Nilotinib (Tasigna ®)
Nilotinib, which is also known as Tasigna®, may be used to treat some people with chronic myeloid leukaemia (CML).
This page describes nilotinib, how it’s taken and some of the possible side effects. It should ideally be read with our general information about chronic myeloid leukaemia (CML).
Nilotinib is a type of treatment called a tyrosine kinase inhibitor. Kinases are important proteins in the body that regulate how the cells grow and divide.
Nilotinib works by blocking (inhibiting) signals within the leukaemia cells that make them grow and divide. Blocking the signals causes the cells to die.
When nilotinib is used
Back to top
Nilotinib is licensed as a treatment for people with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML). It can be used to treat people who are newly diagnosed, or those for whom imatinib (Glivec®) is no longer working and who are in the chronic or accelerated phases of their leukaemia. Nilotinib may also be used when side effects of imatinib are too severe.
The National Institute for Health and Clinical Excellence (NICE) currently gives advice on which new drugs or treatments should be available on the NHS in England and Wales. The Scottish Medicines Consortium (SMC) makes recommendations on the use of new drugs within the NHS in Scotland.
NICE and the SMC both recommend nilotinib as a possible treatment for people with newly diagnosed CML. They also both recommend its use for people who have previously been treated with imatinib, although the SMC only recommend its use in the chronic phase.
If nilotinib isn’t recommended for you, it may not be available on the NHS, although you may be given it as part of a clinical trial. We can give you more information on what you can do if a treatment isn’t available.
What nilotinib looks like
Back to top
Nilotinib is hard capsule. It comes in two strengths: 150mg, which is red, and 200mg which is pale yellow.
How nilotinib is taken
Back to top
The capsules are taken on an empty stomach with a large glass of water. It’s important you don’t eat for two hours before or for one hour after taking nilotinib, as this may increase the side effects. Nilotinib is usually taken twice a day, with 12 hours between each dose.
If you have trouble swallowing capsules, the contents of each capsule can be mixed with a teaspoon of puréed apple and taken immediately. It’s important that no more than one teaspoon of apple sauce, and no food other than apple sauce, is used.
It’s also important that you don’t drink grapefruit juice or eat grapefruit while you're taking nilotinib as this can increase the side effects.
Nilotinib is a long-term treatment and you should carry on taking it for as long as your specialist doctor (haematologist) tells you. You'll have regular blood tests to see how well it’s working for you.
Possible side effects of nilotinib
Back to top
Each person’s reaction to treatment is different. Some people have very few side effects while others may experience more. The side effects of nilotinib are generally mild or moderate.
We have outlined the most common side effects here but haven't included those that are rare and therefore unlikely to affect you. As it’s still a new drug, it’s too early to know everything about the possible side effects.
If you notice any effects that you think may be because of the drug, but are not listed here, let your nurse or doctor know. This is particularly important if the problem is putting you off taking nilotinib.
Risk of infection
Nilotinib can reduce the number of white blood cells in your blood, which help fight infection. White blood cells are produced by the bone marrow. If your number of white blood cells is low, you will be more prone to infections. A low white blood cell count is called neutropenia.
Contact your doctor straight away if:
your temperature goes above 38°C (100.4°F)
you suddenly feel unwell, even with a normal temperature.
You'll have a blood test before having more treatment to make sure that your blood cells have recovered. Occasionally, it may be necessary to delay your treatment if the number of your blood cells (blood count) is still low.
Bruising or bleeding
Nilotinib can reduce the production of platelets, which help the blood to clot. Tell your doctor if you have any unexplained bruising or bleeding, such as nosebleeds, bleeding gums, blood spots or rashes on the skin. You may need to have a platelet transfusion if your platelet count is low.
Anaemia (low number of red blood cells)
Nilotinib can reduce number of red blood cells, which carry oxygen around the body. A low red blood cell count is called anaemia. This may make you feel tired and breathless. Tell your doctor or nurse if you have these symptoms. You may need to have a blood transfusion if umber of red blood cells becomes too low.
Feeling sick (nausea) or being sick (vomiting)
This effect is usually mild. Your doctor can prescribe anti-sickness (anti-emetic) drugs to prevent, or greatly reduce, nausea or vomiting. If the sickness isn't controlled, or if it continues, tell your doctor. They can prescribe other anti-sickness drugs that may be more effective.
Some anti-sickness drugs can cause constipation. Let your doctor or nurse know if this is a problem.
Loss of appetite
Some people lose their appetite while they’re having nilotinib. This can be mild and may only last a few days. If it doesn’t improve, you can ask to see a dietitian or specialist nurse at your hospital. They can give you advice on improving your appetite and keeping to a healthy weight.
Some people find that nilotinib causes headaches. Let your doctor or nurse know if this happens to you. They can give you painkillers to relieve it.
Fatigue is common but usually mild. It’s important to try to pace yourself and get as much rest as you need. Try to balance this with taking some gentle exercise such as short walks, which will help.
Your skin may become dry and itchy or you may develop a mild skin rash. Making sure you drink enough fluids can help. Your doctor can also prescribe medicine or creams to help with this.
