Trulicity 1,5 mg solucion inyectable en pluma precargada

Prescribing Information for the Patient

Trulicity 0.75 mgPre-filled Pen Solution for Injection

Trulicity 1.5 mgPre-filled Pen Solution for Injection

Trulicity 3 mgPre-filled Pen Solution for Injection

Trulicity 4.5 mgPre-filled Pen Solution for Injection

dulaglutida

Read this entire prescribing information carefully before starting to use this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prescribing information. See section 4.

Trulicity contains an active ingredient called dulaglutide and is used to decrease blood sugar levels in adults and children aged 10 years and older with diabetes mellitus type 2 and may help prevent heart disease.

Type 2 diabetes is a disease in which the body does not produce enough insulin and the insulin it produces does not work as well as it should. When this occurs, blood sugar levels increase.

Trulicity is used:

• alone, if blood sugar levels are not adequately controlled with diet and exercise alone and cannot take metformin (another diabetes medication).
• or in combination with other diabetes medications when these are insufficient to control blood sugar levels. These other medications may be taken orally and/or may be an insulin injection.

It is very important that you follow the dietary and physical activity advice provided by your doctor, pharmacist, or nurse.

Do not use Trulicity

• if you are allergic to dulaglutide or any of the other ingredients of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Trulicity if:

• you are on dialysis, as this medication is not recommended.
• you have type 1 diabetes (the type of diabetes in which the body does not produce any insulin) because this medication 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 normal (including gastroparesis).
• you have had pancreatitis (inflammation of the pancreas) which may cause intense pain in the stomach and back that does not go away.
• you are taking a sulfonylurea or insulin for diabetes, as it may cause a drop in blood sugar (hypoglycemia). Your doctor may need to change the dose of these medications to reduce this risk.

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

There have been symptoms, sometimes severe, of delayed emptying of the stomach contents, such as feeling full, nausea, and/or vomiting in patients using Trulicity. Inform your doctor if you develop, while using Trulicity, severe problems with stomach emptying that do not go away.

If you know you will be undergoing a surgical procedure in which you will be under anesthesia (a state of sleep), inform your doctor that you are taking Trulicity.

At the start of treatment with Trulicity, you may experience in some cases fluid loss/dehydration, such as in the case of vomiting, nausea, and/or diarrhea, which may cause a decrease in kidney function. To avoid dehydration, it is essential to drink liquids. 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.No data are available in children under 10 years of age.

Other medications and Trulicity

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication, as Trulicity may slow down the emptying of your stomach, which may affect other medications.

Pregnancy

The safety of dulaglutide for use during pregnancy is unknown. Women who may become pregnant should use contraceptive methods during treatment with dulaglutide. If you are pregnant, think you may be pregnant, or intend to become pregnant, consult your doctor as Trulicity should not be used during pregnancy. Consult your doctor about the best method to control your blood sugar while pregnant.

Breastfeeding

If you intend to breastfeed or are currently breastfeeding, consult your doctor before using this medication.Do not use Trulicity during breastfeeding.The safety of dulaglutide for use during breastfeeding is unknown.

Driving and operating machines

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

Trulicity contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; this is, essentially “sodium-free”.

Always follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

If your blood sugar is not sufficiently controlled, your doctor may increase your dose to 3 mg once a week.

If additional blood sugar control is needed, the dose can be increased again to 4.5 mg once a week.

Children and adolescents

The initial dose for children and adolescents aged 10 years and older is 0.75 mg once a week. If your blood sugar is not sufficiently 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 when you inject your first dose in the pen box or on a calendar.

Trulicity is injected under the skin (subcutaneous injection) in the abdominal area or the upper thigh. If someone else is administering the injection, you can do it in the upper arm.

If you want, you can inject yourself in 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 monitor your blood sugar levels as instructed by your doctor, pharmacist, or nurse if you are taking Trulicity with a sulfonylurea or insulin.

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

If you use more Trulicity than you should

If you use more Trulicity than you should, consult your doctor immediately. Taking too much medication can cause your blood sugar to drop too low (hypoglycemia) and also cause nausea or vomiting.

If you forget to use Trulicity

If you forget to inject a dose and there are 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 there are fewer than 3 days until your next dose, skip the missed dose and inject the next dose on the scheduled day.

Do not inject a double dose to compensate for the missed dose.

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

If you interrupt treatment with Trulicity

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

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

• Severe allergic reactions (anaphylactic reactions, angioedema).

Seek medical attention 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.

• Acute pancreatitis, which could cause intense pain in the stomach and back that does not subside.

Seek medical attention immediately if you experience these symptoms.

