Ivosidenib and azacitidine
Ivosidenib is a targeted cancer drug. It is also known as Tibsovo. Azacitidine is a chemotherapy drug. It is also called Vidaza.
You pronounce ivosidenib as i-voh-sih-deh-nib. And you pronounce azacitidine as ay-za-sye-tih-deen.
It is a treatment for people who can’t have the 
for newly diagnosed acute myeloid leukaemia (AML).
You might have ivosidenib and azacitidine if the cancer has a change (mutation) in the called IDH1. Your doctor will check for this change before you start treatment.
How do ivosidenib and azacitidine work?
Ivosidenib is a type of targeted cancer drug called a cancer growth blocker. It works by targeting certain proteins made by the changed IDH1 gene. These proteins help cancer cells to grow. Ivosidenib blocks these proteins. This stops or slows down the growth of cancer cells.
Azacitidine is a type of chemotherapy called an anti metabolite. It stops cells making and repairing . Cancer cells need to make and repair DNA so they can grow and multiply.
How do you have ivosidenib and azacitidine?
You take ivosidenib as tablets. And you have azacitidine as an injection under the skin (subcutaneously).
Taking your tablets
You take ivosidenib tablets on an empty stomach. This means you must not eat anything for:
- 2 hours before taking your tablets
- 1 hour after taking them
You swallow the tablets whole with a glass of water.
You must take tablets according to the instructions your doctor or pharmacist gives you.
Speak to your pharmacist if you have problems swallowing the tablets.
Whether you have a full or an empty stomach can affect how much of a drug gets into your bloodstream.
You should take the right dose, no more or less.
Talk to your healthcare team before you stop taking a cancer drug or if you miss a dose.
Having an injection under your skin
You usually have injections under the skin (subcutaneous injection) into the stomach, thigh or top of your arm.
You might have stinging or a dull ache for a short time after this type of injection but they don't usually hurt much. The skin in the area may go red and itchy for a while.
How often do you have ivosidenib and azacitidine?
You have ivosidenib and azacitidine as cycles of treatment. This means that you have the drugs and then a rest to allow your body to recover.
Each cycle of treatment lasts 28 days (4 weeks).
The following is an example of how you might have your drugs:
- You have azacitidine as an injection under the skin once a day.
- You take ivosidenib as a tablet once a day.
- You take ivosidenib as a tablet once a day.
You then start the next cycle of treatment.
You continue taking ivosidenib and azacitidine for as long as they are working and the side effects aren’t too bad.
Tests
You have blood tests before and during your treatment. They check your levels of blood cells and other substances in the blood. They also check how well your liver and kidneys are working.
You also have a test to check the electrical activity of your heart. This is called an ECG (electrocardiogram). It can show changes to your heart rate or rhythm and tells your doctor how well your heart is working. You normally have an ECG:
- before you start taking ivosidenib
- once a week for the next 3 weeks
Some people have an ECG every month after that. Your doctor will talk to you about this if you need them.
What are the side effects of ivosidenib and azacitidine?
Side effects can vary from person to person. They also depend on what other treatments you're having.
When to contact your team
Your doctor, nurse or pharmacist will go through the possible side effects. They will monitor you during treatment and check how you are at your appointments. Contact your advice line as soon as possible if:
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you have severe side effects
-
your side effects aren’t getting any better
-
your side effects are getting worse
Early treatment can help manage side effects better.
Contact your advice line immediately if you have signs of infection, including a temperature above 37.5C or below 36C.
We haven't listed all the side effects here. Remember it is very unlikely that you will have all of these side effects. But you might have some of them at the same time.
Common side effects
These side effects happen in more than 10 in 100 people (more than 10%). You might have one or more of them. They include:
Fast release of immune substances into your blood
Let your team know straight away if you develop symptoms such as difficulty in breathing, a cough, chest pain or high temperature.
This could be a sign that you have differentiation syndrome. This is when you have a fast release of immune substances (cytokines) into your blood. It needs to be treated quickly as it can be life threatening.
Increased risk of infection
Increased risk of getting an infection is due to a drop in white blood cells. Symptoms include a change in temperature, aching muscles, headaches, feeling cold and shivery and generally unwell. You might have other symptoms depending on where the infection is.
Infections can sometimes be life threatening. You should contact your advice line urgently if you think you have an infection.
Bruising, bleeding gums or nose bleeds
This is due to a drop in the number of platelets in your blood. These blood cells help the blood to clot when we cut ourselves. You may have nosebleeds or bleeding gums after brushing your teeth. Or you may have lots of tiny red spots or bruises on your arms or legs (known as petechiae).
Feeling or being sick
Feeling or being sick is usually well controlled with anti sickness medicines. It might help to avoid fatty or fried foods, eat small meals and snacks and take regular sips of water. Relaxation techniques might also help.
