreatitis, gallstones, alcoholism or very high levels of triglycerides. These conditions may increase the likelihood of developing pancreatitis for the first time or having a recurrence, whether or not you are taking this medicine.
• STOP taking this medicine and contact your doctor immediately if you have a severe and persistent stomach pain, with or without vomiting, as this may indicate inflammation of the pancreas (pancreatitis).

Side effects very common (may affect more than 1 in 10 people):

• nausea (nausea is the most common side effect at the beginning of treatment with this medicine, but it decreases over time in most patients)
• vomiting
• diarrhoea
• hypoglycaemia

When this medicine is used together with a medicine containing a sulphonylurea or
insulin, episodes of low blood sugar levels (hypoglycaemia, generally mild to moderate) may occur very commonly. While taking this medicine, it may be necessary to reduce the dose of the sulphonylurea or insulin. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, rapid heartbeat, sweating and nervousness. Your doctor should advise you on how to manage a hypoglycaemic episode.
Side effects common (may affect up to 1 in 10 people):

• dizziness
• headache
• nervousness
• constipation
• stomach pain
• bloating
• indigestion
• itching (with or without rash)
• flatulence (intestinal gas)
• increased sweating
• loss of energy and strength
• heartburn
• decreased appetite This medicine may reduce appetite, the amount of food you eat, and body weight.

If you lose weight too quickly (more than 1.5 kg per week), inform your doctor, as this may lead to problems such as gallstones.
Side effects uncommon (may affect up to 1 in 100 people):

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

Side effects rare (may affect up to 1 in 1,000 people):

• intestinal obstruction (blockage of the intestine)

Not known (frequency cannot be estimated from the available data).
In addition, some other side effects have been reported:

• Bleeding or bruising more easily than normal due to low platelet count in the blood
• changes in INR (a measure of blood thinning) have been reported when this medicine was used together with warfarin.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse at your diabetes centre. You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Byetta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP/Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). After first use, store the pen at a temperature below 25 °C for 30 days. Discard a used pen after 30 days, even if there is still medicine remaining in the pen.
Replace the cap on the pen to protect it from light. Do not freeze. Discard the Byetta pen if it has been frozen.
Do not use this medicine if you notice particles in it or if the solution appears cloudy or discoloured.
Do not store the pen with the needle attached. If the needle remains attached, medicine may leak from the pen or air bubbles may form in the cartridge.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Byetta contains:

• The active substance is exenatide.
• Two pre-filled pens are available: one delivering doses of 5 micrograms and another delivering doses of 10 micrograms.
• Each dose of Byetta 5 micrograms injectable solution (injection) contains 5 micrograms of exenatide in 20 microliters.
• Each dose of Byetta 10 micrograms injectable solution (injection) contains 10 micrograms of exenatide in 40 microliters.
• Each milliliter (mL) of injectable solution contains 0.25 milligrams (mg) of exenatide.
• The other ingredients are metacresol (44 micrograms per dose in Byetta 5 micrograms injectable solution and 88 micrograms per dose in Byetta 10 micrograms injectable solution), mannitol, glacial acetic acid, trihydrate sodium acetate and water for injections (see section 2).

Description of the appearance of Byetta and contents of the pack
Byetta is a clear, colourless liquid (injectable solution) contained in a glass cartridge inside a pen. When the pen is empty, it cannot be reused. Each pen contains 60 doses, allowing 30 days of injections twice daily.
Byetta is available in packs of 1 and 3 pre-filled pens. Not all pack sizes may be marketed.
Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
AstraZeneca AB
Karlebyhusentrén Astraallén
SE-152 57 Södertälje
Sweden
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550
България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 (2) 44 55 000 Tél/Tel: +32 2 370 48 11
Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500
Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000
Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 79 363 2222
Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00
Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 2 10 6871500 Tel: +43 1 711 31 0
España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 874 35 00
France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00
Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41
Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) Ltd AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600
Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777
Italia Suomi/Finland
AstraZeneca S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010
Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000
Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu
USER MANUAL FOR THE PEN
Byetta 5 micrograms injectable solution in pre-filled pen
(exenatide)

