0.75 mg, 1.5 mg, 3 mg, and 4.5 mg solution for injection in a pre-filled pen
dulaglutide
What Trulicity is and what it is used for
Trulicity contains an active substance called dulaglutide. It is used to lower blood sugar ( glucose ) in adults with type 2 diabetes and may help prevent heart disease.
In type 2 diabetes, your body does not produce enough insulin, and the insulin your body produces does not work as well as it should. When this happens, the sugar ( glucose ) accumulates in the blood.
Trulicity is used:
– alone if your blood sugar is not well controlled with diet and exercise alone and you cannot take metformin (another diabetes medicine).
– or together with other medicines against diabetes when these are not enough to control your blood sugar level. The other medicines can be those that are taken by mouth and/or the insulin that you take by injection.
You must continue to follow the advice on diet and exercise that you receive from the doctor, pharmacist, or nurse.
What you need to know before using Trulicity
Do not use Trulicity
– if you are allergic to dulaglutide or any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Trulicity if:
– You are receiving dialysis because this medicine is not recommended.
– You have type 1 diabetes (the type where the body does not produce any insulin ) and this medicine may not be suitable for you.
– You have diabetic ketoacidosis (a complication of diabetes that occurs when the body cannot break down glucose because there is not enough insulin ). Signs of this are rapid weight loss, nausea or vomiting, a sweet-smelling breath, a sweet or metallic taste in your mouth, or a different smell to your urine or sweat.
– You have severe indigestion or problems with food staying in the stomach longer than normal (including gastroparesis).
– You have had pancreatitis (inflammation of the pancreas), which causes severe pain in the stomach and back that does not go away.
– You take a sulphonylurea or insulin for your diabetes because you can get low blood sugar (hypoglycemia). Your doctor may need to change the dose of one of these other medicines to reduce the risk of this.
Trulicity is not insulin and therefore should not be used as a substitute for insulin.
When you start treatment with Trulicity, in some cases you may experience fluid loss/dehydration, e.g. in case of vomiting, nausea, and/or diarrhea which can lead to reduced kidney function. It is important to avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.
When you start treatment with Trulicity, in some cases you may experience fluid loss/dehydration, e.g. in case of vomiting, nausea, and/or diarrhea which can lead to reduced 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 young people
Trulicity is not recommended for children and adolescents under 18 years of age as it has not been studied in these patients.
Other medicines and Trulicity
As Trulicity may decrease the rate of gastric emptying, which in turn may affect other medicines, tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
It is not known whether dulaglutide can harm your unborn baby. Women of childbearing potential should use contraception during treatment with dulaglutide. Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, as Trulicity should not be used during pregnancy. Talk to your doctor about how best to control your blood sugar when you’re pregnant.
Talk to your doctor before taking this medicine if you want to breastfeed or are already breastfeeding. Trulicity should not be used if you are breastfeeding. It is not known whether dulaglutide passes into breast milk.
Driving ability and use of machinery
Trulicity has little or no effect on the ability to drive or use machines. However, if you use Trulicity with a sulphonylurea or insulin, you may experience low blood sugar (hypoglycemia), which may impair your ability to concentrate. Avoid driving any vehicle or using machinery if you get signs of low blood sugar. See section 2, “Warnings and precautions”, for information about the increased risk of low blood sugar, and section 4 for warning signs of low blood sugar. Talk to your doctor if you need more information.
Trulicity contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost ‘sodium-free’.
How to use Trulicity
Always use this medicine as directed by your doctor or pharmacist. Ask 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 your diabetes treatment. This is based on your individual needs, or if Trulicity is used alone.
When used alone, the doctor recommends a dose of 0.75 mg once per week. When used together with other diabetes medicines, the doctor may recommend a dose of 1.5 mg once a week.
If your blood sugar is not controlled well enough, the doctor may increase the dose by one to 3 mg once a week.
If blood sugar control is still not sufficient, the dose can be further increased to 4.5 mg once weekly.
Each pen contains a weekly dose of Trulicity (0.75 mg, 1.5 mg, 3 mg, or 4.5 mg). The pens are for single use only.
You can use the pen at any time of the day, with or without food. Take it on the same day of the week if you can. You can tick the day of the week you inject the first dose on the box or in a calendar to make it easier to remember.
Trulicity is injected under the skin ( subcutaneous injection ) in the abdomen or upper leg (thigh). If you receive an injection from someone else, it can be given in the upper arm.
If you want, you can inject in the same area of the body every week. However, be sure to choose a new injection site within that area each time.
You must test your blood sugar as instructed by your doctor, pharmacist, or nurse if you are taking Trulicity together with a sulphonylurea or insulin.
