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Bydureon

exenatide
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Bydureon. It does not contain all the information that is known about Bydureon. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What BYDUREON is used for

BYDUREON is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus.
It is used with metformin or sulfonylureas. It may also be used with a combination of metformin and sulfonylureas.
Ask your doctor or healthcare professional if you are not sure whether your antidiabetic medicine contains sulfonylurea.
Diabetes mellitus is a condition in which your pancreas does not produce enough insulin to control your blood sugar level. BYDUREON helps your body to increase production of insulin when your blood sugar is high.
BYDUREON is not a substitute for insulin in patients who require insulin treatments for their diabetes.
This medicine has not been studied in children.
This medicine is only available with a doctor's prescription.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you use BYDUREON

When you must not use it

Do not use BYDUREON if:
you have type 1 diabetes or diabetic ketoacidosis (often caused by very high blood glucose levels)
you are allergic to exenatide or any of the ingredients listed at the end of this leaflet
you have severe kidney problems or you are on dialysis
Do not use BYDUREON after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
Return the product to your pharmacist if it has expired or is damaged.
Talk to your doctor if you are not sure whether you should start using BYDUREON.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
kidney problems
high blood pressure or other heart problems
high cholesterol and triglycerides (a lipid disorder involving too many fatty acids in the blood stream)
pancreatitis
gall stones
inflammation of the gall bladder (cholecystitis)
alcohol abuse
Tell your doctor if you have severe problems with your stomach or food digestion.
BYDUREON slows stomach emptying so food passes more slowly through your stomach.
Tell your doctor if you are pregnant or plan to become pregnant.
Use of this medicine in pregnancy is limited. Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you are breast-feeding or plan to breast-feed.
It is not known if this medicine passes into your breast milk. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell them before you start using this medicine.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by BYDUREON or may affect how it works. You may need different amounts of your medicines or you may need to take different medicines.
These include:
warfarin, a medicine used to prevent blood clots. Taking BYDUREON while you are taking warfarin may cause you to bleed more easily
angiotensin converting enzyme inhibitors, medicines used to treat high blood pressure and other heart conditions
nonsteroidal anti-inflammatory medicines
diuretics, medicines used to treat fluid retention and high blood pressure. Taking BYDUREON while you are taking these medicines may affect your kidneys
orlistat, a weight loss medicine
opioids, a narcotic commonly used as a pain killer
anticholinergics, a type of medicine used to relieve stomach cramps or spasms, to treat travel sickness and to treat Parkinson's disease
when using BYDUREON in combination with sulfonylureas, you may need to adjust the dose of the sulfonylurea to avoid hypoglycaemia
use of BYDUREON with insulins or other GLP-1 agonists (e.g. BYETTA) is not recommended
Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

How to use BYDUREON

Carefully follow all the directions given to you by your doctor or health care professional.
They may differ from the information contained in this leaflet.

How to use it

BYDUREON is a powder that must be mixed with a diluent (solvent) before use. Only mix BYDUREON with the diluent if the diluent is clear and free of particles.
Once you have mixed BYDUREON with the diluent, the mixture should be white to off white and cloudy.
BYDUREON must be injected immediately after mixing with the diluent.
BYDUREON comes as either a kit containing a vial and syringe or a dual-chamber pen. Your health care professional should teach you how to use the BYDUREON kit or pen.
Read the User Manual for information on how to use the BYDUREON kit or pen before beginning therapy.
Read the User Manual each time you get a new kit or pen, in case something has changed.
Refer to the User Manual each time you inject this medicine.
Use a new injection needle for each injection and dispose of it after each use.
This medicine is for you; never share BYDUREON with others.
If you do not understand the User Manual, ask your doctor or health care professional for help.

How much to use

Each BYDUREON kit or pen contains a single 2 mg dose. The whole dose should be mixed with the diluent for each injection. BYDUREON needs to be injected only once per week.
Use BYDUREON exactly as prescribed by your doctor.

When to use it

Inject BYDUREON once a week, at any time of the day, with or without meals.
You may wish to choose a specific day of the week that will be your BYDUREON injection day.