CONTENTS OF THE USER MANUAL
Section 1 – WHAT YOU NEED TO KNOW ABOUT THE BYETTA PEN
Section 2 – PREPARATION: FOR FIRST-TIME USERS OR NEW PENS
Section 3 – DAILY USE: FOR USERS WHO NEED TO PREPARE THE PEN
Section 4 – FREQUENTLY ASKED QUESTIONS: FOR QUESTIONS ABOUT THE PEN
Section 1. WHAT YOU NEED TO KNOW ABOUT THE BYETTA PEN
Read this section completely before starting. Then, read Section 2 – Preparation
Read these instructions carefully BEFORE using the Byetta pen. Also, read the Package Leaflet of Byetta included in the Byetta pen pack.
You must use the pen correctly to get the maximum benefit from Byetta. Failure to follow these instructions carefully may result in an incorrect dose, pen damage or infection.
These instructions do not replace advice you should receive from healthcare professionals regarding your medical condition or treatment. If you are having problems using the Byetta pen, contact your healthcare provider.
IMPORTANT INFORMATION ABOUT THE BYETTA PEN

• Byetta is injected twice daily; the pen contains enough medicine for 30 days. You do not need to measure the dose each time, as the pen automatically delivers each dose.
• DO NOT TRANSFER THE MEDICINE FROM THE BYETTA PEN INTO A SYRINGE.
• Do not use the pen if any of its parts appear broken or damaged.
• Do not share your pen or needles with others, as there is a risk of transmitting infectious agents.
• This pen is not recommended for use by blind people or those with poor vision. Assistance from a trained person will be required.
• Healthcare professionals should follow local or institutional procedures for needle disposal.
• Follow the instructions provided by healthcare professionals for hygienically correct injection.
• Follow Section 2 only to prepare a new pen before first use.
• Section 3 of this manual must be used for every injection.

INJECTION NEEDLES
The Byetta pen is compatible for use with pen needles from Becton Dickinson and Company.
Should I use a new needle for each injection?

• Yes. Do not reuse needles.
• Remove the needle immediately after each injection. This helps prevent leakage of Byetta, avoids air bubbles, reduces needle blockages and lowers the risk of infection.
• Never press the injection button if no needle is attached.

How should I dispose of used needles?

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

STORAGE OF THE BYETTA PEN
How should I store the Byetta pen?

• Store in the refrigerator (between 2 °C and 8 °C).
• Do not freeze. Discard the Byetta pen if it has been frozen.
• Once in use, the Byetta pen should be kept at a temperature below 25 °C.
• Replace the cap on the pen to protect it from light.
• Do not store the Byetta pen with the needle attached. If the needle remains attached, the medicine may leak from the pen or air bubbles may form in the cartridge.

Keep the pen and needles out of the reach and sight of children.
How long can I use the Byetta pen?

• Use one Byetta pen only for 30 days after preparing a new pen for first use. Discard a used Byetta pen after 30 days, even if medicine remains in the pen.
• Record the date when you first used the pen and the date 30 days later in the spaces provided below:

Date of first use
Date to discard the pen

• Do not use Byetta after the expiry date stated on the label and carton after EXP/Exp. The expiry date refers to the last day of the month.

How should I clean the Byetta pen?

• If necessary, clean the outside of the pen with a clean, damp cloth.
• White particles may appear on the outer end of the cartridge during normal use. These can be removed with a cloth or cotton swab moistened with alcohol.

Read the Package Leaflet included in the Byetta pack. For further information, contact your healthcare provider.
Section 2. PREPARATION
Read and follow the instructions in this section only after reading Section 1 – What you need to know about the Byetta pen.
Prepare a new pen just before first use. Perform the instructions in the section “ Preparing a New Pen ” only once. For daily use, do not repeat the instructions in “Preparing a New Pen”. If you do, you will run out of Byetta before the expected 30 days of use.
COMPONENTS OF THE BYETTA PEN

Blue Pen Cap Cartridge Liquid Label Dose Dose Selector Button Injection Button
Window
COMPONENTS OF THE NEEDLE SYMBOLS IN THE DOSE WINDOW
(Needles not included in the pack)

ready to pull out the dose selector button

ready to rotate the dose selector button

ready to inject 5 micrograms (mcg)

Outer Cap Inner Cap Needle Protection dose selector button pressed and ready to be reset
of needle of needle of paper

PREPARING A NEW PEN – TO BE DONE ONLY ONCE
STEP A Check the Pen

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

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

STEP B Attach the needle

• Remove the paper protection from the outer needle cap.
• Insert the outer needle cap containing the needle straight onto the end of the pen, then rotate the needle until securely attached.

