Acalabrutinib

Acalabrutinib is a targeted medicine that blocks a protein called BTK. This protein helps CLL cells to grow and multiply. Blocking it stops CLL cells from growing and dividing, leading to their death.

The brand name for acalabrutinib is Calquence.

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Acalabrutinib is suitable for adults. Your haematology team might recommend it for you if:

• You have CLL and have not had treatment before and:
  • You have a genetic change in your CLL cells called a 17p deletion or TP53 mutation or
  • Other treatments are not suitable for you
• You have had treatment before, but your CLL didn’t respond to it or came back after treatment. This is called refractory or relapsed CLL.

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Before starting acalabrutinib, your haematology team will carry out checks to ensure it is suitable for you. These include:

• Blood tests to check your blood cell counts, kidney function and liver function
• Blood tests to check whether you have any infections that could flare up during treatment, like viral hepatitis
• Checks of your heart health

Your team may recommend other tests, depending on your circumstances.

Things to tell your haematology team

Your haematology team may ask if there is any possibility you might be pregnant. Acalabrutinib should not be taken during pregnancy.

Some medicines, supplements and food may interact with acalabrutinib. Or they may increase your risk of side effects. 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 blood thinners or medicines used to prevent blood clots, like warfarin
• Some medicines used to treat infections, including some antibiotics, antifungal and antiviral medicines
• Some medicines used to treat schizophrenia and other psychoses
• Some medicines that lower your immune system
• Some medicines used to treat diabetes
• Some medicines used to treat epilepsy
• Theophylline, a medicine sometimes used to treat asthma, chronic lung disease or heart failure

Acalabrutinib tablets contain several ingredients. Tell your haematology team if you have any allergies or sensitivities.

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Acalabrutinib comes as orange, oval-shaped tablets that you take by mouth.

• Swallow your acalabrutinib tablet whole with a glass of water.
• Do not break, crush, or chew your tablets and do not dissolve them in water.
• Try to take your tablet at about the same time each day.
• You can take your tablet with or without food.
• Do not take supplements containing St John’s Wort while taking acalabrutinib. This is because it affects how much acalabrutinib your body absorbs.
• If you also take a medicine called methotrexate, you should take this at least 6 hours before or after taking acalabrutinib.

If you forget to take your tablets

If you forget to take acalabrutinib:

• Take it as soon as you remember, if it’s within 3 hours of your dose time
• If it’s longer than 3 hours by the time you realise you forgot to take it:
  • Skip the missed tablet
  • Take your next tablet at the usual time

Acalabrutinib comes as tablets containing 100mg of acalabrutinib. The number of tablets you need to take and how often should be printed on the medicine packaging. If you are not sure, ask your doctor or nurse.

Most adults with CLL take one tablet of acalabrutinib twice a day. You usually leave around 12 hours between each dose. Try and take it at the same time in the morning and in the evening.

Acalabrutinib comes in a blister pack with pictures on each blister to help you take your dose at the right time. There’s a sun for your morning dose and a moon for your evening dose.

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You take acalabrutinib at home (or anywhere you are staying). You do not have to go to hospital to take it.

You can store acalabrutinib at room temperature. Keep it safe where children cannot see or reach it.

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Most people carry on taking acalabrutinib for as long as it is working. Your haematology team may suggest stopping acalabrutinib 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
• Check-ups show it is affecting other parts of your body, like your heart, lungs or liver
• You become pregnant

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Your haematology team will check how well acalabrutinib is working and how well your body is coping with it.

• You’ll have blood tests to check your blood cell counts.
• You’ll also have occasional blood tests to check how well your liver is working.
• You’ll have regular blood pressure checks.
• Your doctor or nurse will examine you to check for heart or lung problems, signs of infection, and changes in your skin.
• You may have other examinations and scans to check the size of your lymph nodes and organs, like your spleen.

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There are some precautions to be aware of when you are taking acalabrutinib.