It is important to take anti sickness medicines as prescribed even if you don’t feel sick. It is easier to prevent sickness rather than treat it once it has started.
Changes in your heart rhythm
You may have changes to how your heart works. This can cause changes to your heart rhythm. Your doctor will check your heart before you start treatment and for a few weeks afterwards. You should contact your advice line if you feel dizzy or faint at any time.
Difficulty sleeping
If you have difficulty sleeping, it can help to change a few things about how you try to sleep. Try to go to bed and get up at the same time each day and spend some time relaxing before you go to bed. Some light exercise each day may also help.
Headaches
Let your doctor or nurse know if you have headaches. They can find out what is causing it and may give you painkillers.
Pain in your arms, legs and back
You might feel some pain in your arms, legs and your joints. You might also have back pain and your joints might feel stiff. Speak to your doctor or nurse about what painkillers you can take to help with this.
Occasional side effects
These side effects happen in between 1 and 10 out of every 100 people (between 1 and 10%). You might have one or more of them. They include:
- numbness or tingling in your fingers and toes – this is often temporary and can improve after you finish treatment. But for some people it may last a while after they have finished. Tell your healthcare team if you're finding it difficult to walk or complete fiddly tasks such as doing up buttons
- pain in your mouth and throat – this may make it difficult to eat and drink. Painkillers and mouthwash can help
Possible rare and long term side effects
Ivosidenib is a new drug in cancer treatment. This means that there is limited information available at the moment about possible rare and longer term effects that it may cause. Tell your doctor if you notice anything that is not normal for you.
Other side effects
If you have side effects that aren't listed on this page, you can look at the individual drug pages:
Coping with side effects
We have more information about side effects and tips on how to cope with them.
What else do you need to know?
Other medicines, food and drink
Cancer drugs can interact with medicines, herbal products, and some food and drinks. We are unable to list all the possible interactions that may happen. An example is grapefruit or grapefruit juice which can increase the side effects of certain drugs.
Tell your healthcare team about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies. Also let them know about any other medical conditions or allergies you may have.
Loss of fertility
It is not known whether this treatment affects in people. Talk to your doctor before starting treatment if you think you may want to have a baby in the future.
Men might be able to store sperm before starting treatment. And women might be able to store eggs or ovarian tissue. But these services are not available in every hospital. Ask your doctor about this.
Contraception and pregnancy
This treatment may harm a baby developing in the womb. It is important not to become pregnant or get someone pregnant while you are having treatment. Women must not become pregnant for at least 6 months after the end of treatment. Men should not get someone pregnant for at least 3 months after treatment.
Ivosidenib may stop the contraceptive pill, injection or implant working properly. If you are using one of these, you should also use a barrier method of contraception such as condoms during sex.
Talk to your doctor or nurse about effective contraception before starting treatment. Let them know straight away if you or your partner become pregnant while having treatment.
Breastfeeding
Don’t breastfeed during this treatment and for at least 1 month after your last dose. This is because the drugs may come through into your breast milk.
Other conditions
If you are having tests or treatment for anything else, always mention your cancer treatment. For example, if you are visiting your dentist.
Immunisations
Don’t have immunisations with live vaccines while you’re having treatment and for up to 12 months afterwards. The length of time depends on the treatment you are having. Ask your doctor or pharmacist how long you should avoid live vaccinations.
In the UK, live vaccines include rubella, mumps, measles, BCG, yellow fever and one of the shingles vaccines called Zostavax.
You can have:
- other vaccines, but they might not give you as much protection as usual
- the flu vaccine (as an injection)
- the coronavirus (COVID-19) vaccine - talk to your doctor or pharmacist about the best time to have it in relation to your cancer treatment
Members of your household who are aged 5 years or over are also able to have the COVID-19 vaccine. This is to help lower your risk of getting COVID-19 while having cancer treatment and until your recovers from treatment.
Contact with others who have had immunisations - You can be in contact with other people who have had live vaccines as injections. Avoid close contact with people who have recently had live vaccines taken by mouth (oral vaccines) such as the oral typhoid vaccine. Sometimes people who have had the live shingles vaccine can get a shingles type rash. If this happens they should keep the area covered.
If your immune system is severely weakened, you should avoid contact with children who have had the flu vaccine as a nasal spray as this is a live vaccine. This is for 2 weeks following their vaccination.
Babies have the live rotavirus vaccine. The virus is in the baby’s poo for about 2 weeks and could make you ill if your immunity is low. Get someone else to change their nappies during this time if you can. If this isn't possible, wash your hands well after changing their nappy.
More information
For further information about each drug and the possible side effects go to the electronic Medicines Compendium (eMC) website. You can find patient information leaflets for each drug on this website.
You can report any side effect you have to the Medicines Health and Regulatory Authority (MHRA) as part of their Yellow Card Scheme.
