Byetta
exenatide
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or diabetes nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor, pharmacist, or diabetes nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What Byetta is and what it is used for
What you need to know before you use Byetta
How to use Byetta
Possible side effects
How to store Byetta
Contents of the pack and other information
Byetta contains the active substance exenatide. It 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, thiazolidinediones and basal or long acting insulins. 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. The medicine in Byetta helps your body to increase the production of insulin when your blood sugar is high.
If you are allergic to exenatide or any of the other ingredients of this medicine (listed in
section 6).
Talk to your doctor, pharmacist, or diabetes nurse before using Byetta about the following:
Using this medicine in combination with a sulphonylurea, as low blood sugar (hypoglycaemia)
can occur. Ask your doctor, pharmacist, or diabetes nurse if you are not sure if any of your other
medicines contain a sulphonylurea.
If you have type 1 diabetes or diabetic ketoacidosis (a dangerous condition that can occur in
diabetes), as you should not use this medicine.
How to inject this medicine. It should be injected under the skin and not into a vein or into the
muscle.
If you have severe problems with slow stomach emptying or food digestion, as the use of this
medicine is not recommended. The active substance in this medicine slows stomach emptying so
food passes more slowly through your stomach.
If you have ever had inflammation of the pancreas (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 cause problems such as gallstones.
If you have severe kidney disease or you are on dialysis, as the use of this medicine is not
recommended. There is little experience with this medicine in patients with kidney problems
Byetta is not an insulin and should therefore not be used as a substitute for insulin.
Do not give this medicine to children and adolescents less than 18 years as there is no experience with this medicine in this age group.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, particularly:
medicines that are used to treat type 2 diabetes that work like Byetta (e.g. liraglutide and
prolonged-release exenatide), as taking these medicines with Byetta is not recommended.
medicines used to thin the blood (anticoagulants), e.g. warfarin, as you will require additional
monitoring of changes in INR (measurement of blood thinning) during initiation of therapy with
this medicine.
Ask your doctor if the time at which you take any tablets should be changed because this medicine slows stomach emptying and can affect medicines that need to pass through the stomach quickly, e.g.
Stomach resistant tablets or capsules (e.g. medicines that reduce stomach acid (proton pump
inhibitors)) that should not stay too long in your stomach, may need to be taken an hour before,
or four hours after this medicine.
Some antibiotics may need to be taken an hour before your Byetta injection.
For tablets that you need to take with food, it may be best if they are taken at a meal at a time
when this medicine is not being administered.
Use this medicine at any time within the 60 minutes (1 hour) before your meal. (See section 3 “How to use Byetta”). Do not use this medicine after your meal.
It is not known if this medicine may harm your unborn child. If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as it should not be used during pregnancy.
It is not known if exenatide passes into your milk. This medicine should not be used if breast-feeding.
If you use this medicine in combination with a sulphonylurea or insulin, 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 using machines).
Metacresol may cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you. Check with your doctor, pharmacist, or diabetes nurse if you are not sure.
Two strengths of Byetta are available: Byetta 5 micrograms and Byetta 10 micrograms. Your doctor may tell you to use Byetta 5 micrograms twice a day to start with. After using Byetta 5 micrograms twice a day for 30 days the doctor may increase your dose to Byetta 10 micrograms twice a day.
If you are over 70 years old or have problems with your kidneys it may take longer than 30 days to tolerate the Byetta 5 micrograms dose and so your doctor may not increase your dose.
One injection of your pre-filled pen will give you your dose. Do not change your dose unless your doctor has told you to.
You should inject this medicine 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 this medicine after your meal.
You should inject this medicine under the skin (subcutaneous injection) of your upper leg (thigh), stomach area (abdomen), or upper arm. If you are using Byetta and an insulin you must make two separate injections.
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 or an insulin your doctor may tell you to check your blood sugar levels to adjust the dose of sulphonylurea or insulin. If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend that you monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
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 suitable to use with the Byetta pen. Injection needles are not included.
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 of this medicine than you should, talk to a doctor or go to a hospital right away. Using too much of this medicine can cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).
If you miss a dose of this medicine, skip that dose and use your next dose at the next prescribed time.
If you feel you should stop using this medicine, consult your doctor first. If you stop using this medicine this can affect your blood sugar levels.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or diabetes nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should see your doctor immediately if you experience symptoms such as
Swelling of the face, tongue or throat (angioedema)
Rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat
Difficulty to swallow
Hives and difficulties to breathe
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 this medicine.
