Trulicity - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

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

dulaglutide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 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

1. 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 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.

2. 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.

• – 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.

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 is not recommended for children and adolescents under 18 years of age because it has not been studied in these patients.

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 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.

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’.

3. 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.

Your doctor may recommend a dose of 0.75 mg once a week for the treatment of your diabetes either due to your individual needs or 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.

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

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 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 then 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.

4. 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.

You should see a doctor immediately if you experience such symptoms.

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))

• – Dehydration, often associated with nausea, vomiting and/or diarrhoea

• – Gallstones

• – Inflamed gallbladder

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 national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trulicity

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.

6. 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.

• - Trulicity 1.5 mg: Each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 ml solution.

• - Trulicity 3 mg: Each pre-filled pen contains 3 mg of dulaglutide in 0.5 ml solution.

• - Trulicity 4.5 mg: Each pre-filled pen contains 4.5 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.

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.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy

Lilly France, 2, rue du Colonel Lilly, 67640 Fegershe­im, France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgique/Belgi­e/Belgien Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84	Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649600
Etnrapuu Tn „Enu ^unu HegepnaHg“ E.B. – Etnrapua men. + 359 2 491 41 40	Luxembourg/Lu­xemburg Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84
Česká republika ELI LILLY ČR, s.r.o. Tel: + 420 234 664 111	Magyarország Lilly Hungária Kft. Tel: + 36 1 328 5100
Danmark Eli Lilly Danmark A/S Tlf: +45 45 26 60 00	Malta Charles de Giorgio Ltd. Tel: + 356 25600 500
Deutschland Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222	Nederland Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800
Eesti Eli Lilly Nederland B.V. Tel: +372 6 817 280	Norge Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00
EXXáSa OAPMAZEPB-AIAAY A.E.B.E. Tql: +30 210 629 4600	Österreich Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780
España Lilly S.A. Tel: + 34–91 663 50 00	Polska Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 00
France Lilly France Tél: +33-(0) 1 55 49 34 34	Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351–21–4126600
Hrvatska Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999	România Eli Lilly România S.R.L. Tel: + 40 21 4023000
Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377	Slovenija Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10
Ísland Icepharma hf. Sími + 354 540 8000	Slovenská republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 111

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

This leaflet was last revised in Month YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Trulicity 0.75 mg solution for injection in pre-filled syringe

Trulicity 1.5 mg solution for injection in pre-filled syringe

dulaglutide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 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

1. 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 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.

2. 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.

• – 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.

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 is not recommended for children and adolescents under 18 years of age because it has not been studied in these patients.

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 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.

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’.

3. 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.

Your doctor may recommend a dose of 0.75 mg once a week for the treatment of your diabetes either due to your individual needs or 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.

Each syringe contains one weekly dose of Trulicity (0.75 mg or 1.5 mg). Each syringe delivers only one dose.

You can use your syringe 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 syringe 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 syringe carefully before using Trulicity.

If you use more Trulicity than you should

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 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 then 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.

4. 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.

You should see a doctor immediately if you experience such symptoms.

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))

• – Dehydration, often associated with nausea, vomiting and/or diarrhoea

• – Gallstones

• – Inflamed gallbladder

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 national reporting system listed in By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trulicity

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 syringe 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 syringe 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.

6. Contents of the pack and other information

What Trulicity contains

The active substance is dulaglutide.

• - Trulicity 0.75 mg: Each pre-filled syringe contains 0.75 mg of dulaglutide in 0.5 ml solution.

• - Trulicity 1.5 mg: Each pre-filled syringe contains 1.5 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 syringe.

Each pre-filled syringe contains 0.5 ml solution.

The pre-filled syringe is for single-use only.

Pack sizes of 4 or multipacks of 12 (3 packs of 4) pre-filled syringes. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy

Lilly France, 2, rue du Colonel Lilly, 67640 Fegershe­im, France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last revised in Month YYYY

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Instructions for use

Trulicity 0.75 mg solution for injection in pre-filled pen dulaglutide

ABOUT TRULICITY PRE-FILLED PEN

Please read these instructions for use and the information for the patient in the package leaflet carefully and completely before using your pre-filled pen. Talk to your doctor, pharmacist or nurse about how to inject Trulicity correctly.

