Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using MOUNJARO?
MOUNJARO contains the active ingredient tirzepatide. In adults with type 2 diabetes,
MOUNJARO is used to improve blood sugar control. For more information, see Section
1. Why am I using MOUNJARO? in the full CMI.
2. What should I know before I use MOUNJARO?
Do not use if you have ever had an allergic reaction to tirzepatide or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How do I use MOUNJARO?
MOUNJARO is supplied as a single-use vial that is used once a week, on the same day each week if you can.
When you first start using MOUNJARO, the starting dose is 2.5 mg once a week for 4
weeks. After 4 weeks your dose will be increased to 5 mg once a week.
Your doctor may choose to increase your dose by 2.5 mg every 4 weeks to achieve a
dose of 7.5 mg, 10 mg, 12.5 mg or 15 mg once a week if needed. The maximum dose is
15 mg once weekly.
5. What should I know while using MOUNJARO?
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Things you should do
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Remind any doctor, surgeon, anaesthetist, dentist, pharmacist, or diabetes nurse educator
you visit that you are using MOUNJARO.
Always carry glucose or sugary foods with you. Tell your doctor if you experience
low blood sugar, called hypoglycaemia and this occurs often.
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Things you should not do
|
Do not stop using this medicine suddenly and without consulting your Doctor/Healthcare
provider.
Do not use this medicine if you think it has been frozen or exposed to excessive heat.
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Driving or using machines
|
Be careful before you drive or use machines or tools until you know how MOUNJARO affects
you.
Hypoglycaemia (low blood sugar) may affect your ability to concentrate.
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Drinking alcohol
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Tell your doctor if you drink alcohol. Alcohol may mask the symptoms of hypoglycaemia
(low blood sugar) or make it worse.
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|
Looking after your medicine
|
Store MOUNJARO in a refrigerator (2°C - 8°C). Do not freeze.
Keep MOUNJARO in the original package in order to protect from light until ready to
use.
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6. Are there any side effects?
The most common side effects are nausea, diarrhoea, vomiting, abdominal (stomach)
pain, and decreased appetite. These side effects are usually not severe. Serious side
effects which may require urgent medical attention may include inflamed pancreas (acute
pancreatitis - sudden severe pain in the stomach and back), gallbladder complaints
and allergic reactions. For more information, including what to do if you have any
side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient:
tirzepatide
Consumer Medicine Information (CMI)
This leaflet provides important information about using MOUNJARO. You should also speak to your doctor, pharmacist, or diabetes nurse educator if you
would like further information or if you have any concerns or questions about using
MOUNJARO.
Where to find information in this leaflet:
1. Why am I using MOUNJARO?
MOUNJARO contains the active ingredient tirzepatide. MOUNJARO is a type of medicine called 'GIP and GLP-1 receptor agonists', which are
used to help treat diabetes.
Diabetes mellitus is a condition in which your pancreas does not produce enough insulin
to control your blood sugar (glucose) level.
In adults with type 2 diabetes, MOUNJARO is used to improve blood sugar control.
MOUNJARO may be used alone or in combination with other diabetes medicines to control
your blood sugar levels.
2. What should I know before I use MOUNJARO?
Warnings
Do not use MOUNJARO if:
you are allergic to tirzepatide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age
because it has not been studied in this age group.
Check with your doctor if you:
have any other medical conditions such as:
gastrointestinal disease (including severe gastroparesis (also called delayed gastric
emptying)), a condition affecting your digestive system. Your doctor may need to monitor
your condition more closely while you are using MOUNJARO.
inflammation of the pancreas (pancreatitis) - an inflamed pancreas causing severe
stomach and back pain which does not go away. MOUNJARO may cause inflammation of the
pancreas.
problems with your eyes (diabetic retinopathy). Your doctor may need to monitor your
condition more closely while you are using MOUNJARO.
congestive heart failure.
kidney impairment (kidneys are not working as well as they should).
liver impairment (liver does not work as well as it should).
are taking other medicines to treat your type 2 diabetes (such as a sulfonylurea or
insulin) as this may cause your blood sugar to be too low (hypoglycaemia). Your doctor
may tell you to test your blood sugar to decide if any of the medicine/s or doses
need to be changed.
take any medicines for any other condition.
have had an allergic reaction to any medicine which you have used previously to treat
your type 2 diabetes.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Do not use MOUNJARO if you are pregnant as the effects of this medicine during pregnancy
have not been studied.
If you could become pregnant while using MOUNJARO, it is recommended to use contraception.
It is unknown if MOUNJARO passes into breast milk. Talk to your doctor if you are
breastfeeding or intend to breastfeed.
Dehydration
When starting treatment with MOUNJARO, you may experience dehydration due to vomiting
or diarrhoea.
Dehydration can lead to kidney problems. It is important to avoid dehydration by drinking plenty of fluids.
Symptoms of dehydration include dry mouth, decreased frequency of urination, dark
urine, headache, muscle weakness, or dizziness. Check with your doctor if you have
any questions or concerns.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket, or health food shop.