• Remove the outer needle cap. Do not discard it. The outer needle cap will be used when removing the needle from the pen after injection.

• Remove the inner needle cap and discard it. A small drop of liquid may appear. This is normal.

STEP C Select the dose

• Check that the symbol is visible in the dose window. If not, rotate the dose selector button clockwise until it stops and the symbol appears in the dose window.

• Pull out the dose selector button until it stops and the symbol appears in the dose window.

• Rotate the dose selector button clockwise until it stops at the symbol . Ensure that the 5 with the line underneath is visible in the centre of the dose window.

Note: If you cannot rotate the dose selector button clockwise to the symbol , see Frequently Asked Questions , number 9, in Section 4 of this User Manual.
STEP D Prepare the Pen

• Point the pen needle upwards and away from you.

PRESS AND HOLD

• Use your thumb to press the injection button steadily until it stops , then continue holding the injection button while counting slowly to 5.
• If you do not see a continuous stream (flow) or several drops of liquid from the needle tip, repeat the steps described in Steps C and D.

• The pen preparation is complete when the symbol appears in the centre of the dose window and you have seen a continuous stream (flow) or several drops of liquid from the needle tip.

Note: If you do not see liquid flow after 4 attempts, see Frequently Asked Questions , number 3, in Section 4 of this User Manual.
STEP E Complete the preparation of a New Pen

• Rotate the dose selector button clockwise until it stops , and the symbol appears in the dose window.
• The preparation of a New Pen is now complete. Do not repeat the instructions in Section 2 for daily use, otherwise you will run out of Byetta before the expected 30 days of use.
• You are now ready to administer your first dose of Byetta.
• See Section 3, Step 3, for instructions on how to administer the first dose for daily use. Note: If you cannot rotate the dose selector button, see Frequently Asked Questions , number 9, in Section 4 of this User Manual.

Section 3. DAILY USE
Now that you have completed the Preparation of a New Pen, follow the instructions in Section 3 for all injections.
STEP 1 Check the Pen

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

• Check Byetta in the cartridge.
• The liquid should be clear, colourless and free of particles. If not, do not use the pen.

Note: A small air bubble in the cartridge will not be harmful and will not affect your dose.
STEP 2 Attach the needle

• Remove the paper protection from the outer needle cap.
• Insert the outer needle cap containing the needle straight onto the end of the pen, then rotate the needle until securely attached.

• Remove the outer needle cap. Do not discard it. The outer needle cap will be used when removing the needle from the pen after injection.

• Remove the inner needle cap and discard it. A small drop of liquid may appear. This is normal.

Note: If the needle is not securely attached, you will not be able to inject the full dose.
STEP 3 Select the dose

• Check that the symbol is visible in the dose window. If not, rotate the dose selector button clockwise until it stops and the symbol appears in the dose window.

• Pull out the dose selector button until it stops and the symbol appears in the dose window.

• Rotate the dose selector button clockwise until it stops at the symbol . Ensure that the 5 with the line underneath is visible in the centre of the dose window.

Note: If you cannot rotate the dose selector button clockwise to the symbol , see Frequently Asked Questions , number 9, in Section 4 of this User Manual.
STEP 4 Administer the dose

• Hold the pen firmly.
• Avoid pinching the skin too tightly before injection. Insert the needle under the skin using the hygienically correct injection technique as taught by your healthcare provider.

PRESS AND HOLD

• Use your thumb to press the injection button steadily until it stops, then continue holding the injection button while counting slowly to 5 to deliver the full dose.
• Keep the injection button pressed while removing the needle from the skin to ensure the clear medicine remains in the cartridge. See Frequently Asked Questions , number 4.

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

Note: If you see several drops of Byetta leaking from the needle after injection, the injection button was not pressed fully. See Frequently Asked Questions , number 5, in Section 4 of this User Manual.
STEP 5 Reset the pen

• Rotate the dose selector button clockwise until it stops and the symbol appears in the dose window.

Note: This must be done after every injection.
Note: If you cannot rotate the dose selector button or if the pen leaks, the full dose was not delivered. See Frequently Asked Questions , numbers 5 and 9, in Section 4 of this User Manual.
STEP 6 Remove and dispose of the needle

• Carefully replace the outer needle cap onto the needle.
• Remove the needle after each injection. This prevents leakage of liquid.

• Remove the needle.
• Replace the blue pen cap for storage.