Unknown frequency: cannot be estimated from available data

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

Seek medical attention immediately if you experience these symptoms.

Other side effects

Very common: may affect more than 1 in 10people

• Nausea – usually resolves over time
• Vomiting – usually resolves over time
• Diarrhea– usually resolves over time
• Abdominal pain (stomach pain).

These side effects are usually not severe. They are more frequent when starting to use dulaglutide, but decrease over time in most patients.

• Hypoglycemia (low blood sugar) is very common when using dulaglutide with other medications containing 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.
• The symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, hunger, confusion, irritability, rapid heart rate, and sweating. Your doctor should instruct you on how to treat low blood sugar.

Common: may affect up to 1 in 10people

• Hypoglycemia (low blood sugar) is common when using dulaglutide alone, or with metformin and pioglitazone together, or with an SGLT2 inhibitor with or without metformin. For a list of possible symptoms, see above in the very common side effects section.
• Reduced appetite
• Indigestion
• Constipation
• Gas (flatulence)
• Abdominal bloating
• Reflux or acid stomach (also known as gastroesophageal reflux disease – GERD) – a disease caused by stomach acid rising up into the tube that connects the stomach to the mouth.
• Belching
• Fatigue
• Increased heart rate
• Slowing of heart electrical currents

Rare: may affect up to 1 in 100people

• Reactions at the injection site (e.g. rash or redness)
• Allergic reactions (hypersensitivity) (e.g. swelling, hives on the skin with a sensation of itching (urticaria))
• Dehydration, often associated with nausea, vomiting, and/or diarrhea
• Formation of gallstones
• Inflamed gallbladder

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

• Delayed gastric emptying

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the pen label and on the carton after CAD. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

Trulicity may be stored outside the refrigerator for up to 14days at a temperature below 30°C.

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

Medications should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe containers and medications that you no longerneed.This will help protect the environment.

Composition of Trulicity

The active ingredient is dulaglutide.

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

Appearance of the product and contents of the pack

Trulicity is a colourless, transparent 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 only.

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

Marketing Authorisation 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

For more information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:

Other sources of information

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

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TRULICITY PRE-FILLED PEN

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

• The pre-filled pen is a disposable and pre-filled device that is already prepared for administration. Each pre-filled pen contains a weekly dose of Trulicity (0.75 mg). Each pre-filled pen provides a single dose.

• Trulicity is administered once a week. To remember when to inject the next dose, you may want to note it in your calendar.

• When you press the green injection button, the pre-filled pen will automatically insert the needle into your skin, inject the medicine, and once the injection is complete, it will retract the needle back.

1. REMOVE

2. PLACE AND UNLOCK

3. PRESS AND HOLD

IMPORTANT INFORMATION

Storage and Handling

Disposal of the Pre-Filled Pen

Frequently Asked Questions

Other Information

Where to Learn More

STORAGE AND HANDLING

• The pre-filled pen contains glass parts. Handle it with care. If it falls on a hard surface, do not use it. Use a new pre-filled pen for your injection.
• Store your pre-filled pen in the fridge.
• If it is not possible to store it in the fridge, you can keep the pre-filled pen at room temperature (below 30°C) for a maximum of 14 days.
• Do not freeze your pre-filled pen. If the pre-filled pen has frozen, DO NOT USE IT.
• Keep the pre-filled pen in the original packaging to protect it from light.
• Keep the pre-filled pen out of sight and reach of children.
• Read the patient information leaflet for a complete guide on proper storage.

FAQs

What happens if I see bubbles in my pre-filled pen?

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

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

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

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

A drop of liquid at the tip of the needle is normal 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 pre-filled pen steady and firm on your skin.

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

Some patients may hear a low click just before the second high click. This is due to the normal functioning of the pre-filled pen. Do not remove the pre-filled 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 normal and will not affect your dose.

I am not sure if my pre-filled pen has worked correctly.

Check if you have received your dose. The dose has been administered correctly if the grey part is visible (see step 3). You can also contact your local Lilly office as listed in the Patient Information Leaflet for further information. Until then, store your pre-filled pen safely to avoid accidental needlestick injury.

OTHER INFORMATION

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

WHERE TO LEARN MORE

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

Last update in month AAAA

TRULICITY PRE-FILLED PEN

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

• The pre-filled pen is a disposable and pre-filled device that is already prepared for administration. Each pre-filled pen contains a weekly dose of Trulicity (1.5 mg). Each pre-filled pen provides a single dose.

• Trulicity is administered once a week. To remember when to inject the next dose, you may want to note it in your calendar.

• When you press the green injection button, the pre-filled pen will automatically insert the needle into your skin, inject the medicine, and once the injection is complete, it will retract the needle back.