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 KwikPen?
MOUNJARO KwikPen contains the active ingredient tirzepatide. In adults with type 2
diabetes, MOUNJARO KwikPen is used to improve blood sugar control. In adults who are
overweight or have obesity, MOUNJARO is used for weight management. For more information,
see Section
1. Why am I using MOUNJARO KwikPen? in the full CMI.
2. What should I know before I use MOUNJARO KwikPen?
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.
3. What if I am taking other medicines?
4. How do I use MOUNJARO KwikPen?
MOUNJARO KwikPen is supplied as a multiple-dose (4 doses), pre-filled Pen that is
used once a week, on the same day each week if you can.
When you first start using MOUNJARO KwikPen, 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 KwikPen?
|
Things you should do
|
Remind any doctor, surgeon, anaesthetist, pharmacist, or nurse you visit that you
are using MOUNJARO KwikPen.
If you have diabetes, always carry glucose or sugary foods with you. Tell your doctor
if you experience low blood sugar, called hypoglycaemia and this occurs often.
|
|
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.
|
|
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.
|
|
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 KwikPen in a refrigerator (2°C - 8°C). Do not freeze.
Keep MOUNJARO KwikPen in the original package in order to protect from light until
ready to use.
|
6. Are there any side effects?
The most common side effects are nausea, diarrhoea, vomiting and constipation. 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 due to approval of an extension
of indications. 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 KwikPen. You should also speak to your doctor, pharmacist, or nurse if you would like further
information or if you have any concerns or questions about using MOUNJARO
KwikPen.
Where to find information in this leaflet:
1. Why am I using MOUNJARO KwikPen?
MOUNJARO KwikPen contains the active ingredient tirzepatide. MOUNJARO KwikPen is a type of medicine called 'GIP and GLP-1 receptor agonists'.
In adults, this medicine is used to help treat diabetes. In adults who are overweight
or have obesity, this medicine is used to reduce weight or maintain weight loss.
Type 2 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 KwikPen is used to improve blood sugar control.
MOUNJARO KwikPen may be used alone or in combination with other diabetes medicines
to control your blood sugar levels.
Weight Management
In adults who are overweight or have obesity, MOUNJARO KwikPen is used for weight
management, including weight loss and weight maintenance.
2. What should I know before I use MOUNJARO KwikPen?
Warnings
Do not use MOUNJARO KwikPen 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 and in some cases your doctor may need to change your
dose or stop MOUNJARO KwikPen if symptoms are severe.
malnutrition (your body does not get enough of the right nutrients to meet your body’s
needs).
inflammation of the pancreas (pancreatitis) - an inflamed pancreas causing severe
stomach and back pain which does not go away. MOUNJARO KwikPen 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 KwikPen.
thoughts of suicide or death.
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 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
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 KwikPen if you are pregnant as the effects of this medicine during
pregnancy have not been studied.
If you could become pregnant while using MOUNJARO KwikPen, it is recommended to use
contraception.
It is unknown if the active ingredient, tirzepatide passes into breast milk. Talk
to your doctor if you are breastfeeding or intend to breastfeed.
Dehydration
When starting treatment with MOUNJARO KwikPen, 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 KwikPen and affect how it works.
When MOUNJARO KwikPen 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 KwikPen and affect how they work.
MOUNJARO KwikPen 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 KwikPen 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
KwikPen.
4. How do I use MOUNJARO KwikPen?
How much to use
When you first start using MOUNJARO KwikPen, 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 KwikPen 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 KwikPen
MOUNJARO KwikPen should be used once a week, on the same day each week if you can.
You can inject MOUNJARO KwikPen at any time of the day, with or without meals.
To help you remember, you may wish to tick the day of the week when you take your
first dose of MOUNJARO KwikPen on the calendar found at the end of the Instructions
for Use leaflet.
If necessary, you can change the day of your usual weekly injection of MOUNJARO KwikPen
as long as it has been at least 3 days since your last injection of MOUNJARO KwikPen.
Speak to your doctor, pharmacist or nurse if you are unsure.
How to use MOUNJARO KwikPen
Read the Instructions for Use leaflet contained in the carton carefully before using
MOUNJARO KwikPen.
Follow all directions given to you by your doctor, nurse, or pharmacist carefully.
They may differ from the information contained in this leaflet. If you do not understand
these instructions, ask your doctor, nurse, or pharmacist for help.
