PATIENT MEDICATION INFORMATION

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

Pr

TRULICITY

®

dulaglutide injection

For Subcutaneous Use Only

Read this carefully before you start taking Trulicity and each time you get a refill. This leaflet is a summary and

will not tell you everything about this drug. Talk to your healthcare professional about your medical condition

What is Trulicity used for?

Trulicity may improve blood sugar control in adults with type 2 diabetes mellitus in combination with:

• diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance

• metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate

blood sugar control

• mealtime insulin with metformin, when diet and exercise plus basal or basal-bolus insulin therapy (up to

two injections of basal or basal plus mealtime insulin per day) with or without oral diabetes medications, do

not achieve adequate blood sugar control

Trulicity may be used, along with diet and exercise, to reduce the risk of non-fatal stroke in adults with type 2

diabetes mellitus.

Trulicity is not a substitute for insulin. Trulicity should not be used in patients with type 1 diabetes mellitus

(formerly known as insulin-dependent diabetes mellitus or IDDM) or for the treatment of diabetic ketoacidosis

(a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting).

Trulicity has not been approved in children under 18 years of age.

How does Trulicity work?

What are the ingredients in Trulicity?

Medicinal ingredients: dulaglutide

Non-medicinal ingredients: citric acid anhydrous, mannitol, polysorbate 80, trisodium citrate dihydrate

Trulicity comes in the following dosage forms:

Trulicity is a solution for injection. Trulicity is available as a single-use prefilled pen in either 0.75 mg/0.5 mL,

1.5 mg/0.5 mL, 3 mg/0.5 mL or 4.5 mg/0.5 mL strengths. Each pen contains one weekly dose of Trulicity.

Do not use Trulicity if:

• you are allergic to this drug or to any ingredient in the formulation or component of the container.

• you or a member of your family has ever had medullary thyroid cancer.

• have type 1 diabetes.

• have ever had diabetic ketoacidosis (increased ketones in the blood or urine).

• have ever had an allergic reaction to Trulicity

• are taking an anti-diabetic medicine known as a sulfonylurea (e.g., glyburide, gliclazide, glimepiride) or

insulin. Your doctor may want to reduce your dose of sulfonylurea or insulin when you take it together with

Trulicity in order to avoid low blood sugar. Take precautions to avoid low blood sugar while driving or using

machinery.

• have or have had pancreas problems such as inflammation of the pancreas.

• have severe problems with your stomach (gastroparesis) or food digestion. Trulicity slows stomach

emptying so food passes more slowly through your stomach.

• have kidney problems.

• have liver problems.

• have severe vomiting and/or diarrhea and/or dehydration.

Other warnings you should know about:

• See “Serious Warnings and Precautions” black box.

• Heart rate increase and PR interval prolongation. Trulicity may increase heart rate and could cause

changes known as PR prolongation, which are detected by electrocardiogram (ECG) tracings. Increased

heart rate is the same as a faster pulse. Rarely, drugs with these effects can cause changes in heart

rhythm that could result in dizziness, palpitations (a feeling of rapid, pounding, or irregular heart beat),

fainting or death. These heart rhythm changes are more likely if you have heart disease, or if you are taking

certain other drugs. It is important to follow your doctor's advice about the dose of Trulicity or about any

problems. Stomach problems, sometimes severe, have been reported in people who use Trulicity. Tell your

healthcare provider if you have stomach problems that are severe or will not go away.

• Food or liquid getting into lungs during anesthesia. Some patients taking medicines like Trulicity have had

problems with food or liquid from their stomach getting into their lungs while under general anesthesia or

deep sedation. Tell your healthcare provider that you are taking Trulicity before you have a procedure that

requires general anesthesia or deep sedation.

• 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.

• Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms

of a serious allergic reaction including itching, rash, or difficulty breathing.

Trulicity is not approved for use in children under 18 years of age.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins,

minerals, natural supplements or alternative medicines.

The following may interact with Trulicity:

• A sulfonylurea medicine (e.g., glibenclamide or glimepiride) or insulin. This is because using Trulicity at the

same time may cause your blood sugar to get too low (hypoglycemia). When you first start using these

medications together, your doctor may tell you to lower the dose of the sulfonylurea or insulin.

The following list includes some, but not all, of the drugs that may increase the risk of heart rhythm problems

while receiving Trulicity. You should check with your doctor or pharmacist before taking any other medication

with Trulicity:

• Drugs to treat asthma.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals,

natural supplements or alternative medicines.

How to take Trulicity:

• Before using Trulicity, talk to your doctor about low blood sugar and how to manage it.

• Take Trulicity exactly as your physician has prescribed.

• Read the Instructions for Use leaflet for instructions on how to use the Trulicity pen.

• Talk to your healthcare provider about how to correctly administer Trulicity before you use it for the first

time. If you do not understand the instructions or have any questions, talk with your doctor, diabetes nurse,

or pharmacist.

• Trulicity is an injection which is given under the skin (subcutaneously). The Trulicity injection pen has been

shown to be easy to learn and easy to use. Do not inject Trulicity into a vein or muscle. The best places to

• Do not share your pen, or needles with another person. You may give another person an infection or get an

infection from them.

• Keep pens and needles out of the reach of children.

Usual dose:

The recommended starting adult dose is 0.75 mg once weekly administered subcutaneously (under the skin).

The dose may be increased to 1.5 mg once-weekly based on your blood sugar response. After at least four

weeks your doctor may increase your dose to 3 mg once weekly if your blood sugar is not well controlled on

the 1.5 mg dose. After at least four weeks your doctor may further increase your dose to 4.5 mg once weekly if

your blood sugar is not well controlled on the 3 mg dose. The maximum recommended dose is 4.5 mg once-

weekly.

What are possible side effects from using Trulicity?

These are not all the possible side effects you may have when taking Trulicity. If you experience any side

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