Ibrutinib

Ibrutinib 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.

Ibrutinib is a common treatment for CLL that has been used successfully in the UK since 2017. The brand name for ibrutinib is Imbruvica.

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

• You have genetic changes in your CLL cells called del17p or TP53 mutation or
• You have already had at least one previous treatment for CLL

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

• Checks of your heart health
• Blood tests to check your white blood cell count, kidney function and liver function
• Blood tests to check whether you have any infections that could flare up during treatment, such as viral hepatitis
• Your team may recommend other tests, depending on your circumstances

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

Things to tell your haematology team

Some medicines, supplements and food may interact with ibrutinib. It is important to tell your haematology team about any medicines 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 prevent blood clots, like warfarin
• Some antibiotic, antifungal and antiviral medicines
• Some medicines used to treat epilepsy
• Some medicines used to treat high blood pressure or heart problems
• Some medicines used to treat depression or obsessive-compulsive disorder
• Some cancer medicines
• Some anti-sickness medicines used alongside chemotherapy

Ibrutinib tablets contain lactose. Tell your haematology team if you are lactose intolerant.

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Ibrutinib comes as tablets you take by mouth.

• Swallow your ibrutinib tablets whole with a glass of water.
• Do not break or chew your tablets.
• Try to take ibrutinib at about the same time every day, if you can.
• Avoid grapefruit or bitter oranges (Seville oranges), including the fruit, fruit juice or supplements containing them. This is because they affect how much ibrutinib your body absorbs.
• Do not take supplements containing St John’s Wort while taking ibrutinib. This is because it affects how much ibrutinib your body absorbs.
• If you also take medicines called digoxin or methotrexate, you should take these at least 6 hours before or after taking your ibrutinib.

If you miss a dose

If you forget to take ibrutinib:

• Take it as soon as you remember on the same day
• If it’s the next day by the time you realise you forgot to take it:
  • Skip the missed dose
  • Take your next dose at the usual time

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Ibrutinib comes as tablets containing 140mg, 280mg, 420mg or 560mg of ibrutinib. The number of tablets you need to take depends on the dose and strength of the tablets. This should be printed on the medicine packaging. If you are not sure, ask your doctor or nurse.

Most adults with CLL take 420mg of ibrutinib once a day. Your haematology team may suggest a higher or lower dose if needed. They will tell you what dose they recommend for you.

• If you have liver or kidney problems, you usually have a lower dose.
• If you are taking some other medicines, you might also have a lower dose.

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

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Most people carry on taking ibrutinib for as long as it is working. Your haematology team may suggest stopping ibrutinib 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, liver or kidneys
• You become pregnant

Rarely, stopping ibrutinib may lead to a ruptured spleen. Your haematology team will monitor this by feeling your tummy and doing ultrasound scans.

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Your haematology team will monitor you to check how well ibrutinib is working and how well your body is coping with it.

• You’ll have regular blood tests to check your blood cell counts
• You’ll also have blood tests to check how well your liver and kidneys are 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 ibrutinib.

• Ibrutinib can make you vulnerable to infections. You might need to take medicines to prevent infections while taking ibrutinib.
• You should avoid eating grapefruit. This includes the fruit, fruit juice, or foods or supplements containing them.
• You should avoid eating bitter oranges (Seville oranges). This includes the fruit, bitter orange juice or food made with bitter oranges, like marmalade.
• If you need surgery or to have a tooth out, you’ll need to stop ibrutinib 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 ibrutinib and when to start it again.
• Ibrutinib might make you feel tired, dizzy or weak. This might affect your ability to drive or operate machinery.

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We do not know what effect ibrutinib has on fertility or pregnancy. Based on animal studies, it may harm unborn babies, especially during the early stages of pregnancy.

• If you could get pregnant, it’s important to use effective contraception while you are taking ibrutinib and for up to 3 months after you stop.
• If you’re taking ibrutinib and you think you might be pregnant, tell your haematology team as soon as possible.
• If you are 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 ibrutinib passes into breastmilk or what effect it might have on breastfed babies or children.

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You may get some side effects while you are taking ibrutinib. 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.

If you are worried about any symptoms or side effects, contact your haematology team. You do not have to wait until your next appointment.

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 ibrutinib if your side effects are serious or difficult to cope with
• Recommend pausing or stopping ibrutinib, if needed

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This is not a full list of all the side effects that can happen. The patient information leaflet in your medicine package has more information. Or you can find the leaflet in the Electronic Medicines Compendium.

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

• 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
• 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, indigestion or heartburn. 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 or muscle spasms.
• Swollen hands, feet or ankles.
• Changes to your skin and nails. You might get a rash, redness, hives, skin infection or brittle nails. This might look different in black or brown skin.
• Sore mouth or mouth ulcers.
• Headaches or dizziness.
• Weakness, pain or tingling in your hands or feet.
• Blurred vision.
• Lung problems. Ibrutinib can sometimes cause inflammation or scarring of the lungs. You may have symptoms like shortness of breath or a dry cough. If this happens, your doctor might stop ibrutinib for a while or adjust your dose.
• Heart problems. Contact your doctor if you get a fast or irregular heartbeat, chest pain, feel very breathless or lightheaded, or have swollen legs or ankles. They will check your heart function. If there are problems, they might suggest stopping ibrutinib.

Sepsis

Ibrutinib can cause a severe response to an infection called sepsis. In clinical trials, this happened to around 3 in every 100 people taking ibrutinib. So it did not happen to around 97 in every 100 people taking ibrutinib.

Sepsis is serious and needs prompt treatment.

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

• High blood pressure. If this happens, you might need blood pressure medicines.
• Low levels of white blood cells called neutrophils (neutropenia). This makes you more vulnerable to infections.
• Low levels of platelets (thrombocytopenia). This can cause unusual bruising and bleeding because platelets help your blood to clot. You might need a transfusion if your platelets fall below a safe level.
• Changes in the level of salts in your blood. This can be a sign of kidney problems.
• High levels of uric acid in your blood. This can cause gout.
• High levels of white blood cells. This might happen when you first start ibrutinib. Your white blood cells may go up before they come down again. It doesn’t mean your CLL is getting worse.

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Rarely, ibrutinib might cause serious side effects, including:

• Allergic reaction
• Stroke
• Immune system problems
• Heart problems

These affect less than 1 in every 100 people taking ibrutinib. So, they do not happen to more than 99 in every 100 people. However, if they happen, they can be serious, so it’s sensible to know what to look out for.

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If ibrutinib is not working well, 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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