Inspect the pre-filled Pen carefully before using. MOUNJARO KwikPen should be clear and colourless to slightly yellow.
Check the name and coloured label of your Pen to make sure it is the correct medicine 'MOUNJARO KwikPen' and is the
correct strength prescribed for you.
To avoid underdosing (injecting too little of the medicine), ensure the dose knob
on the MOUNJARO KwikPen is turned until it stops at the ‘1’ icon (see step-by-step
instructions in the Instructions for Use leaflet in the carton).
Inject MOUNJARO KwikPen under the skin (subcutaneous) of your stomach (abdomen) or
upper leg (thigh). MOUNJARO KwikPen must not be injected into a vein or muscle.
When injecting, it is important to change the injection site to different areas of
the body, to help reduce potential pain and irritation. 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 you forget to use MOUNJARO KwikPen
MOUNJARO KwikPen 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 KwikPen 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 KwikPen
If you think that you have used too much MOUNJARO KwikPen, 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 KwikPen?
Things you should do
Remind any doctor, surgeon, anaesthetist, pharmacist or nurse you visit that you are
using MOUNJARO KwikPen.
Tell your doctor, pharmacist, or nurse if you are planning to travel overseas. You
may not be able to get MOUNJARO KwikPen 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 nurse can provide you with some helpful information.
If you have diabetes:
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.
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 Pen
for your injection.
Do not use this medicine if the packaging is torn or shows signs of tampering.
Do not give your MOUNJARO KwikPen to anyone else, even if they have the same condition
as you. Your doctor has prescribed MOUNJARO KwikPen only for you.
Hypoglycaemia (low blood sugar) in patients with diabetes
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 nurse 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
KwikPen 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 KwikPen in a refrigerator (2°C - 8°C).
When refrigeration is not possible, you can keep your Pen at room temperature (below
30°C) for up to a total of 30 days.
Do not allow the KwikPen to freeze. DO NOT use if it has been frozen.
MOUNJARO KwikPen contains glass parts. Handle it carefully. If you drop your MOUNJARO
KwikPen on a hard surface, DO NOT use it. Appropriately discard it and use a new Pen
for your injection.
Keep MOUNJARO KwikPen in the original package in order to protect from light.
Never use MOUNJARO KwikPen after the expiry date (month, year) stamped or printed
on the carton, or on the Pen label.
Follow the Instructions for Use leaflet in the carton on how to take care of your
medicine properly.
Keep it where young children cannot reach it.
When to discard your medicine
If your doctor tells you to stop taking MOUNJARO KwikPen, or
If the expiry date on the carton or KwikPen has passed.
Empty KwikPens 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 nurse 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 nurse
if you have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor, pharmacist or nurse 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 KwikPen contains
|
Active ingredient
(main ingredient)
|
tirzepatide
|
|
Other ingredients
(inactive ingredients)
|
dibasic sodium phosphate heptahydrate
benzyl alcohol
glycerol
phenol
sodium chloride
hydrochloric acid
sodium hydroxide
water for injections
|
|
Potential allergens
|
none
|
Do not take this medicine if you are allergic to any of these ingredients.
What MOUNJARO KwikPen looks like
MOUNJARO KwikPen is a clear, colourless to slightly yellow solution available as a
multiple-dose (4 doses), pre-filled Pen.
No needles are included in the pack.
MOUNJARO KwikPen is available in the following strengths:
|
Quantity per dose
(dose volume = 0.6 mL)
|
Quantity expressed per 1 mL
|
AUST R number
|
|
2.5 mg/dose
|
4.17 mg/mL
|
439430
|
|
5 mg/dose
|
8.33 mg/mL
|
439690
|
|
7.5 mg/dose
|
12.5 mg/mL
|
439691
|
|
10 mg/dose
|
16.67 mg/mL
|
439692
|
|
12.5 mg/dose
|
20.83 mg/mL
|
439693
|
|
15 mg/dose
|
25 mg/mL
|
439694
|
Who distributes MOUNJARO KwikPen
Australia:
Eli Lilly Australia Pty Ltd
Level 9, 60 Margaret Street
Sydney NSW 2000
Further Information
If you have any questions about MOUNJARO KwikPen, contact Lilly at 1800 454 559 or
your healthcare professional for assistance.
® = Registered Trademark
This leaflet was prepared in September 2024.
(vA3.0)