STOP taking this medicine and contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).
nausea, (nausea is most common when first starting this medicine, but decreases over time in most patients)
vomiting
diarrhoea
hypoglycaemia
When this medicine is used with a medicine that contains a sulphonylurea or an insulin, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur very commonly. The dose of your sulphonylurea or insulin medicine may need to be reduced while you use this medicine. 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.
dizziness
headache
feeling jittery
32
constipation
pain in the stomach area
bloating
indigestion
itching (with or without rash)
flatulence (passing gas)
increased sweating
loss of energy and strength
heartburn
reduced appetite
This medicine 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 cause problems such as gallstones.
decreased in kidney function
dehydration, generally associated with nausea, vomiting and/or diarrhoea
unusual taste in the mouth
burping
injection site reactions (redness)
sleepiness
hair loss
weight decreased
a delay in the emptying of the stomach
intestinal obstruction (blockage in intestine)
bleeding or bruising more easily than normal due to low level of blood platelets.
changes in INR (measurement of blood thinning) have been reported when used together with warfarin.
If you get any side effects, talk to your doctor, pharmacist or diabetes nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the label and the carton after ‘EXP’. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ºC – 8 ºC). Once in use, keep your pen below 25 ºC for 30 days. Dispose of a used pen after 30 days, even if some medicine remains in the pen.
Replace the cap on the pen in order to protect from light. Do not freeze. Throw away any Byetta pen that has been frozen.
Do not use this medicine if you notice particles in the solution, or if it is cloudy or coloured.
Do not store the pen with the needle attached. If the needle is left on, medicine may leak from the pen or air bubbles may form in the cartridge.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is exenatide.
Two pre-filled pens are available. One to deliver doses of 5 micrograms and one 10 micrograms.
Each dose of Byetta 5 micrograms solution for injection (injection) contains 5 micrograms
exenatide in 20 microlitre.
Each dose of Byetta 10 micrograms solution for injection (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 (see section 2).
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.
Byetta is available in pack sizes of 1 and 3 pre-filled pens. Not all pack sizes may be marketed.
AstraZeneca AB
SE-151 85 Södertälje Sweden
AstraZeneca AB
Global External Sourcing (GES) Astraallén
Gärtunaporten (B 674:5)
SE-151 85 Södertälje
Sweden
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB AstraZeneca Lietuva Tel: +370 5 2660550
АстраЗенека България ЕООД
Тел.: +359 24455000
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111
Associated Drug Co. Ltd
Tel: +356 2277 8000
AstraZeneca BV
Tel: +31 79 363 2222
AstraZeneca
Tel: +372 6549 600
AstraZeneca AS
Tlf: +47 21 00 64 00
AstraZeneca A.E.
Τηλ: +30 210 6871500
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0
AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00
AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
AstraZeneca
Tél: +33 1 41 29 40 00
AstraZeneca Produtos Farmacêuticos, Lda.
Tel: +351 21 434 61 00
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41
AstraZeneca Pharmaceuticals (Ireland) Ltd
Tel: +353 1609 7100
AstraZeneca UK Limited
Tel: +386 1 51 35 600
Vistor hf.
Sími: +354 535 7000
AstraZeneca S.p.A. Tel: +39 02 9801 1
AstraZeneca Oy
Puh/Tel: +358 10 23 010
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305
AstraZeneca AB
Tel: +46 8 553 26 000
SIA AstraZeneca Latvija
Tel: +371 67377100
AstraZeneca UK Ltd
Tel: +44 1582 836 836
Read these instructions carefully BEFORE using your Byetta pen. 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.
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.
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 Section 2 only to set up a new pen before first use.
Section 3 of this manual should be used for every injection.
Your Byetta pen is suitable for use with Becton, Dickinson and Company pen injection needles.
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.
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.
Store in a refrigerator (2 ºC to 8 ºC).
Do not freeze. Throw away any Byetta pen that has been frozen.
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 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.
Use a Byetta pen for only 30 days after setting up a new pen for first use.
Mark the date when you first used your pen and the date 30 days later in the spaces below:
Do not use Byetta after the expiry date, which is stated on the label and the carton after ‘EXP’.
The expiry date refers to the last date of that month.
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.
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.
Blue Pen Cap Cartridge Byetta Liquid
Label Dose Window
Dose Knob
Injection Button
(Needles Not Included)
ready to pull dose knob out ready to turn to dose position
ready to inject 5 micrograms (mcg)
Outer Needle Shield
Inner Needle Shield
Needle Paper Tab
dose knob pushed in and ready to reset
Wash hands prior to use.
Check pen label to make sure it is your 5 microgram 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.
Remove paper tab from outer needle shield.
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.
Check that theis 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.
Note: If you cannot turn the dose knob clockwise to the , see Commonly Asked Questions, number 9, in Section 4 of this user manual.
Point the needle of the pen up and away from you.
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.
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.
Now that you have done the New Pen Setup, follow Section 3 for all of your injections.
