Nilotinib (Tasigna)

Nilotinib is pronounced nil-ot-in-ib and is also known by its brand name Tasigna. It is a type of biological therapy called a protein tyrosine kinase inhibitor (TKI). It treats chronic myeloid leukaemia (CML). Tyrosine kinases are proteins that act as chemical messengers (enzymes). They stimulate cancer cells to grow. There are a number of different tyrosine kinases.

Nilotinib blocks a tyrosine kinase protein called Bcr-Abl. The protein is made by chronic myeloid leukaemia cells that have an abnormal chromosome called the Philadelphia chromosome. Blocking this protein stops the leukaemia cells growing. 95 out of 100 people with CML (95%) have the Philadelphia chromosome.

Nilotinib is a tablet. You usually take 2 tablets twice a day, 12 hours apart. You should not take them with food. You need to take them at least 2 hours before you eat and at least 1 hour after eating. Swallow them whole with a glass of water.

It is very important that you take tablets according to the instructions your doctor or pharmacist gave you. Whether you have a full or empty stomach, for example, can affect how much of a drug gets into your bloodstream. You should take the right dose, not more or less. And never stop taking a cancer drug without talking to your specialist first.

You usually carry on taking nilotinib for as long as it works.

The side effects associated with nilotinib are listed below. Remember that most people only have a few of them and they may be mild.

More than 10 in every 100 people have one or more of the side effects listed below.

Temporary drop in the number of blood cells made by the bone marrow, causing

• Increased risk of getting an infection from a drop in white blood cells – it is harder to fight infections and you can become very ill. You may have headaches, aching muscles, a cough, sore throat, pain passing urine or feel cold and shivery
• Tiredness and breathlessness due to a drop in red blood cells (anaemia) – you may need a blood transfusion
• Bruising more easily due to a drop in platelets – you may have nosebleeds, bleeding gums after brushing your teeth, or lots of tiny red spots or bruises on your arms or legs (known as petechia)

Some of these side effects can be life threatening, particularly infections. You should contact your doctor if you have any of these effects. Your doctor or nurse will check your blood counts regularly to see how well your bone marrow is working.

Other common side effects include

• Skin changes in just over 2 out of 10 people (20%), including a rash or red, dry, itchy skin – this can be difficult to cope with so tell your doctor or nurse if you have it
• Feeling or being sick happens in about 2 out of every 10 people (20%) but is usually well controlled with anti sickness drugs
• Tiredness (fatigue) affects just under 2 in 10 people (20%) during and after treatment – most people find their energy levels are back to normal within 6 months to a year
• Headaches affect just over 1 in 10 people (10%)
• Diarrhoea affects 1 out of 10 people (10%) – drink plenty of fluid and tell your doctor if diarrhoea gets severe, or continues for more than 3 days
• Constipation in 1 out of 10 people (10%) – your doctor or nurse may give you laxatives to help prevent this but do tell them if you are constipated for more than 3 days
• Shortness of breath and a cough
• Loss of fertility – we don’t know exactly how this drug may affect fertility so do talk to your doctor before starting treatment if having a baby is important to you
• We don’t know whether nilotinib can harm a developing baby – do talk to your doctor about contraception before having treatment if there is any chance that you or your partner could become pregnant

Between 1 and 10 in every 100 people have one or more of these.

• Eye problems – these include blurred vision, dry eyes and inflammation of the surface of the eye
• Skin flushing
• Aching joints
• Indigestion
• Dizziness
• Fluid build up in the body (including your legs, face or around your organs) – you may need to take tablets to reduce the amount of fluid
• Numbness in fingers and toes can cause difficulty with fiddly things such as doing up buttons – this starts within a few days or weeks and usually goes within a few months of finishing treatment
• Liver changes that are very mild and unlikely to cause symptoms – the liver will almost certainly go back to normal when treatment finishes, but you will have regular blood tests to check how well your liver is working
• Kidney changes that are mild and unlikely to cause symptoms may occur – they will almost certainly go back to normal when treatment ends, but you will have regular blood tests to check how well your kidneys are working
• Weakness

A few people have heart problems including chest pain or palpitations – you must contact your doctor as soon as possible if you have any pain.

You will not get all these side effects and they may be mild. A side effect may get worse through your course of treatment. Or you may have more side effects as the course goes on. This depends on

• How many times you've had a drug before
• Your general health
• How much of the drug you have (the dose)
• Other drugs you are having

Talk to your doctor, pharmacist or nurse about all your side effects so they can help you manage them. Your chemotherapy nurse, clinic or ward nurse will give you a contact number. You can ring if you have any questions or problems. They can give you advice or reassure you. If in doubt, call them.

Tell your doctor, nurse or pharmacist about any other medicines you are taking, including vitamins, herbal supplements and other over the counter remedies. Some drugs can increase the levels of nilotinib in the body – these include some anti fungal medicines and antibiotics. Grapefruit juice can also increase nilotinib levels so it is important to avoid this while you are having nilotinib treatment.

Some drugs and herbal products can lower the levels of nilotinib – these include some antibiotics, some anti epileptic drugs, and some herbal products such as St. John's Wort.

You should not have immunisations with live vaccines while you are having this treatment or for at least 6 months afterwards. In the UK, these include rubella, mumps, measles (usually given together as MMR), BCG and yellow fever. You can have other vaccines, but they may not give you as much protection as usual until your immune system has fully recovered.

It is safe for you to be in contact with other people who've had live vaccines as injections. There can be problems with oral vaccines, but not many people in the UK have oral vaccines now. So there is usually no problem in being with any baby or child who has recently had any vaccination in the UK. You might need to make sure that you aren't in contact with anyone who has had oral polio, cholera or typhoid vaccination recently, particularly if you live abroad.