Dulaglutide

What it is used for

TRULICITY ® is indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

TRULICITY ® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated: As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Limitations of Use: Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients ( 1, 5.2 ). Not for treatment of type 1 diabetes mellitus. Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis ( 1, 5.6 ). Limitations of Use TRULICITY: Has not been studied in patients with a history of pancreatitis.

Consider other antidiabetic therapies in patients with a history of pancreatitis. Should not be used in patients with type 1 diabetes mellitus. Has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients.

The most important thing to know

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 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 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 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 the end of this Medication Guide 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 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 use 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 lea

Side effects, and when to stop

TRULICITY may cause serious side effects, including: 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.

Who should not take it

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.