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 Itovebi?
Itovebi contains the active ingredient inavolisib. Itovebi is used to treat a certain
type of breast cancer where, following surgery, that cancer:
has spread to nearby tissue or lymph nodes, or to other parts of the body, and
was recently, or is currently, being treated with a category of medicines called endocrine
therapy, and
has a change in a gene called 'PIK3CA.’
2. What should I know before I use Itovebi?
Do not use if you have ever had an allergic reaction to inavolisib or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have a history of diabetes or high blood sugar, including
during a previous pregnancy (gestational diabetes). Tell your doctor if you are pregnant
or plan to become pregnant, or you are breastfeeding or planning to breastfeed, as
Itovebi can harm your baby. Tell your doctor if you have other medical conditions
or use other medicines.
3. What if I am using other medicines?
4. How do I use Itovebi?
The usual dose of Itovebi is 9 mg per day. Use Itovebi once daily, at about the same
time each day. Itovebi can be used with or without food. More instructions can be
found in Section
4. How do I use Itovebi? in the full CMI.
5. What should I know while using Itovebi?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Itovebi.
Your doctor may ask you to monitor your blood sugar at home during treatment with
Itovebi. Tell your doctor, nurse or pharmacist right away if you develop symptoms
of high blood sugar levels (hyperglycaemia) such as a fruity smelling on the breath,
difficulty breathing, feeling very thirsty, passing urine more often than usual or
in higher amounts than usual, blurred vision.
Tell your doctor, nurse or pharmacist as soon as you notice any signs or symptoms
of inflammation of the lining of the mouth, or diarrhoea
You should stay well-hydrated during treatment with Itovebi
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Things you should not do
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Do not change your dose or stop using Itovebi unless your doctor tells you to.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Itovebi
affects you.
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Looking after your medicine
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Store Itovebi at room temperature (below 30°C).
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6. Are there any side effects?
Itovebi can cause side effects. Speak to your doctor if you have any of these side
effects and they concern you: stomach problems such as pain, nausea; skin problems;
painful urination or urinary tract infection; abnormal laboratory tests; tiredness,
loss of appetite; weight loss; general unwell feeling. Tell your doctor, nurse or
pharmacist straight away if you notice symptoms of high blood sugar levels (hyperglycaemia),
inflammation of the lining of the mouth (stomatitis), or diarrhoea. 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: inavolisib
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Itovebi. 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 Itovebi.
Where to find information in this leaflet:
1. Why am I using Itovebi?
Itovebi contains the active ingredient inavolisib. Itovebi is an anti-cancer medicine used in combination with medicines called palbociclib
(tradename 'Ibrance®') and fulvestrant (of various tradenames).
Itovebi is used to treat adults with a type of breast cancer called hormone receptor
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer,
where, following surgery, that cancer:
has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of
the body (metastatic), and
is currently being treated with a category of medicines called endocrine therapy,
or it is within 12 months of completing endocrine therapy, and
has a change in a gene called 'PIK3CA.'
2. What should I know before I use Itovebi?
Warnings
Do not use Itovebi if:
you are allergic to inavolisib, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have a history of diabetes or high blood sugar, including during a previous pregnancy
(gestational diabetes)
Tell your doctor or pharmacist before using Itovebi if you have ever had diabetes
or signs of increased sugar levels in your blood, such as:
feeling very thirsty
dry mouth
needing to pass urine more often than usual
producing greater amounts of urine than usual
feeling tired
feeling sick (nausea)
increased appetite with weight loss
a fruity smelling on the breath
blurred vision
feeling lightheaded
are pregnant or plan to become pregnant, or you are breastfeeding or plan to breastfeed.
See ‘Pregnancy and breastfeeding’ below.
have other medical conditions
use medicines for any other condition
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 plan to become pregnant. Itovebi can harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider will do a pregnancy test before you start treatment with
Itovebi.
You should use non-hormonal birth control (contraception) during treatment and for
2 weeks after your last dose of Itovebi. Talk to your healthcare provider about what
birth control method is right for you during this time.
Tell your healthcare provider right away if you become pregnant or think you may be
pregnant during treatment with Itovebi.
If you or your partner are planning to have a baby, ask your doctor for advice before
using this medicine.
Males with female partners who are able to become pregnant, or who are currently pregnant,
should use condoms during treatment with Itovebi and for 2 weeks after the last dose.
are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your
breastmilk. Do not breastfeed during treatment with Itovebi. Talk to your doctor if
you are breastfeeding or intend to breastfeed.
How Itovebi works
Itovebi works by blocking the effects of a protein called 'p110 alpha', which is produced
by the PIK3CA gene.
PIK3CA is a gene that controls a pathway that is often disrupted in cancer. This pathway
is called the PI3K cancer pathway.
The p110 alpha protein, when changed (mutated) due to a mutation in PIK3CA, causes
cancer cells to grow and multiply more rapidly.
By blocking its action, Itovebi can reduce growth and spread of the cancer and help
to destroy cancer cells.
Prior to starting treatment with Itovebi, your healthcare provider may take a sample
of your blood and/or tumour tissue to test for changes in the PIK3CA gene.
3. What if I am using other medicines?
Tell your doctor or pharmacist if you are using any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are using and if these affect Itovebi.
4. How do I use Itovebi?
How much to use
Use Itovebi exactly as your doctor tells you to.
The usual dose of Itovebi is 9 mg per day.
If you are a woman experiencing pre-menopause or perimenopause, your doctor may add
an additional medicine called a luteinising hormone-releasing hormone (LHRH) agonist
to your treatment plan.