• The pen is a disposable, pre-filled delivery device that is ready to use. Each pen contains one

weekly dose of Trulicity (0.75 mg). Each pen delivers one dose only.

• Trulicity is administered once a week. You may want to mark your calendar to remind you when to inject your next dose.
• When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medicine, and pull back (retract) the needle after the injection is complete.

BEFORE YOU GET STARTED

Remove Check Inspect Prepare

from the refrigerator.

Leave the base cap on until you are ready to inject. the label to make sure you have the correct medicine and it has not expired. the pen. Do not use if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.

by washing your hands.

CHOOSE YOUR INJECTION SITE

• Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.
• You may inject the medicine into your stomach (abdomen) or thigh.
• Another person may give you the injection in your upper arm.
• Change (rotate) your injection site each week. You may use the same area of your body, but be sure to choose a different injection site in that area.

1 UNCAP

fi Make sure the pen is locked.

• Pull off the grey base cap.

Do not put the base cap back on – this could damage the needle. Do not touch the needle.

• When removed, the grey base cap appears as shown and can be discarded.

2 PLACE AND UNLOCK

• Place the clear base flat and firmly against your skin at the injection site.

J'' Unlock by turning the lock ring.

3 PRESS AND HOLD

Press and hold the green injection button; you will hear a loud click.

Continue holding the clear base firmly against your skin until you hear a second click. This occurs when the needle starts retracting in about 5–10 seconds.

Remove the pen from your skin.

IMPORTANT INFORMATION

Storage and Handling Disposal of Pen

Commonly Asked Questions Other Information

Where to Learn More

STORAGE AND HANDLING

The pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it.

Use a new pen for your injection.

Store your pen in the refrigerator.

When refrigeration is not possible, you can keep your pen at room temperature (below 30°C) for up to a total of 14 days.

Do not freeze your pen. If the pen has been frozen, DO NOT USE.

Store the pen in the original package in order to protect from light.

Keep the pen out of sight and reach of children.

For complete information about proper storage, read the Information for the patient.

DISPOSAL OF PEN

• Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
• Do not recycle the filled sharps container.
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.

COMMONLY ASKED QUESTIONS

What if I see an air bubble in my pen?

Air bubbles are normal. They will not harm you or affect your dose.

What if I unlock the pen and press the green injection button before pulling off the base cap

Do not remove the base cap and do not use the pen. Dispose of the pen as directed by your doctor, pharmacist or nurse. Inject your dose using another pen.

What if there is a drop of liquid on the tip of the needle when I remove the base cap?

A drop of liquid on the tip of the needle is not unusual and will not affect your dose.

Do I need to hold the injection button down until the injection is complete?

This is not necessary, but it may help you keep the pen steady and firm against your skin.

I heard more than two clicks during my injection – two louder clicks and a soft one. Did I get my complete injection?

Some patients may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second louder click.

What if there is a drop of liquid or blood on my skin after my injection?

This is not unusual and will not affect your dose.

I’m not sure my pen worked correctly.

Check to see if you have received your dose. Your dose was delivered correctly if the grey part is visible (see step 3.) Also contact your local Lilly office listed in the Information for the patient for further instructions. Until then, store your pen safely to avoid an accidental needle stick injury.

OTHER INFORMATION

• If you have vision problems, DO NOT use your pen without help from a person trained to use the Trulicity pen.

WHERE TO LEARN MORE

• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist or nurse.

SCAN THIS CODE TO LAUNCH

Last revised in Month YYYY

Instructions for use

Trulicity 1.5 mg solution for injection in pre-filled pen dulaglutide

BKLAK

^ Unfold and lay flat ^

Read both sides for full instructions

ABOUT TRULICITY PRE-FILLED PEN

Please read these instructions for use and the information for the patient in the package leaflet carefully and completely before using your pre-filled pen. Talk to your doctor, pharmacist or nurse about how to inject Trulicity correctly.

