Trulicity

Uses

What is Trulicity® (dulaglutide) used for?

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. Dulaglutide is usually given after other diabetes medicines have been tried without success.

Trulicity® is not for treating type 1 diabetes.

How should I take Trulicity® (dulaglutide)?

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

Trulicity® 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 Trulicity® with or without food.

Trulicity® 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 Trulicity®. Do not inject into the same place two times in 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.

Trulicity® 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.

How do I store Trulicity® (dulaglutide)?

Store injection pens or prefilled syringes in the refrigerator, protected from light. Throw away any Trulicity® 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 Trulicity®, and throw away the medicine if it has become frozen.

Precautions & warnings

What should I know before using Trulicity® (dulaglutide)?

Before using this drug, tell your doctor if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Trulicity® or other medications.
• You have any other illnesses, disorders, or medical conditions.

You should not use Trulicity® 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)
• Diabetic ketoacidosis (call your doctor for treatment with insulin)

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.

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Trulicity® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Trulicity®. Trulicity® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Trulicity® (dulaglutide)?

Get emergency medical help if you have signs of an allergic reaction to Trulicity®: 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
• 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
• Loss of appetite

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Trulicity® (dulaglutide)?

Trulicity® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

• All diabetes medications you use
• All medicines you take by mouth

Does food or alcohol interact with Trulicity® (dulaglutide)?

Trulicity® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Trulicity® (dulaglutide)?

Trulicity® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Health conditions that may interact with this drug are:

• 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
• If you have been sick with vomiting or diarrhea

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Trulicity® (dulaglutide).

What is the dose of Trulicity® (dulaglutide) for an adult?

Usual Adult Dose for Diabetes Type 2:

Initial dose: 0.75 mg subcutaneously once a week

Maximum dose: May increase to 1.5 mg subcutaneously once a week for additional glycemic control

What is the dose of Trulicity® (dulaglutide) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Trulicity® (dulaglutide) available?

Trulicity® is available in the following dosage forms and strengths:

• Injection, solution: Dulaglutide 0.75mg in 0.5mL

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Trulicity®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.