Dasatinib

Dasatinib is a type of medicine called a tyrosine kinase inhibitor (TKI). It blocks an abnormal protein called BCR-ABL1, which is a type of tyrosine kinase. This abnormal protein is present in people with CML. It encourages the blood-forming cells in your bone marrow to make too many white blood cells. Blocking the protein helps stop the leukaemia cells from multiplying.

There are several different brands of dasatinib, but they all contain the same active medicine. Brand names include:

• Dasatinib Sandoz
• Dasatinib Zentiva
• Sprycel

Dasatinib is a common treatment for CML suitable for adults and children. Your haematology team might recommend it for you if:

• You have just been diagnosed with CML
• You have chronic or accelerated phase CML and previous treatment, including imatinib, either:
  • Did not work
  • Stopped working
  • Caused side effects that were difficult to cope with

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Before starting your course of dasatinib, your haematology team will carry out checks to make sure it’s suitable for you. These include:

• Checks of your heart health, like taking pulse and blood pressure measurements, and an electrocardiogram (ECG). Dasatinib may not be suitable if you have heart problems.
• Blood tests to measure the level of fats and sugars in your blood.
• Blood tests to check for viruses like HIV or hepatitis B. Dasatinib can reactivate hepatitis B infection, so if you have it you may need to take an antiviral treatment to prevent this.

They will also check to see if you have any medical conditions such as diabetes, lung diseases or liver problems.

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Dasatinib comes as film-coated tablets in a number of different strengths. The number of tablets you need to take depends on your dose and the strength of the tablets. This should be printed on the named label on the medicine packaging. If you are not sure, ask your doctor or nurse.

• You should take dasatinib every day as prescribed so it can work as well as possible. Try and take it at the same time every day if you can.
• Swallow your dasatinib tablets whole with a large glass of water. You can take it with or without food.
• Do not take dasatinib with grapefruit or grapefruit juice because this affects how much of it your body absorbs.
• Do not cut, crush, chew or dissolve the tablets because this can alter the dose you absorb into your body.
• If you forget to take your dasatinib tablet, skip the missed tablet and take your next dose at the normal time. It is important not to take a double dose.

Dasatinib also comes as a powder that can be dissolved in water. This is usually used for children. It is also an option for adults who cannot swallow tablets.

Dose

Most adults with CML start on 100mg dasatinib daily in the chronic phase or 140mg daily in the blast phase. Your haematology team might increase or decrease your dose depending on your circumstances. They may start you on a lower dose if they are worried about side effects. They will tell you what dose they recommend for you.

• People over 65 and those with liver or kidney problems can usually have the same starting dose as other people.
• Doses for children are based on their body weight.

You take dasatinib once a day.

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Some medicines may interact with dasatinib. 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:

• Some medicines used to treat infections
• Some medicines used to treat epilepsy
• Antacids and other medicines that reduce stomach acid, such as omeprazole
• Herbal medicines such as St John’s Wort
• Medicines to prevent blood clots, like aspirin or warfarin
• Grapefruit or grapefruit juice

Dasatinib may make you feel dizzy or drowsy or cause blurred vision. Take care if you are driving or using tools or machinery.

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Dasatinib may harm unborn babies.

• If you could get pregnant or make someone pregnant, it is important to use effective contraception while you are taking dasatinib.
• If you are taking dasatinib and you think you might be pregnant, tell your haematology team as soon as possible. They will talk to you about your treatment options. They may recommend stopping treatment for a while or switching to a different treatment.
• If you are planning to get pregnant in the future, tell your haematology team. They will talk to you about your treatment options.

Breastfeeding

Scientists think dasatinib probably passes into breastmilk, which could be a risk to breastfed babies or children. You should not breastfeed while you are taking dasatinib.

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During your treatment with dasatinib, you will have regular tests to check how well your CML is responding to treatment. These will usually be blood tests and sometimes bone marrow tests.

You are likely to have blood tests every week or two for the first few months of treatment. If you respond well and your body is coping with the treatment, this might reduce to every 3 months.

Monitoring your response to treatment

Tests to monitor how well your CML is responding to dasatinib look at:

• Your blood cell counts.
• The level of the BCR-ABL1 fusion gene in your white blood cells. This is called ‘molecular response’.

Your haematology team will use the results of these tests to check how well dasatinib is working for you.

Monitoring your body’s response to dasatinib

Your haematology team will also check how well your body is coping with dasatinib treatment. This might include:

• Blood tests to check your blood counts. Dasatinib can cause low red blood cell counts, white blood cell counts and platelet counts. Your haematology team will monitor this carefully. They may reduce your dose, or stop dasatinib for a while until your blood counts improve.
• Blood tests to check how well your liver, kidneys, pancreas and thyroid are working.
• Blood pressure checks. Dasatinib can increase your blood pressure. If this happens, your doctor might prescribe blood pressure medications. If your blood pressure is very high, you may need to stop taking dasatinib for a while.
• ECG checks and blood tests to check your heart health.
• Blood tests to check your blood sugar and fat.