• The pen is a disposable, pre-filled delivery device that is ready to use. Each pen contains one

weekly dose of Trulicity (1.5 mg). Each pen delivers one dose only.

• Trulicity is administered once a week. You may want to mark your calendar to remind you when to inject your next dose.
• When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medicine, and pull back (retract) the needle after the injection is complete.

BEFORE YOU GET STARTED

Remove

from the refrigerator.

Leave the Base Cap on until you are ready to inject.

Check

the label to make sure you have the correct medicine and it has not expired.

Inspect

the pen. Do not use if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.

Prepare

by washing your hands

CHOOSE YOUR INJECTION SITE

• Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.
• You may inject the medicine into your stomach (abdomen) or thigh.
• Another person may give you the injection in your upper arm.
• Change (rotate) your injection site each week. You may use the same area of your body, but be sure to choose a different injection site in that area.

1 UNCAP

fi Make sure the pen is locked.

• Pull off the grey base cap.

Do not put the base cap back on – this could damage the needle. Do not touch the needle.

• When removed, the grey base cap appears as shown and can be discarded.
• Do not use the Pen.
• Safely store the Pen and cap and contact Lilly.
• Use a new Pen.

2 PLACE AND UNLOCK

• Place the clear base flat and firmly against your skin at the injection site.

J'' Unlock by turning the lock ring.

3 PRESS AND HOLD

Press and hold the green injection button; you will hear a loud click.

■J— Continue holding the clear base firmly against your skin until you hear a second click. This occurs when the needle starts retracting in about 5–10 seconds.

Remove the pen from your skin.

IMPORTANT INFORMATION

Storage and Handling Disposal of Pen

Commonly Asked Questions Other Information

Where to Learn More

STORAGE AND HANDLING

• The pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new pen for your injection.
• Store your pen in the refrigerator.
• When refrigeration is not possible, you can keep your pen at room temperature (below 30°C) for up to a total of 14 days.
• Do not freeze your pen. If the pen has been frozen, DO NOT USE.
• Store the pen in the original package in order to protect from light.
• Keep the pen out of sight and reach of children.
• For complete information about proper storage, read the Information for the patient.

DISPOSAL OF PEN

• Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
• Do not recycle the filled sharps container.
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.

COMMONLY ASKED QUESTIONS

What if I see an air bubble in my pen?

Air bubbles are normal. They will not harm you or affect your dose.

What if I unlock the pen and press the green injection button before pulling off the base cap

Do not remove the base cap and do not use the pen. Dispose of the pen as directed by your doctor, pharmacist or nurse. Inject your dose using another pen.

What if there is a drop of liquid on the tip of the needle when I remove the base cap?

A drop of liquid on the tip of the needle is not unusual and will not affect your dose.

Do I need to hold the injection button down until the injection is complete?

This is not necessary, but it may help you keep the pen steady and firm against your skin.

I heard more than two clicks during my injection – two louder clicks and a soft one. Did I get my complete injection?

Some patients may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second louder click.

What if there is a drop of liquid or blood on my skin after my injection?

This is not unusual and will not affect your dose.

I’m not sure my pen worked correctly.

Check to see if you have received your dose. Your dose was delivered correctly if the grey part is visible (see step 3.) Also contact your local Lilly office listed in the Information for the patient for further instructions. Until then, store your pen safely to avoid an accidental needle stick injury.

OTHER INFORMATION

• If you have vision problems, DO NOT use your pen without help from a person trained to use the Trulicity pen.

WHERE TO LEARN MORE

• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist or nurse.

SCAN THIS CODE TO LAUNCH

Last revised in Month YYYY

Instructions for use

Trulicity 3 mg solution for injection in pre-filled pen dulaglutide

BREAK SEAL

^ Unfold and lay flat ^

Read both sides for full instructions

ABOUT TRULICITY PRE-FILLED PEN

Please read these instructions for use and the information for the patient in the package leaflet carefully and completely before using your pre-filled pen. Talk to your doctor, pharmacist or nurse about how to inject Trulicity correctly.

