WARNINGS
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).
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 the section SIDE EFFECTS, below for symptoms of a serious allergic reaction.
USES
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.
HOW TO USE
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.
TRULICITY may cause serious side effects, including:
See the sections WARNINGS and PRECAUTIONS above.
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
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.
What are the ingredients in TRULICITY?
Active ingredient: dulaglutide
Inactive ingredients: citric acid anhydrous, mannitol, polysorbate 80, trisodium citrate dihydrate, in water for injection
OVERDOSE
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.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store TRULICITY in the refrigerator at 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C).
If needed, each single-dose pen can be kept at room temperature, not to exceed 86-degrees F (30-degrees C) for a total of 14 days.
Do not freeze TRULICITY. Do not use TRULICITY if it has been frozen.
Protect TRULICITY from light. Storage of TRULICITY in the original carton is recommended until time of administration.
NOTES
Medication Guide: revision date 05/2025
Prescribing Information: revision date 06/2025
1.) Oral Medications
TRULICITY delays gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. The delay in gastric emptying is dose-dependent but is attenuated with the recommended dose escalation to higher doses of TRULICITY [see Dosage and Administration (2.1)]. The delay is largest after the first dose and diminishes with subsequent doses. In clinical pharmacology studies, TRULICITY 1.5 mg did not affect the absorption of the tested orally administered medications to a clinically relevant degree [see Clinical Pharmacology (12.3)]. There is limited experience with the use of concomitant medications in clinical trials with TRULICITY doses of 3 mg and 4.5 mg.
Monitor drug levels of oral medications with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with TRULICITY.
2.) Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
When initiating TRULICITY, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see the sections WARNINGS and PRECAUTIONS, above.].
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.