Some medicines may interfere with MOUNJARO and affect how it works.
When MOUNJARO is used with a medicine that contains sulfonylurea or insulin, hypoglycaemia
can occur. The dose of your sulfonylurea or insulin may need to be reduced.
Some medicines may be affected by MOUNJARO and affect how they work.
MOUNJARO delays stomach (gastric) emptying. If you take any medicines via mouth (orally),
such as slow-release medicines, medicines with quick absorption from the stomach,
medicines that have a narrow therapeutic index (e.g., warfarin, digoxin), or an oral
contraceptive ('the pill'), MOUNJARO may affect how well these medicines work. Check
with your doctor or pharmacist if you are not sure.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect MOUNJARO.
4. How do I use MOUNJARO?
How much to use
When you first start using MOUNJARO, the starting dose is 2.5 mg once a week for 4
weeks. After 4 weeks your doctor will increase your dose to 5 mg once a week.
Your doctor may increase your dose by 2.5 mg every 4 weeks to achieve a dose of 7.5
mg, 10 mg, 12.5 mg or 15 mg once a week if needed. The maximum dose is 15 mg once
weekly.
Follow the instructions provided and use MOUNJARO until your doctor tells you to stop.
Do not change your dose unless your doctor has told you to do so. If you stop using it, your blood sugar levels may increase.
When to use MOUNJARO
MOUNJARO should be used once a week, on the same day each week if you can.
You can inject MOUNJARO at any time of the day, with or without meals.
To help you remember, you may wish to write the day of the week when you take your
first dose of MOUNJARO on a calendar.
If necessary, you can change the day of your usual weekly injection of MOUNJARO as
long as it has been at least 3 days since your last injection of MOUNJARO. Speak to
your doctor, pharmacist or diabetes nurse educator if you are unsure.
How to use MOUNJARO
Follow all directions given to you by your doctor, nurse, or pharmacist carefully.
They may differ from the information contained in this leaflet.
How to inject MOUNJARO will be explained to you by a healthcare professional. After
being trained by your healthcare professional, you can inject MOUNJARO yourself at
home.
MOUNJARO must not be injected into a vein or muscle. MOUNJARO is intended for subcutaneous
(under the skin) injection.
If you do not understand these instructions, ask your doctor, nurse, or pharmacist
for help.
When injecting, it is important to change the injection site to different areas of
the body, to help reduce potential pain and irritation.
Areas with a good amount of fat below the skin (upper thigh, upper arm or stomach)
are the most suitable areas to inject.
Prepare:
Inspect the vial carefully before using. MOUNJARO should be clear and colourless to slightly yellow.
Check the name and coloured label to make sure it is the correct medicine 'MOUNJARO' and it is the correct strength
prescribed for you.
Wash your hands.
Place all the items you will need on a clean surface where you will not be disturbed.
These should include:
syringe with needle attached (or as recommended by your healthcare provider).
A sharps container
Pull off the protective cap from the vial, but do not remove the rubber stopper.
Remove the needle shield/cap.
Draw Up
Push the needle through the rubber stopper of the vial.
Turn the vial and syringe upside down.
Slowly pull the plunger down until the plunger tip is past the 0.5 mL line.
If there are air bubbles in the syringe, tap the syringe gently a few times to let
any air bubbles rise to the top.
Slowly push the plunger up until the plunger tip reaches the 0.5 mL line.
Pull the syringe out of the rubber stopper of the vial.
Inject
You can use MOUNJARO under the skin (subcutaneous) of your stomach (abdomen) or upper
leg (thigh) as you have been instructed. If MOUNJARO is given by someone else, they
may inject in the back of your upper arm.
If you want to do so, you can inject the same area of your body each week. But be
sure to choose a different injection site within that area.
If using a needle that is 8 mm or longer, pinch up a fold of skin and insert the needle
into your skin at a 45 degree angle. For needles less than 8 mm, you can insert the
needle into your skin at 90 degree angle, there is no need to pinch up the skin.
Push down on the plunger to inject your dose.
The plunger tip should be at the bottom of the syringe and the needle should stay
in your skin for at least 5 seconds to make sure you have injected all of your medicine.
Pull the needle out of your skin and place the needle directly into your sharps container.
Do not share or reuse your needle or syringe.
Dispose of the used vial (including any residue) in your sharps container.
If you forget to use MOUNJARO
MOUNJARO should be used regularly each week on the same day each week.
If you miss or forget your dose, it should be administered as soon as possible.
If there are fewer than 3 days until your next dose, then skip the missed dose. Inject
the next MOUNJARO dose as usual on your regular day.
Do not take a double dose to make up for a forgotten dose.
If you use too much MOUNJARO
If you think that you have used too much MOUNJARO, seek urgent medical attention.
You should immediately:
phone the Poisons Information Centre (by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using MOUNJARO?