• The pen is a disposable, pre-filled delivery device that is ready to use. Each pen contains one

weekly dose of Trulicity (3 mg). Each pen delivers one dose only.

• Trulicity is administered once a week. You may want to mark your calendar to remind you when to inject your next dose.
• When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medicine, and pull back (retract) the needle after the injection is complete.

BEFORE YOU GET STARTED

Remove	Check	Inspect	Prepare
from the refrigerator. Leave the Base Cap on until you are ready to inject.	the label to make sure you have the correct medicine and it has not expired.	the pen. Do not use if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.	by washing your hands

CHOOSE YOUR INJECTION SITE

• Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.
• You may inject the medicine into your stomach (abdomen) or thigh.
• Another person may give you the injection in your upper arm.
• Change (rotate) your injection site each week. You may use the same area of your body, but be sure to choose a different injection site in that area.

1 UNCAP

fi Make sure the pen is locked.

• Pull off the grey base cap.

Do not put the base cap back on – this could damage the needle. Do not touch the needle.

• When removed, the grey base cap appears as shown and can be discarded.
• Do not use the Pen.
• Safely store the Pen and cap and contact Lilly.
• Use a new Pen.

2 PLACE AND UNLOCK

• Place the clear base flat and firmly against your skin at the injection site.

J'' Unlock by turning the lock ring.

3 PRESS AND HOLD

Press and hold the green injection button; you will hear a loud click.

■J— Continue holding the clear base firmly against your skin until you hear a second click. This occurs when the needle starts retracting in about 5–10 seconds.

Remove the pen from your skin.

IMPORTANT INFORMATION

Storage and Handling Disposal of Pen

Commonly Asked Questions Other Information

Where to Learn More

STORAGE AND HANDLING

• The pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new pen for your injection.
• Store your pen in the refrigerator.
• When refrigeration is not possible, you can keep your pen at room temperature (below 30°C) for up to a total of 14 days.
• Do not freeze your pen. If the pen has been frozen, DO NOT USE.
• Store the pen in the original package in order to protect from light.
• Keep the pen out of sight and reach of children.
• For complete information about proper storage, read the Information for the patient.

DISPOSAL OF PEN

• Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
• Do not recycle the filled sharps container.
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.

COMMONLY ASKED QUESTIONS

What if I see an air bubble in my pen?

Air bubbles are normal. They will not harm you or affect your dose.

What if I unlock the pen and press the green injection button before pulling off the base cap

Do not remove the base cap and do not use the pen. Dispose of the pen as directed by your doctor, pharmacist or nurse. Inject your dose using another pen.

What if there is a drop of liquid on the tip of the needle when I remove the base cap?

A drop of liquid on the tip of the needle is not unusual and will not affect your dose.

Do I need to hold the injection button down until the injection is complete?

This is not necessary, but it may help you keep the pen steady and firm against your skin.

I heard more than two clicks during my injection – two louder clicks and a soft one. Did I get my complete injection?

Some patients may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second louder click.

What if there is a drop of liquid or blood on my skin after my injection?

This is not unusual and will not affect your dose.

I’m not sure my pen worked correctly.

Check to see if you have received your dose. Your dose was delivered correctly if the grey part is visible (see step 3.) Also contact your local Lilly office listed in the Information for the patient for further instructions. Until then, store your pen safely to avoid an accidental needle stick injury.

OTHER INFORMATION

• If you have vision problems, DO NOT use your pen without help from a person trained to use the Trulicity pen.

WHERE TO LEARN MORE

• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist or nurse.

SCAN THIS CODE TO LAUNCH

Last revised in Month YYYY

Instructions for use

Trulicity 4.5 mg solution for injection in pre-filled pen dulaglutide

ABOUT TRULICITY PRE-FILLED PEN

Please read these instructions for use and the information for the patient in the package leaflet carefully and completely before using your pre-filled pen. Talk to your doctor, pharmacist or nurse about how to inject Trulicity correctly.

• The pen is a disposable, pre-filled delivery device that is ready to use. Each pen contains one

weekly dose of Trulicity (4.5 mg). Each pen delivers one dose only.