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

STEP 7 Store the pen for the next injection

• Store Byetta appropriately. (For more information, see Storage of the Byetta Pen in Section 1 of this User Manual)
• When it is time for your next daily dose, go to Section 3, Step 1 , and repeat Steps 1 to 7.

Section 4. FREQUENTLY ASKED QUESTIONS

1. Should I follow the instructions in the section “Preparing a new pen” before administering each dose?
   • No. The instructions in the section “Preparing a new pen” should be performed only once, only before first use of a new pen.
   • The purpose of preparation is to ensure the Byetta pen is ready for use over the next 30 days.
   • If you repeat the instructions in “Preparing a new pen” before each daily injection, you will not have enough Byetta for 30 days of injections. The small amount used during “Preparing a new pen” does not affect the doses of Byetta over 30 days of injections.

2. Why are there air bubbles in the cartridge?

• A small air bubble is normal. It will not be harmful and will not 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 attempts during "Preparing a new pen"?

• Remove the needle, carefully placing the outer needle cap back onto the needle. Remove and dispose of the needle properly.
• Attach a new needle and repeat the instructions in section "Preparing a new pen", Steps B to E, in Section 2 of this User Manual. When you see several drops or a continuous flow (stream) of liquid from the needle tip, the preparation is complete.

4. Why do I see particles in the cartridge after I have completed the injection?

After an injection, particles or discoloration may appear in the cartridge. This can occur if the skin was pinched too firmly or if the injection button is released before the needle is removed from the skin.

5. Why do I see Byetta leaking from the needle after I have completed the injection?

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

• You may not have received the full dose. Do not inject another dose. Contact your healthcare provider for instructions on what to do if you receive an incomplete dose.
• To avoid this, for the next dose, press the injection button steadily and continue holding it down while slowly counting to 5 (see Section 3, Step 4: “Inject the dose”).

6. What do the arrows mean?

The arrows indicate that you are ready for the next step. The following arrows show the
direction to pull out or rotate the dose selector button in the next step. The

symbol indicates that the dose selector button is pressed and the pen is ready to be
set again.

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

The injection is complete when:

• You have steadily pressed the injection button all the way down until it stops and

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

• The symbol appears in the center of the dose window.

8. Where should I inject Byetta?

Byetta must be injected into the abdomen, thigh, or upper arm, using the injection technique shown to you by your healthcare provider.
Front Back

9. What should I do if I cannot pull out, select, or press the dose selector button?
   Check the symbol in the dose window. Follow the instructions below so that the correct symbol appears.

If the symbol is visible in the dose window:

• Pull out the dose selector button until the symbol appears.

If the symbol is visible in the dose window and the dose selector button does not rotate:

• The cartridge in your Byetta pen may not contain enough liquid to deliver the full dose. A small amount of Byetta will always remain in the cartridge. If the cartridge appears to contain very little liquid or looks empty, obtain a new Byetta pen.

If the symbol and part of the are visible in the dose window and you cannot press the dose
selector button:

• The dose selector button was not rotated completely. Continue rotating the dose selector button clockwise until the symbol appears in the center of the dose window.

If part of the and part of the symbol are visible in the dose window and you cannot
press the dose selector button:

• The needle may be blocked, bent, or incorrectly attached.
• Attach a new needle. Make sure the needle is attached straight and screwed on fully.
• Press the dose button steadily and completely until it stops. Byetta must come out of the needle tip.

If the symbol is visible in the dose window and the dose selector button does not rotate:

• The injection button was not fully pressed, and the full dose was not delivered. Contact your healthcare provider for advice on what to do if a dose is incomplete.

• Follow the instructions below to reset the pen for subsequent injections:

• Press the injection button steadily and completely until it stops. Keep holding the injection button down and count slowly to 5. Then rotate the dose selector button clockwise until the symbol appears in the dose window.

• If you cannot rotate the dose selector button, the needle may be blocked. Replace the needle and repeat the procedure described above.

• For the next injection, make sure to press steadily and hold the injection button while counting slowly to 5 before removing the needle from the skin.

