Trulicity

What is Trulicity?

• Trulicity is an injectable prescription medicine that is used:
  • along with diet and exercise to improve blood sugar (glucose) in adults 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 can be used in people who have had pancreatitis.
• Trulicity is not for use in people with type 1 diabetes.
• Trulicity is not recommended for use in people with severe stomach or intestinal problems.
• It is not known if Trulicity is safe and effective for use in children. Trulicity should not be used in children under 18 years of age.

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).

Who should not use Trulicity?

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).
• you have had a serious allergic reaction to dulaglutide or any of the ingredients in Trulicity. See below for a complete list of ingredients in Trulicity. Symptoms of a serious allergic reaction include:
  • swelling of your face, lips, tongue or throat
  • problems breathing or swallowing
  • severe rash or itching
  • fainting or feeling dizzy
  • very rapid heartbeat

What should I tell my healthcare provider before using Trulicity?

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

• have or have had problems with your pancreas, kidneys or liver.
• 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 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, tell your healthcare provider if you are taking other medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar and how to manage it.

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 take Trulicity?

• Read the Instructions for Use that comes with Trulicity.
• Use Trulicity exactly as your healthcare provider tells you to.
• Trulicity is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• 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 go to the nearest 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 vomiting. 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
• Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
• Severe stomach problems. Other medicines like Trulicity may cause severe stomach problems. It is not known if Trulicity causes or worsens stomach problems.
• 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

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 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.

How should I store Trulicity?

• 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.

What are the ingredients in Trulicity?

Active ingredient: dulaglutide

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

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

Instructions for use for Trulicity

Trulicity (TRU-li-si-tee)
(dulaglutide)
injection, for subcutaneous use
Single-Dose Pen strengths 0.75 mg/0.5 mL, 1.5 mg/0.5 mL, 3mg/0.5 mL, 4.5mg/0.5 mL
Use 1 time each week (once weekly)

Trulicity 0.75 mg/0.5 mL Single-Dose Pen

Trulicity 1.5 mg/0.5 mL Single-Dose Pen

Trulicity 3 mg/0.5 mL Single-Dose Pen

Trulicity 4.5 mg/0.5 mL Single-Dose Pen

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. 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

Choose Your Injection Site

• Your healthcare provider can help you choose the injection site that is best for you.
• You may inject the medicine into your stomach (abdomen) or thigh.
• Another person may give you the injection in your 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.

Note: Each strength Trulicity pen has the same features and is administered the same way, but the colors on your pen may be different to those pictured below if you use a different strength to the Trulicity 1.5 mg/0.5ml Pen. The different Pen strengths and color combinations are shown above.

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

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.

Instructions for use approved 09/2018 (1.5 mg/0.5 ml and 0.75 mg/0.5 ml) and 09/2020 (3 mg/0.5 ml and 4.5 mg/0.5 ml).