Some people may feel light-headed or as if they’re going to lose their balance. If this happens, be careful not to move too quickly.
This can usually be easily controlled with medicine, but tell your doctor if it's severe or continues. It's important to drink plenty of fluids if you have diarrhoea.
You may get constipated. This can usually be helped by drinking plenty of fluids, eating more fibre in your diet and doing some gentle exercise. You may need to take medicine (laxatives) to help. Your doctor can prescribe these or you can buy them at a pharmacy.
Changes in the way your liver or kidneys work
You'll have regular blood tests to check how well your liver and kidneys are working.
Tummy (abdominal) pain
Some people have pain or discomfort in their tummy when taking nilotinib.
Changes to the heart
A small number of people taking nilotinib develop a change in their heart rhythm. Heart beats may become less regular or the heart may feel as if it's beating too fast. If you notice any changes in your heart rhythm or pain in your chest, let your doctor know straight away.
Some people may have an increase in their blood pressure while taking nilotinib.
Muscle and bone pain
You may have muscle, joint or bone pain while having treatment. Your doctor can prescribe painkillers to ease this.
Fluid build-up can affect different parts of the body. Most commonly, it causes swelling of the ankles or swelling around the eyes. Drugs that make you pass more urine (diuretics) can help to get rid of some of the fluid. A short course of steroids may also be helpful. Usually, fluid retention settles without treatment.
Sometimes, fluid may collect in the lining of the lungs, which is known as pleural effusion. Rarely, fluid collects in the tummy area, called ascites, or in the sac around the heart, called pericardial effusion.
If you develop a cough, have chest pain, are feeling more breathless than usual or gain weight suddenly, let your doctor know straight away. It’s also important to let your doctor know immediately if you feel unwell or have any severe side effects, even if they’re not mentioned above.
Back to top
Some medicines, including those that you can buy in a shop or chemist, can be harmful to take when you are having nilotinib. Tell your doctor about any medicines you are taking, including over-the-counter drugs, complementary therapies and herbal drugs.
Your ability to become pregnant or father a child may be affected by having this treatment. It's important to discuss fertility with your doctor before starting treatment.
It's not advisable to become pregnant or father a child while taking nilotinib, as it may harm the developing baby. It’s important to use effective contraception while taking this drug, and for at least a few months afterwards. You can discuss this with your doctor or nurse.
It’s not known whether nilotinib is present in semen or vaginal fluids. To protect your partner, it’s safest to either avoid sex or use a barrier form of contraception for about 48 hours after treatment.
There is a potential risk that nilotinib may be present in breast milk, so women are advised not to breastfeed while taking nilotinib and for a few months afterwards.
If you’re admitted to hospital for a reason not related to the cancer, it’s important to tell the doctors and nurses looking after you that you are having nilotinib treatment. You should tell them the name of your cancer specialist so that they can ask for advice.
It’s a good idea to know who you should contact if you have any problems or troublesome side effects when you’re at home. During office hours, you can contact the clinic or ward where you had your treatment. Your specialist nurse or doctor will tell you who to contact during the evening or at weekends.
Things to remember about nilotinib capsules
Back to top
It’s important to take your capsules as directed by your doctor.
Always tell any doctors treating you for non-cancerous conditions that you are taking a course of nilotinib tablets that should not be stopped or restarted without advice from your cancer specialist.
Keep the tablets in the original packaging and store them at room temperature away from heat and direct sunlight.
Keep the tablets in a safe place, out of the reach of children.
If your doctor decides to stop the treatment, return any capsules you have to the pharmacist. Don't flush them down the toilet or throw them away.
If you forget to take a capsule, don’t take a double dose. Tell your doctor and keep to your regular dose schedule.
This information has been compiled using information from a number of sources, including:
British Medical Association and Royal Pharmaceutical Society of Great Britain.British National Formulary. 63rd edition. 2012. British Medical Association and Royal Pharmaceutical Society of Great Britain.
electronic Medicines Compendium (eMC). www.medicines.org.uk (accessed October 2012).
National Institute for Health and Clinical Excellence (NICE). Dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia (CML), and dasatinib and nilotinib for people with CML for whom treatment with imatinib has failed because of intolerance (TA241). January 2012. National Institute for Health and Clinical Excellence (NICE).
National Institute for Health and Clinical Excellence (NICE). Dasatinib, nilotinib and standard-dose imatinib and for the first-line treatment of chronic myeloid leukaemia (CML) (TA251). April 2012. National Institute for Health and Clinical Excellence (NICE).
Scottish Medicines Consortium (SMC). Advice on 709/11 – Nilotinib (Tasigna). August 2011. Scottish Medicines Consortium (SMC).
Scottish Medicines Consortium (SMC). Advice on 440/08 – Nilotinib (Tasigna). June 2008. Scottish Medicines Consortium (SMC).
With thanks to Helen Flint, Clinical Lead Pharmacist, and the people affected by cancer who reviewed this edition. Reviewing information is just one of the ways you could help when join our Cancer Voices network.