Patient information: uses, side effects, how to take - Trulicity

What is the most important information I should know about TRULICITY?

TRULICITY may cause serious side effects, including:

Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats or mice, TRULICITY and medicines that work like TRULICITY caused thyroid tumors, including thyroid cancer. It is not known if TRULICITY will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use TRULICITY if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

What is TRULICITY?

TRULICITY is an injectable prescription medicine that is used:
- along with diet and exercise to improve blood sugar (glucose) in adults and children 10 years of age and older with type 2 diabetes mellitus.
- to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with type 2 diabetes mellitus with known heart disease or multiple cardiovascular risk factors.
It is not known if TRULICITY is safe and effective to lower blood sugar (glucose) in children under 10 years of age.

Do not use TRULICITY if:

you or any of your family have ever had a type of thyroid cancer called MTC or if you have an endocrine system condition called MEN 2.
you have had a serious allergic reaction to dulaglutide or any of the ingredients in TRULICITY. See the end of this Medication Guide for a complete list of ingredients in TRULICITY. See " What are the possible side effects of TRULICITY? " for symptoms of a serious allergic reaction.

Before using TRULICITY, tell your healthcare provider about all of your medical conditions, including if you:

have or have had problems with your pancreas.
have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
have a history of diabetic retinopathy.
are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation).
are pregnant or plan to become pregnant. It is not known if TRULICITY will harm your unborn baby. Tell your healthcare provider if you become pregnant while using TRULICITY.
are breastfeeding or plan to breastfeed. It is not known if TRULICITY passes into your breast milk. You and your healthcare provider should decide if you should breastfeed while taking TRULICITY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRULICITY may affect the way some medicines work, and some medicines may affect the way TRULICITY works.

Before using TRULICITY, talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking other medicines to treat diabetes, including insulin or sulfonylureas.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use TRULICITY?

Read the Instructions for Use that comes with TRULICITY.
Use TRULICITY exactly as your healthcare provider tells you to.
Your healthcare provider should show you how to use TRULICITY before you use it for the first time.
Inject TRULICITY under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject TRULICITY into a muscle (intramuscularly) or vein (intravenously).
Use TRULICITY 1 time each week on the same day each week at any time of the day.
You may change the day of the week as long as your last dose was given 3 or more days before.
If you miss a dose of TRULICITY, take the missed dose as soon as possible if there are at least 3 days (72 hours) until your next scheduled dose. If there are less than 3 days remaining, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of TRULICITY within 3 days of each other.
TRULICITY may be taken with or without food.
Do not mix insulin and TRULICITY together in the same injection.
You may give an injection of TRULICITY and insulin in the same body area (such as, your stomach area), but not right next to each other.
Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
If you take too much TRULICITY, call your healthcare provider or Poison Helpline at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What are the possible side effects of TRULICITY?

TRULICITY may cause serious side effects, including:

See “What is the most important information I should know about TRULICITY?”
inflammation of your pancreas (pancreatitis). Stop using TRULICITY and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TRULICITY with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin.
Signs and symptoms of low blood sugar may include:
dizziness or light-headedness
sweating
confusion or drowsiness
headache
blurred vision
slurred speech
shakiness
fast heartbeat
anxiety, irritability, or mood changes
hunger
weakness
feeling jittery
serious allergic reactions. Stop using TRULICITY and get medical help right away if you have any symptoms of a serious allergic reaction including:
swelling of your face, lips, tongue or throat
problems breathing or swallowing
severe rash or itching
fainting or feeling dizzy
very rapid heartbeat
dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.
severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use TRULICITY. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
changes in vision. Tell your healthcare provider if you have changes in vision during treatment with TRULICITY.
gallbladder problems. Gallbladder problems have happened in some people who take TRULICITY. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include:
pain in your upper stomach (abdomen)
fever
yellowing of skin or eyes (jaundice)
clay-colored stools
food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). TRULICITY may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking TRULICITY before you are scheduled to have surgery or other procedures.

