Trulicity 0.75 mg solution for injection in pre-filled pen
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
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 questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.
Contents of the leaflet
- What Trulicity is and what it is used for
- What you need to know before using Trulicity
- How to use Trulicity
- Possible side effects
- How to store Trulicity
- 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) 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 in which 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 is 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 sufficient 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 continue to follow the dietary and physical activity advice provided by your doctor, pharmacist, or nurse.
2. What you need to know before using Trulicity
Do not use Trulicity
- if you are allergic to dulaglutide or to any of the other ingredients of this medicine (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 medicine is not recommended.
- you have type 1 diabetes (the type of diabetes in which the body produces no insulin), because this medicine may not be suitable for you.
- you have diabetic ketoacidosis (a complication of diabetes that occurs when your body cannot break down glucose due to insufficient insulin). Symptoms include rapid weight loss, nausea or vomiting, sweet-smelling breath, a metallic or sweet taste in your mouth, or a change in the smell of your urine or sweat.
- you have severe problems digesting food or food remains in your stomach longer than normal (including gastroparesis).
- you have ever had pancreatitis (inflammation of the pancreas), which can cause severe stomach and back pain that does not go away.
- you are taking a sulfonylurea or insulin for diabetes, as low blood sugar (hypoglycemia) may occur. Your doctor may need to adjust the dose of these medicines to reduce this risk.
Trulicity is not insulin and should not be used as a substitute for insulin.
Symptoms, sometimes serious, of delayed stomach emptying such as feeling full, nausea and/or vomiting have been reported in patients using Trulicity. Inform your doctor if you develop severe problems with stomach emptying that do not go away while using Trulicity.
If you know you are going to undergo surgery under anesthesia (a state of sleep), inform your doctor that you are taking Trulicity.
At the start of treatment with Trulicity, you may in some cases experience fluid loss/dehydration, such as with vomiting, nausea and/or diarrhea, which may lead to reduced kidney function. To prevent dehydration, it is important to drink enough fluids. Contact your doctor if you have any questions or concerns.
Children and adolescents
Trulicity can be used in children and adolescents aged 10 years and older. Data are not available for children under 10 years of age.
Other medicines and Trulicity
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines, as Trulicity may slow stomach emptying, which could affect the absorption of other medicines.
Pregnancy
It is unknown whether dulaglutide can harm the fetus. Women who could become pregnant should use contraceptive methods during treatment with dulaglutide. If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor, as Trulicity should not be used during pregnancy. Speak with your doctor about the best way to manage your blood sugar levels during pregnancy.
Breast-feeding
If you plan to breast-feed or are currently breast-feeding, consult your doctor before using this medicine. Do not use Trulicity while breast-feeding. It is unknown whether dulaglutide passes into breast milk.
Driving and using machines
Trulicity has little or no effect on the ability to drive or operate machinery. However, if you use Trulicity with a sulfonylurea or insulin, you may experience low blood sugar (hypoglycemia), which can impair your concentration. Avoid driving or operating machinery if you have any symptoms of low blood sugar. See section 2, “Warnings and precautions,” for information on increased risk of low blood sugar and section 4 for warning signs of low blood sugar. Consult your doctor for further 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 follow exactly the administration instructions for this medicine given 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 weekly for the treatment of your diabetes when Trulicity is used alone.
When used in combination with other diabetes medicines, your doctor may recommend a dose of 1.5 mg once weekly.
If your blood sugar is not adequately controlled, your doctor may increase your dose to 3 mg once weekly.
If additional blood sugar control is needed, the dose may be increased again to 4.5 mg once weekly.
Children and adolescents
The starting dose for children and adolescents from 10 years of age is 0.75 mg once weekly. If your blood sugar is not sufficiently controlled after at least 4 weeks, your doctor may increase your dose to 1.5 mg once weekly.
Each pen contains one weekly dose of Trulicity (0.75 mg, 1.5 mg, 3 mg or 4.5 mg). Each pen provides only one dose.
You may use your pen at any time of day, with or without food. You should use it on the same day each week, if possible. To help you remember, you may write down the day of the week when you inject your first dose on the pen carton or on a calendar.
Trulicity is injected under the skin (subcutaneous injection) in the stomach (abdominal) area or in the upper leg (thigh). If someone else administers the injection, it may be given in the upper arm.
