What is gilteritinib (Xospata®)?

Gilteritinib (Xospata®) 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.

Gilteritinib is a type of targeted therapy drug called a cancer growth inhibitor.

Your doctor will talk to you about this treatment and its possible side effects before you agree (consent) to have treatment.

How gilteritinib is given

Gilteritinib comes as tablets, so you can take it at home. During treatment you usually see a leukaemia doctor (a haematologist), a cancer nurse or specialist nurse, and a specialist pharmacist. This is who we mean when we mention doctor, nurse or pharmacist in this information.

Your doctor, nurse or pharmacist will discuss your treatment plan with you. They will explain how to take gilteritinib. They will give you the tablets to take home with you. Take them exactly as they have been explained to you.

Taking gilteritinib tablets

Try to take your gilteritinib tablets at the same time every day. Swallow the tablets whole with water. Do not chew, break or crush them. You can take them with or without food.

If you forget to take the tablets, take the missed dose as soon as possible on the same day. Do not take a double dose.

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 to protect them from light.
  • Keep them safe and out of sight and reach of children. 
  • If your treatment is stopped, return any unused tablets to the pharmacist.

About side effects

We explain the most common side effects of this treatment here. We also include some less common side effects.

You may get some of the side effects we mention, but you are unlikely to get all of them. If you are also having treatment with other cancer drugs, you may have some side effects that we have not listed here. Always tell your doctor, nurse or pharmacist about any side effects you have.

Your doctor can give you drugs to help control some side effects. It is important to take them exactly as your nurse or pharmacist explains. This means they will be more likely to work for you. Your nurse will give you advice about managing your side effects. After your treatment is over, most side effects start to improve.

Serious and life-threatening side effects

Some cancer treatments can cause severe side effects. Rarely, these may be life-threatening. Your cancer doctor or nurse can explain the risk of these side effects to you.

Contact the hospital

Your nurse will give you telephone numbers for the hospital. If you feel unwell or need advice, you can call them at any time of the day or night. Save these numbers in your phone or keep them somewhere safe.

More information

We cannot list every side effect for this treatment. There are some rare side effects that are not listed. You can visit the electronic Medicines Compendium (eMC) for more detailed information.

Common side effects

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.

Diarrhoea

This treatment may cause severe diarrhoea. Diarrhoea means passing more stools (poo) than is usual for you, or having watery or loose stools. If you have a stoma, it will be more active than usual.

Your hospital team may give you anti-diarrhoea drugs to take at home.

If you have diarrhoea or a mild increase in stoma activity:

  • follow any advice from your cancer team about taking anti-diarrhoea drugs
  • drink at least 2 litres (3½ pints) of fluids each day
  • avoid alcohol, caffeine, milk products, high-fat foods and high-fibre foods.

Contact the hospital straight away if:

  • you have diarrhoea at night
  • you have diarrhoea more than 4 times in a day
  • you have a moderate or severe increase in stoma activity
  • the anti-diarrhoea drugs do not work within 24 hours.

You may need to go to hospital to have fluids through a drip.

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 for advice. Your doctor can give you drugs called laxatives to help.

Effects on the liver

This treatment can affect how your liver works. You will have regular blood tests to check how well your liver is working.

Muscle or joint pain

You may get pain in your muscles or joints for a few days after treatment. If this happens, tell your doctor so they can give you painkillers. Tell them if the pain does not get better. Having warm baths and resting regularly may help. 

Tiredness

Feeling tired is a common side effect. Try to pace yourself and plan your day so you have time to rest. Gentle exercise, like short walks, can give you more energy. If you feel sleepy, do not drive or operate machinery.

Feeling dizzy

This treatment may cause dizziness. Sometimes this is because treatment has lowered your blood pressure. Always tell your doctor if you feel dizzy. They can check your blood pressure and arrange further tests if needed.

Cough and breathlessness

This treatment may cause a mild cough or shortness of breath. Always tell your doctor if you have these side effects. They can check the cause and give you advice.

Build-up of fluid

During this treatment your ankles and legs may swell because of fluid building up. Tell your doctor or nurse if this happens. The swelling gets better after your treatment ends.