How long to use it

Do not stop using BYDUREON unless your doctor tells you to.

If you forget to use it

If you miss a dose of BYDUREON, you should take it as soon as you notice.
The next weekly dose can be taken on the preferred day of the week as long as it is at least one day after the last dose taken.
Do not take an extra dose or increase the amount of your next dose to make up for the one you missed.
If you are not sure if you have taken your entire dose, do not inject another dose of BYDUREON. Wait until your next weekly dose is due.
Ask your healthcare professional if you are not sure what to do.
If you have trouble remembering to use your medicine, ask your doctor or healthcare professional for some hints.

If you take too much (overdose)

If you take too much BYDUREON, immediately call your doctor or the Poisons Information Centre (telephone AU: 13 11 26, NZ: 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital.
Symptoms of an overdose may include nausea, vomiting, dizziness, or symptoms of low blood sugar. You may need urgent medical attention.

While you are using BYDUREON

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using BYDUREON.
Tell any other doctors, dentists and health care professionals who treat you that you are using this medication.
If you are going to have surgery, tell the surgeon or anaesthetist that you are using this medicine.
It may affect other medicines used during surgery.
If you become pregnant while using this medicine, tell your doctor immediately.
Make sure all friends, relatives, workmates or carers know that you have diabetes.
Tell your doctor if you experience hypoglycaemia (low blood sugar levels).
When BYDUREON is used with a medicine that contains sulfonylurea, hypoglycaemia can occur. The dose of your sulfonylurea medicine may need to be reduced while you use BYDUREON.
Some symptoms of hypoglycaemia are:
drowsiness
weakness
confusion
irritability
hunger
fast heartbeat
sweating
If you are experiencing any of these symptoms of hypoglycaemia, immediately eat some sugary food or have a drink, e.g. lollies, biscuits or fruit juice.
Tell your doctor if you have trouble recognising the symptoms of hypoglycaemia.
Under certain conditions, the early warning signs of hypoglycaemia can be different or less obvious.
Tell your doctor, diabetes education nurse or pharmacist if you are travelling.
You may not be able to get BYDUREON in the country you are visiting.
Ask your doctor for a letter explaining why you are taking injecting devices with you.
Each country you visit will need to see this letter, so you should take several copies.
Your doctor, diabetes education nurse or pharmacist can provide you with some helpful information.

Things you must not do

Do not stop using your medicine or change your dosage unless your doctor tells you to.
Do not use the medicine if you think it has been frozen or exposed to excessive heat.
It will not work as it should.
Do not use this medicine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Tell your doctor if you drink alcohol.
Alcohol may mask the symptoms of hypoglycaemia, or make it worse.
Be careful driving or operating machinery.
If you use BYDUREON in combination with sulfonylureas, hypoglycaemia can occur. Hypoglycaemia may reduce your ability to concentrate.

Side effects

Tell your doctor or healthcare professional as soon as possible if you do not feel well while you are using BYDUREON.
BYDUREON helps most people with type 2 diabetes, but it may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Ask your doctor or healthcare professional to answer any questions you may have.
When BYDUREON is used with a medicine that contains sulfonylurea, hypoglycaemia can occur.
Tell your doctor if you experience hypoglycaemia.
Tell your doctor if you notice any of the following:
nausea
vomiting
diarrhoea
constipation
dizziness or light headedness
headache
feeling jittery
acid stomach
abdominal pain or distension
loss of energy and strength
redness, swelling or itching at the injection site (local allergy)
a lump or hardening under the skin at the injection site
indigestion (dyspepsia)
excessive sweating (hyperhidrosis)
mood changes
flu-like symptoms
bone or muscle pain
These are the more common side effects of BYDUREON. Mostly these are mild and short-lived.
BYDUREON may reduce your appetite. Nausea and vomiting were very commonly reported in patients using BYDUREON. Mostly these were mild to moderate and short-lived. In most patients who initially experienced nausea, the frequency and severity decreased with continued therapy.
You may experience dehydration as a result of nausea, vomiting and/or diarrhoea. Some symptoms of mild to moderate dehydration are:
dry mouth
decreased frequency of urination and concentrated urine
headache
muscle weakness
dizziness or light headedness
Drink plenty of fluids if you are experiencing any of these symptoms. Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you continue to experience these symptoms.
Tell your doctor immediately if you notice any of the following:
passing little or no urine
taste disturbance or loss of taste
sleepiness or drowsiness
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
stomach discomfort relieved by belching or passing wind
constipation
itching
hives, pinkish, itchy swellings on the skin, itchy rash
red raised skin rash
bleeding more easily than normal, if you are taking warfarin
These are rare or very rare side effects of BYDUREON. The above list includes serious side effects which may require medical attention.
Tell your doctor immediately if you are experiencing any of the following:
severe abdominal pain and
vomiting and/or
diarrhoea and/or
nausea
These can be symptoms of acute pancreatitis which has been reported rarely in patients taking BYDUREON.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Tell your doctor if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.