If you wish, you may inject in the same body area each week. However, in this case, make sure to choose different injection sites within the same area.
It is important that you monitor your blood sugar levels as instructed by your doctor, pharmacist, or nurse if you are taking Trulicity together 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 can cause your blood sugar level to drop too low (hypoglycemia) and may 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. Then inject your next dose on the scheduled day.
If there are less 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 make up for a missed dose.
The day of the week on which you inject Trulicity may be changed if necessary, provided that it is done at least 3 days after the last Trulicity dose.
If you stop using 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 further questions about 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 will experience them.
Serious side effects
Rare: may affect up to 1 in 1,000 people
- Severe allergic reactions (anaphylactic reactions, angioedema).
Seek immediate medical attention if you experience symptoms such as hives, itching, rapid swelling of the tissues in the neck, face, mouth, or throat, urticaria, or difficulty breathing.
- Inflammation of the pancreas (acute pancreatitis), which could cause severe stomach and back pain that does not go away.
Seek immediate medical attention if you experience these symptoms.
Frequency not known: cannot be estimated from available data
- Intestinal obstruction – a serious form of constipation with additional symptoms such as stomach pain, abdominal distension, or vomiting.
Seek immediate medical attention if you experience these symptoms.
Other side effects
Very common: may affect more than 1 in 10 people
- Nausea – usually resolves over time
- Vomiting – usually resolves over time
- Diarrhea – usually resolves over time
- Stomach (abdominal) pain
These side effects are usually not serious. They are more common when starting dulaglutide, but decrease over time in most patients.
- Low blood sugar levels (hypoglycemia) are very common when dulaglutide is used together with other medicines containing metformin, a sulfonylurea, and/or insulin. If you are taking a sulfonylurea or insulin, your dose may need to be reduced while using dulaglutide.
- Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, rapid heartbeat, and sweating. Your doctor should advise you on how to treat low blood sugar levels.
Common: may affect up to 1 in 10 people
- Low blood sugar (hypoglycemia) is common when dulaglutide is used alone, or together with metformin and pioglitazone, or with a sodium-glucose cotransporter-2 inhibitor (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)
- Stomach bloating
- Reflux or heartburn (also called gastroesophageal reflux disease – GERD) – a condition caused by stomach acid rising into the tube connecting the stomach to the mouth.
- Burping
- Fatigue
- Increased heart rate
- Slowing of electrical impulses 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, itchy skin rash (urticaria))
- Dehydration, often associated with nausea, vomiting and/or diarrhea
- Gallstones
- Inflamed gallbladder
Rare: may affect up to 1 in 1,000 people
- Delayed stomach emptying
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included 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 stated on the label of the pen and the carton after EXP. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 °C to 8 °C). Do not freeze.
Keep in the original packaging to protect from light.
Trulicity may be kept outside 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 if the medicine is cloudy, discolored, or contains particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Trulicity
The active substance is dulaglutide.
- Trulicity 0.75 mg: each pre-filled pen contains 0.75 mg of dulaglutide in 0.5 ml of solution.
- Trulicity 1.5 mg: each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 ml of solution.
- Trulicity 3 mg: each pre-filled pen contains 3 mg of dulaglutide in 0.5 ml of solution.
- Trulicity 4.5 mg: each pre-filled pen contains 4.5 mg of dulaglutide in 0.5 ml of solution.
The other components are sodium citrate (for further information see section 2 “Trulicity contains sodium”), citric acid, mannitol, polysorbate 80, and water for injections.
Nature of the product and contents of the container
Trulicity is a colourless, clear 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.
Pack sizes are 2, 4 or multiple packs of 12 pre-filled pens (3 packs of 4). Only some pack sizes may be marketed.