Read the Package Leaflet provided in the package. For further information, contact your
healthcare provider.
USER MANUAL FOR THE PEN
Byetta 10 micrograms solution for injection in pre-filled pen
(exenatide)

CONTENTS OF THE USER MANUAL
Section 1 – WHAT YOU NEED TO KNOW ABOUT THE BYETTA PEN
Section 2 – PREPARATION: FOR FIRST-TIME USERS OR NEW PENS
Section 3 – DAILY USE: FOR USERS PREPARING THE PEN
Section 4 – FREQUENTLY ASKED QUESTIONS: QUESTIONS ABOUT THE PEN
Section 1. WHAT YOU NEED TO KNOW ABOUT THE BYETTA PEN
Read this section completely before starting. Then, read Section 2 – Preparation
Read these instructions carefully BEFORE using the Byetta pen. Also, read the Package Leaflet for Byetta included in the pen packaging.
You must use the pen correctly to get the maximum benefit from Byetta. Failure to follow these instructions carefully may result in an incorrect dose, pen damage, or infection.
These instructions do not replace the advice you should receive from your healthcare provider regarding your medical condition or treatment. If you are having problems using the Byetta pen, contact your healthcare provider.
IMPORTANT INFORMATION ABOUT THE BYETTA PEN

• Byetta is injected twice daily; the pen contains enough medication for 30 days. You do not need to measure the dose each time—the pen measures each dose automatically.
• DO NOT TRANSFER THE MEDICATION FROM THE BYETTA PEN INTO A SYRINGE.
• Do not use the pen if any part appears broken or damaged.
• Do not share your pen or needles with others, as this may risk transmission of infectious agents.
• This pen is not recommended for use by people who are blind or have poor vision. Assistance from a trained person will be required.
• Healthcare staff or other professionals should follow local or institutional procedures for needle disposal.
• Follow the instructions provided by your healthcare provider for hygienic injection technique.
• Follow Section 2 only when preparing a new pen before first use.
• Section 3 of this manual must be used for every injection.

INJECTION NEEDLES
The Byetta pen is compatible with pen needles from Becton Dickinson and Company.
Should I use a new needle for each injection?

• Yes. Do not reuse needles.
• Remove the needle immediately after each injection. This helps prevent Byetta from leaking, avoids air bubbles, reduces needle blockages, and lowers the risk of infection.
• Never press the injection button on the pen if no needle is attached.

How should I dispose of used needles?

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

STORAGE OF THE BYETTA PEN
How should I store the Byetta pen?

• Store in the refrigerator (between 2°C and 8°C).
• Do not freeze. Discard the Byetta pen if it has been frozen.
• Once in use, the Byetta pen should be kept at a temperature below 25°C.
• Replace the cap on the pen to protect it from light.
• Do not store the Byetta pen with the needle attached. If the needle remains attached, medication may leak from the pen or air bubbles may form in the cartridge.
• Keep the pen and needles out of the reach and sight of children.

How long can I use the Byetta pen?

• Use each Byetta pen for only 30 days after first preparing a new pen for initial use. Discard a used Byetta pen after 30 days, even if there is still medication left in the pen.
• Record the date you first used the pen and the date 30 days later in the spaces provided below:

Date of first use
Date to discard the pen

• Do not use Byetta after the expiry date stated on the label and carton after EXP/Exp. The expiry date refers to the last day of the month.

How should I clean the Byetta pen?

• If necessary, clean the outside of the pen with a clean, damp cloth.
• White particles may appear on the outer end of the cartridge during normal use. These can be removed with a cloth or alcohol-soaked cotton swab.

Read the Package Leaflet included in the Byetta packaging. For further information, contact your
healthcare provider.
Section 2. PREPARATION
Read and follow the instructions in this section only after reading Section 1 – What you need to know about the Byetta pen.
Prepare a new pen just before first use. Perform the instructions in the section “Preparing a New Pen” only once. For daily use, do not repeat the instructions in “Preparing a New Pen.” If you do, you will use up the Byetta pen before the expected 30 days.

COMPONENTS OF THE

BYETTA PEN

Blue Pen Cap Cartridge Liquid Label Dose Window Dose Selector Button Injection Button
Byetta
NEEDLE COMPONENTS SYMBOLS IN THE DOSE WINDOW

ready to pull out the dose selector button

ready to rotate the dose selector button

ready to inject 10 micrograms
Outer Cap Inner Cap Needle Paper Shield dose selector button pressed and ready to be reset
of needle of needle
PREPARING A NEW PEN – TO BE DONE ONCE ONLY
STEP A Check the Pen

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

• Check Byetta in the cartridge. The liquid should be clear, colourless, and free from particles. If not, do not use the pen. Note: A small air bubble in the cartridge is normal.

