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TRULICITY 0.75mg 1.5mg 3mg 4.5mg solution for injection in pre-filled pen
Trulicity® 0.75 mg solution for injection in pre-filled pen
Trulicity® 1.5 mg solution for injection in pre-filled pen
Trulicity® 3 mg solution for injection in pre-filled pen
Trulicity® 4.5 mg solution for injection in pre-filled pen
1. What Trulicity is and what it is used for
2. What you need to know before you use Trulicity
3. How to use Trulicity
4. Possible side effects
5. How to store Trulicity
6. Contents of the pack and other information
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:
It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
Talk to your doctor, pharmacist or nurse before using Trulicity if:
Trulicity is not an insulin and should therefore not be used as a substitute for insulin.
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.
Trulicity can be used in children and adolescents aged 10 years and above. Data is not available in children below 10 years of age.
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.
It is not known if dulaglutide could harm your unborn child. Women who could become pregnant should use contraception during treatment with dulagutide. 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.
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.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
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.
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.
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 use more Trulicity than you should talk to your doctor immediately. Too much of this medicine may make your blood sugar too low (hypoglycaemia) and can make you feel sick or be sick.
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare: may affect up to 1 in 1,000 people
Not known: the frequency cannot be estimated from the available data
Very common: may affect more than 1 in 10 people
These side effects are usually not severe. They are most common when first starting dulaglutide but decrease over time in most patients.
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
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.
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 pen label and on the carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original packaging in order to protect from light.
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.
The active substance is dulaglutide.
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.
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.
Pack sizes of 2, 4 or multipacks of 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be available in your country.
For 0.75 mg only:
For 1.5 mg, 3 mg and 4.5 mg only:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in May 2023