Marketing Authorization 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, Florence (FI), Italy
Lilly France, 2, rue du Colonel Lilly, 67640 Fegersheim, France
For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Eli Lilly Benelux S.A./N.V. Tel/Tel: + 32-(0)2 548 84 84 | Lithuania Eli Lilly Lithuania Tel. +370 (5) 2649600 |
| Luxembourg/Luxembourg Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84 |
Czech Republic ELI LILLY CR, s.r.o. Tel: + 420 234 664 111 | Hungary Lilly Hungária Kft. Tel: + 36 1 328 5100 |
Denmark Eli Lilly Danmark A/S Tlf: +45 45 26 60 00 | Malta Charles de Giorgio Ltd. Tel: + 356 25600 500 |
Germany Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222 | Netherlands Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800 |
Estonia Eli Lilly Nederland B.V. Tel: +372 6 817 280 | Norway Eli Lilly Norge A.S. Tlf: + 47 22 88 18 00 |
Greece PHARMASERV-LILLY S.A. Tel: +30 210 629 4600 | Austria Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780 |
Spain Lilly S.A. Tel: + 34-91 663 50 00 | Poland 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 |
Croatia Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999 | Romania Eli Lilly România S.R.L. Tel: + 40 21 4023000 |
Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 | Slovenia Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10 |
Iceland Icepharma hf. Sími + 354 540 8000 | Slovakia Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 111 |
Italy Eli Lilly Italia S.p.A. Tel: + 39- 055 42571 | Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250 |
Cyprus Phadisco Ltd Tel: +357 22 715000 | Sweden Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800 |
Latvia Eli Lilly (Suisse) S.A. Representative Office Latvia Tel: +371 67364000 | United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377 |
Date of the most recent review of this leaflet:
Other sources of information
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Instructions for use |
Trulicity 0.75 mg solution for injection in pre-filled pen |
dulaglutide |
|
|
TRULICITY PREFILLED PEN
Before using your prefilled pen, please read these instructions for use and the patient information in the package leaflet completely and carefully. Consult your doctor, pharmacist, or nurse about how to properly inject Trulicity.
- The pen is a disposable, prefilled delivery device that is ready to use. Each pen contains one weekly dose of Trulicity (0.75 mg). Each pen provides a single dose.
- Trulicity is administered once a week. To help remember when to inject your next dose, you may wish to mark it on your calendar.
- When you press the green injection button, the pen will automatically insert the needle into your skin, deliver the medication, and once the injection is complete, withdraw the needle back (retract it).
BEFORE STARTING | |||
Remove | Check | Inspect | Prepare |
from the refrigerator. Leave the base cap on until you are ready to inject. | the label to make sure it is the correct medicine and has not expired. | the pen. Do not use this medicine if you notice the pen is damaged or if the medicine is cloudy, discolored, or contains particles. | by washing your hands. |
CHOOSE YOUR INJECTION SITE |
| ||
|
1. UNCAP
2. INSERT AND UNLOCK
3. PRESS AND HOLD
Make sure the pen is locked.
Do not reattach the base cap – this could damage the needle. Do not touch the needle.
|
|
Unlock by turning the locking ring. |
|
Continue holding the transparent base firmly against your skin until you hear a second click. This will occur as the needle begins to retract, approximately 5–10 seconds.
|
|
IMPORTANT INFORMATION
Storage and Handling
Disposal of the Pen
Frequently Asked Questions
Additional Information
Where to Learn More
STORAGE AND HANDLING
- The pen contains glass parts. Handle with care. If it is dropped 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, the pen may be kept 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 sight and reach of children.
- Read the patient information leaflet for complete information on proper storage.
DISPOSAL OF THE PEN
|
|
FREQUENTLY ASKED QUESTIONS
What should I do if I see air bubbles in my pen?
Air bubbles are normal. They will not harm you or affect your dose.
What should I do 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. Discard the pen as instructed by your doctor, pharmacist, or nurse. Inject your dose using a new pen.
What should I do if there is a drop of liquid at the needle tip when I remove the base cap?
A drop of liquid at the needle tip is common and will not affect your dose.
Do I need to keep pressing the injection button until the injection is complete?
It is not required, but it may help you keep the pen steady and firmly against your skin.
I heard more than two clicks during the injection—two high-pitched clicks and one low-pitched click. Is the injection complete?
Some patients may hear a low-pitched click just before the second high-pitched click. This is part of the pen's normal operation. Do not remove the pen from your skin until you hear the second, higher-pitched click.
What should I do if there is a drop of liquid or blood on my skin after the injection?
This is common and will not affect your dose.
I am not sure whether my pen worked correctly.
Check whether you received your dose. The dose has been delivered correctly if the gray part is visible (see step 3). You may also contact your local Lilly office listed in the Patient Information for additional assistance. Until then, keep your pen safe to avoid accidental needlestick injury.
