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.
1. Why am I using TAGRISSO?
TAGRISSO contains the active ingredient osimertinib mesilate. TAGRISSO is used to
treat adults with a type of cancer called 'non-small cell lung cancer' when the tumour
has a defect (mutation) in a gene called EGFR (epidermal growth factor receptor).
2. What should I know before I use TAGRISSO?
Do not use if you have ever had an allergic reaction to osimertinib mesilate, or any
other similar medicines for example other tyrosine kinase inhibitors, or any of the
ingredients listed at the end of this leaflet.
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?
Some medicines may interfere with TAGRISSO and affect how it works.
4. How do I use TAGRISSO?
The usual dose is one 80 mg tablet per day. Your doctor may however prescribe a different
dose such as one 40 mg tablet.
Continue taking TAGRISSO for as long as your doctor tells you.
5. What should I know while using TAGRISSO?
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Things you should do
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If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking TAGRISSO.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
TAGRISSO.
Ensure you are using effective contraception (man or woman). Even if you stop treatment,
you should continue to use effective contraception for at least a further 6 weeks
if you are a woman and a further 4 months if you are a man.
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Things you should not do
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Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop using this medicine even if you feel well.
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Driving or using machines
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This medicine is not expected to affect your ability to drive a car or operate machinery,
however, if symptoms occur that affect your ability to concentrate, do not drive or
operate machinery until the effect subsides.
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Looking after your medicine
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Keep your tablets in a cool, dry place where the temperature stays below 30°C.
Keep your tablets in the pack until it is time to take them.
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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. These include diarrhoea, dry skin, skin greying or darkening,
rash, pain and redness around the fingernails or hair thinning. However, some serious
side effects may need medical attention. These include sudden difficulty in breathing
with a cough or fever, sore or red eyes, light sensitivity, blurred vision, rapid
or irregular heartbeats, chest discomfort, shortness of breath, fainting, persistent
fever, bruising easily, increased tiredness, severe blistering or peeling of skin
or skin reactions that look like rings.
Active ingredient:
Osimertinib mesilate
Consumer Medicine Information (CMI)
This leaflet provides important information about using TAGRISSO. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using TAGRISSO.
Where to find information in this leaflet:
1. Why am I using TAGRISSO?
TAGRISSO contains the active ingredient osimertinib mesilate. TAGRISSO is a tyrosine kinase inhibitors (TKIs). It works by stopping cancer cells
with a defect (mutation) in a gene called EGFR (epidermal growth factor receptor)
from growing and multiplying. It may also help prevent the tumour from coming back
after removal by surgery.
TAGRISSO is used to treat adults with a type of cancer called 'non-small cell lung
cancer' when the tumour has an EGFR mutation. It may help to prevent your cancer from
coming back after the tumour(s) have been removed by surgery. TAGRISSO may also help
to slow or stop your lung cancer growing when your cancer is advanced and is worsening.
TAGRISSO may be used alone or in combination with other anti-cancer medicines.
When TAGRISSO is given in combination with other anti-cancer medicines, it is important
that you also read the Consumer Medicine Information for these other medicines. If
you have any questions about these medicines, ask your doctor.
TAGRISSO can be prescribed for you if you test positive for EGFR mutation.
2. What should I know before I use TAGRISSO?
Warnings
Do not use TAGRISSO if:
you are allergic to osimertinib mesilate, or any of the ingredients listed at the
end of this leaflet. Always check the ingredients to make sure you can use this medicine.
you are allergic to any other similar medicines for example other tyrosine kinase
inhibitors.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Check with your doctor if you:
have or have had inflamed lungs (called 'interstitial lung disease'), pneumonia or
other lung problems.
have or have had heart problems or risk factors for heart problems. Your doctor may
wish to monitor your heart before and during TAGRISSO treatment.
have any other medical conditions
take any medicines for any other condition
have a history of eye problems
use or want to use contact lenses while you are taking TAGRISSO.
have allergies to any other medicines, foods, preservatives or dyes.
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
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Do not take this medicine if you are pregnant or if you (male or female) are planning
to have a baby.
It may affect your developing baby if you take it during pregnancy.
If you are a man, tell your doctor if you are planning to have a baby with your partner.
Your doctor can discuss with you the risks and benefits involved. Whether you are
male or female, your doctor will advise you to use an effective contraception while
taking TAGRISSO and for at least 6 weeks for woman and 4 months for men after stopping
the medicine.
Do not breast-feed if you are taking this medicine.
It is not known if the active ingredient in TAGRISSO passes into breast milk. If it
does, your baby may be affected.