STEP B Attach the needle

• Remove the paper shield from the outer needle cap.
• Attach the outer needle cap containing the needle straight onto the end of the pen, then rotate the needle until it is securely fastened.

• Remove the outer needle cap. Do not discard it. The outer needle cap will be used later to remove the needle from the pen after injection.

• Remove the inner needle cap and discard it. A small drop of liquid may appear. This is normal.

STEP C Select the dose

• Check that the symbol is visible in the dose window. If not, rotate the dose selector button clockwise until it stops and the symbol appears in the dose window.

• Pull out the dose selector button until it stops and the symbol appears in the dose window.

• Rotate the dose selector button clockwise until it stops at the symbol. Make sure the "10" with the line underneath is visible in the center of the dose window.

Note: If you cannot rotate the dose selector button clockwise to the symbol , see Frequently Asked Questions, number 9, in Section 4 of this User Manual.
STEP D Prepare the Pen

• Point the pen needle upwards and away from you.

PRESS AND HOLD

• Use your thumb to press the injection button steadily until it stops, then continue holding the injection button while counting slowly to 5.
• If you do not see a continuous stream (flow) or several drops of liquid from the needle tip, repeat the steps in Steps C and D.

• The pen preparation is complete when the symbol appears in the center of the dose window and you have seen a continuous stream (flow) or several drops of liquid from the needle tip.

Note: If you do not see liquid after 4 attempts, see Frequently Asked Questions, number 3, in Section 4 of this User Manual.
STEP E Complete the preparation of a New Pen

• Rotate the dose selector button clockwise until it stops and the symbol appears in the dose window.
• The preparation of a new pen is now complete. Do not repeat the instructions in Section 2 for daily use, otherwise you will use up the Byetta pen before the 30-day period.
• You are now ready to administer your first dose of Byetta.
• See Section 3, Step 3, for instructions on how to inject your first dose for daily use. Note: If you cannot rotate the dose selector button, see Frequently Asked Questions, number 9, in Section 4 of this User Manual.

Section 3. DAILY USE
Now that you have completed the preparation of a new pen, follow the instructions in Section 3 for all injections.
STEP 1 Check the Pen

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

• Check Byetta in the cartridge.
• The liquid should be clear, colourless, and free from particles. If not, do not use the pen.

Note: A small air bubble in the cartridge is not harmful and will not affect your dose.
STEP 2 Attach the needle

• Remove the paper shield from the outer needle cap.
• Attach the outer needle cap containing the needle straight onto the end of the pen, then rotate the needle until it is securely fastened.

• Remove the outer needle cap. Do not discard it. The outer needle cap will be used to remove the needle from the pen after injection.

• Remove the inner needle cap and discard it. A small drop of liquid may appear. This is normal. Note: If the needle is not securely attached, you may not be able to inject the full dose.

STEP 3 Select the dose

• Check that the symbol is visible in the dose window. If not, rotate the dose selector button clockwise until it stops and the symbol appears in the dose window.

• Pull out the dose selector button until it stops and the symbol appears in the dose window.

• Rotate the dose selector button clockwise until it stops at the symbol. Make sure the "10" with the line underneath is visible in the center of the dose window.

Note: If you cannot rotate the dose selector button clockwise to the symbol , see Frequently Asked Questions, number 9, in Section 4 of this User Manual.
STEP 4 Inject the dose

• Hold the pen firmly.
• Avoid pinching the skin tightly before injection. Insert the needle under the skin using the hygienically correct injection technique as taught by your healthcare provider.

PRESS AND HOLD

• Use your thumb to press the injection button steadily until it stops, then continue holding the injection button while counting slowly to 5 to deliver the full dose.
• Keep the injection button pressed while removing the needle from the skin to ensure the clear medication remains in the cartridge. See Frequently Asked Questions, number 4.

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

Note: If you see several drops of Byetta leaking from the needle after injection, the injection button was not pressed fully. See Frequently Asked Questions, number 5, in Section 4 of this User Manual.
STEP 5 Reset the pen

• Rotate the dose selector button clockwise until it stops and the symbol appears in the dose window.

Note: This must be done after every injection.
Note: If you cannot rotate the dose selector button or if the pen leaks, the full dose was not delivered. See Frequently Asked Questions, numbers 5 and 9, in Section 4 of this User Manual.
STEP 6 Remove and dispose of the needle

• Carefully replace the outer needle cap onto the needle.
• Remove the needle after each injection. This prevents leakage.

