TRULICITY 4.5 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

Introduction

Patient Information: Summary of Product Characteristics

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

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

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

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

dulaglutide

Read all of this leaflet carefully before you start using 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.

Contents of the pack and other information

1. What is Trulicity and what is it used for
2. What you need to know before you use Trulicity
3. How to use Trulicity
4. Possible side effects
5. Storage of Trulicity
6. Contents of the pack and other information

1. What is Trulicity and what is it used for

Trulicity contains the active substance dulaglutide and is used to lower blood sugar levels in adults and children from 10 years of age with type 2 diabetes mellitus and may help prevent heart disease.

Type 2 diabetes is a condition where your body does not produce enough insulin and the insulin it does produce 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 levels are not adequately controlled by diet and exercise alone and you cannot take metformin (another diabetes medicine).
• or in combination with other diabetes medicines when these are not enough to control your blood sugar levels. These other medicines may be taken by mouth and/or may be an insulin injection.

It is very important that you follow the advice about your diet and physical activity given 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 of diabetes where the body does not produce any insulin) because this medicine may not be suitable for you.
• you have diabetic ketoacidosis (a complication of diabetes that occurs when your body is unable to break down glucose because there is not enough insulin). These signs include rapid weight loss, nausea or vomiting, your breath has a sweet smell, you have a metallic or sweet taste in your mouth, or the smell of your urine or sweat is different.
• you have severe problems with digestion of food or food stays in your stomach for longer than usual (including gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas) which can cause severe pain in the stomach and back that does not go away.
• you are taking a sulfonylurea or insulin for diabetes, as you may get low blood sugar (hypoglycemia). Your doctor may need to change the dose of these medicines to reduce this risk.

Trulicity is not an insulin, so it should not be used as a substitute for insulin.

When starting treatment with Trulicity, you may experience fluid loss/dehydration, such as vomiting, nausea, and/or diarrhea, which can lead to a decrease in kidney function. To avoid dehydration, it is essential to drink plenty of fluids. Contact your doctor if you have any questions or concerns.

Children and adolescents

Trulicity can be used in children and adolescents from 10 years of age. There is no data available in children under 10 years of age.

Other medicines and Trulicity

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines, as Trulicity may slow down the emptying of your stomach, which could affect other medicines.

Pregnancy

It is not known if dulaglutide can harm the fetus. Women who may become pregnant should use contraceptive methods during treatment with dulaglutida. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, as Trulicity should not be used during pregnancy. Consult your doctor about the best way to control your blood sugar while pregnant.

Breast-feeding

If you are breast-feeding or plan to breast-feed, consult your doctor before using this medicine. Do not use Trulicity during breast-feeding. It is not known if dulaglutide passes into breast milk.

Driving and using machines

Trulicity has little or no effect on the ability to drive or use machines. However, if you use Trulicity with a sulfonylurea or insulin, you may get low blood sugar (hypoglycemia), which can reduce your ability to concentrate. Avoid driving or using machines if you have any signs of low blood sugar. See section 2, "Warnings and precautions" for information on the increased risk of getting low blood sugar and section 4 for warning signs of low blood sugar. Consult your doctor for more information.

Trulicity contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to use Trulicity

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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 diabetes medicines, your doctor may recommend a dose of 1.5 mg once a week.

If your blood sugar levels are not adequately controlled, your doctor may increase your dose to 3 mg once a week.

If further control of your blood sugar levels is needed, the dose may be increased again to 4.5 mg once a week.

Children and adolescents

The initial dose for children and adolescents from 10 years of age is 0.75 mg once a week. If your blood sugar levels are not adequately controlled after at least 4 weeks, your doctor may increase your dose to 1.5 mg once a week.

Each pen contains a weekly dose of Trulicity (0.75 mg, 1.5 mg, 3 mg, or 4.5 mg). Each pen provides only one dose.

You can use your pen at any time of the day with or without food. You should use it on the same day each week if possible. To help you remember, you can note the day of the week you inject your first dose on the carton of your pen or on a calendar.

Trulicity is injected under the skin (subcutaneous injection) of the stomach area (abdomen) or in the top of the leg (thigh). If someone else is giving you the injection, they can also inject it into the top of the arm.

If you want, you can inject into the same area of your body each week. But in this case, make sure to choose different injection sites within the same area.

It is essential that you check your blood sugar levels as advised by your doctor, pharmacist, or nurse if you are taking Trulicity with a sulfonylurea or insulin.