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.
These include:
antibiotics such as rifampicin for treating bacterial infections
medicines for epilepsy such as phenytoin and carbamazepine
St John's Wort for treating depression
rosuvastatin, a medicine used to treat high cholesterol levels
medicines used to prevent blood clots such as warfarin and dabigatran
digoxin, a medicine used to treat heart problems
aliskiren, a medicine used for high blood pressure
bosentan, a medicine used to treat high blood pressure in the lungs
efavirenz and etravirine, medicines used to treat HIV infections
any medicine being used to treat your cancer.
These medicines may not work properly if you are taking TAGRISSO or they may affect
how well TAGRISSO works. You may need different amounts of your medicines, or you
may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TAGRISSO.
4. How do I use TAGRISSO?
How much to take
The usual dose is one 80 mg tablet per day. Your doctor may however prescribe a different
dose such as one 40 mg tablet.
Follow all directions given to you by your doctor or pharmacist carefully.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
When to take
Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take this medicine before or after food.
How to take
Swallow the tablets whole with a full glass of water. If you can swallow the tablet whole, do not split, crush or chew it. If you cannot
swallow the tablet, it can be dispersed by stirring in about one quarter of a cup
of water and then immediately swallowed (it will not completely dissolve). Once finished,
swirl the same amount of water in the cup and swallow it to ensure that none of the
dispersed tablet is missed.
How long to take
Continue taking your medicine for as long as your doctor tells you. It is important to keep taking your medicine even if you feel well.
If you forget to use TAGRISSO
TAGRISSO should be used regularly at the same time each day. If you miss your dose
at the usual time and it is less than 12 hours before your next dose, skip the dose
you missed and take your next dose when you are meant to. If it is more than 12 hours
until your next dose, take it as soon as you remember, and then go back to taking
your medicine as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much TAGRISSO
If you think that you have used too much TAGRISSO, you may need 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 TAGRISSO?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking TAGRISSO.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
Ensure you are using effective contraception. Even if you stop treatment, you should
continue to use effective contraception for at least a further 6 weeks if you are
a woman and a further 4 months if you are a man.
If you become pregnant while you are taking this medicine or within 6 weeks of stopping
this medicine, tell your doctor immediately.
If you are a man and your partner becomes pregnant while you are taking this medicine
or within 4 months of stopping this medicine, tell your doctor immediately.
If you develop symptoms such as persistent fever, bruising or bleeding more easily,
increasing tiredness and fatigue, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine. It may interfere with the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects. For example, periodic tests may be done if you
have had heart problems in the past.
Things you should not do
Do not take TAGRISSO to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine even if you feel well.
Do not lower the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TAGRISSO
affects you. This medicine is not expected to affect your ability to drive a car or
operate machinery, however, if symptoms occur that affect your ability to concentrate,
do not drive or operate machinery until the effect subsides.
Looking after your medicine
Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
Keep your tablets below 30°C.
Store your tablets in a cool dry place away from moisture, heat or sunlight; for example,
do not store them:
in the bathroom or near a sink, or
in the car or on window sills.
Keep your medicine where young children cannot reach it. A locked cupboard at least
one-and-a-half metres above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking this medicine or it is out of date, take it
to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you start feeling worse while
you are taking TAGRISSO.
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 or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Some of these side effects can only be found when your doctor does tests from time
to time to check your progress. These tests could show a change, kidney, levels of
blood cells or other changes.
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 TAGRISSO contains
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Active ingredient
(main ingredient)
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osimertinib mesilate
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Other ingredients
(inactive ingredients)
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mannitol
microcrystalline cellulose
polyvinyl alcohol
hyprolose
sodium stearylfumarate
titanium dioxide
purified talc
iron oxide black
iron oxide red
iron oxide yellow
macrogol 3350
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Do not take this medicine if you are allergic to any of these ingredients.
What TAGRISSO looks like
There are 2 tablet strengths:
TAGRISSO 40 mg tablets are round, beige, coated tablets approximately 9 mm wide. The
tablets have ‘AZ’ and ‘40’ on one side. (AUST R 255493)
TAGRISSO 80 mg tablets are oval, beige, coated tablets measuring approximately 7.25
× 14.5 mm. The tablets have ‘AZ 80’ on one side. (AUST R 255492)
TAGRISSO tablets are packed into aluminium blister strips in cartons of 30 tablets.
Who distributes TAGRISSO
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in November 2024.
TAGRISSO is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca 2024
VV-RIM-01405710 v17.0