Read the user manual of the pen carefully before using Trulicity.
If you use too much Trulicity
If you have used too much Trulicity, talk to your doctor immediately. Too much of this medicine can cause your blood sugar to be too low (hypoglycemia) and make you feel sick or vomit.
If you forget to use Trulicity
If you have forgotten to inject a dose and there are at least 3 days left before you are due to take the next dose, you should inject dose one as soon as possible. Then inject the next dose on a usual day.
If it is less than 3 days before the next dose, skip the missed dose and inject the next dose on a usual day.
Do not take a double dose to make up for a missed dose.
If necessary, you can also change the day of the week you take Trulicity, as long as at least 3 days have passed since the last dose of Trulicity.
If you stop using Trulicity
Do not stop using Trulicity without first talking to your doctor. If you stop using Trulicity, your blood sugar levels may rise.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Rare (may affect up to 1 in 1,000 users)
- Severe allergic reactions (anaphylactic reactions, angioedema ). You should seek medical help immediately if you develop symptoms such as a rash, itching and rapid swelling of the tissues in the throat, face, mouth, or throat, hives, and difficulty breathing.
- Inflamed pancreas ( acute pancreatitis ) can cause severe pain in the stomach and back that does not go away. You should seek medical help immediately if you experience such symptoms.
Has been reported (occurring in an unknown number of users)
- Intestinal obstruction – a severe form of constipation that also causes other symptoms such as abdominal pain, bloating, or vomiting. You should seek medical help immediately if you experience such symptoms.
Other side effects are
Very common (may affect more than 1 in 10 users)
- Nausea – this usually goes away after a period of treatment
- Vomiting – this usually goes away after a period of treatment
- Diarrhea – this usually goes away after a period of treatment
- Stomach pains.
These side effects are usually not serious. They are most common when starting dulaglutide and decrease over time in most patients.
- Low blood sugar (hypoglycemia) is very common when dulaglutide is used together with medicines containing metformin, sulphonylurea, and/or insulin. If you are taking a sulphonylurea or insulin, your dose may need to be reduced while you are being treated with dulaglutide.
- Symptoms of low blood sugar can include headache, drowsiness, weakness, dizziness, feelings of hunger, confusion, irritability, fast heartbeat, and sweating. The doctor will tell you how to treat low blood sugar.
Common (may affect up to 1 in 10 users)
- Low blood sugar ( hypoglycemia ) is common when dulaglutide is used alone or with a combination of metformin and pioglitazone, or with a sodium-glucose cotransporter 2 inhibitor (SGLT2 inhibitor) with or without metformin. A list of possible symptoms can be found above in the section on very common side effects.
- Decreased appetite
- Indigestion
- Constipation
- Intestinal gases
- Bloating
- Reflux or heartburn – when stomach acid comes up from the stomach, through the esophagus, and up to the mouth
- Burps
- Fatigue
- Increased heart rate
- Slower electrical activity in the heart.
Uncommon (may affect up to 1 in 100 users)
- Injection site reactions (eg rash or redness )
- Allergic reactions (hypersensitivity) (eg swelling, raised itchy rash ( hives ))
- Dehydration is often associated with nausea, vomiting, and/or diarrhea
- Gallstones are
- Inflamed gallbladder.
Rare (may affect up to 1 in 1,000 users):
- Delayed emptying of the stomach.
How Trulicity is to be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label of the pen and the carton after EXP.
The expiration date is the last day of the specified month.
Store in a refrigerator (2 ºC–8 ºC). Do not freeze.
Store in the original packaging. Light sensitive.
Trulicity can be taken out of the refrigerator and stored at a temperature of no more than 30 °C for up to 14 days.
Do not use the medicine if the pen is damaged or if the medicine is cloudy, discolored, or contains particles.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is dulaglutide.
Trulicity 0.75 mg: A pre-filled pen contains 0.75 mg dulaglutide in 0.5 ml solution.
Trulicity 1.5 mg: A pre-filled pen contains 1.5 mg dulaglutide in 0.5 ml solution.
Trulicity 3 mg: A pre-filled pen contains 3 mg dulaglutide in a 0.5 ml solution.
Trulicity 4.5 mg: One pre-filled pen contains 4.5 mg dulaglutide in a 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.
Appearance and package sizes of the medicine
Trulicity is a clear, colorless solution for injection in a pre-filled pen.
A pre-filled pen contains 0.5 ml of solution.
The pre-filled pen is for single use only.
Pack sizes: 2, 4, or multipacks of 12 (3 packs of 4 each) pre-filled pens. Not all pack sizes may be available in your country.
Marketing Authorisation Holder
Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Manufacturer
Eli Lilly Italia SpA, Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy.