Patient Medication Information: uses, side effects, how to take - Mounjaro

Serious warnings and precautions box

Tirzepatide, the medicinal ingredient in MOUNJARO, increased the risk of developing thyroid C-cell tumors in rats. It is not known if the risk seen in rats applies to humans. It is uncertain if MOUNJARO may increase your risk for developing thyroid C-cell tumors, including medullary thyroid carcinoma.
Do not use MOUNJARO if you:
- have a personal or family history of Medullary Thyroid Cancer (MTC);
- have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Your healthcare professional will speak to you about the risk and symptoms of thyroid tumors.

What MOUNJARO is used for:

MOUNJARO is used along with diet and exercise to improve blood sugar levels when you have type 2 diabetes.

In adults, MOUNJARO is used:

alone, if you cannot take metformin;
with metformin;
with metformin and a sulfonylurea;
with metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i);
with basal insulin (with or without metformin).

In children and adolescents, aged 10 to less than 18 years of age, MOUNJARO is used with:

metformin;
basal insulin (with or without metformin)

How MOUNJARO works:

MOUNJARO belongs to a class of medicines called GIP and GLP-1 receptor agonists. MOUNJARO lowers your blood sugar by helping your body release more insulin when your blood sugar is high. It also reduces levels of glucagon, a hormone that prevents blood sugar from decreasing too much.

The ingredients in MOUNJARO are:

Medicinal ingredients: tirzepatide

Non-medicinal ingredients:

MOUNJARO single-dose pen and single-dose vial (preservative-free):

Hydrochloric acid solution, sodium chloride, sodium hydroxide solution, sodium phosphate dibasic heptahydrate, water for injection.

MOUNJARO KwikPen multi-dose pen (includes preservatives):

Benzyl alcohol (preservative), glycerin, hydrochloric acid solution, phenol (preservative), sodium chloride, sodium hydroxide solution, sodium phosphate dibasic heptahydrate, water for injection.

MOUNJARO comes in the following dosage forms:

MOUNJARO – solution in a single-dose prefilled pen or vial: 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL, and 15 mg/0.5 mL.

MOUNJARO KwikPen – solution in a multi-dose prefilled pen containing 4 fixed-doses: 2.5 mg/0.6 mL, 5 mg/0.6 mL, 7.5 mg/0.6 mL, 10 mg/0.6 mL, 12.5 mg/0.6 mL, and 15 mg/0.6 mL.

Do not use MOUNJARO if:

you are allergic to tirzepatide or to any ingredient in MOUNJARO or component of its container. This includes benzyl alcohol, which is used as a preservative in MOUNJARO KwikPen.
you or a member of your family has ever had Medullary Thyroid Cancer (MTC).
you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
you are pregnant.

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

type 1 diabetes.
a heart condition that causes an increase in heart rate.
experienced severe allergic reactions and swelling when taking GLP-1 receptor agonist medicines.
ever had diabetic ketoacidosis (increased ketones in the blood or urine).
severe problems with your stomach (gastroparesis) or food digestion. MOUNJARO slows stomach emptying so food passes more slowly through your stomach.
very low food intake or inadequate nutrition (including low vitamins and minerals).
ever had depression or other mental health problems.

Other warnings you should know about:

Gallbladder Disease

You may suddenly develop symptoms of gallbladder disease when taking MOUNJARO.
Gallbladder disease can include inflammation of the gallbladder (cholecystitis), or gallstones blocking the bile duct (biliary colic).
Symptoms may include sudden and intensifying pain in your abdomen, between your shoulder blades or your right shoulder. You should seek immediate medical attention if you experience severe abdominal pain, yellowing of your skin, or high fever with chills. If you think you might have a problem with your gallbladder, consult your healthcare professional.

Benzyl alcohol

Benzyl alcohol is a preservative used in MOUNJARO KwikPen. Benzyl alcohol can cause you to develop metabolic acidosis (acid in the blood). Metabolic acidosis can develop when large amounts of benzyl alcohol build-up in your body. Talk to your healthcare professional if you:
- are taking other medications containing benzyl alcohol.
- have liver or kidney problems.

Children and adolescents

MOUNJARO is not recommended in children under 10 years.

Pregnancy

Tell your healthcare professional if you are pregnant, planning to become pregnant or think you are pregnant. There are specific risks you should discuss with your healthcare professional.
You should not take MOUNJARO if you are pregnant. It may harm your unborn baby.
If you are able to become pregnant:
- Avoid becoming pregnant while you are taking MOUNJARO. Use effective birth control during treatment and at least one month after your last dose. If you are using oral hormonal drugs as a birth control method:
  - switch to a non-oral hormonal birth control medicine, or
  - add a barrier method of birth control (e.g., condoms). Use this method for 4 weeks when beginning treatment with MOUNJARO and for 4 weeks after each time your dose is increased.

Breastfeeding

MOUNJARO may pass into your breast milk. Talk to your healthcare professional about the potential risks of breastfeeding your baby while taking MOUNJARO.

Driving and using machines

Low blood sugar (hypoglycemia) may affect your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar.
See “What are possible side effects from using MOUNJARO” for the warning signs of low blood sugar. Talk to your healthcare professional for further information.

Pancreas problems

Taking MOUNJARO can cause an inflamed pancreas (acute pancreatitis).
Speak to your healthcare professional if you have or have had pancreas problems such as inflammation of the pancreas.
Your healthcare professional will monitor you for any symptoms of acute pancreatitis. Speak to your healthcare professional immediately if you have severe and on-going pain in the stomach area. See “What are possible side effects from using MOUNJARO” for more symptoms of acute pancreatitis.

Serious allergic reactions

Stop using MOUNJARO and get medical help right away if you have any symptoms of a serious allergic reaction. This can include itching, rash, or difficulty breathing. See “What are possible side effects from using MOUNJARO” for more symptoms of an allergic reaction.

Blood tests

Your blood sugar levels should be monitored at the start of treatment if you are taking MOUNJARO with anti-diabetic medicines known as sulfonylurea or insulin. Monitoring your blood sugar levels will help reduce the risk of developing hypoglycemia (low blood sugar).
Your healthcare professional will monitor your blood sugar levels periodically during your treatment with MOUNJARO.

Kidney problems

During treatment with MOUNJARO, you may experience feeling sick (nausea) or being sick (vomiting), and diarrhea. These side effects can cause dehydration (loss of fluids). Dehydration can lead to problems with your kidneys, such as sudden kidney failure.
It is therefore important to drink plenty of fluids to prevent dehydration.
Talk to your healthcare professional if you have any questions or concerns.

Eye problems

Diabetic eye disease (retinopathy):
- Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. This may require treatment or lead to a loss of vision.
- You should inform your healthcare professional if you have diabetic eye disease (retinopathy) or if you experience vision problems during treatment with MOUNJARO.
Non-arteritic anterior ischaemic optic neuropathy (NAION):
- If you experience a sudden loss of vision or rapidly worsening eyesight during treatment with MOUNJARO, urgently contact your healthcare professional. This may be caused by NAION. Your healthcare professional will refer you for an eye examination by an ophthalmologist and you may have to stop your treatment with MOUNJARO.

Gastrointestinal (stomach and intestine) problems

Stomach problems, sometimes severe, have been reported in people who use MOUNJARO. Tell your healthcare professional if you have stomach problems that are severe or will not go away.

Malnutrition

Nutrition problems, sometimes severe or serious, have been reported in people who use MOUNJARO. This can cause you to have low vitamin, mineral, and/or protein levels and low body weight.
While you are using MOUNJARO, your healthcare professional may give you guidance on nutrition and/or recommend you take vitamins or supplements.

Food or liquid getting into lungs during anesthesia

Some patients taking medicines like MOUNJARO have had problems with food or liquid from their stomach getting into their lungs while under general anesthesia or deep sedation.
Tell your healthcare professional that you are taking MOUNJARO before you have a procedure that requires general anesthesia or deep sedation.

Depression or thoughts of suicide

You should pay attention to any changes in your mood, behaviours, feelings, or thoughts. Call your healthcare professional right away if you have any:
- thoughts or behaviours of harming or killing yourself, or
- changes to your mental health that are new, worse, or worry you.

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 MOUNJARO:

oral birth control medicines.
anti-diabetic medicines known as a sulfonylurea (e.g., glyburide, gliclazide, glimepiride) or insulin. Combining these medicines with MOUNJARO might increase the risk of getting low blood sugar. Your healthcare professional may tell you to lower your regular dose of these drugs when adding MOUNJARO treatment.
medicines that may increase your heart rate.
other incretin medicines. The use of MOUNJARO in combination with other GLP-1 receptor agonists or with DPP-4 inhibitors has not been studied and MOUNJARO should not be used in combination with those drugs.