The most common side effects of TRULICITY may include:

nausea
diarrhea
vomiting

stomach (abdominal) pain
decreased appetite

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TRULICITY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of TRULICITY.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRULICITY for a condition for which it was not prescribed. Do not give TRULICITY to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about TRULICITY. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about TRULICITY that is written for health professionals.

What are the ingredients in TRULICITY?

Active ingredient: dulaglutide

Inactive ingredients: citric acid anhydrous, mannitol, polysorbate 80, trisodium citrate dihydrate, in water for injection

TRULICITY^®is a registered trademark of Eli Lilly and Company.

Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA, US License Number 1891

www.TRULICITY.com.

For more information, go to www.TRULICITY.com or call 1-800-545-5979.

TRULICITY 0.75 MG SINGLE-DOSE PEN INSTRUCTIONS FOR USE

Instructions for Use
TRULICITY^®(TRU-li-si-tee) (dulaglutide) injection, for subcutaneous use 0.75 mg/0.5 mL Single-Dose Pen use 1 time each week (once weekly)



Information About TRULICITY Single-Dose Pen Please read this Instructions for Use and the Medication Guide carefully and completely before using your TRULICITY Single-Dose Pen. Talk to your healthcare provider about how to inject TRULICITY the right way. TRULICITY Single-Dose Pen (Pen) is a disposable, prefilled medicine delivery device. Each Pen contains 1 dose of TRULICITY (0.75 mg/0.5 mL). Each Pen should only be used 1 time. TRULICITY is used 1 time each week. You may want to mark your calendar to remind you when to take your next dose.

Before You Get Started

Remove	Check	Inspect	Prepare
Remove the Pen from the refrigerator. Leave the Base Cap on until you are ready to inject.	Check the Pen label to make sure you have the right medicine and it has not expired.	Check the Pen to make sure that it is not damaged and inspect the medicine to make sure it is not cloudy, discolored or has particles in it.	Wash your hands.
Choose Your Injection Site
Your healthcare provider can help you choose the injection site that is best for you.

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.

You may inject the medicine into your stomach (abdomen) or thigh.

Another person should give you the injection in the back of your upper arm.



Step 1 Uncap the Pen Make sure the Pen is locked. Pull the Base Cap straight off and throw it away in your household trash. Do not put the Base Cap back on — this could damage the needle. Do not touch the needle.
Step 2 Place and Unlock Place the Clear Base flat and firmly against your skin at the injection site. Unlock by turning the Lock Ring.
Step 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 happens when the needle starts retracting in about 5-10 seconds. Remove the Pen from your skin.	You will know your injection is complete when the gray plunger is visible.

Important Information Disposal of Pen Storage and Handling Commonly Asked Questions Other Information Where to Learn More
Disposing of Your Used Pens Put your used Pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) Pens in your household trash. If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. Do not recycle your used sharps disposal container.

Storage and Handling
Store your Pen in the refrigerator between 36°F to 46°F (2°C to 8°C). You may store your Pen at room temperature below 86°F (30°C) for up to a total of 14 days. Do not freeze your Pen. If the Pen has been frozen, throw the Pen away and use a new Pen. Storage of your Pen in the original carton is recommended. Protect your Pen from direct heat and light. The Pen has glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new Pen for your injection. Keep your TRULICITY Pen and all medicines out of the reach of children.
Commonly Asked Questions
What if I see air bubbles in my Pen? Air bubbles are normal. What if I unlock the Pen and press the green Injection Button before pulling off the Base Cap? Do not remove the Base Cap. Throw away the Pen and get a new 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 normal. 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 2 clicks during my injection—2 louder clicks and 1 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 normal. I am not sure if my Pen worked the right way. Check to see if you have received your dose. Your dose was delivered the right way if the gray plunger is visible (see step 3). Also contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) for further instructions. Until then, store your Pen safely to avoid an accidental needle stick.

