Patient leaflet - Trulicity 0.75 mg solution for injection in Pre Filled pen
What Trulicity is and what it is used for
Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in adults and children aged 10 years and above, with type 2 diabetes mellitus and can help prevent heart disease.
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
When this happens, sugar (glucose) builds up in the blood.
Trulicity is used:
- on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can’t take metformin (another diabetes medicine).
- or with other medicines for diabetes when they are not enough to control your blood sugar levels. These other medicines may be medicines taken by mouth and/or insulin given by injection.
It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
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What you need to know before you use Trulicity
Do not use Trulicity
- if you are allergic to dulaglutide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Trulicity if:
- you are on dialysis as this medicine is not recommended.
- you have type 1 diabetes (the type when your body does not produce any insulin) as this medicine may not be right for you.
- you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin). The signs include rapid weight loss, feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
you have severe problems with food digestion or food remaining in your stomach for longer than normal (including gastroparesis).
- you have ever had pancreatitis (inflammation of the pancreas which causes severe pain in the stomach and back which does not go away; see section 4).
- you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) can occur. Your doctor may need to change your dose of these other medicines to reduce this risk.
Trulicity is not an insulin and should therefore not be used as a substitute for insulin.
Symptoms, sometimes severe, of delayed emptying of stomach contents such as feeling of fullness, nausea and/or vomiting have been reported in patients using Trulicity. Tell your doctor if you develop severe problems with your stomach emptying that will not go away while using Trulicity.
If you know that you are due to have surgery where you will be under anaesthesia (sleeping), please tell your doctor that you are using Trulicity.
When initiating treatment with Trulicity, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and/or diarrhoea which may lead to a decrease in kidney function. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.
Children and adolescents
Trulicity can be used in children and adolescents aged 10 years and above. Data is not available in children below 10 years of age.
Other medicines and Trulicity
Because Trulicity can slow stomach emptying which could affect other medicines, tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicine.
Pregnancy
It is not known if dulaglutide could harm your unborn child. Women who could become pregnant should use contraception during treatment with dulaglutide. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as Trulicity should not be used during pregnancy. Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Breast-feeding
Talk to your doctor if you would like to or are breast-feeding before taking this medicine. Do not use Trulicity if you are breast-feeding. It is not known if dulaglutide passes into human breast milk.
Driving and using machines
Trulicity has no to little effect on the ability to drive or use machines. However, if you use Trulicity in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for information on increased risk of low blood sugar and section 4 for the warning signs of low blood sugar. Talk to your doctor for further information.
Trulicity contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
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How to use Trulicity
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.
Adults
Your doctor may recommend a dose of 0.75 mg once a week for the treatment of your diabetes when Trulicity is used alone.
When used with other medicines for diabetes, your doctor may recommend a dose of 1.5 mg once a week.
If your blood sugar is not controlled well enough, your doctor may increase your dose to 3 mg once a week.
If further blood sugar control is needed the dose may be increased again to 4.5 mg once a week.
Children and adolescents
The starting dose for children and adolescents aged 10 years and above is 0.75 mg once a week. If your blood sugar is not controlled well enough after at least 4 weeks, your doctor may increase your dose to 1.5 mg once a week.
Each pen contains one weekly dose of Trulicity (0.75 mg, 1.5 mg, 3 mg or 4.5 mg). Each pen delivers only one dose.
You can use your pen at any time of the day, with or without meals. You should use it on the same day each week if you can. To help you remember, you may wish to tick the day of the week when you inject your first dose on the box that your pen comes in, or on a calendar.
Trulicity is injected under the skin (subcutaneous injection) of your stomach area (abdomen) or upper leg (thigh). If the injection is given by someone else, they may inject in your upper arm.
If you want to do so, you can use the same area of your body each week. But be sure to choose a different injection site within that area.
It is important that you test your blood glucose levels as instructed by your doctor, pharmacist or nurse, if you are taking Trulicity with a sulphonylurea or insulin.
Read the “Instructions for Use” for the pen carefully before using Trulicity.
If you forget to use Trulicity
If you forget to inject a dose, and if there are at least 3 days before your next dose is due, then inject your dose as soon as possible. Inject your next dose on your regular scheduled day.
If there are less than 3 days before your next dose is due, skip the dose and inject the next one on your regular scheduled day.