ADDITIONAL INFORMATION
- If you have vision problems, DO NOT use your pen without help from someone 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.
| SCAN THIS CODE TO ACCESS www.trulicity.eu |
Last review in month AAAA
Instructions for use |
Trulicity 1.5 mg solution for injection in pre-filled pen |
dulaglutide |
|
|
TRULICITY PRE-FILLED PEN
Before using your pre-filled pen, please read these instructions for use and the patient information in the package leaflet completely and carefully. Consult your doctor, pharmacist, or nurse on how to properly inject Trulicity.
- 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 provides a single dose.
- Trulicity is administered once a week. To help remember when to inject your next dose, you may wish to mark it on your calendar.
- When you press the green injection button, the pen will automatically insert the needle into your skin, deliver the medication, and once the injection is complete, retract the needle back into the pen.
BEFORE STARTING | |||
Remove | Check | Inspect | Prepare |
from the refrigerator. Leave the base cap on until you are ready to inject. | the label to make sure it is the correct medicine and has not expired. | the pen. Do not use this medicine if you notice the pen is damaged or if the medicine is cloudy, discolored, or contains particles. | by washing your hands. |
CHOOSE YOUR INJECTION SITE |
| ||
|
1.UNCAP
2.INSERT AND UNLOCK
3.PRESS AND HOLD
|
Make sure the pen is locked.
Do not replace the base cap – this could damage the needle. Do not touch the needle.
|
|
Unlock by turning the locking ring. |
|
Continue holding the transparent base firmly against your skin until you hear a second click. This will occur when the needle begins to retract, approximately 5–10 seconds.
|
|
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 components. Handle with care. If it is dropped 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, the pen may be kept at room temperature (below 30 ºC) 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 sight and reach of children.
- Read the patient information leaflet for complete information on proper storage.
DISPOSAL OF THE PEN
|
|
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. Discard the pen as instructed by your doctor, pharmacist, or nurse. Inject your dose using another pen.
What if there is a drop of liquid at the needle tip when I remove the base cap?
A drop of liquid at the needle tip is not unusual and will not affect your dose.
Do I need to keep pressing the injection button until the injection is complete?
It is not necessary, but it may help you keep the pen steady and firmly against your skin.
I heard more than two clicks during the injection—two high-pitched clicks and one low-pitched click. Is the injection complete?
Some patients may hear a low-pitched click just before the second high-pitched 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-pitched 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 whether my pen worked correctly.
Check whether your dose has been delivered. The dose has been administered correctly if the gray section is visible (see step 3). You may also contact your local Lilly office listed in the Patient Information for additional assistance. Until then, keep your pen safe to avoid an accidental needlestick injury.
ADDITIONAL INFORMATION
- If you have vision problems, DO NOT use your pen without help from someone 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.
| SCAN THIS CODE TO ACCESS www.trulicity.eu |
Last review in month AAAA
Instructions for use |
Trulicity 3 mg solution for injection in a pre-filled pen |
dulaglutide |
|
|
TRULICITY PREFILLED PEN
Before using your prefilled pen, please read these instructions for use and the patient information in the package leaflet thoroughly and carefully. Consult your doctor, pharmacist, or nurse on how to properly inject Trulicity.
- The pen is a disposable, prefilled delivery device that comes ready for administration. Each pen contains one weekly dose of Trulicity (3 mg). Each pen provides a single dose.
- Trulicity is administered once a week. To help remember when to administer your next dose, you may wish to mark it on your calendar.
- When you press the green injection button, the pen will automatically insert the needle into your skin, deliver the medication, and once the injection is complete, retract the needle back (it will withdraw automatically).
BEFORE STARTING | |||
Remove | Check | Inspect | Prepare |
from the refrigerator. Leave the base cap on until you are ready to inject. | the label to make sure it is the correct medicine and has not expired. | the pen. Do not use this medicine if you notice the pen is damaged or if the medicine is cloudy, discolored, or contains particles. | by washing your hands. |
CHOOSE YOUR INJECTION SITE |
| ||
|
- UNCAP
- PLACE AND UNLOCK
- PRESS AND HOLD
Make sure the pen is locked.
Do not replace the base cap – this could damage the needle. Do not touch the needle.
|
|
Unlock by turning the locking ring. |
|
Continue holding the transparent base firmly against your skin until you hear a second click. This will occur as the needle begins to retract, in approximately 5–10 seconds.
|
|
IMPORTANT INFORMATION
Storage and Handling
Disposal of the Pen
Frequently Asked Questions
Additional Information
Where to Learn More
STORAGE AND HANDLING
- The pen contains glass components. Handle with care. If it is dropped 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, the pen may be kept at room temperature (below 30 ºC) 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 leaflet for complete information on proper storage.