How to inject MOUNJARO:

MOUNJARO is an injection which is given under the skin (subcutaneously). Do not inject MOUNJARO into a vein or muscle
Inject MOUNJARO once per week at any time of the day, with or without food. Set a reminder on a calendar to remind yourself of your weekly dose.
- Changing the day of the week for your injection: If necessary, you can change the day of your weekly injection. There has to be at least 3 days since your last injection of MOUNJARO
Read the Instructions for Use and watch the instructional video before injecting MOUNJARO (single-dose prefilled pen, or single-dose vial) and MOUNJARO KwikPen (multi-dose prefilled pen). These provide instructions on how to use the prefilled pen, multi-use prefilled pen or vial.
Talk to your healthcare professional about how to correctly administer MOUNJARO before you use it for the first time. Do not use MOUNJARO without receiving this training. If you do not understand the instructions or have any questions, talk with your healthcare professional.
A caregiver may give you your MOUNJARO injections or you may self-inject if your healthcare provider determines that it is appropriate.
Take MOUNJARO exactly as your healthcare professional has prescribed. Do not change your dose or stop taking MOUNJARO without talking to your healthcare professional.
You will be using the following number of pens, vials or KwikPens during a month’s treatment:
- 4 different pens or vials if you are using MOUNJARO single-dose prefilled pen, or single-dose vial.
- 1 pen if you are using multi-dose prefilled MOUNJARO KwikPen.
The pen, KwikPen and vial have glass parts. Handle carefully. If you drop the pen, KwikPen or vial on a hard surface, do not use it. Use a new pen, KwikPen or vial for your injection.
The best places to give yourself the injection are your stomach area (abdomen) or upper leg (thigh). Another person should give you the injection in the back of your upper arm.
Do not use the same site for each injection. Change (rotate) your injection site with each weekly injection.
If you also are taking insulin in addition to MOUNJARO:
- Never mix both medications (insulin and MOUNJARO) in the same container. Give yourself separate injections of insulin and MOUNJARO.
- You may give both injections in the same body area (for example, your stomach area), but not right next to each other.
Your dose of MOUNJARO may change depending on:
- If you are taking other diabetic medication
- your physical health (e.g., weight, illness, physical activity)
- your diet
If your healthcare professional increases your dose, a new MOUNJARO (pen, vial or KwikPen) for the different dose should be used.

Usual dose:

Adult:
- The recommended starting dose of MOUNJARO is 2.5 mg administered subcutaneously once weekly. After 4 weeks your dose will go up to 5 mg once weekly. If needed, the dose may be increased by 2.5 mg after at least 4 weeks on your current dose.
- Maximum dose is 15 mg once weekly.
Children and adolescents (10 to less than 18 years of age):
- The recommended starting dose is 2.5 mg administered subcutaneously once weekly. After 4 weeks your dose will go up to 5 mg once weekly. If needed, the dose may be increased by 2.5 mg after at least 4 weeks on your current dose.
- Maximum dose is 10 mg once weekly.

Overdose:

If you think you, or a person you are caring for, have taken too much MOUNJARO, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss a dose and:

it has been 4 days (96 hours) or less since you should have used MOUNJARO, use it as soon as you remember. Then inject your next dose on your usual scheduled day.
it has been more than 4 days (96 hours) since you should have used MOUNJARO, skip the missed dose. Then inject your next dose on your usual scheduled day.

Possible side effects from using MOUNJARO:

These are not all the possible side effects you may have when taking MOUNJARO. If you experience any side effects including side effects not listed here, tell your healthcare professional.

