The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 17901/0317.
Byetta 5 micrograms solution for injection, prefilled pen. Byetta 10 micrograms solution for injection, prefilled pen.
Byetta® 5 micrograms solution for injection in pre-filled pen
Byetta® 10 micrograms solution for injection in pre-filled pen
1. What Byetta is and what it is used for
2. What you need to know before you use Byetta
3. How to use Byetta
4. Possible side effects
5. How to store Byetta
6. 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.
Talk to your doctor, pharmacist, or diabetes nurse before using Byetta about the following:
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:
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.
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).
See the accompanying Pen User Manual for instructions for using the Byetta Pen.
Your doctor or nurse must teach you how to inject Byetta before you use it for the first time.
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.
Do not use an extra dose or increase the amount of your next dose to make up for the one you missed.
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.
Severe allergic reactions (anaphylaxis) have been reported rarely (may affect up to 1 in 1,000 people).
You should see your doctor immediately if you experience symptoms such as
Cases of inflammation of the pancreas (pancreatitis) have been reported (frequency not known) in patients receiving this medicine. Pancreatitis can be a serious, potentially life-threatening medical condition.
Very common side effects (may affect more than 1 in 10 people):
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.
Common side effects (may affect up to 1 in 10 people):
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.
Uncommon side effects (may affect up to 1 in 100 people):
Rare side effects (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data).
In addition some other side effects have been reported:
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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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°C – 8ºC). Once in use, keep your pen below 25ºC 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 waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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.
This leaflet was last revised in 07/2023
© AstraZeneca 2023
Byetta is a registered trademark of the AstraZeneca group of companies.
CV 23 0059
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Product name Reference number
Byetta 10 micrograms solution for injection in pre-filled pen 17901/0316
Byetta 5 micrograms solution for injection in pre-filled pen 17901/0317
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