PURPOSE AND SAFETY SUMMARY WITH WARNINGS
Important Facts About Trulicity® (Trῡ-li-si-tee). It is also known as dulaglutide.
- Trulicity is a prescription medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). Trulicity is also used in adults with type 2 diabetes to reduce the risk of major cardiovascular events (problems having to do with the heart and blood vessels) such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors.
- It is not known if TRULICITY can be used in people who have had inflammation of the pancreas (pancreatitis). TRULICITY is not for use in people with type 1 diabetes and 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.
- Trulicity is given through an injection (needle). You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm.
Trulicity may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. If you have a symptom, tell your doctor.
- Do not use Trulicity if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity.
Ask your doctor how to recognize the serious side effects below and what to do if you think you have one:
Inflamed pancreas (pancreatitis). Stop using Trulicity and call your healthcare provider right away if you have severe pain in your stomach area (abdomen), with or without vomiting, that will not go away. 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, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability, or mood changes.
Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms of a serious allergic reaction which may include swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting, or feeling dizzy, or very rapid heartbeat.
Acute kidney injury. In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration). This may cause kidney problems to get worse.
Severe stomach problems. Trulicity may cause stomach problems, which could be severe.
Changes in vision. Tell your healthcare provider if you have changes in your eyesight (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.
Common side effects
The most common side effects of Trulicity include nausea, diarrhea, vomiting, abdominal pain and decreased appetite, indigestion, and fatigue.
These are not all the possible side effects of Trulicity.
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Your healthcare provider should show you how to use Trulicity before you use it for the first time.
- Before you use Trulicity, talk to your doctor about low blood sugar and how to manage it.
Review these questions with your doctor:
- Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy (vision problems related to diabetes)?
- Do you take other diabetes medicines, such as insulin or sulfonylureas?
- Are you pregnant or plan to become pregnant or breastfeeding or plan to breastfeed?
- Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbs?
How to take
- Read the Instructions for Use that come with Trulicity.
- Use Trulicity exactly as your doctor says.
- Do not share your Trulicity pen, syringe, or needles with another person.
- Do not give Trulicity to other people.
- If you take too much Trulicity, call your healthcare provider or seek medical advice promptly.
For more information, call 1-844-TRU-INFO (1-844-878-4636) or go to www.TRULICITY.com.
This summary provides basic information about Trulicity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Trulicity and how to take it. Your doctor is the best person to help you decide if Trulicity is right for you.
Trulicity® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
DG CON HL BS 10JUN2022