Do not use a double dose to make up for a forgotten dose.
You can also change the day of the week on which you inject Trulicity if necessary, as long as it has been at least 3 days since your last dose of Trulicity.
If you stop using Trulicity
Do not stop using Trulicity without talking with your doctor. If you stop using Trulicity, your blood sugar levels can increase.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe side effects
Rare: may affect up to 1 in 1,000 people
- Severe allergic reactions (anaphylactic reactions, angioedema). You should see a doctor immediately if you experience symptoms such as rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat, hives and difficulties breathing.
Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. This is a serious, potentially life-threatening condition.
You should see a doctor immediately if you experience such symptoms.
Stop using this medicine and seek urgent medical help if you experience:
- Severe, persistent pain in the stomach area (abdomen), with or without nausea and vomiting. This could be a sign of acute pancreatitis, which is serious and potentially life-threatening.
Not known: the frequency cannot be estimated from the available data
- Bowel obstruction – a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting. You should see a doctor immediately if you experience such symptoms.
Other side effects
Very common: may affect more than 1 in 10 people
- Feeling sick (nausea) – this usually goes away over time
- Being sick (vomiting) – this usually goes away over time
- Diarrhoea – this usually goes away over time
- Stomach (abdominal) pain.
These side effects are usually not severe. They are most common when first starting dulaglutide but decrease over time in most patients.
- Low blood sugar (hypoglycaemia) is very common when dulaglutide is used with medicines that contain metformin, a sulphonylurea and/or insulin. If you are taking a sulphonylurea or insulin, the dose may need to be lowered while you use dulaglutide.
- Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to treat low blood sugar.
Common: may affect up to 1 in 10 people
Low blood sugar (hypoglycaemia) is common when dulaglutide is used alone, or with both metformin and pioglitazone together, or with a sodium-glucose co-transporter 2 inhibitor (SGLT2i) with or without metformin.
For a list of possible symptoms, see above under very common affects.
- Feeling less hungry (decreased appetite)
- Indigestion
- Constipation
- Gas (flatulence)
- Bloating of the stomach
- Reflux or heartburn (also called gastroesophageal reflux disease - GERD) - a disease caused by stomach acid coming up into the tube from your stomach to your mouth
- Burping
- Feeling tired
- Increased heart rate
- Slowing of the electrical currents in the heart
Uncommon: may affect up to 1 in 100 people
- Injection site reactions (e.g. rash or redness)
Allergic reactions (hypersensitivity) (e.g. swelling, raised itchy skin rash (hives))
Rare: may affect up to 1 in 1,000 people
- A delay in the emptying of the stomach
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: 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.
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How to store Trulicity
- Keep this medicine out of the sight and reach of children.
- Store in a refrigerator (2°C - 8°C). Do not freeze.
- Store in the original packaging in order to protect from light.
- Do not use this medicine after the expiry date which is stated on the pen label and on the carton after EXP. The expiry date refers to the last day of that month.
- Trulicity can be taken out of the fridge for up to 14 days at a temperature not above 30°C.
- Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.
- 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.
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Contents of the pack and other information
What Trulicity contains
The active substance is dulaglutide.
- Trulicity 0.75 mg: Each pre-filled pen contains 0.75 mg of dulaglutide in 0.5 ml solution.
The other ingredients are sodium citrate (see section 2 under ‘Trulicity contains sodium’ for further information); citric acid; mannitol; polysorbate 80 and water for injections.
What Trulicity looks like and contents of the pack
Trulicity is a clear, colourless, solution for injection in a pre-filled pen. Each pre-filled pen contains 0.5 ml solution.
The pre-filled pen is for single use only.
Trulicity comes in a pack of 4 pre-filled pens containing 0.5 ml solution.
Manufacturer and Licence Holder
Manufactured by Lilly France, 2, Rue du Colonel Lilly, 67640 Fegersheim, France and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM
PL 15184/2648 Trulicity 0.75 mg solution for injection in pre‐filled pen
Trulicity is a registered trademark of Eli Lilly and company.
For any information about this medicine, please contact the Product Licence Holder: Lexon UK Limited, Tel: 01527 505414.
Leaflet revision date: 27/05/2026
Blind or partially sighted? Is this leaflet hard to see or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet in a format suitable for you
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