Trulicity is an injectable diabetes medicine that helps control blood sugar levels.

Trulicity is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Trulicity is also used to help reduce the risk of serious heart problems such as heart attack or stroke in adults who have type 2 diabetes and heart disease.

Trulicity is not for treating type 1 diabetes.

You should not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer). Do not use this medicine if you are in a state of diabetic ketoacidosis (call your doctor for treatment).

In animal studies, Trulicity caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

Call your doctor at once if you have signs of a thyroid tumor, such as swelling or a lump in your neck, trouble swallowing, a hoarse voice, or shortness of breath.

Before taking this medicine

You should not use Trulicity if you are allergic to dulaglutide, or if you have:

• multiple endocrine neoplasia type 2 (tumors in your glands);

• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or

• diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• pancreatitis;

• a stomach or intestinal disorder;

• gastroesophageal reflux disease (GERD) or slow digestion;

• eye problems caused by diabetes (retinopathy);

• liver or kidney disease;

• if you also use insulin or oral diabetes medicine; or

• if you have been sick with vomiting or diarrhea.

In animal studies, Trulicity caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

It is not known whether dulaglutide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Trulicity is not approved for use by anyone younger than 18 years old.

Use Trulicity exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Trulicity is injected under the skin once per week. Use this medicine on the same day each week at the same time of day. If you change your dosing day, allow at least 3 days to pass between doses.

You may use this medicine with or without food.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Trulicity if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you do not understand these instructions.

Your healthcare provider will show you where on your body to inject Trulicity. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Each injection pen or prefilled syringe is for one use only. Throw away after one use, even if there is still medicine left inside. Use a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Store Trulicity Pens in the refrigerator, protected from light. Do not use past the expiration date on the medicine label. Do not freeze this medicine, and throw away the medicine if it has become frozen.

You may also store Trulicity Pens at room temperature for up to 14 days before use.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 0.75 mg subcutaneously once a week
-Dose may be increased in 1.5 mg increments for additional glycemic control; patients should remain on 3 mg once a week dose for at least 4 weeks prior to increasing dose to 4.5 mg once a week
Maintenance dose: 0.75 to 4.5 mg subcutaneously once a week
Maximum dose: 4.5 mg weekly

Comments:
-This drug should not be used in patients with type 1 diabetes mellitus.
-This drug has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is not recommended in these patients.
-This drug has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in these patients.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in adults 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.

Usual Adult Dose for Cardiovascular Risk Reduction:

Initial dose: 0.75 mg subcutaneously once a week
-Dose may be increased in 1.5 mg increments for additional glycemic control; patients should remain on 3 mg once a week dose for at least 4 weeks prior to increasing dose to 4.5 mg once a week
Maintenance dose: 0.75 to 4.5 mg subcutaneously once a week
Maximum dose: 4.5 mg weekly

Comments:
-This drug should not be used in patients with type 1 diabetes mellitus.
-This drug has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is not recommended in these patients.
-This drug has not been studied in patients with a history of pancreatitis; consider other antidiabetic therapies in these patients.

Uses:
-As an adjunct to diet and exercise to improve glycemic control in adults 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.

You should not use Trulicity if you are allergic to dulaglutide, or if you have:

• multiple endocrine neoplasia type 2 (tumors in your glands);

• a personal or family history of medullary thyroid carcinoma (a type of thyroid cancer); or

• diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• pancreatitis;

• a stomach or intestinal disorder;

• gastroesophageal reflux disease (GERD) or slow digestion;

• eye problems caused by diabetes (retinopathy);

• liver or kidney disease;

• if you also use insulin or oral diabetes medicine; or

• if you have been sick with vomiting or diarrhea.

In animal studies, Trulicity caused thyroid tumors or thyroid cancer. It is not known whether these effects would occur in people using regular doses. Ask your doctor about your risk.

It is not known whether dulaglutide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Trulicity is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 3 days. Do not use two doses at one time.

Do not use Trulicity twice within a 72-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Never share an injection pen or prefilled syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Stop using Trulicity and get emergency medical help if you have signs of an allergic reaction to Trulicity: hives; difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting;

• signs of a thyroid tumor - swelling or a lump in your neck, trouble swallowing, a hoarse voice, or if you feel short of breath;

• low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Tell your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while using this medicine and this can lead to kidney failure.

Common Trulicity side effects may include:

• nausea, vomiting, stomach pain;

• diarrhea; or

• loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Trulicity can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.

Other drugs may interact with dulaglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.