Things you should do
Remind any doctor, surgeon, anaesthetist, dentist, pharmacist or diabetes nurse educator
you visit that you are using MOUNJARO.
Make sure all your family, relatives, friends, workmates, or carers know that you
have diabetes and can recognise the symptoms of hypoglycaemia (low blood sugar).
Let your doctor know if you start taking/using another medicine to treat type 2 diabetes.
This could affect your blood sugar levels. Your doctor may want you to monitor your
blood sugar levels more often.
Always carry something to show you have diabetes.
Always carry glucose or sugary foods with you.
Let your doctor know if you plan to have any surgery or need general anaesthesia for
any reason
Tell your doctor, pharmacist, or diabetes nurse educator if you are planning to travel
overseas. You may not be able to get MOUNJARO in the country you are visiting, and
you may need to carry a letter explaining why you are taking injecting devices with
you. Your doctor, pharmacist or diabetes nurse educator can provide you with some
helpful information.
Call your doctor straight away if you:
Experience severe low blood sugar, called hypoglycaemia, and this worries you.
Things you should not do
Do not stop using this medicine suddenly and without consulting your Doctor/Healthcare
provider.
Do not use this medicine if you think it has been frozen or exposed to excessive heat,
or if it is cloudy or contains particles. Appropriately discard and use a new vial
for your injection.
Do not use this medicine if the packaging is torn or shows signs of tampering.
Do not give your MOUNJARO to anyone else, even if they have the same condition as
you. Your doctor has prescribed MOUNJARO only for you.
Hypoglycaemia (low blood sugar)
It is important you know and can recognise the symptoms of hypoglycaemia.
Symptoms of mild to moderate hypoglycaemia can include:
sweating
hunger, headache
tremor, unsteady movement
light-headedness
drowsiness, dizziness
depressive mood, anxiety
irritability, personality change
abnormal behaviour
inability to concentrate
sleep disturbance
blurred vision
increased heart rate or irregular heartbeat
tingling in the hands/feet/lips or tongue
slurred speech
Tell your doctor, pharmacist or diabetes nurse educator if you have trouble recognising
the symptoms of hypoglycaemia.
Recognising these mild to moderate hypoglycaemic symptoms early may allow you to take
the necessary steps to avoid more serious hypoglycaemia.
Symptoms of severe hypoglycaemia can include:
disorientation
seizures
unconsciousness
If you experience symptoms of hypoglycaemia, eat some sugary food or drink, such as
jellybeans, orange juice or glucose tablets.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how MOUNJARO
affects you.
Hypoglycaemia (low blood sugar) may affect your ability to concentrate. Avoid driving
or using machines if you get any signs of hypoglycaemia.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may mask the symptoms of hypoglycaemia (low blood sugar) or make it worse.
Looking after your medicine
Store MOUNJARO in a refrigerator (2°C - 8°C).
When refrigeration is not possible, you can keep your vial at room temperature (below
30°C) for up to a total of 21 days.
Do not allow the vial to freeze. DO NOT use if it has been frozen.
Keep MOUNJARO in the original package in order to protect from light.
Never use MOUNJARO after the expiry date (month, year) stamped or printed on the carton,
or on the label.
Keep it where young children cannot reach it.
When to discard your medicine
If your doctor tells you to stop taking MOUNJARO, or
If the expiry date on the carton or vial has passed.
Empty vials and used syringes and needles, should be disposed of in a yellow plastic
sharps container or similar puncture proof container composed of hard plastic or glass.
Ask your doctor, pharmacist, or diabetes nurse educator for further information.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor, pharmacist, or diabetes
nurse educator if you have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor, pharmacist or diabetes nurse educator if you notice anything else
that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What MOUNJARO contains
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Active ingredient
(main ingredient)
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tirzepatide
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Other ingredients
(inactive ingredients)
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dibasic sodium phosphate heptahydrate
sodium chloride
hydrochloric acid
sodium hydroxide
water for injections
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Potential allergens
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none
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Do not take this medicine if you are allergic to any of these ingredients.
MOUNJARO vials are for single-use and do not contain any preservative. Discard after
use.
What MOUNJARO looks like
MOUNJARO is a clear, colourless to slightly yellow solution available as a single-use
vial.
MOUNJARO vials are available in the following strengths:
2.5 mg/0.5 mL (AUST R 407055)
5.0 mg/0.5 mL (AUST R 407050)
7.5 mg/0.5 mL (AUST R 407051)
10 mg/0.5 mL (AUST R 407053)
12.5 mg/0.5 mL (AUST R 407052)
15 mg/0.5 mL (AUST R 407054)
Who distributes MOUNJARO
Australia:
Eli Lilly Australia Pty Ltd
Level 9, 60 Margaret Street,
Sydney, NSW 2000
Further Information
If you have any questions about MOUNJARO, contact Lilly at 1800 454 559 or your healthcare
professional for assistance.
® = Registered Trademark
This leaflet was prepared in January 2024.
(vA2.0)