Patient Medication Information: uses, side effects, how to take - Trulicity (Eli Lilly Canada, 0.75 mg, 1.5 mg)

Serious Warnings and Precautions

In male and female rats, dulaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and carcinoma) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

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
metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate blood sugar control
sodium glucose co-transporter 2 inhibitor (SGLT2i) with metformin, when diet and exercise plus
SGLT2i with or without metformin do not achieve adequate glycemic control
basal insulin with metformin, when diet and exercise plus basal insulin with or without 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 studied in children under 18 years of age.

How does TRULICITY work?

TRULICITY belongs to a class of medicines called GLP-1 receptor agonists (glucagon-like peptide-1 receptor agonists). TRULICITY may lower blood sugar in adults with type 2 diabetes mellitus by helping your body release more insulin when your blood sugar is high.

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 or as a single-use prefilled syringe^‡in either 0.75 mg/0.5 mL or 1.5 mg/0.5 mL strengths. Each pen or syringe^‡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.
you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
you are pregnant or breastfeeding.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRULICITY. Talk about any health conditions or problems you may have, including if:

you or a member of your family has or has had medullary thyroid carcinoma, or if you have Multiple
Endocrine Neoplasia syndrome type 2 (MEN 2).
you have type 1 diabetes.
you have ever had diabetic ketoacidosis (increased ketones in the blood or urine).
you have ever had an allergic reaction to TRULICITY
you 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.
you have or have had pancreas problems such as inflammation of the pancreas.
you have severe problems with your stomach (gastroparesis) or food digestion. TRULICITY slows stomach emptying so food passes more slowly through your stomach.
you are pregnant or plan to become pregnant.
you are breastfeeding or plan to breastfeed.
have a high heart rate (fast pulse).
have a condition called heart block.
have any heart disease, such as angina, heart rhythm disturbances or congestive heart failure; or if you have ever had a myocardial infarction (heart attack).
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 special tests that you may need.
Inflammation of your pancreas (pancreatitis). Stop using TRULICITY and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel pain from your abdomen to your back.
It is not known if TRULICITY can be used in people who have had pancreatitis.
Gastrointestinal disorders. TRULICITY is not recommended for use in people with severe stomach or intestinal problems.
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.
Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse.
Dehydration: Nausea, vomiting and diarrhea can lead to dehydration. It is important to avoid dehydration which can cause serious kidney problems even in people with normal kidney function.

Talk to your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of TRULICITY.

TRULICITY is not recommended for use in children under 18 years of age.

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 hypertension.
Drugs to treat heart failure.
Drugs to treat HIV infection.
Drugs to treat attention deficit-hyperactivity disorder.
Drugs to suppress appetite/cause weight loss.
Decongestants.
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 or syringe^‡.
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 give yourself the injection are your stomach area (abdomen), upper leg (thigh), or upper arm. Do not use the same site for each injection. Change (rotate) your injection site with each weekly injection.
You can give yourself the injection at any time of the day.
If you give yourself insulin in addition to TRULICITY, never mix them in the same container. Give yourself separate injections of insulin and TRULICITY. You may give both injections in the same body area (for example, your stomach area), but not right next to each other.
Do not share your pen, syringe^‡, 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. The maximum recommended dose is 1.5 mg once-weekly.

TRULICITY can be taken any time of the day, with or without food.

Use TRULICITY exactly as prescribed. Do not change your dose or stop TRULICITY without talking to your doctor. Your doctor should start you on a diet and exercise program when you start taking TRULICITY. Stay on this program while you are taking TRULICITY. The response on your blood sugar control should be monitored by periodic measurements of blood glucose and HbA1c levels.

Your dose of TRULICITY and other diabetes medicines may need to change because of change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take. Talk to your doctor to seek medical advice promptly.

Overdose:

If you think you have taken too much TRULICITY, contact your healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of TRULICITY, take your missed dose as soon as possible if there are at least 3 days (72 hours) until your next scheduled dose. If there are less than 3 days remaining, skip the missed dose and take your next dose on the regularly scheduled day. Do not take 2 doses of TRULICITY within 3 days of each other.

The dosing day of your weekly administration can be changed if necessary, as long as there are at least 3 days between doses.

What are possible side effects from using TRULICITY?