Before using Trulicity, carefully read the "Instructions for Use" for the pen.

If you use more Trulicity than you should

If you use more Trulicity than you should, contact your doctor immediately. Too much medicine may cause your blood sugar levels to drop too low (hypoglycemia) and may also cause nausea or vomiting.

If you forget to use Trulicity

If you miss a dose and it is 3 days or more until your next scheduled dose, inject your dose as soon as possible. Inject your next dose on the scheduled day.

If it is less than 3 days until your next dose, skip the missed dose and inject your next dose on the scheduled day.

Do not inject a double dose to make up for a missed dose.

The day of the week you inject Trulicity can be changed if necessary, as long as it is 3 days or more after the last dose of Trulicity.

If you stop using Trulicity

Do not stop using Trulicity without consulting your doctor. If you stop using Trulicity, your blood sugar levels may 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.

Serious side effects

Rare: may affect up to 1 in 1,000 people

• Severe allergic reactions (anaphylactic reactions, angioedema).

See a doctor immediately if you experience symptoms such as hives, itching, and rapid swelling of the tissues of the neck, face, mouth, or throat, urticaria, and difficulty breathing.

• Pancreatitis (inflammation of the pancreas) which can cause severe stomach and back pain that does not go away.

See a doctor immediately if you experience these symptoms.

Frequency not known: cannot be estimated from the available data

• Intestinal obstruction – a severe form of constipation with additional symptoms such as stomach pain, abdominal distension, or vomiting.

See a doctor immediately if you experience these symptoms.

Other side effects

Very common: may affect more than 1 in 10 people

• Nausea – usually goes away over time
• Vomiting – usually goes away over time
• Diarrhea – usually goes away over time
• Stomach pain (abdominal).

These side effects are usually not serious. They are more common when starting dulaglutide but decrease over time in most patients.

• Getting low blood sugar (hypoglycemia) is very common when dulaglutide is used with other medicines that contain metformin, a sulfonylurea, and/or insulin. If you are taking a sulfonylurea or insulin, you may need to have your dose reduced while using dulaglutide.
• Symptoms of low blood sugar can include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, rapid 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 (hypoglycemia) is common when dulaglutide is used alone, or with metformin and pioglitazone together, or with a sodium-glucose cotransporter 2 (SGLT2) inhibitor with or without metformin. For a list of possible symptoms, see above in the "Very common" section.
• Decreased appetite
• Indigestion
• Constipation
• Gas (flatulence)
• Bloating of the stomach
• Acid reflux or heartburn (also called gastroesophageal reflux disease – GERD) – a disease caused by stomach acid flowing back up into the tube that connects the stomach to the mouth.
• Belching
• Fatigue
• Increased heart rate
• Slowing of the heart's electrical currents

Uncommon: may affect up to 1 in 100 people

• Injection site reactions (e.g., rash or redness)
• Allergic reactions (hypersensitivity) (e.g., swelling, hives on the skin with itching)
• Dehydration, often associated with nausea, vomiting, and/or diarrhea
• 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 experience 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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 label of the pen and on the carton after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (2°C to 8°C). Do not freeze.

Keep the pen in the original package to protect it from light.

Trulicity can be out of the refrigerator for up to 14 days at a temperature below 30°C.

Do not use this medicine if you notice that the pen is damaged or the medicine is cloudy, has color, or has particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Trulicity

The active ingredient is dulaglutide.

• Trulicity 0.75mg:each pre-filled pen contains 0.75 mg of dulaglutide in 0.5 ml of solution.
• Trulicity 1.5mg:each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 ml of solution.
• Trulicity 3mg:each pre-filled pen contains 3 mg of dulaglutide in 0.5 ml of solution.
• Trulicity 4.5mg:each pre-filled pen contains 4.5 mg of dulaglutide in 0.5 ml of solution.

The other components are sodium citrate (for more information, see section 2 "Trulicity contains sodium"), citric acid, mannitol, polysorbate 80, and water for injectable preparations.

Appearance and Container Contents of the Product

Trulicity is a clear, colorless injectable solution in a pre-filled pen.

Each pre-filled pen contains 0.5 ml of solution.

The pre-filled pen is for single use.

The package sizes are 2, 4, or multiple packages of 12 pre-filled pens (3 packages of 4). Some package sizes may only be marketed.