DISPOSAL OF THE PEN
|
|
FREQUENTLY ASKED QUESTIONS
What should I do if I see air bubbles in my pen?
Air bubbles are normal. They will not harm you or affect your dose.
What should I do 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. Discard the pen as instructed by your doctor, pharmacist, or nurse. Inject your dose using another pen.
What should I do if there is a drop of liquid at the needle tip when I remove the base cap?
A drop of liquid at the needle tip is normal and will not affect your dose.
Do I need to keep holding down the injection button until the injection is complete?
It is not necessary, but it may help you keep the pen steady and firmly against your skin.
I heard more than two clicks during the injection—two high-pitched clicks and one low-pitched click. Is the injection complete?
Some patients may hear a low-pitched click just before the second high-pitched 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-pitched click.
What should I do 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 whether my pen worked correctly.
Check whether you received your dose. The dose has been properly administered if the gray part is visible (see step 3). You may also contact your local Lilly office listed in the Patient Information for additional assistance. Until then, keep your pen safe to avoid an accidental needlestick injury.
ADDITIONAL INFORMATION
- If you have vision problems, DO NOT use your pen without help from someone 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.
| SCAN THIS CODE TO ACCESS www.trulicity.eu |
Last review in month AAAA
Instructions for use |
Trulicity 4.5 mg solution for injection in a pre-filled pen |
dulaglutide |
|
|
TRULICITY PRE-FILLED PEN
Before using your pre-filled pen, please read these instructions for use and the patient information in the package leaflet completely and carefully. Consult your doctor, pharmacist, or nurse on how to properly inject Trulicity.
- The pen is a disposable, pre-filled delivery device that comes ready to use. Each pen contains one weekly dose of Trulicity (4.5 mg). Each pen provides a single dose.
- Trulicity is administered once weekly. To help remember when to inject your next dose, you may wish to mark it on your calendar.
- When you press the green injection button, the pen will automatically insert the needle into your skin, deliver the medication, and once the injection is complete, retract the needle back into the pen.
BEFORE YOU BEGIN | |||
Remove | Check | Inspect | Prepare |
from the refrigerator. Leave the base cap on until you are ready to inject. | the label to make sure it is the correct medicine and it is not expired. | the pen. Do not use this medicine if you notice the pen is damaged or if the medicine is cloudy, discolored, or contains particles. | by washing your hands. |
CHOOSE YOUR INJECTION SITE |
| ||
|
- UNCAP
- PLACE AND UNLOCK
- PRESS AND HOLD
Make sure the pen is locked.
Do not replace the base cap – this could damage the needle. Do not touch the needle.
|
|
Unlock by turning the locking ring. |
|
Continue holding the transparent base firmly against your skin until you hear a second click. This will occur as the needle starts to retract, in about 5–10 seconds.
|
|
IMPORTANT INFORMATION
Storage and Handling
Disposal of the Pen
Frequently Asked Questions
Additional Information
Where to Learn More
STORAGE AND HANDLING
- The pen contains glass parts. Handle with care. If it is dropped 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, the pen may be kept 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 sight and reach of children.
- Read the patient information leaflet for complete information on proper storage.
DISPOSAL OF THE PEN
|
|
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. Discard the pen as instructed by your doctor, pharmacist, or nurse. Inject your dose using a new pen.
What if there is a drop of liquid at the needle tip when I remove the base cap?
A drop of liquid at the needle tip is not unusual and will not affect your dose.
Do I need to keep pressing the injection button until the injection is complete?
It is not necessary, but it may help you keep the pen steady and firmly against your skin.
I heard more than two clicks during the injection—two high-pitched clicks and one low-pitched click. Is the injection complete?
Some patients may hear a low-pitched click just before the second high-pitched 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-pitched 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 whether my pen worked correctly.
Check whether you received your dose. The dose has been properly administered if the gray section is visible (see step 3). You may also contact your local Lilly office listed in the Patient Information for additional assistance. 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 help from someone 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.
| SCAN THIS CODE TO ACCESS www.trulicity.eu |
Last review in month AAAA