These are not all the possible side effects you may feel when taking TRULICITY. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Very Common (≥1 in 10):

Nausea
Diarrhea
Vomiting
Abdominal pain
Low blood sugar (hypoglycemia) when used in combination with other diabetes medicines especially metformin, insulin, or secretagogues (e.g. sulfonylurea)

If nausea happens, it is most common when first starting TRULICITY. In most people, nausea decreases over time as their body gets use to the medicine.

Common (≥1 in 100 and <1 in 10):

decreased appetite
upset stomach (dyspepsia)
constipation
gassiness (flatulence)
abdominal distension
heartburn (gastroesophageal reflux disease)
belching (eructation)
fatigue
fast heartbeat (sinus tachycardia)
first degree atrioventricular block (AV block)
hypoglycemia when used as monotherapy and in combination with metformin and pioglitazone

Uncommon (≥1 in 1000 and <1 in 100):

injection site reaction

Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare professional

Stop taking drug and get immediate medical help

Only if severe

In all cases

UNCOMMON

Severe hypoglycemia* (low blood sugar) symptoms: disorientation, loss of consciousness, or seizures

✓

Thyroid tumour symptoms: lump in the neck, difficulty in swallowing difficulty in breathing or persistent hoarseness	✓
Atrial fibrillation/ flutter, irregular heart rate, palpitations, fatigue or shortness of breath	✓	✓
RARE Severe allergic reaction (anaphylactic reaction) symptoms: breathing problems, swelling of throat and face, and fast heartbeat.	✓	✓
Pancreatitis symptoms: prolonged severe abdominal pain with or without vomiting	✓	✓

*The risk of severe hypoglycemia is dependent on the other medications you may be taking.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

Online at MedEffect;
By calling 1-866-234-2345 (toll-free);
By completing a Patient Side Effect Reporting Form and sending it by:
- Fax to: 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
  Health Canada, Address Locator 1908C Ottawa, ON
  K1A 0K9
  Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

TRULICITY should be stored in the refrigerator at 2°C to 8°C, up to the expiration date. Do not use
TRULICITY beyond the expiration date.
Do not freeze. Do not use TRULICITY if it has been frozen.
Do not store in the freezer.
Protect from light.
Each single-use prefilled pen or prefilled syringe^‡may be stored unrefrigerated for up to 14 days at a temperature not to exceed 30ºC.
The TRULICITY prefilled pen or prefilled syringe^‡must be discarded after use in a puncture-resistant container.

Keep out of reach and sight of children.

If you want more information about TRULICITY:

Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes this Patient
Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website http://www.lilly.ca, or by calling 1-888-545-5972.

‡ The pre-filled syringe is not currently marketed in Canada.

Last Revised September 11, 2020

TRULICITY is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

A3.0-TRU-0006-CA-PM- YYYYMMDD

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TRULICITY^®

dulaglutide injection

For Subcutaneous Use Only

0.75 mg/0.5 mL Single-Use Pen, Once-Weekly

Unfold and lay instructions flat >

Read both sides for full instructions

www.lilly.ca

ABOUT TRULICITY SINGLE-USE PEN

Please read these Instructions for Use and the Patient Medication Information Leaflet carefully and completely before using your TRULICITY Single-Use Pen. Talk to your healthcare provider about how to inject TRULICITY correctly or contact Lilly at 1-888-545-5972.

TRULICITY Single-Use Pen (Pen) is a disposable, prefilled delivery device that is ready-to-use. Each Pen contains one weekly dose of TRULICITY (0.75 mg/0.5 mL). Each Pen is for one-time use only.
TRULICITY is taken once a week. You may want to mark your calendar to remind you when to take your next dose.
The Pen has been designed with input from patients to be easy to use.
When you press the green Injection Button, the Pen will automatically insert the needle into your skin, inject the medicine, and pull back (retract) the needle after the injection is complete.

BEFORE YOU GET STARTED

Remove Check Inspect Prepare from the refrigerator.

Leave the Base Cap on

until you are ready to inject.

For a more comfortable

injection, you may want to

allow the Pen to warm to

room temperature for about

30 minutes. Do not

microwave or run under hot

water.

the label to make sure you

have the correct medicine

and it has not expired.

Expiration Date

the Pen to make sure that it is not damaged and inspect the medicine to make sure it is not cloudy, discoloured or has particles in it.

by washing your hands.

