Quizartinib

Your haematology team might recommend quizartinib for you if:

• You have been newly diagnosed with AML AND
• Your leukaemia cells have a change in the FLT3 gene known as FLT3-ITD

What is quizartinib?

Quizartinib is a targeted medicine. It blocks some proteins cells need to grow and divide. This includes a protein called FLT3. The FLT3 protein is abnormal in around 1 in every 3 people with AML due to a change in the FLT3 gene. It encourages the blood-forming cells in your bone marrow to make too many white blood cells. Blocking FLT3 helps stop the leukaemia cells from growing and dividing.

The brand name for quizartinib is Vanflyta.

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Before starting quizartinib, your haematology team will carry out checks. These make sure quizartinib is suitable for you. These might include:

• Blood tests to measure your blood cell counts
• Blood tests to check the levels of salts in your blood
• Bone marrow tests
• A heart tracing (ECG) to check the electrical activity of your heart
• A pregnancy test

Things to tell your haematology team

Before starting treatment, you should let your haematology team know if you:

• Have any allergies or have ever had an allergic reaction
• Have or ever had any heart problems or uncontrolled chest pain
• Have high blood pressure
• Have low levels of potassium or magnesium in your blood
• Have or recently had fever, cough, chest pain, shortness of breath, tiredness or pain when you pee

Some medicines or drugs may interact with quizartinib. It is important to tell your haematology team about any medicines or supplements you are taking. This includes prescribed medicines and medicines you have bought yourself without a prescription. Examples include:

• Herbal medicines, such as St John’s Wort
• Some medicines used to treat infections
• Some medicines used to treat fits (seizures) or epilepsy
• Some medicines used to treat prostate cancer
• Medicines that can affect your heart
• Mitotane, a medicine used to treat symptoms of tumours of the adrenal glands
• Bosentan, a medicine used to treat high blood pressure in the lungs
• Nefazodone, a medicine used to treat depression

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Quizartinib is used as part of intensive treatment for AML. You might take it as part of induction, consolidation and maintenance treatment.

During the induction and consolidation phases, you take it after chemotherapy in each treatment cycle. During the maintenance phase, you take quizartinib on its own at home.

Quizartinib comes as tablets. When you are on quizartinib:

• You should take quizartinib as prescribed so it can work as well as possible. Try and take it at the same time of day if you can.
• Swallow the quizartinib tablets with a full glass of water.
• You can take the tablets with food, or between meals, whichever is best for you.
• If you are sick after taking a tablet, do not take another dose on the same day. Instead, wait until the next day and take your dose as normal. It is important not to take a double dose.
• If you forget to take your quizartinib tablets, take it as soon as you remember on the same day. If it is the next day, just take your usual dose at the usual time. Do not take a double dose to make up for forgotten tablets.

Dose

During induction and consolidation, you will have treatment in cycles. You usually take two 17.7mg tablets once a day for 14 days in each treatment cycle.

During maintenance you usually take one 26.5mg tablet once a day, every day for the first 2 weeks. After 2 weeks, you usually take two 26.5mg tablets once a day, every day.

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Quizartinib can affect your heart. This can mean that your heart may take longer to recover after each heartbeat. You should tell your doctor straight away if:

• You feel dizzy, light-headed or faint
• You have fainted, or been unconscious
• You have a fast, irregular heartbeat, or other change in your heart rate
• You have diarrhoea or are being sick
• You are struggling to eat or drink enough
• You suddenly feel unwell

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Quizartinib may harm unborn babies.

• If you could get pregnant, it is important to use effective contraception. You need to do this while you are taking quizartinib and for at least 7 months after you stop.
• If you could make someone pregnant, it is important to use effective contraception. You need to do this while you are taking quizartinib and for at least 4 months after you stop.
• If you think you might be pregnant, tell your haematology team as soon as possible. They may recommend stopping quizartinib for a while. They could also recommend switching to a different treatment.
• If you are planning to get pregnant, or make someone pregnant, tell your haematology team. They can discuss your treatment options with you.

Breastfeeding

Scientists are not sure if quizartinib passes into breastmilk. If it does, it could be a risk for breastfed babies or children. You should not breastfeed when taking quizartinib and for at least 5 weeks after you stop.

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During your treatment with quizartinib, you will have regular blood tests and heart tracings (ECGs).

You may also have bone marrow tests, further heart tests and other tests. Your haematology team will let you know what heart tests you need and how often.

Your haematology team will use the results of these tests to:

• Check how well quizartinib is working for you
• Make sure your blood counts have not dropped too low
• Check the levels of salts in your blood
• Check how well your heart is working

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The number of cycles you have depends on how you respond to treatment and how well your body is coping with it. You can have a maximum of two induction cycles and four consolidation cycles. You can have maintenance treatment for up to 3 years.

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Like all medicines, quizartinib can cause side effects. Some of these may be serious. Side effects are different for everyone, and we cannot predict what side effects you may or may not get.

Tell your haematology team about any side effects you have. They may be able to suggest things you can do or give you medicines to help.

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Your medical team will closely monitor you for serious side effects. This means that they can treat them promptly if they happen.

The most important serious side effects for people taking quizartinib are:

• A low white blood cell count, which increases your chance of getting infections, which might be more serious or last longer than usual
• Viral or fungal infections

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Very common side effects affect more than 10 in every 100 people who are taking quizartinib.

Very common side effects include:

• A cough, blocked or runny nose, sneezing, a sore throat, shortness of breath.
• Unexpected bruising or bleeding, like nosebleeds, bleeding gums, blood spots or rashes, due to a low platelet count.
• Feeling tired, dizzy or short of breath, due to a low red blood cell count (anaemia).
• Decreased appetite.
• Indigestion.
• Headaches.
• Diarrhoea.
• Feeling sick or being sick.
• Tummy pain.
• Changes in your liver function, found on blood tests.
• Swelling of your face, arms, hands, legs, ankles and feet.
• Palpitations, dizziness or fainting due to a change in your heart rhythm.
• Bacteria in your blood, found on blood tests. This is probably because your body is less able to fight bacteria than usual.

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Common side effects affect more than 1 but less than 10 out of every 100 people who are taking quizartinib.

Common side effects include:

• Low levels of all your blood cells (red blood cells, white blood cells and platelets)

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Tell your medical team if you get any side effects. They may be able to suggest things to help. This could include:

• Medicines like antibiotics, antifungals or antivirals to treat and prevent infections
• Blood or platelet transfusions if you have low levels of blood cells
• Medicines to prevent and treat sickness and diarrhoea
• Pausing or stopping your treatment
• Lowering your dose of quizartinib

You may need to stay in hospital to manage some of these side effects.

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If quizartinib is not working well, your haematology team might suggest altering how often you have treatment or changing the dose of treatments you are having with quizartinib. This could be a different combination of chemotherapy or targeted medicines, a stem cell transplant or less intensive treatment. Your team will let you know what they recommend for you.

If this is not suitable for you, or does not work, they will talk to you about your treatment options.

If your AML does not respond to treatment, this is known as refractory AML. We have more information about relapsed and refractory AML.

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