Patient Medication Information: uses, side effects, how to take - Itovebi
Serious warnings and precautions box
What ITOVEBI is used for:
ITOVEBI is used with palbociclib and fulvestrant to treat breast cancer in adults. The breast cancer:
- is endocrine-resistant (has come back while the patient is receiving, or after the patient has completed hormonal treatment),
- is HR-positive (hormone receptor-positive),
- is HER2-negative (human epidermal growth factor receptor 2-negative),
- has a change (mutation) in a gene called ‘PIK3CA’, and
- has spread to nearby tissue or lymph nodes, or other parts of the body.
Before taking ITOVEBI, a test will be performed. This is to confirm if ITOVEBI is right for you.
How ITOVEBI works:
ITOVEBI works by blocking the effects of a protein that is made by the mutated PIK3CA gene. This helps destroy cancer cells, and slows the growth and spread of the cancer.
The ingredients in ITOVEBI are:
Medicinal ingredient: inavolisib
Non-medicinal ingredients: iron oxide red, iron oxide yellow (9 mg tablet only), lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, purified water, sodium
ITOVEBI can cause serious side effects including:
|
starch glycolate, talc, titanium dioxide
ITOVEBI comes in the following dosage form:
Tablet: 3 mg and 9 mg
Do not use ITOVEBI if:
- you are allergic to inavolisib or any of the other ingredients of ITOVEBI or the container.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ITOVEBI. Talk about any health conditions or problems you may have, including if you:
- are pregnant or plan to become pregnant. ITOVEBI can harm your unborn baby,
- have kidney problems,
- have or had high blood sugar levels, diabetes, gestational diabetes, a family history of diabetes,
- are 65 years of age or older.
Other warnings you should know about:
Stomatitis (mouth sores, redness and swelling of the lining of the mouth): ITOVEBI can cause stomatitis. Your healthcare professional will monitor you for signs and symptoms of stomatitis. They may recommend you use a mouthwash that does not contain alcohol and avoid eating certain foods.
Diarrhea: ITOVEBI can cause severe diarrhea. This can lead to dehydration and kidney problems. Your healthcare professional will monitor your electrolyte levels and treat you as needed.
Blood Tests for Hyperglycemia (high blood sugar):
- Your healthcare professional will do blood tests before, during and after treatment with ITOVEBI. This is to check your blood health and blood sugar levels.
Your healthcare professional may also ask you to check your blood sugar at home. They will tell you exactly how and when to test your blood sugar.
- Always follow your healthcare professional’s exact instructions for checking blood sugar levels. This helps detect if you have high blood sugar early.
- Your healthcare professional will tell you if your blood sugar levels are abnormal and if you need treatment. Treatment can include medicines or lifestyle changes like diet and exercise.
- If you are taking certain medications called corticosteroids or have an infection, you may need to have your blood sugar levels checked more often.
Pregnancy and Breastfeeding:
- If you are pregnant, able to get pregnant, or planning on having a baby, there are risks you should discuss with your healthcare professional.
- You should not take ITOVEBI if you are pregnant. It may harm your unborn baby.
- Your healthcare professional may do a pregnancy test before you start taking ITOVEBI. This test must show you are not pregnant.
- If you think you are pregnant, become pregnant while taking ITOVEBI, or become pregnant by your male partner who is taking ITOVEBI, tell your healthcare professional right away.
- You should not breast-feed while taking ITOVEBI and for 1 week after your last dose.
Birth Control for Females and Males:
- Females: Use a non-hormonal method of birth control during treatment and for 1 week after your last dose. Ask your healthcare professional about birth control that is right for you.
Males: Use effective birth control each time you have sex with a woman who is pregnant, may be pregnant or could get pregnant. Keep using effective birth control until 1 week after your last dose. Ask your healthcare professional about birth control that is right for you.
- If, during your treatment with ITOVEBI, your sexual partner becomes pregnant or thinks she may be pregnant, tell your healthcare professional right away.
Fertility for Females and Males:
- Treatment with ITOVEBI may affect your ability to have or father a child. If you have questions about this, talk to your healthcare professional.
Children and Adolescents:
- ITOVEBI is not for children and adolescents under 18 years old.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take ITOVEBI:
- Always take this medicine exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
Take ITOVEBI with or without food, at the same time each day.
- Swallow tablets whole. Do not chew, crush or split tablets.
- Take ITOVEBI for as long as your healthcare professional prescribes it. Do not stop taking this medicine unless your healthcare professional tells you to.
Usual dose:
Adults: Take exactly as directed. Your healthcare professional will decide on the right dose for you.
- Your healthcare professional may lower your dose, stop treatment for a period of time, or stop treatment completely. This may happen if you experience serious side effects.
- You will also receive treatment with palbociclib and fulvestrant. Your healthcare professional will determine your dose and schedule.
Overdose:
| If you think you, or a person you are caring for, have taken too much ITOVEBI, contact a healthcare professional, hospital emergency department, 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 of ITOVEBI, you may still take it up to 9 hours after the time you should have taken it.
- If it has been more than 9 hours from the time you should have taken it, skip the dose for that day. The next day, take the dose at your usual time.
- Do not take an extra dose to make up for the one that you missed.
- If you vomit after taking a dose of ITOVEBI, do not take an extra dose on that day. Take your regular dose of ITOVEBI at your usual time the next day.
Possible side effects from using ITOVEBI:
These are not all the possible side effects you may have when taking ITOVEBI. If you experience any side effects not listed here, tell your healthcare professional.
- Diarrhea
- Tiredness
- Feeling sick to your stomach (nausea), vomiting
- Rash
- Dry skin
- Loss of appetite
- Headache
- Hair loss or hair thinning
- Weight loss
- Abdominal pain
- Dry eyes
- Upset stomach or indigestion
- Changes in the way food tastes or lost sense of taste
- COVID-19 infection or cold symptoms
ITOVEBI can cause abnormal blood test results. Your healthcare professional will do blood tests before, during and after your treatment. These will tell your healthcare professional how ITOVEBI is affecting your blood.
Serious side effects and what to do about them
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.
| 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 | |||
|---|---|---|---|
| Hyperglycemia (high blood sugar): difficulty breathing, confusion, nausea and vomiting, stomach pain, feeling very thirsty or dry mouth (dehydration), passing urine more often than usual or passing greater amounts of urine than usual, blurred vision, unusually increased appetite, weight loss, fruity-smelling breath, flushed face and dry skin, feeling unusually sleepy or tired, and feeling lightheaded | ✓ | ||
| Stomatitis (mouth sores, redness and swelling of the lining of the mouth): painful, red, shiny or swollen gums, tongue, mouth or throat sores, blood in the mouth, difficult or painful swallowing or talking, dry mouth, mild burning, or pain when eating food, redness and swelling of the lining of the mouth | ✓ | ||
| Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): Pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine | ✓ | ||
| Common | |||
| Diarrhea, nausea, vomiting (severe): dehydration, thirst, dark urine, decreased urine output, blood in urine, and weight gain (from retaining fluid) | ✓ | ||
| Unknown | |||
| Ketoacidosis (build-up of acids in your blood): feeling very thirsty, urinating often, nausea, feeling weak, fruity scented breath, trouble breathing, confusion | ✓ |
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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:
- Store at room temperature, 15°C to 30°C.
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date (EXP) that is stated on the packaging. It refers to the last day of that month. Do not take this medicine if you notice any damage to the packaging or if there are any signs of tampering.
- Do not throw away any medicines via wastewater or household waste. Ask your healthcare professional how to throw away medicines you no longer use. These measures will help protect the environment.
If you want more information about ITOVEBI:
- 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.rochecanada.com], or by calling 1-888-762-4388.
Last Revised: 2026-07-16
ITOVEBI® is a registered trademark of F. Hoffmann-La Roche AG, used under license.
©Copyright 2026, Hoffmann-La Roche Limited
Hoffmann-La Roche Limited
Mississauga, ON L5N 5M8