Marketing Authorization Holder

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

Manufacturer

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

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

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Instructions for Use

Trulicity0.75mg solution for injection in pre-filled pen

dulaglutide

TRULICITY PRE-FILLED PEN

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

• The pen is a disposable, pre-filled administration device that comes ready to use. Each pen contains a weekly dose of Trulicity (0.75 mg). Each pen provides a single dose.
• Trulicity is administered once a week. To remember when you need to inject your next dose, you may want to note it on your calendar.
• When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medication, and once the injection is complete, withdraw the needle (it will retract).

1. REMOVE CAP
2. PLACE AND UNLOCK
3. PRESS AND HOLD

IMPORTANT INFORMATION

Storage and Handling

Disposal of the Pen

Frequently Asked Questions

Other Information

Where to Learn More

STORAGE AND HANDLING

• The pen contains glass parts. Handle with care. If it falls on a hard surface, do not use it. Use a new pen for your injection.
• Store your pen in the refrigerator.
• When it is not possible to store it in the refrigerator, you can keep the pen at room temperature (below 30°C) for up to 14 days.
• Do not freeze your pen. If the pen has been frozen, DO NOT USE IT.
• Keep the pen in its original packaging to protect it from light.
  • Keep the pen out of the sight and reach of children.

• Read the patient information for complete information on proper storage.

FREQUENTLY ASKED QUESTIONS

What if I see air bubbles 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 removing the base cap?

Do not remove the base cap or use the pen. Dispose of the pen as your doctor, pharmacist, or nurse has instructed. 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 keep the injection button pressed until the injection is complete?

It is not necessary, but it can help you keep the pen stable and firm against your skin.

I heard more than two clicks during the injection - two loud clicks and one low click. Is the injection complete?

Some patients may hear a low click just before the second loud click. This 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 the injection?

This is not unusual and will not affect your dose.

I am not sure if my pen worked correctly.

Check if you received your dose. The dose has been administered correctly if the gray part is visible (see step 3). You can also contact your local Lilly office listed in the Patient Information for additional information. Until then, keep your pen safe to avoid an accidental needlestick injury.

OTHER INFORMATION

• If you have vision problems, DO NOT use your pen without the help of another trained person.

WHERE TO LEARN MORE

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

Last Revised in Month YYYY

Instructions for Use

Trulicity1.5mg solution for injection in pre-filled pen

dulaglutide

TRULICITY PRE-FILLED PEN

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

• The pen is a disposable, pre-filled administration device that comes ready to use. Each pen contains a weekly dose of Trulicity (1.5 mg). Each pen provides a single dose.
• Trulicity is administered once a week. To remember when you need to inject your next dose, you may want to note it on your calendar.
• When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medication, and once the injection is complete, withdraw the needle (it will retract).

1. REMOVE CAP
2. PLACE AND UNLOCK
3. PRESS AND HOLD

IMPORTANT INFORMATION

Storage and Handling

Disposal of the Pen

Frequently Asked Questions

Other Information

Where to Learn More

STORAGE AND HANDLING

• The pen contains glass parts. Handle with care. If it falls on a hard surface, do not use it. Use a new pen for your injection.
• Store your pen in the refrigerator.
• When it is not possible to store it in the refrigerator, you can keep the pen at room temperature (below 30°C) for up to 14 days.
• Do not freeze your pen. If the pen has been frozen, DO NOT USE IT.
• Keep the pen in its original packaging to protect it from light.
  • Keep the pen out of the sight and reach of children.

FREQUENTLY ASKED QUESTIONS

What happens if I see air bubbles in my pen?

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

What happens if I unlock the pen and press the green injection button before removing the base cap?

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

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

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

Do I need to keep the injection button pressed until the injection is complete?

No, but it may help you keep the pen stable and firm on your skin.

I heard more than two clicks during the injection - two high clicks and one low click. Is the injection complete?

Some patients may hear a low click just before the second high click. This is due to the normal operation of the pen. Do not remove the pen from your skin until you hear the second high click.

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

This is not unusual and will not affect your dose.

I am not sure if my pen worked correctly.

Check if you received your dose. The dose has been administered correctly if the gray part is visible (see step 3). You can also contact your local Lilly office listed in the Patient Information for additional information. Until then, keep your pen safe to avoid an accidental needlestick injury.

OTHER INFORMATION

• If you have vision problems, DO NOT use your pen without the help of another person trained in the use of the Trulicity pen.