• Trulicity is administered once a week. You may want to mark your calendar to remind you when to inject your next dose.
• When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medicine, and pull back (retract) the needle after the injection is complete.

BEFORE YOU GET STARTED

Remove	Check	Inspect	Prepare
from the refrigerator. Leave the base cap on until you are ready to inject.	the label to make sure you have the correct medicine and it has not expired.	the pen. Do not use if you notice that the pen is damaged, or the medicine is cloudy, discoloured or has particles in it.	by washing your hands

CHOOSE YOUR INJECTION SITE

• Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.
• You may inject the medicine into your stomach (abdomen) or thigh.
• Another person may give you the injection in your upper arm.
• Change (rotate) your injection site each week. You may use the same area of your body, but be sure to choose a different injection site in that area.

fi Make sure the pen is locked.

• Pull off the grey base cap.

Do not put the base cap back on – this could damage the needle. Do not touch the needle.

• When removed, the grey base cap appears as shown and can be discarded.
• Do not use the Pen.
• Safely store the Pen and cap and contact Lilly.
• Use a new Pen.

2 PLACE AND UNLOCK

• Place the clear base flat and firmly against your skin at the injection site.

Unlock by turning the lock ring.

3 PRESS AND HOLD

Press and hold the green injection button; you will hear a loud click.

■J— Continue holding the clear base firmly against your skin until you hear a second click. This occurs when the needle starts retracting in about 5–10 seconds.

Remove the pen from your skin.

IMPORTANT INFORMATION

Storage and Handling Disposal of Pen

Commonly Asked Questions Other Information

Where to Learn More

STORAGE AND HANDLING

• The pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new pen for your injection.
• Store your pen in the refrigerator.
• When refrigeration is not possible, you can keep your pen at room temperature (below 30°C) for up to a total of 14 days.
• Do not freeze your pen. If the pen has been frozen, DO NOT USE.
• Store the pen in the original package in order to protect from light.
• Keep the pen out of sight and reach of children.
• For complete information about proper storage, read the Information for the patient.

DISPOSAL OF PEN

• Dispose of the pen in a sharps container or as directed by your doctor, pharmacist or nurse.
• Do not recycle the filled sharps container.
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.

COMMONLY ASKED QUESTIONS

What if I see an air bubble in my pen?

Air bubbles are normal. They will not harm you or affect your dose.

What if I unlock the pen and press the green injection button before pulling off the base cap

Do not remove the base cap and do not use the pen. Dispose of the pen as directed by your doctor, pharmacist or nurse. Inject your dose using another pen.

What if there is a drop of liquid on the tip of the needle when I remove the base cap?

A drop of liquid on the tip of the needle is not unusual and will not affect your dose.

Do I need to hold the injection button down until the injection is complete?

This is not necessary, but it may help you keep the pen steady and firm against your skin.

I heard more than two clicks during my injection – two louder clicks and a soft one. Did I get my complete injection?

Some patients may hear a soft click right before the second loud click. That is the normal operation of the pen. Do not remove the pen from your skin until you hear the second louder click.

What if there is a drop of liquid or blood on my skin after my injection?

This is not unusual and will not affect your dose.

I’m not sure my pen worked correctly.

Check to see if you have received your dose. Your dose was delivered correctly if the grey part is visible (see step 3.) Also contact your local Lilly office listed in the Information for the patient for further instructions. Until then, store your pen safely to avoid an accidental needle stick injury.

OTHER INFORMATION

• If you have vision problems, DO NOT use your pen without help from a person trained to use the Trulicity pen.

WHERE TO LEARN MORE

• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist or nurse.

SCAN THIS CODE TO LAUNCH

Last revised in Month YYYY

Instructions for use

Trulicity 0.75 mg solution for injection in pre-filled syringe

dulaglutide

ABOUT TRULICITY PRE-FILLED SYRINGE

Please read these instructions for use and the information for the patient in the package leaflet carefully and completely before using your pre-filled syringe.