Wash hands prior to use.
Check pen label to make sure it is your 5 microgram 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.
Remove paper tab from outer needle shield.
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.
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.
Note: If you cannot turn the dose knob clockwise to the , see Commonly Asked Questions, number 9, in Section 4 of this user manual.
Grip pen firmly.
Avoid tightly pinching the skin before injecting. Insert needle into skin using hygienic injection technique recommended by your healthcare professional.
Keep the pressure on the injection button as you remove the needle from your skin, this keeps the medication in the cartridge clear. See Commonly Asked Question 4.
| Injection is complete when the | is in the centre of the dose window. |
| The pen is now ready to reset. |
Turn dose knob clockwise until it stops and the is in the dose window.
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.
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.
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.
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.
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.
Particles or discolouration may appear in the cartridge after an injection. This may happen if the skin
is pinched too tightly or if the pressure on the injection button is released before the needle is removed from the skin.
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).
The arrows mean you are ready for the next step. These arrows show the direction to pull or turn the dose knob in the next step. This symbol means the dose knob is pushed in and the pen is ready to reset.
The injection is complete when:
You have firmly pushed the injection button in all the way until it stops and
The is in the centre of the dose window.
Byetta should be injected into your abdomen, thigh, or upper arm using the injection technique
recommended by your healthcare professional. Front Back
Check the symbol in the dose window. Follow the steps next to the matching symbol.
Pull the dose knob out until appears.
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.
The dose knob was not turned all the way. Continue turning the dose knob clockwise until
is in the centre of the dose window.
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.
The injection button was not pushed in all the way and a complete dose was not delivered.
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 button in 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 repeat the 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.
Read these instructions carefully BEFORE using your Byetta pen. 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.
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.
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 Section 2 only to set up a new pen before first use.
Section 3 of this manual should be used for every injection.
Your Byetta pen is suitable for use with Becton, Dickinson and Company pen injection needles.
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.
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.
Store in a refrigerator (2 ºC to 8 ºC).
Do not freeze. Throw away any Byetta pen that has been frozen.
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 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.
Use a Byetta pen for only 30 days after setting up a new pen for first use.
Mark the date when you first used your pen and the date 30 days later in the spaces below:
Do not use Byetta after the expiry date, which is stated on the label and the carton after ‘EXP’.
The expiry date refers to the last date of that month.
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.
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.
Blue Pen Cap Cartridge Byetta Liquid
Label Dose Window
Dose Knob
Injection Button
(Needles Not Included)
ready to pull dose knob out ready to turn to dose position
ready to inject 10 micrograms (mcg)
Outer Needle Shield
Inner Needle Shield
Needle Paper Tab
dose knob pushed in and ready to reset
Wash hands prior to use.
Check pen label to make sure it is your 10 microgram 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.
Remove paper tab from outer needle shield.
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.
Check that theis 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.
Note: If you cannot turn the dose knob clockwise to the , see Commonly Asked Questions, number 9, in Section 4 of this user manual.
Point the needle of the pen up and away from you.
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.
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.
Now that you have done the New Pen Setup, follow Section 3 for all of your injections.
Wash hands prior to use.
Check pen label to make sure it is your 10 microgram 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.
Remove paper tab from outer needle shield.
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.
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.
Note: If you cannot turn the dose knob clockwise to the , see Commonly Asked Questions, number 9, in Section 4 of this user manual.
Grip pen firmly.
Avoid tightly pinching the skin before injecting. Insert needle into skin using hygienic injection technique recommended by your healthcare professional.
Keep the pressure on the injection button as you remove the needle from your skin, this keeps the medication in the cartridge clear. See Commonly Asked Question 4.
| Injection is complete when the | is in the centre of the dose window. |
| The pen is now ready to reset. |
Turn dose knob clockwise until it stops and the is in the dose window.
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.
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.
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.
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.
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.
Particles or discolouration may appear in the cartridge after an injection. This may happen if the skin
is pinched too tightly or if the pressure on the injection button is released before the needle is removed from the skin.
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).
The arrows mean you are ready for the next step. These arrows show the direction to pull or turn the dose knob in the next step. This symbol means the dose knob is pushed in and the pen is ready to reset.
The injection is complete when:
You have firmly pushed the injection button in all the way until it stops and
The is in the centre of the dose window.
Byetta should be injected into your abdomen, thigh, or upper arm using the injection technique
recommended by your healthcare professional. Front Back
Check the symbol in the dose window. Follow the steps next to the matching symbol.
Pull the dose knob out until appears.
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.
The dose knob was not turned all the way. Continue turning the dose knob clockwise until
is in the centre of the dose window.
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.
The injection button was not pushed in all the way and a complete dose was not delivered.
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 button in 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 repeat the 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.