dulaglutide

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Pronunciation: DOO la GLOO tide

Brand: Trulicity Pen

What is the most important information I should know about dulaglutide?

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 with insulin).

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.

What is dulaglutide?

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

Dulaglutide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Dulaglutide is usually given after other diabetes medicines have been tried without success.

This medicine is not for treating type 1 diabetes.

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

What should I discuss with my healthcare provider before using dulaglutide?

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 with insulin).

To make sure dulaglutide is safe for you, tell your doctor if you have:

  • a history of pancreatitis;
  • a stomach or intestinal disorder (especially if you also have kidney disease);
  • gastroesophageal reflux disease (GERD) or slow digestion;
  • 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 this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dulaglutide passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

How should I use dulaglutide?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Dulaglutide comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Dulaglutide is injected under the skin. You will be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

You may use dulaglutide with or without food.

Dulaglutide is usually given only one time per week. Use the medicine on the same day each week at the same time of day. If needed, you may change your dosing day, but allow at least 3 days to pass between doses.

Use a different place on your stomach, thigh, or upper arm each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.

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 single-use injection pen or prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Dulaglutide is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store injection pens or prefilled syringes in the refrigerator, protected from light. Throw away any dulaglutide not used before the expiration date on the medicine label.

You may also store injection pens or prefilled syringes at room temperature for up to 14 days before use.

Do not freeze dulaglutide, and throw away the medicine if it has become frozen.

What happens if I miss a dose?

If your next dose is 3 or more days away, use the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 3 days away. Do not use extra medicine to make up the missed dose.

Do not use this medicine twice within a 72-hour period.

What happens if I overdose?

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

Overdose symptoms may include severe nausea and vomiting.

What should I avoid while using dulaglutide?

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.

What are the possible side effects of dulaglutide?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • symptoms of pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • 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
  • signs of a kidney problem --little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Common side effects may include:

  • stomach pain, indigestion;
  • nausea, diarrhea, vomiting; 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.

What other drugs will affect dulaglutide?

Some drugs can affect how well dulaglutide controls your blood sugar, and dulaglutide may affect how other drugs work.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • all diabetes medications you use; and
  • all medicines you take by mouth.

This list is not complete. Other drugs may interact with dulaglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about dulaglutide.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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