• The syringe is a disposable, pre-filled delivery device. Each syringe contains one weekly dose

of Trulicity (0.75 mg). Each syringe delivers one dose only.

• Trulicity is administered once a week. You may want to mark your calendar to remind you when to inject your next dose.

BEFORE YOU GET STARTED

Remove

Check Inspect Prepare

from the refrigerator. the label to make sure you have the correct medicine and it has not expired.

the syringe. Do not use by washing your if you notice that the hands. syringe is damaged, or the medicine is cloudy, discoloured or has particles in it.

CHOOSE YOUR INJECTION SITE

Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.

You may inject the medicine into your stomach (abdomen) or thigh. Another person may give you the injection in your upper arm.

Change (rotate) your injection site each week. You may use the same area of your body, but be sure to choose a different injection site in that area.

• 1. UNCAP

• 2. INSERT

• 3. INJECT

Plunger Rod

Pull off and discard the needle cover.

Do not touch the needle.

Gently grasp a fold of skin at the injection site.

Insert the needle into your skin at about a 45-degree angle.

3 INJECT

• Slowly push the plunger all the

way in until all the medicine is injected.

• Remove the needle from your skin.
• Gently let go of the fold of skin.

IMPORTANT INFORMATION

Storage and Handling Disposal of Syringe Commonly Asked Questions Other Information

Where to Learn More

STORAGE AND HANDLING

• Store your syringe in the refrigerator.
• When refrigeration is not possible, you can keep your syringe at room temperature (below 30°C) for up to a total of 14 days.
• Do not freeze your syringe. If the syringe has been frozen, DO NOT USE.
• Keep the syringe out of sight and reach of children.
• Store the syringe in the original package in order to protect from light.

For complete information about proper storage, read the Information for the patient.

DISPOSAL OF SYRINGE

• Do not put the needle cover back

on – this may result in an accidental needle stick injury to your hand.

• Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse
• Do not recycle the filled sharps container.
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
• The directions regarding syringe handling and disposal are not intended to replace local or institutional policies.

COMMONLY ASKED QUESTIONS

What if the needle looks bent?

• Do not use your syringe.
• Do not touch the needle.
• Dispose of the syringe as directed.
• Inject your dose using another syringe.

What if I see an air bubble in my Syringe?

Air bubbles are normal. They will not harm you or affect your dose.

I don’t know how to do a subcutaneous injection.

You should receive training from your doctor, pharmacist or nurse on the right way to prepare and inject your medicine. Gently grasp a fold of skin at the injection site. With your other hand, hold the syringe like a pencil. Insert the needle into your skin at about a 45-degree angle. Slowly push the plunger all the way in until all the medicine is injected. Remove the needle from the skin. Gently release the skin.

What if there is a drop of liquid on the tip of the needle when I remove the needle cover?

Drops of liquid on the tip of the needle are not unusual and will not affect your dose.

What if I cannot push in the plunger?

• Do not continue to use your syringe.
• Remove the needle from your skin.
• Dispose of the syringe as directed.
• Inject your dose using another syringe.

How can I tell if I have completed my injection?

When your injection is complete, the plunger should be pushed fully into the syringe, with no more medicine left in it.

What if there is a drop of liquid or blood on my skin after my injection?

This is not unusual and will not affect your dose.

OTHER INFORMATION

• If you have vision problems, DO NOT use your syringe without help from a person trained to use the Trulicity syringe.
• Do not share your syringe with anyone else. You may give them an infection or get an infection

from them.

WHERE TO LEARN MORE

• If you have any questions or problems with your Trulicity syringe, contact your doctor, pharmacist or nurse.

Last revised in Month YYYY

Instructions for use

Trulicity 1.5 mg solution for injection in pre-filled syringe

dulaglutide

^ Unfold and lay flat ^

Read both sides for full instructions

ABOUT TRULICITY PRE-FILLED SYRINGE

Please read these instructions for use and the information for the patient in the package leaflet carefully and completely before using your pre-filled syringe.

• The syringe is a disposable, pre-filled delivery device. Each syringe contains one weekly dose of Trulicity (1.5 mg). Each syringe delivers once dose only.
• Trulicity is administered once a week. You may want to mark your calendar to remind you when to inject your next dose.

