Lilly TRULICITY Instructions For Use Manual

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Instructions for Use
TRULICITY®(TRU-li-si-tee)
(dulaglutide)
injection, for subcutaneous use
use 1 time each week (once weekly)
Unfold and lay flat
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SEAL
Read both sides for full instructions
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.
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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
Choose Your Injection Site
• Your healthcare provider can help you choose the
injection site that is best for you.
• You may inject themedicine into your stomach
(abdomen) or thigh.
• Another person may give you the injection inyour upper
arm.
• Change (rotate) your injection site each week. You may
use the same area of your body, but be sure to choose a different injection site in that area.
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.
FRONT BACK
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Top InjectionButton
Lock Ring
Indicator Lock/Unlock
Medicine
Bottom/ Needle End
Clear Base
Base Cap
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Step 1 Uncap the Pen
You will know
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.
5-10 Seconds
your injection is complete when the gray plunger is visible.
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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 (2C to 8C).
• 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?
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A drop of liquid on the tip of the needle is normal.
SCAN THIS CODE TO LAUNCH
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.
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, 2018, 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: 09/2018
TRULOAI-0003-IFU-20180921
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