Belching
Bloating of the stomach
Change in taste
Constipation
Decreased appetite
Diarrhea
Feeling tired
Gas (flatulence)
Increased heart rate
Indigestion
Injection site reactions – such as bruising, pain, irritation, itching, and rash
Nausea
Reflux or heart burn – also called gastro-esophageal reflux disease
Stomach pain
Unusual skin sensations - such as burning, tingling or pricking
Vomiting
Weight loss

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional	Stop taking this drug and get immediate medical help
Only if severe	In all cases
Very common
Gastrointestinal problems: diarrhea, nausea, vomiting, abdominal pain, feeling full		✓
Common
Diabetic retinopathy (Diabetic eye disease): blurred vision, lines in vision		✓
Uncommon
Hypoglycemia (severe low blood sugar): disorientation, loss of consciousness, or seizure		✓
Rare
Acute pancreatitis (sudden inflammation of pancreas): prolonged severe abdominal pain with or without vomiting		✓	✓
Dehydration that can cause sudden kidney failure: dark yellow and strong-smelling pee, feeling extremely thirsty, feeling dizzy or lightheaded		✓	✓
Sudden gallbladder problems: severe abdominal pain, yellowing of your skin, or high fever with chills		✓	✓
Unknown
Anaphylactic reaction, angioedema (serious allergic reaction): breathing problems, swelling of the throat and face, fast heartbeat		✓	✓
Malnutrition (lack of proper nutrition): low vitamin, mineral, and/or protein levels, low body weight		✓
Gastroparesis (slow stomach emptying): pain, severe nausea and vomiting, prolonged belching, and prolonged bloating		✓	✓
Ileus (slow movement of food through intestines): inability to tolerate an oral diet, abdominal bloating and pain, severe nausea and vomiting		✓	✓
Non-arteritic anterior ischemic optic neuropathy (NAION, eye condition): sudden decreased vision (blurring or cloudiness) or permanent loss of vision		✓	✓

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

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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:

MOUNJARO single-dose prefilled pen and single-dose vial:

Store MOUNJARO in a refrigerator at 2°C to 8°C.
If needed, each single-dose prefilled pen or single-dose vial can be stored at room temperature below 30°C for up to a total of 21 days.
Do not freeze MOUNJARO. Do not use MOUNJARO if frozen. If the pen or vial has been frozen, throw it away and use a new pen or vial.
Store MOUNJARO in the original carton to protect from light.
Keep out of reach and sight of children.
The single-dose prefilled pen must be discarded after use in a puncture-resistant container.
Throw away all opened vials after use, even if there is medicine left in the vial.

MOUNJARO KwikPen multi-dose prefilled pen:

Store MOUNJARO KwikPen in a refrigerator at 2°C to 8°C up to the expiration date. Do not use MOUNJARO KwikPen beyond the expiration date.
Do not freeze MOUNJARO KwikPen. Do not use MOUNJARO KwikPen if frozen.
Protect MOUNJARO KwikPen from light.
If needed, each multi-dose prefilled pen can be stored unrefrigerated at temperatures not to exceed 30°C for up to 30 days.
The MOUNJARO KwikPen must be discarded after four weekly doses of tirzepatide in a puncture-resistant container or in accordance with local requirements.
Keep out of reach and sight of children.

If you want more information about MOUNJARO:

Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.lilly.ca, or by calling 1-888-545-5972.

MOUNJARO^®and MOUNJARO^®KwikPen^®are registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

Date of Authorization: 2026-06-23

B5.0-MOU-0007-PM-YYYY-MM-DD

INSTRUCTIONS FOR USE

MOUNJARO^®

tirzepatide injection

Prefilled pen for subcutaneous use

A white and black arrow

Description automatically generated

2.5 mg/0.5 mL single-dose pen

5 mg/0.5 mL single-dose pen

7.5 mg/0.5 mL single-dose pen

10 mg/0.5 mL single-dose pen

12.5 mg/0.5 mL single-dose pen

15 mg/0.5 mL single-dose pen

Once-weekly

Important information you need to know before injecting MOUNJARO.

Talk to your healthcare provider about how to inject MOUNJARO the right way. This INSTRUCTIONS FOR USE is written for the person who will be using MOUNJARO. This may be you or a person you are caring for. After training from a healthcare professional, MOUNJARO may be self injected or given by a caregiver.

Read this “INSTRUCTIONS FOR USE” and the Patient Medication Information before using your MOUNJARO single-dose pen and each time you get a new pen. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

MOUNJARO is a single-dose prefilled pen.
One MOUNJARO single-dose prefilled pen is used 1 time each week.
Inject under the skin (subcutaneously) only.
You or another person can inject into your stomach (abdomen) or thigh.
Another person should give you the injection in the back of your upper arm.