WHERE TO LEARN MORE

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

LATEST REVISION IN MONTH AAAA

INSTRUCTIONS FOR USE

Trulicity3mg solution for injection in a pre-filled pen

dulaglutida

TRULICITY PRE-FILLED PEN

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

• The pen is a disposable and pre-filled administration device that comes ready to be administered. Each pen contains a weekly dose of Trulicity (3 mg). Each pen provides a single dose.
• Trulicity is administered once a week. To remember when you need to inject your next dose, you may want to note it in your calendar.
• When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medication, and once the injection is complete, withdraw the needle (it will retract).

1. REMOVE CAP
2. PLACE AND UNLOCK
3. PRESS AND HOLD

IMPORTANT INFORMATION

Storage and Handling

Disposal of the Pen

Frequently Asked Questions

Other Information

Where to Learn More

STORAGE AND HANDLING

• The pen contains glass parts. Handle it with care. If it falls on a hard surface, do not use it. Use a new pen for your injection.
• Store your pen in the refrigerator.
• When it is not possible to store it in the refrigerator, you can keep the pen at room temperature (below 30 °C) for up to 14 days.
• Do not freeze your pen. If the pen has been frozen, DO NOT USE IT.
• Keep the pen in its original container to protect it from light.
  • Keep the pen out of sight and reach of children.

• Read the patient information to get complete information on proper storage.

FREQUENTLY ASKED QUESTIONS

What happens if I see air bubbles in my pen?

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

What happens if I unlock the pen and press the green injection button before removing the base cap?

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

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

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

Do I need to keep the injection button pressed until the injection is complete?

No, but it may help you keep the pen stable and firm on your skin.

I heard more than two clicks during the injection - two high clicks and one low click. Is the injection complete?

Some patients may hear a low click just before the second high click. This is due to the normal operation of the pen. Do not remove the pen from your skin until you hear the second high click.

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

This is not unusual and will not affect your dose.

I am not sure if my pen worked correctly.

Check if you received your dose. The dose has been administered correctly if the gray part is visible (see step 3). You can also contact your local Lilly office listed in the Patient Information for additional information. Until then, keep your pen safe to avoid an accidental needlestick injury.

OTHER INFORMATION

• If you have vision problems, DO NOT use your pen without the help of another person trained in the use of the Trulicity pen.

WHERE TO LEARN MORE

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

LATEST REVISION IN MONTH AAAA

INSTRUCTIONS FOR USE

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

dulaglutida

TRULICITY PRE-FILLED PEN

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

• The pen is a disposable and pre-filled administration device that comes ready to be administered. Each pen contains a weekly dose of Trulicity (4.5 mg). Each pen provides a single dose.
• Trulicity is administered once a week. To remember when you need to inject your next dose, you may want to note it in your calendar.
• When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medication, and once the injection is complete, withdraw the needle (it will retract).

1. REMOVE CAP
2. PLACE AND UNLOCK
3. PRESS AND HOLD

IMPORTANT INFORMATION

Storage and Handling

Disposal of the Pen

Frequently Asked Questions

Other Information

Where to Learn More

STORAGE AND HANDLING

• The pen contains glass parts. Handle it with care. If it falls on a hard surface, do not use it. Use a new pen for your injection.
• Store your pen in the refrigerator.
• When it is not possible to store it in the refrigerator, you can keep the pen at room temperature (below 30 °C) for up to 14 days.
• Do not freeze your pen. If the pen has been frozen, DO NOT USE IT.
• Keep the pen in its original container to protect it from light.
  • Keep the pen out of sight and reach of children.

• Read the patient information to get complete information on proper storage.

This is unusual and will not affect your dose.

Do I need to keep the injection button pressed until the injection is complete?

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

I heard more than two clicks during the injection - two high clicks and one low click. Is the injection complete?

Some patients may hear a low click just before the second high click. This is due to the normal functioning of the pen. Do not remove the pen from your skin until you hear the second higher click.

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

This is not unusual and will not affect your dose.

I am not sure if my pen has worked correctly.

Check if you have received your dose. The dose has been administered correctly if the gray part is visible (see step 3). You can also contact your local Lilly office listed in the Patient Information for additional information. In the meantime, keep your pen safe to avoid an accidental needlestick injury.

ADDITIONAL INFORMATION

• If you have vision problems, DO NOT use your pen without the help of another person trained in the use of the Trulicity pen.

WHERE TO LEARN MORE

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

Last revised in month AAAA