Gilteritinib (Xospata®)
Gilteritinib (Xospata®) is a cancer drug. It is used to treat acute myeloid leukaemia (AML).
What is gilteritinib (Xospata®)?
Gilteritinib is also called Xospata®. It is a type of targeted therapy drug called a cancer growth inhibitor.
Gilteritinib is used to treat acute myeloid leukaemia (AML). It is used if tests show that the leukaemia cells have a gene change called an FLT3 mutation. It is best to read this information with our general information about AML and targeted therapy drugs.
Your cancer team will talk to you about this treatment and its possible side effects before you agree (consent) to have treatment.
More information about this treatment
This information is correct at time of publishing. But sometimes the types of cancer this treatment is used for, or treatment side effects, may change between revision dates.
You can talk to your cancer team if you want more detailed information about this treatment. Or visit the electronic Medicines Compendium (eMC) website, which has patient information leaflets (PIL) for individual drugs.
How gilteritinib is given
Gilteritinib comes as tablets, so you can take it at home.
During a course of treatment, you will meet someone from your cancer team, such as a:
- leukaemia doctor (a haematologist)
- specialist nurse
- specialist pharmacist.
This is who we mean when we mention doctor, nurse or pharmacist in this information.
During your course of treatment, you will have regular blood tests and appointments with your doctor, nurse or pharmacist. This is to check that it is safe for you to have treatment.
Your course of treatment
Your cancer team will discuss your treatment plan with you.
They will give you the tablets to take home. Always take them exactly as they tell you to. This is important to make sure they work as well as possible for you.
Your cancer team may also give you anti-sickness drugs and other medicines to take home. Take all your capsules or tablets exactly as they tell you to.
Taking gilteritinib tablets
Try to take your gilteritinib tablets at the same time every day. You can take them with or without food.
Make sure you:
- swallow them whole with a glass of water
- do not chew, break or crush them.
If you forget to take the tablets, take the missed dose as soon as possible within the same day. If a full day has passed, do not take a double dose. Contact the hospital on the 24-hour number you have been given for advice.
If you are sick after taking the tablets, do not take another dose. Take your next dose at the usual time.
Other things to remember about your tablets:
- Keep them in the original package and at room temperature, away from moisture, heat and direct sunlight.
- Keep them safe, where children cannot see or reach them.
- Do not throw away unused tablets. Return them to your cancer team at the hospital.
About side effects
We explain the most common side effects of this treatment here. We also include some that are less common.
You may get some of the side effects we mention, but you are unlikely to get all of them. And you may have some side effects, including rarer ones, that we have not listed here.
Other cancer treatments may cause different side effects. If you are also having other cancer treatment, you may have other side effects.
Always tell your doctor, nurse or pharmacist about any side effects you have. They can give you:
- drugs to help control some side effects
- advice about managing side effects.
It is important to take any drugs exactly as explained. This means they will be more likely to work for you.
Serious and life-threatening side effects
Some cancer treatments can cause serious side effects. Sometimes, these may be life-threatening. Your doctor, nurse or pharmacist can explain the risk of these side effects to you.
Contact the hospital
Your doctor, nurse or pharmacist will give you 24-hour contact numbers for the hospital. If you feel unwell or need advice, you can call at any time of the day or night. Save these numbers in your phone or keep them somewhere safe.
Very common side effects
Diarrhoea
This treatment may cause severe diarrhoea. Diarrhoea means passing more stools (poo) than is normal for you, or having watery or loose stools. If you have a stoma, it will be more active than usual.
Your doctor, nurse or pharmacist may give you anti-diarrhoea drugs to take at home.
If you have diarrhoea or a mild increase in stoma activity, follow their advice about:
- taking anti-diarrhoea drugs
- how much and what type of fluids to drink
- any changes to your diet that might help.
Contact the hospital straight away on the 24-hour number if any of the following things happen:
- you have diarrhoea at night
- you have uncomfortable stomach cramps
- you have diarrhoea 4 or more times in a day
- you have a moderate increase in stoma activity
- the anti-diarrhoea drugs do not work within 24 hours.
You may need to give a stool sample, or go to hospital to have fluids through a drip or antibiotics.
Feeling sick
You may feel sick during this treatment. Your doctor can give you anti-sickness drugs to help prevent or control sickness. Take the drugs exactly as your nurse or pharmacist tells you. It is easier to prevent sickness than to treat it after it has started.
If you feel sick, take small sips of fluids and eat small amounts often. If you continue to feel sick, or if you vomit more than once in 24 hours, contact the hospital as soon as possible. They will give you advice and may change the anti-sickness drug to one that works better for you.
Constipation
This treatment can cause constipation. Constipation means that you are not able to pass stools (poo) as often as you normally do. It can become difficult or painful. Here are some tips that may help:
- Drink at least 2 litres (3½ pints) of fluids each day.
- Eat high-fibre foods, such as fruit, vegetables and wholemeal bread.
- Do regular gentle exercise, like going for short walks.
If you have constipation, contact the hospital on the 24-hour number for advice. They can give you drugs called laxatives to help.
If you have not been able to pass stools for over 2 days and are being sick, contact the 24-hour number straight away.
Feeling dizzy
Cough and breathlessness
Fluid build-up
Feeling tired (fatigue)
Feeling tired is a common side effect of this treatment. Try to pace yourself and plan your day so you have time to rest. Gentle exercise, like short walks, can help you feel less tired.
If you feel sleepy, do not drive or use machinery.
Effects on the liver
This treatment may affect how your liver works. This is usually mild. You will have blood tests to check how well your liver is working.
Muscle or joint pain
You may get pain in your muscles or joints during treatment. If this happens, tell your doctor, nurse or pharmacist. They can give you painkillers and advice. They can also tell you if any of the painkillers you usually take are suitable.
