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

Dulaglutide 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.

dulaglutide is not for treating type 1 diabetes.

Dulaglutide may also be used for purposes not listed in this medication guide.

You should not use dulaglutide 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 dulaglutide if you are in a state of diabetic ketoacidosis (call your doctor for treatment).

In animal studies, dulaglutide 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.

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

Dulaglutide is injected under the skin once per week. Use dulaglutide 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 dulaglutide with or without food.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Your healthcare provider will show you where on your body to inject dulaglutide. 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 dulaglutide in the refrigerator, protected from light. Do not use past the expiration date on the medicine label. Do not freeze dulaglutide, and throw away the medicine if it has become frozen.

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

You should not use dulaglutide if you are allergic to it, 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, dulaglutide 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.

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

Dulaglutide may cause serious side effects. 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 dulaglutide. This can lead to kidney failure.

Common side effects of dulaglutide 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.

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

Other drugs may affect 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.