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 Single-Dose Pen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider. For more information about TRULICITY Single-Dose Pen, visit our website at: www.trulicity.com.
	SCAN THIS CODE TO LAUNCH www.trulicity.com
This Instructions for Use has been approved by the U.S. Food and Drug Administration. Eli Lilly and Company Indianapolis, IN 46285, USA US License Number 1891 TRULICITY is a registered trademark of Eli Lilly and Company. Copyright © 2014, 2022, Eli Lilly and Company. All rights reserved. The TRULICITY Pen meets the current dose accuracy and functional requirements of ISO 11608-1:2012 and 11608-5:2012. Revised: 11/2022 TRULOAI-0004-IFU-20221117

TRULICITY 1.5 MG SINGLE-DOSE PEN INSTRUCTIONS FOR USE

Instructions for Use
TRULICITY^®(TRU-li-si-tee) (dulaglutide) injection, for subcutaneous use 1.5 mg/0.5 mL Single-Dose Pen use 1 time each week (once weekly)



Information About TRULICITY Single-Dose Pen Please read this Instructions for Use and the Medication Guide carefully and completely before using your TRULICITY Single-Dose Pen. Talk to your healthcare provider about how to inject TRULICITY the right way. TRULICITY Single-Dose Pen (Pen) is a disposable, prefilled medicine delivery device. Each Pen contains 1 dose of TRULICITY (1.5 mg/0.5 mL). Each Pen should only be used 1 time. TRULICITY is used 1 time each week. You may want to mark your calendar to remind you when to take your next dose.

Before You Get Started

Remove	Check	Inspect	Prepare
Remove the Pen from the refrigerator. Leave the Base Cap on until you are ready to inject.	Check the Pen label to make sure you have the right medicine and it has not expired.	Check the Pen to make sure that it is not damaged and inspect the medicine to make sure it is not cloudy, discolored or has particles in it.	Wash your hands.
Choose Your Injection Site
Your healthcare provider can help you choose the injection site that is best for you.

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.

You may inject the medicine into your stomach (abdomen) or thigh.

Another person should give you the injection in the back of your upper arm.

Step 1 Uncap the Pen

Make sure the Pen is locked.

Pull the Base Cap straight off and throw it away in your household trash.
Do not put the Base Cap back on — this could damage the needle.
Do not touch the needle.

Step 2 Place and Unlock

Place the Clear Base flat and firmly against your skin at the injection site.
Unlock by turning the Lock Ring.

Step 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 happens when the needle starts retracting in about 5-10 seconds.
Remove the Pen from your skin.

You will know your injection is complete when the gray plunger is visible.

Important Information

Disposal of Pen

Storage and Handling

Commonly Asked Questions

Other Information

Where to Learn More

Disposing of Your Used Pens

Put your used Pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) Pens in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.

Storage and Handling

Store your Pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
You may store your Pen at room temperature below 86°F (30°C) for up to a total of 14 days.
Do not freeze your Pen. If the Pen has been frozen, throw the Pen away and use a new Pen.
Storage of your Pen in the original carton is recommended. Protect your Pen from direct heat and light.
The Pen has glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new Pen for your injection.
Keep your TRULICITY Pen and all medicines out of the reach of children.

Commonly Asked Questions
What if I see air bubbles in my Pen? Air bubbles are normal. What if I unlock the Pen and press the green Injection Button before pulling off the Base Cap? Do not remove the Base Cap. Throw away the Pen and get a new 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 normal. 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 2 clicks during my injection—2 louder clicks and 1 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 normal. I am not sure if my Pen worked the right way. Check to see if you have received your dose. Your dose was delivered the right way if the gray plunger is visible (see step 3). Also contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) for further instructions. Until then, store your Pen safely to avoid an accidental needle stick.