CHOOSE YOUR INJECTION SITE

Your healthcare provider can help you choose the
injection site that is best for you.
You may inject the medicine into your stomach
(abdomen) or thigh.
Another person may give you the injection in your
upper arm.
Change (rotate) your injection site each week. You
may use the same area of your body, but be sure to choose a different injection site in that area.
FRONT BACK

Remember to:

1. UNCAP
2. PLACE AND UNLOCK
3. PRESS AND HOLD

Top

Injection Button Lock Ring Indicator Lock/Unlock Medicine Bottom/

Needle

End

Clear Base Base Cap

1 UNCAP

Make sure the Pen is locked.

Pull off and discard the gray Base Cap.
Do not put the Base Cap back on — this could damage the needle.
Do not touch the needle.

2 PLACE AND UNLOCK

Place the Clear Base flat and firmly against your skin at the injection site.
Unlock by turning the Lock Ring.

3 PRESS AND HOLD

Press and hold the green Injection Button;
you will hear a loud click.
Continue holding the Clear Base firmly against your skin until you hear a second click. This occurs when the needle starts retracting in about 5-10 seconds.
Remove the Pen from your skin.
You will know your injection is complete when the gray part is visible.
5-10 Seconds

IMPORTANT INFORMATION

Disposal of Pen

Storage and Handling

Commonly Asked Questions

Other Information

Where to Learn More

DISPOSAL OF PEN

Put the Pen in a closeable, puncture-resistant sharps
container (like a biohazard container).
Do not recycle the filled sharps container.
Ask your healthcare provider about options available in
your area to dispose of the sharps container properly.
The directions regarding Pen handling and disposal are
not intended to replace local, healthcare provider or
institutional policies.

STORAGE AND HANDLING

The Pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new Pen for your injection.
Store your Pen in the refrigerator.
When refrigeration is not possible, you can keep your Pen unrefrigerated for up to 14 days at a temperature not to exceed 30°C.
Do not freeze your Pen. If the Pen has been frozen, DO NOT USE.
Keep TRULICITY out of direct heat and light.
For complete information about proper storage, read the Patient Medication Information Leaflet.

COMMONLY ASKED QUESTIONS

What if I see an air bubble in my Pen?

Air bubbles are normal. They will not harm you or affect your dose.

What if I unlock the Pen and press the green Injection Button before pulling off the Base Cap?

Do not remove the Base Cap. Dispose of the Pen as directed. Inject your dose using another Pen.

What if there is a drop of liquid on the tip of the needle when I remove the Base Cap?

A drop of liquid on the tip of the needle is not unusual and will not affect your dose.

Do I need to hold the Injection Button down until the injection is complete?

This is not necessary, but it may help you keep the Pen steady and firm against your skin.

I heard more than two clicks during my injection - two louder clicks and one soft one. Did I get my complete injection?

Some patients may hear a soft click right before the second loud click. That is the normal operation of the Pen. Do not remove the Pen from your skin until you hear the second louder click.

What if there is a drop of liquid or blood on my skin after my injection?

This is not unusual and will not affect your dose.

I’m not sure my Pen worked correctly.

Check to see if you have received your dose. Your dose was delivered correctly if the gray part is visible. (See step 3.) Please contact Lilly at 1-888-545-5972 for further instructions on your Pen. Until then, store your Pen safely to avoid an accidental needle stick. If your dose was not delivered, you should also contact your healthcare provider to discuss your blood sugar control.

OTHER INFORMATION

If you have vision problems, DO NOT use your Pen without help from a person trained to use the TRULICITY Pen.
Keep the Pen out of sight and reach of children.

WHERE TO LEARN MORE

If you have any questions or problems with your TRULICITY Single-Use Pen, contact your healthcare provider or Lilly at 1-888-545-5972.
For more information about TRULICITY Single-Use Pen visit our website at www.lilly.ca.

Manufactured by:

Eli Lilly and Company

Pharmaceutical Delivery Systems

Lilly Corporate Center

Indianapolis, IN 46285, USA

Distributed by:

Eli Lilly Canada Inc.

3650 Danforth Avenue

Toronto, Ontario

M1N 2E8

TRULICITY is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

The information in this document is current as of the last revision date shown below. For the most current information please visit our website at www.lilly.ca or contact us directly at 1-888-545-5972.

Revision Date: September 11, 2020

The TRULICITY Pen meets the current dose accuracy and functional requirements of ISO 11608-1:2012 and 11608- 5:2012.

TRULOAI-0004-CA-IFU-20190305

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