• Remove the needle.
• Replace the blue pen cap for storage.

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

STEP 7 Store the pen for the next injection

• Store Byetta properly. (For more information, see Storage of the Byetta Pen in Section 1 of this User Manual.)
• When it is time for your next daily dose, go to Section 3, Step 1, and repeat Steps 1 to 7.

Section 4. FREQUENTLY ASKED QUESTIONS

1. Should I follow the instructions in the “Preparing a New Pen” section before administering each dose?
   • No. The instructions in the “Preparing a New Pen” section must be performed only once, and only before first use of a new pen.
   • The purpose of preparation is to ensure the Byetta pen is ready for use over the next 30 days.
   • If you repeat the “Preparing a New Pen” instructions before each daily injection, you will not have enough Byetta for 30 days of injections. The small amount used during “Preparing a New Pen” does not affect the 30-day supply of Byetta doses.

2. Why are there air bubbles in the cartridge?

• A small air bubble is normal. It will not be harmful and will not 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 attempts during "Preparing a new pen"?

• Remove the needle, carefully replacing the outer needle cap. Remove and dispose of the needle properly.
• Attach a new needle and repeat the instructions in section "Preparing a new pen", Steps B to E, in Section 2 of this User Manual. When you see several drops or a continuous flow of liquid from the needle tip, the preparation is complete.

4. Why do I see particles in the cartridge after I have completed the injection?

After an injection, particles or discoloration may appear in the cartridge. This may occur if the skin was pinched too tightly or if the injection button is released before the needle is removed from the skin.

5. Why do I see Byetta leaking from the needle after I have completed the injection?

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

• You may not have received the full dose. Do not inject another dose. Contact your healthcare provider for instructions on what to do if you have an incomplete dose.
• To avoid this, for the next injection, press the injection button steadily and continue pressing it while slowly counting to 5 (see Section 3, Step 4: “Inject the dose”).

6. What do the arrows mean?

The arrows indicate that you are ready for the next step. The following arrows show the
direction for pulling out or rotating the dose selector button during the next step. The

symbol indicates that the dose selector button is pressed and the pen is ready to be
set again.

7. How can I tell when the injection has been completed?

The injection is complete when:

• You have steadily pressed the injection button all the way down until it stops and

• You have slowly counted to 5 while continuing to press the injection button and the needle is still in the skin and

• The symbol appears in the center of the dose window.

8. Where should I inject Byetta?

Byetta must be injected into the abdomen, thigh, or upper arm, using the injection technique as taught to you by your healthcare provider.
Front Back

9. What should I do if I cannot pull out, select, or press the dose selector button?
   Check the symbol in the dose window. Follow the instructions below to ensure the correct symbol appears.

If the symbol is visible in the dose window:

• Pull out the dose selector button until the symbol appears.

If the symbol is visible in the dose window and the dose selector button does not rotate:

• The cartridge in the Byetta pen may not contain enough liquid to deliver the full dose. A small amount of Byetta will always remain in the cartridge. If the cartridge contains only a small amount or appears empty, obtain a new Byetta pen.

If the symbol and part of the are visible in the dose window and the dose selector button cannot be pressed:

• The dose selector button was not fully rotated. Continue rotating the dose selector button clockwise until the symbol appears in the center of the dose window.

If part of the and part of the symbol are visible in the dose window and the dose selector button cannot be pressed:

• The needle may be blocked, bent, or incorrectly attached.
• Attach a new needle. Make sure the needle is attached straight and twisted fully into place.
• Press the dose button steadily all the way in. Byetta must come out of the needle tip.

If the symbol is visible in the dose window and the dose selector button does not rotate:

• The injection button was not pressed completely down, and the full dose was not administered. Contact your healthcare provider for advice on what to do if a dose was not fully delivered.

• Follow the instructions below to reset the pen for subsequent injections:

• Press the injection button steadily all the way in until it stops. Keep holding the injection button down and count slowly to 5. Then rotate the dose selector button clockwise until the symbol appears in the dose window.

• If you are unable to rotate the dose selector button, the needle may be blocked. Replace the needle and repeat the procedure described above.

• For the next injection, make sure to press steadily and keep pressing the injection button while counting slowly to 5 before removing the needle from the skin.

Read the Package Leaflet included in the package. For further information, contact your healthcare provider.