If you are a male, your doctor may also add an LHRH agonist medicine to your treatment
plan.
It is recommended that you continue using Itovebi until your cancer progresses or
until any side effects become unacceptable (see section
6. Are there any side effects?, below)
Itovebi is not addictive
When to use Itovebi
Use Itovebi once daily, at about the same time each day.
Itovebi can be used with or without food.
If you vomit after using a dose of Itovebi, do not use an extra dose on that day.
Use your regular dose of Itovebi at your usual time the next day.
If you forget to use Itovebi
Itovebi should be used regularly at the same time each day. If you miss your dose
at the usual time, you may still use it up to 9 hours after the time you should have
used it.
If it has been more than 9 hours from the time you should have used it, skip the dose
you missed and use your next dose when you are meant to the next day. Do not use a
double dose to make up for the dose you missed.
If you use too much Itovebi
If you think that you have used too much Itovebi, 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 Itovebi?
High blood sugar levels (hyperglycaemia)
Hyperglycaemia is common with Itovebi and may be severe.
Monitoring hyperglycaemia during your treatment with Itovebi
Your doctor may do blood tests before and regularly during treatment with Itovebi.
This is to monitor your blood sugar levels.
Your doctor may also ask you to monitor your blood sugar at home during treatment
with Itovebi.
Your doctor will tell you exactly when to test your blood sugar.
This will be needed more often in the first 4 weeks of treatment. If you are not sure
how to test your blood sugar, talk to your doctor or pharmacist.
Based on the results, your doctor will take any necessary actions - such as prescribing
a medicine to lower blood sugar levels. If necessary, your doctor may decide to pause
treatment with Itovebi - or reduce your Itovebi dose to let your blood sugar go down.
Your doctor may also decide to stop Itovebi treatment permanently.
Inflammation of the lining of the mouth (stomatitis)
Stomatitis is very common with Itovebi and may be severe.
Your doctor may advise you to start an alcohol-free corticosteroid mouthwash and to
avoid alcohol- or peroxide-containing mouthwashes as they may worsen the inflammation.
Your doctor or pharmacist may also give you dietary advice (e.g. to avoid spicy foods)
to help you manage this side effect.
Diarrhoea
Diarrhoea is very common with Itovebi and may be severe.
If not managed properly, severe diarrhoea can lead to dehydration and can damage your
kidneys.
Things you should do
Tell your doctor, nurse or pharmacist right away if you develop symptoms of hyperglycaemia
or its complications, including:
difficulty breathing
nausea and vomiting (lasting more than 2 hours)
stomach pain
excessive thirst
dry mouth
more frequent urination than usual or a higher amount of urine than normal
blurred vision
unusually increased appetite
weight loss
fruity-smelling breath
flushed face and dry skin
feeling unusually sleepy or tired
Tell your doctor, nurse or pharmacist as soon as you notice any signs or symptoms
of stomatitis inside the mouth, such as:
pain
redness
swelling
mouth ulcers
Tell your doctor, nurse or pharmacist as soon as you notice any signs or symptoms
of diarrhoea (liquid or watery poo, often with tummy pain and gas).
You should stay well-hydrated during treatment with Itovebi. Your doctor, nurse or
pharmacist will advise you to drink plenty of (non-alcoholic) fluids and may advise
you to use a medicine which reduces diarrhoea. Your doctor may also reduce, or cease,
your dose of Itovebi.
Things you should not do
Do not change your dose or stop using Itovebi unless your doctor tells you to.
Older people (≥ 65 years)
You can use Itovebi if you are aged 65 years or over at the same dose as for other
adults.
Children and adolescents (< 18 years)
Itovebi should not be used in children or adolescents below 18 years of age. This
is because Itovebi has not been studied in this age group
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Itovebi
affects you.
Looking after your medicine
Store Itovebi at room temperature (below 30°C). Store it in a cool dry place away
from moisture or heat; for example, do not store it:
In the bathroom or near a sink, or
In the car or on window sills.
Keep it where young children cannot reach it.
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.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are likely to be minor and temporary. However, some side effects may need medical
attention.
Your healthcare provider may tell you to decrease your dose, temporarily stop your
treatment, or completely stop your treatment with Itovebi if you develop certain side
effects.
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, nurse 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 side effects will
only be identified when your doctor orders tests to monitor your treatment.
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
using any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Itovebi contains
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Active ingredient
(main ingredient)
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inavolisib
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose
Lactose
Sodium starch glycollate
Magnesium stearate
Polyvinyl alcohol
Titanium dioxide
Macrogol/polyethylene glycol
Purified talc
Iron oxide red
Iron oxide yellow (9 mg tablet only)
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Potential allergens
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Nil
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Do not use this medicine if you are allergic to any of these ingredients.
What Itovebi looks like
Itovebi 3 mg film-coated tablet is red and round, convex-shaped with an “INA 3” embossing
on one side. (AUST R 446750)
Itovebi 9 mg film-coated tablet is pink and oval-shaped with an “INA 9” embossing
on one side. (AUST R 446751)
Itovebi 3 mg and 9 mg film-coated tablets are supplied in cartons of 28 tablets (4
aluminium blister cards, each with 7 tablets, per carton).
Who distributes Itovebi
Itovebi is distributed by:
Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30 - 34 Hickson Road
Sydney NSW 2000
AUSTRALIA
Please check with your pharmacist for the latest Consumer Medicine Information.
This leaflet was prepared in March 2025.