BEFORE YOU GET STARTED

Remove

Check Inspect Prepare

from the refrigerator. the label to make sure you have the correct medicine and it has not expired.

the syringe. Do not use by washing your if you notice that the hands. syringe is damaged, or the medicine is cloudy, discoloured or has particles in it.

CHOOSE YOUR INJECTION SITE

Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.

You may inject the medicine into your stomach (abdomen) or thigh. Another person may give you the injection in your upper arm.

Change (rotate) your injection site each week. You may use the same area of your body, but be sure to choose a different injection site in that area.

• 1. UNCAP

• 2. INSERT

  3. INJECT

  Plunger Rod

  Plunger

  Medicine

  Needle Cover

  
  

1 UNCAP

• Pull off and discard the needle

cover.

Do not touch the needle.

Gently grasp a fold of skin at the injection site.

Insert the needle into your skin at about a 45-degree angle.

Slowly push the plunger all the way in until all the medicine is injected.

Remove the needle from your skin.

Gently let go of the fold of skin.

IMPORTANT INFORMATION

Storage and Handling Disposal of Syringe Commonly Asked Questions Other Information

Where to Learn More

STORAGE AND HANDLING

• Store your syringe in the refrigerator.
• When refrigeration is not possible, you can keep your syringe at room temperature (below 30°C) for up to a total of 14 days.
• Do not freeze your syringe. If the syringe has been frozen, DO NOT USE.
• Keep the syringe out of sight and reach of children.
• Store the syringe in the original package in order to protect from light.

For complete information about proper storage, read the Information for the patient.

DISPOSAL OF SYRINGE

• Do not put the needle cover back

on – this may result in an accidental needle stick injury to your hand.

• Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse
• Do not recycle the filled sharps container.
• Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
• The directions regarding syringe handling and disposal are not intended to replace local or institutional policies.

COMMONLY ASKED QUESTIONS

What if the needle looks bent?

• Do not use your syringe.
• Do not touch the needle.
• Dispose of the syringe as directed.
• Inject your dose using another syringe.

What if I see an air bubble in my syringe?

Air bubbles are normal. They will not harm you or affect your dose.

I don’t know how to do a subcutaneous injection.

You should receive training from your doctor, pharmacist or nurse on the right way to prepare and inject your medicine. Gently grasp a fold of skin at the injection site. With your other hand, hold the syringe like a pencil. Insert the needle into your skin at about a 45-degree angle. Slowly push the plunger all the way in until all the medicine is injected. Remove the needle from the skin. Gently release the skin.

What if there is a drop of liquid on the tip of the needle when I remove the needle cover?

Drops of liquid on the tip of the needle are not unusual and will not affect your dose.

What if I cannot push in the plunger?

• Do not continue to use your syringe.
• Remove the needle from your skin.
• Dispose of the syringe as directed.
• Inject your dose using another syringe.

How can I tell if I have completed my injection?

When your injection is complete, the plunger should be pushed fully into the syringe, with no more medicine left in it.

What if there is a drop of liquid or blood on my skin after my injection?

This is not unusual and will not affect your dose.

OTHER INFORMATION

• If you have vision problems, DO NOT use your syringe without help from a person trained to use the Trulicity syringe.
• Do not share your syringe with anyone else. You may give them an infection or get an infection

from them.

WHERE TO LEARN MORE

• If you have any questions or problems with your Trulicity syringe, contact your doctor, pharmacist or nurse.

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for dulaglutide, the scientific conclusions of CHMP are as follows:

In view of available data on pancreatitis and acute pancreatitis from spontaneous reports, the PRAC considers that the wording currently included in section 4.8 of the SmPC is not adequate. Such wording refers only to pre-authorisation studies, and does not reflect the current knowledge, where acute pancreatitis and pancreatitis have been reported also in the post-marketing setting. The PRAC concluded that the product information of products containing dulaglutide should be amended accordingly.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for dulaglutide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing dulaglutide is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

167