• If you need surgery or to have a tooth out, you’ll need to stop acalabrutinib for a few days before and after. This is to reduce your risk of bleeding. Your doctor will tell you exactly when to stop taking acalabrutinib and when to start it again.
• Acalabrutinib can make you vulnerable to serious infections. You might need to take medicines to prevent infections while taking acalabrutinib.
• Acalabrutinib might make you feel very tired or dizzy. You should not drive or operate machinery if you have these symptoms.
• If you’ve had viral hepatitis in the past, it might flare up during acalabrutinib treatment. You’ll have a blood test before you start treatment. If this shows you’ve had viral hepatitis, your team will monitor you for flare-ups. You might be referred to a liver specialist for treatment.

We do not know what effect acalabrutinib has on fertility or pregnancy. Based on animal studies, it may harm unborn babies, especially during the later stages of pregnancy and during labour and birth.

• If you could get pregnant, it’s important to use effective contraception while you are taking acalabrutinib.
• If you’re taking acalabrutinib and you think you might be pregnant, tell your haematology team as soon as possible.
• If you’re planning to get pregnant in the future, tell your haematology team. They will talk to you about your treatment options.

Breastfeeding

We do not know if acalabrutinib passes into breastmilk or what effect it might have on breastfed babies or children.

You may get some side effects while you are taking acalabrutinib. Some people have very few side effects, whereas others get more serious side effects. They may differ from day to day.

Your haematology team should tell you what side effects to look out for and who to contact if you need to.

Your haematology team might:

• Prescribe medicines to help manage some side effects
• Suggest things you can do to help you cope with side effects
• Lower your dose of acalabrutinib if your side effects are serious or difficult to cope with
• Recommend pausing or stopping acalabrutinib, if needed

You can also report side effects via the MHRA Yellow Card Scheme.

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Here, we list some of the more common side effects of acalabrutinib. These affect at least 1 in every 100 people who take acalabrutinib.

• Infections. Contact your team straight away if you think you have an infection. Look out for:
  • A high temperature (38°C or higher)
  • Shivering, chills or sweating
  • Sore throat, sneezing, blocked or runny nose or earache
  • Cough, chest pain or shortness of breath
  • Burning or stinging when you pee, or peeing more often than usual
  • Sickness or diarrhoea
  • Cold sores, or ulcers or blisters around your mouth or genitals
• Unexpected or unusual bruising or bleeding, like nosebleeds, bleeding gums or heavy periods. Look out for blood in your poo or pee, or red or purple spots under your skin. This may look different in black or brown skin. Tell your team if you notice any of these.
• Tummy problems. You might get diarrhoea, constipation, or tummy ache. You might feel sick or be sick. If you have these side effects, your team can give you medicines to help.
• Muscle, bone or joint pain. Talk to your team if this becomes troublesome.
• Changes to your skin. You might get a rash. This might look different on black or brown skin.
• Headache. This is common in the first weeks of taking acalabrutinib and usually gets better with time.
• Fatigue. You might experience extreme tiredness or lack of energy.
• Heart problems. Contact your doctor if you get a fast or irregular heartbeat or a heart flutter. They will check your heart function. If there are problems, they might suggest stopping acalabrutinib.

There might be some side effects that your haematology team find during regular checks and blood tests. These include:

• Low levels of white blood cells (leukopenia), including low levels of white blood cells called neutrophils (neutropenia). This can make you more vulnerable to infections. You might need treatment to prevent or treat infections. Or growth factors to boost your production of white blood cells.
• Low levels of red blood cells (anaemia).
• Low levels of platelets (thrombocytopenia). This can cause unusual bruising and bleeding because platelets help your blood to clot. You might need to have a transfusion.
• High blood pressure. If this happens, you might need to take blood pressure medicines.

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Rarely, acalabrutinib might cause a side effect called tumour lysis syndrome. This is a serious side effect of some cancer treatments. It happens if a large number of cancer cells die quickly and release chemicals into your bloodstream.

This affects fewer than 1 in every 100 people taking acalabrutinib. So, it does not happen to more than 99 in every 100 people. However, if it does happen, it can be serious, so it’s sensible to know what to look out for.

If acalabrutinib is not working well for you, your doctor will discuss your options with you. They might suggest changing your dose, pausing or stopping treatment. They will talk to you about other treatment options that might be suitable for you.

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