Less common side effects

Allergic reaction

Some people have an allergic reaction while having this treatment. Signs of a reaction can include:

  • feeling hot or flushed
  • a skin rash
  • itching
  • shivering
  • feeling dizzy
  • a headache
  • feeling breathless.

If you feel unwell or have any of these signs, tell a doctor or nurse straight away. Do not take any more of this treatment until you have spoken to them.

Effects on the heart

This treatment can affect the way your heart works. You will have tests to see how well your heart is working. You will have these tests before and during treatment.

Contact a doctor straight away if you:

  • have pain or tightness in your chest
  • feel breathless or dizzy
  • feel your heart is beating too fast or too slowly.

Other conditions can cause these symptoms. But is important to get them checked by a doctor.

Effects on the nervous system

Rarely, this treatment can affect the nervous system and cause symptoms such as:

  • memory loss
  • confusion
  • changes in your eyesight
  • unsteadiness
  • fits (seizures).

Contact the hospital straight away if you have any of these symptoms. It is important not to drive or operate machinery if you have these side effects.

Effects on the pancreas

Sometimes this treatment can affect how your pancreas works. Tell your doctor if you have pain in the centre of your tummy (abdomen).

Other information

Blood clot risk

Cancer and some cancer treatments can increase the risk of a blood clot. Symptoms of a blood clot include:

  • throbbing pain, redness or swelling in a leg or arm
  • suddenly feeling breathless or coughing
  • sharp chest pain, which may be worse when you cough or take a deep breath.

If you have any of these symptoms, contact the hospital straight away on the 24-hour contact number you have been given. If you cannot get through to your doctor, call the NHS urgent advice number on 111.

A blood clot is serious, but it can be treated with drugs that thin the blood (anticoagulants). Your doctor or nurse can give you more information.

You can help reduce the risk of developing a blood clot by:
  • staying active during treatment
  • drinking plenty of fluids, especially water.

You may be given anticoagulants to help prevent a clot.

Vaccinations

Vaccinations can reduce your risk of getting certain infections. Your doctor or nurse may talk to you about having vaccinations.

Doctors usually recommend that people with cancer have a flu vaccination and a coronavirus vaccination. These are both inactivated vaccinations that can help reduce the risk of infection. People with weak immune systems can have these, as they are not live vaccinations.

If your immune system is weak, you need to avoid live vaccinations. This is because they can make you unwell. Live vaccines, such as shingles, contain a very weak version of the illness they are vaccinating you against. Your cancer doctor or GP can tell you more about live and inactivated vaccinations.

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.

Contraception

Your doctor will advise you not to get pregnant or make someone pregnant while having this treatment. The drugs may harm a developing baby. It is important to use contraception during your treatment and for a while after treatment finishes. Your doctor, nurse or pharmacist can tell you more about this.

Breastfeeding

You are advised not to breastfeed while having this treatment, or for some time after treatment finishes. This is because the drugs could be passed to the baby through breast milk.

Your doctor or nurse can give you more information.

Medical and dental treatment

If you need medical treatment for any reason other than cancer, always tell the doctors and nurses you are having cancer treatment. Give them the contact details for your cancer doctor so they can ask for advice.

If you think you need dental treatment, talk to your cancer doctor or nurse. Always tell your dentist you are having cancer treatment.

Other medicines

Some medicines can affect how this treatment works or be harmful when you are having it. Always tell your cancer doctor about any drugs you are taking or planning to take, such as:

  • medicines you have been prescribed
  • medicines you buy in a shop or chemist
  • vitamins, herbal drugs and complementary therapies.

Tell other doctors, pharmacists or dentists who prescribe or give you medicines that you are having this cancer treatment.

You can visit the electronic Medicines Compendium (eMC) for more detailed information about your treatment.

About our information


  • Reviewers

    This information has been written, revised and edited by Macmillan Cancer Support’s Cancer Information Development team. It has been reviewed by expert health professionals and people living with cancer.

    Our cancer information has been awarded the PIF TICK. Created by the Patient Information Forum, this quality mark shows we meet PIF’s 10 criteria for trustworthy health information.