Tell them if the pain does not get better. Having warm baths and resting regularly may help.
Other side effects
Allergic reaction
This treatment might cause an allergic reaction. But this is not common. Signs of a reaction can include:
- a skin rash or itching
- feeling breathless or wheezy
- swelling of your face, mouth or throat.
If you feel unwell or have any of these signs, contact the hospital straight away on the 24-hour number. Do not take any more of this treatment until you have checked with them.
Always call 999 if swelling happens suddenly or you are struggling to breathe.
Differentiation syndrome
Gilteritinib can affect your blood cells and cause symptoms called differentiation syndrome. This is more likely to happen in the first 3 months of treatment. It is important to contact the hospital straight away on the 24-hour contact number if you have any of these symptoms:
- high temperature
- cough
- feeling dizzy
- putting on weight very quickly
- problems breathing
- swelling of legs or arms
- rash
- peeing less than usual.
If your symptoms are caused by differentiation syndrome, you may need treatment with steroids until they improve.
Effects on the kidneys
This treatment can affect how the kidneys work. This is usually mild and goes back to normal after treatment ends. You will have blood tests to check how well your kidneys are working. Contact the hospital on the 24-hour number if you:
- have blood in your urine (pee)
- are passing less urine or peeing less often than usual.
Drinking fluids helps protect your kidneys. The advice is usually to try to drink at least 2 litres (3½ pints) of fluid each day. But follow any advice from your doctor, nurse or pharmacist about how much is right for you.
Effects on the heart
This treatment can affect how the heart works. You may have tests to check how well your heart is working. These may be done before, during and after treatment.
If the treatment is causing heart problems, your doctor may change the type of treatment you are having.
Contact the hospital straight away on the 24-hour number if you have any of these symptoms during or after treatment:
- breathlessness
- dizziness
- changes to your heartbeat (palpitations)
- swollen feet and ankles.
Other conditions can cause these symptoms, but it is important to get them checked by a doctor.
Always call 999 if you have:
- chest pain, pressure, heaviness, tightness or squeezing across the chest
- difficulty breathing.
Effects on the pancreas
Sometimes this treatment can affect how your pancreas works.
Contact the hospital straight away if you have the following symptoms:
- pain in your tummy (abdomen)
- feeling or being sick
- high temperature.
Effects on the brain
Rarely, this treatment causes a brain condition that can be serious. You can make a full recovery from this. But it must be diagnosed and treated quickly.
This condition can cause:
- a headache that does not get better
- drowsiness or confusion
- changes in eyesight
- fits (seizures).
If you have any of these symptoms, it is important to either:
- contact the hospital straight away on the 24-hour number
- go to the hospital straight away.
You should not drive yourself to hospital.
Other information
Blood clot risk
Cancer and some cancer treatments can increase the risk of a blood clot. Contact the hospital straight away on the 24-hour number if you have any of these symptoms during or after treatment:
- throbbing pain or swelling in a leg or arm
- reddening of the skin in the area – if you have black or brown skin, this can be harder to notice, but the skin might become darker
- suddenly feeling breathless or coughing.
Always call 999 if you have:
- chest pain
- difficulty breathing.
A blood clot is serious, but it can be treated with drugs called anticoagulants. These thin the blood. Your doctor, nurse or pharmacist can give you more information about preventing and treating blood clots.
Other medicines
Some medicines can affect how this treatment works or be harmful while you are having it. Always tell your cancer doctor, nurse or pharmacist about any drugs you are taking or planning to take, such as:
- medicines you have been prescribed
- medicines you buy in a shop, pharmacy or online
- vitamins or supplements
- herbal drugs and complementary or homeopathic therapies
- recreational drugs – for example, cannabis.
Vaccinations
Cancer doctors usually recommend that people with cancer have vaccinations for flu and coronavirus (covid). They may also recommend other vaccines, such as Shingrix® for shingles. These all help reduce your risk of serious illness from these infections. Most people can have these vaccines, including people with weak immune systems.
You should not have live vaccines if your immune system is weak. This includes if you are having or recently had chemotherapy, radiotherapy or other cancer treatments that affect your immune system. Live vaccines can make you unwell because they contain a very weak version of the illness they protect you against. There are several live vaccines, including the yellow fever vaccine.
It is important to ask your doctor, nurse or pharmacist for advice about having vaccinations. They can explain what vaccines are right for you and when it is best to have them.
Contraception
Your doctor, nurse or pharmacist will advise you not to get pregnant or make someone pregnant while having this treatment and for some time afterwards. The drugs may harm a developing baby. It is important to use contraception to prevent pregnancy. Follow their advice about:
- what types of contraception to use
- how long after treatment you should continue to use contraception.
Breastfeeding
You are advised not to breastfeed while having this treatment, or for some time after treatment ends. This is because the drugs could be passed to the baby through breast milk.
Your doctor, nurse or pharmacist can give you more information.
Fertility
Some cancer drugs can affect whether you can get pregnant or make someone pregnant. If you are worried about this, it is important to talk with your doctor before you start treatment.
Medical and dental treatment
If you need medical treatment for any reason other than cancer, always tell the healthcare professional that you are having cancer treatment. Give them the contact details for your cancer doctor or cancer team so they can ask for advice.
If you have appointments with a dentist, always tell them you are having cancer treatment. Talk to your cancer team before you have any dental treatment.
About our information
This information has been written, revised and edited by Macmillan Cancer Support’s Cancer Information Development team. It has been reviewed by expert medical and health professionals and people living with cancer.
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References
Visit the electronic Medicines Compendium (eMC) to download a Patient Information Leaflet (PIL) for more detailed information. The leaflet lists all known side effects.
Date reviewed

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