Guide to parts of MOUNJARO single-dose prefilled pen

Preparing to inject MOUNJARO

Remove the Pen from the refrigerator.

Leave the gray base cap on until you are ready to inject.

Check the Pen label to make sure you have the right medicine and dose, and that it has not expired.

Inspect the Pen to make sure that it is not damaged.

Make sure the medicine in the pen is colourless to slightly yellow.

Do not use the medicine if it is: frozen, cloudy, or has particles.

Expiration Date

Bottom and Needle End

Top

Purple Injection Button

Lock Ring

Indicator

Lock or Unlock

Medicine

Clear Base

Gray Base Cap

Wash your hands.

Choose your injection site

Your healthcare provider can help you choose the injection site that is best for you. 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.

You or another person can inject the medicine in your stomach (abdomen) or thigh,

Another person should give you the injection in the back of your upper arm.

Step

1 Pull off the gray base cap

Make sure the Pen is Locked.

Do not unlock the Pen until you place the clear base on your skin and are ready to inject.

Pull the gray base cap straight off and throw it away in your household trash.

Do not put the gray base cap back on – this could damage the needle.

Do not touch the needle.

Clear Base

Gray Base Cap

Step

2 Place Clear Base on skin, then Unlock

A close-up of a person holding a syringe

Description automatically generated

Place the clear base flat against your skin at the injection site. The Purple button should be away from the skin.

A hand holding a pen

Description automatically generated

Unlock by turning the lock ring toward the unlock icon.

Step

3 Press and Hold up to 10 seconds

A hand holding a syringe

Description automatically generated

Press and Hold the purple injection button.

Listen for two loud clicks:

First click = injection started
Second click = injection completed

A close-up of a transparent device

Description automatically generated

You will know your injection is complete when the gray plunger is visible.

After your injection, place the used Pen in a sharps container.

Disposing of your used Pen

Put your used Pen in a sharps disposal container right away after use. Do not throw away (dispose of) Pens in your household trash.
If you do not have a sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
  Gray Plunger
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local laws about how you should throw away used needles and syringes.
Do not recycle your used sharps disposal container.
Keep the disposal container out of the sight and reach of children.

Storage and handling

Store your Pen in the refrigerator between 2°C to 8°C.
You may store your Pen at room temperature below 30°C for up to a total of 21 days.
Do not freeze your Pen. If the Pen has been frozen, throw the Pen away and use a new Pen.
Store your Pen in the original carton to protect your Pen from light.
The Pen has glass parts. Handle it carefully. If you drop the Pen on a hard surface, do not use it. Use a new Pen for your injection.
Keep your MOUNJARO single-dose prefilled pen and all medicines out of the sight and reach of children.

Commonly asked questions

What if I see air bubbles in my Pen?

Air bubbles are normal.

What if my Pen is not at room temperature?

It is not necessary to warm the Pen to room temperature.

What if I unlock the Pen and press the purple injection button before pulling off the gray base cap?

Do not remove the gray base cap. Throw away the Pen and get a new Pen.

What if there is a drop of liquid on the tip of the needle when I remove the gray base cap?

A drop of liquid on the tip of the needle is normal. Do not touch the needle.

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 against your skin.

I heard more than 2 clicks during my injection — 2 loud clicks and 1 soft one. Did I get my complete injection?

Some people 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 loud click.

I am not sure if my Pen worked the right way.

A close-up of a device

Description automatically generated

Check to see if you have received your dose. Your dose was delivered the right way if the gray plunger is visible. Also, see Step 3 of the instructions.

If you do not see the gray plunger, contact Lilly at 1-888-545-5972 for further instructions. Until then, store your Pen safely to avoid an accidental needle stick.

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

This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Other Information

If you have vision problems, do not use your Pen without help from a person trained to use the MOUNJARO single-dose prefilled pen.

Where to learn more

If you have questions or problems with your MOUNJARO single-dose prefilled pen, contact Lilly at 1-888-545-5972 or call your healthcare provider.
For more information about MOUNJARO, visit our website at www.lilly.ca.

Manufactured by:

Eli Lilly Canada Inc.

P.O. Box 73

Toronto, Ontario

M5X 1B1

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

Date of Authorization: 2026-06-23

B5.0-MOU-0006-IFU-YYYYMMDD

Gray Plunger