Long term follow-up

Once you have reached a response to treatment, your haematology team will make a follow-up care plan for you. You will have regular follow-up appointments to check for any signs of relapse or complications.

It is important to go to your follow-up appointments. This is so your team can check how well your treatment is working and how your body is coping. You are likely to have blood tests every few months, and possibly a bone marrow test if you lose response.

Your follow-up appointments will continue in the long term. How often you have appointments will depend on your individual needs - for example, any support you need to manage ongoing side effects.

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Most people carry on taking dasatinib for as long as it is working. Your haematology team may suggest stopping dasatinib and trying a different treatment if:

• It is not working well
• It stops working
• You are having side effects that are difficult to cope with

Your haematology team might also discuss reducing your dose, or stopping treatment completely.

Reducing your dasatinib dose

Your haematology team might suggest reducing your dose of dasatinib if you are getting difficult side effects or you are in a major molecular response.

They will monitor your treatment response closely after reducing your dose. If you lose your response, they might slowly increase the dose until you reach a response again. The aim is to find the lowest dose that works for you. This keeps your risk of side effects as low as possible.

Stopping dasatinib

Your haematology team might discuss stopping dasatinib completely if:

• You have been taking it for at least 3 years (ideally 5 years) AND
• Your CML has been in DMR (MR4 or MR5) for at least 2 years

This is called treatment-free remission. Your haematology team will talk to you about the benefits and risks of treatment-free remission, so you can decide if it’s something you would like to try.

We have separate information about treatment-free remission.

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You may get some side effects while you are taking dasatinib. For most people, these side effects are usually mild to moderate. They may differ from day to day.

Some people have very few side effects, whereas other people experience more serious side effects.

The possible side effects of dasatinib are very similar to those with other TKIs. Some are more common, and some less common. Most people with CML need to take one of the TKIs. Your haematology team should tell you about the likelihood of key side effects with different medications.

If you are getting side effects that are difficult to cope with, your haematology team might suggest reducing your dose of dasatinib. They may then try slowly increasing it to find a dose that works for you.

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• Unexpected bruising or bleeding. Your levels of platelets may be low. Your haematology team may stop dasatinib and give you blood transfusions. Signs of bleeding can include:
  • Nosebleeds
  • Bleeding gums
  • Blood spots or rashes
  • Blood in your wee, poo or vomit, or black poo
• Infections. This may be due to a low white blood cell count, which means you cannot fight infections as well as usual. If you get an infection, you need prompt treatment and you may need to stop dasatinib treatment for a while. Signs of infection include:
  • High temperature over 37.5°C or severe chills
  • Sore throat
  • Cough
  • Pain when you wee or weeing more often than usual
  • Diarrhoea
  • Feeling very tired or short of breath – your level of red blood cells may be low.
• Chest pain, difficulty breathing or sweating a lot – you may have developed a heart problem. Your doctor will assess you. They may stop dasatinib treatment.
• Rapid weight gain or swelling in most of your body. This is because dasatinib can cause your body to retain water. Medicines called diuretics can help treat water retention.
• Shortness of breath or cough - you may have fluid on your lungs. You may have a chest X-ray and maybe a short course of steroids. Your dasatinib might need to be stopped, or your dose reduced.
• Fainting or seizures (fits), which could be due to an abnormal heart rhythm.
• Any other unusual or worrying symptom.

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

Very common side effects include:

• Infections
• Headache
• Feeling tired or weak
• Bleeding
• Shortness of breath due to a build-up of fluid around your lungs
• Feeling sick or being sick
• Diarrhoea – if this affects you badly, your doctor might prescribe antidiarrhoeal medicine
• Tummy pain
• Skin rash
• Muscle or bone pain
• Swelling in your face or limbs due to a build-up of fluid
• High temperature
• Low blood counts

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

Common side effects include:

• Change in appetite
• Depression
• Blurred vision or dry eyes
• Ringing in your ears
• Difficulty sleeping
• Feeling dizzy or drowsy
• Tingling, numbness or other changes in your sense of touch
• Changes in taste
• Heart problems, including palpitations, a change in your heart rhythm or a fast heart rate
• Cough, lung inflammation or fluid on your lungs
• Bleeding from your gut
• Inflammation of your mouth, stomach or large bowel
• Indigestion
• Bloating
• Constipation
• Hair loss
• Dry, red, itchy skin, hives or acne
• Excessive sweating
• Joint and muscle pain, weakness, spasms or stiffness
• Feeling generally weak
• Pain, including chest pain
• General swelling of your body due to fluid retention
• Chills
• Change in weight
• Bruising
• High level of uric acid in your blood

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If dasatinib hasn’t worked, or has stopped working for you, there are lots of other options. These include:

• Increasing your dose of dasatinib.
• A different TKI. All TKIs work in slightly different ways. If your CML does not respond to dasatinib, it might still respond to a different one. Some people try several different TKIs.
• A stem cell transplant using donor cells. This is called an allogeneic stem cell transplant.

Your haematology team will tell you which option they recommend for you.

We have separate information about:

• Second- and later-line treatments for CML
• Stem cell transplants

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