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 Single-Dose Pen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider. For more information about TRULICITY Single-Dose Pen, visit our website at: www.trulicity.com.
	SCAN THIS CODE TO LAUNCH www.trulicity.com

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Eli Lilly and Company Indianapolis, IN 46285, USA US License Number 1891 TRULICITY is a registered trademark of Eli Lilly and Company. Copyright © 2014, 2022, Eli Lilly and Company. All rights reserved. The TRULICITY Pen meets the current dose accuracy and functional requirements of ISO 11608-1:2012 and 11608-5:2012. Revised: 11/2022 TRUHIAI-0004-IFU-20221117

TRULICITY 3 MG SINGLE-DOSE PEN INSTRUCTIONS FOR USE

	Instructions for Use
	TRULICITY ^®(TRU-li-si-tee) (dulaglutide) injection, for subcutaneous use 3 mg/0.5 mL Single-Dose Pen use 1 time each week (once weekly)

Information About TRULICITY Single-Dose Pen

Please read this Instructions for Use and the Medication Guide carefully and completely before using your TRULICITY Single-Dose Pen. Talk to your healthcare provider about how to inject TRULICITY the right way.

TRULICITY Single-Dose Pen (Pen) is a disposable, prefilled medicine delivery device. Each Pen contains 1 dose of TRULICITY (3 mg/0.5 mL). Each Pen should only be used 1 time.
TRULICITY is used 1 time each week. You may want to mark your calendar to remind you when to take your next dose.

Before You Get Started

Remove

Check

Inspect

Prepare

Remove the Pen from the refrigerator.

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

Check the Pen label to make sure you have the right medicine and it has not expired.

Expiration Date

Check the Pen to make sure that it is not damaged and inspect the medicine to make sure it is not cloudy, discolored or has particles in it.

Wash your hands.

Choose Your Injection Site

Your healthcare provider can help you choose the injection site that is best for you.

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.

You may inject the medicine into your stomach (abdomen) or thigh.

Another person should give you the injection in the back of your upper arm.

Step 1 Uncap the Pen

Make sure the Pen is locked.

Pull the Base Cap straight off and throw it away in your household trash.
Do not put the Base Cap back on — this could damage the needle.
Do not touch the needle.

Step 2 Place and Unlock

Place the Clear Base flat and firmly against your skin at the injection site.

Unlock by turning the Lock Ring.

Step 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 happens when the needle starts retracting in about 5-10 seconds.
Remove the Pen from your skin.

Important Information

Disposal of Pen

Storage and Handling

Commonly Asked Questions

Other Information

Where to Learn More

Disposing of Your Used Pens

Put your used Pens in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) Pens in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.

Storage and Handling

Store your Pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
You may store your Pen at room temperature below 86°F (30°C) for a total of 14 days.
Do not freeze your Pen. If the Pen has been frozen, throw the Pen away and use a new Pen.
Storage of your Pen in the original carton is recommended. Protect your Pen from direct heat and light.
The Pen has glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new Pen for your injection.
Keep your TRULICITY Pen and all medicines out of the reach of children.

Commonly Asked Questions

What if I see air bubbles in my Pen?

Air bubbles are normal.

What if I unlock the Pen and press the green Injection Button before pulling off the Base Cap?

Do not remove the Base Cap. Throw away the Pen and get a new 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 normal.

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 2 clicks during my injection—2 louder clicks and 1 soft one. Did I get my complete injection?

Some people 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 normal.

I am not sure if my Pen worked the right way.

Check to see if you have received your dose. Your dose was delivered the right way if the gray plunger is visible (see step 3). Also contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) for further instructions. Until then, store your Pen safely to avoid an accidental needle stick.

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 Single-Dose Pen, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider.
For more information about TRULICITY Single-Dose Pen, visit our website at: www.trulicity.com.

Scan this code to launch

www.trulicity.com

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

TRULICITY is a registered trademark of Eli Lilly and Company.

The TRULICITY Pen meets the current dose accuracy and functional requirements of ISO 11608-1:2012 and 11608-5:2012.

Implemented: 04/2023

TRU3MG-0002-IFU-20230407

TRULICITY 4.5 MG SINGLE-DOSE PEN INSTRUCTIONS FOR USE

Instructions for Use

TRULICITY ^®(TRU-li-si-tee)

(dulaglutide)

injection, for subcutaneous use

4.5 mg/0.5 mL Single-Dose Pen

use 1 time each week (once weekly)