After using BYDUREON

Storage

Keep BYDUREON in the refrigerator where the temperature stays between 2-8°C. Do not freeze. Do not use BYDUREON if it has been frozen.
Keep this medicine where children cannot reach it.
Each BYDUREON kit or pen contains one dose, you should use the full dose each time you inject.
Use a new BYDUREON kit or pen for each injection.
BYDUREON can be kept out of the refrigerator (below 30°C) for a total of 4 weeks.
Discard the used BYDUREON components, including the needle, immediately after use.
Ask your pharmacist how to discard BYDUREON.
BYDUREON is for use in a single patient only.

Disposal

Dispose of your syringe or pen with the needle still attached into a yellow plastic sharps container or similar puncture proof container composed of hard plastic or glass.
Ask your doctor, nurse or pharmacist where you can dispose of the container when it is full.
If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

BYDUREON powder is white to off white. The diluent is a clear colourless to pale yellow to pale brown liquid. When mixed together, the solution is white to off white and cloudy.
BYDUREON Kit
BYDUREON is supplied in a kit containing a vial of exenatide powder, a syringe of diluent (solvent), an adapter and 2 needles (1 spare). Each kit contains dosing for 1 week of treatment as a single dose.
BYDUREON Pen
BYDUREON is supplied in a dual-chambered pen containing exenatide powder in one chamber and diluent (solvent) in the other chamber for suspension.
Each pre-filled pen is provided with one custom needle. Each pack also contains one spare needle.
Each pen contains dosing for 1 week of treatment as a single dose.
BYDUREON is available in packs of 4 single dose kits, 4 single dose pens or 1 single dose pen.

Ingredients

BYDUREON powder contains 2 mg of exenatide as the active ingredient. It also contains lactic-glycolic copolymer and sucrose.
The diluent contains:
carmellose sodium
sodium chloride
polysorbate 20
monobasic sodium phosphate monohydrate
dibasic sodium phosphate (as heptahydrate)
sodium hydroxide (pen only)
water for injection

Suppliers

Supplied in Australia by
AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
NORTH RYDE NSW 2113
Supplied in New Zealand by
AstraZeneca Limited
Auckland
For all enquiries contact AstraZeneca by calling 1800 805 342 (Australia) or 09 306 5650 (New Zealand)

Australian Registration Number:

The Australian Registration Numbers for BYDUREON 2 mg are:
BYDUREON Kit - AUST R 175504
BYDUREON Pen - AUST R 235962

Further information

Your food and exercise plan, along with your periodic blood sugar testing and scheduled A1C (also known as HbA1C) checks, will continue to be important in managing your diabetes while you are taking BYDUREON.
You can get more information about diabetes from:
Diabetes Australia
free call helpline 1300 136 588
www.diabetesaustralia.com.au
Diabetes New Zealand
toll free helpline 0800 342 238
www.diabetes.org.nz
 
This leaflet was prepared in June 2015.
 
BYDUREON® is a registered trademark of the AstraZeneca group of companies.
 
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