Nilotinib (Tasigna)

Nilotinib is a type of targeted cancer drug. It is also known as Tasigna. It is a treatment for chronic myeloid leukaemia (CML).

You might have nilotinib:

• as a first treatment for chronic phase CML if you can’t have imatinib

• if other treatment such as imatinib doesn't work, stops working or is causing difficult side effects

How does nilotinib work?

Nilotinib is a type of targeted cancer drug called a tyrosine kinase inhibitor (TKI). Tyrosine kinases are proteins that act as chemical messengers and can stimulate cancer cells to grow.

Nilotinib blocks a tyrosine kinase protein called BCR-ABL. The protein is made by CML cells that have an abnormal chromosome called the Philadelphia chromosome . Blocking this protein stops the leukaemia cells that have the Philadelphia chromosome growing. Most people with CML have the Philadelphia chromosome.

How do you take nilotinib?

You take nilotinib as capsules.

You swallow the capsules whole with water. You take nilotinib on an empty stomach. This means taking your capsules at least 2 hours before a meal and you not eating for 1 hour after.  

If you can't swallow the capsules, you can mix the powder from the capsule with a teaspoon of apple sauce. You need to swallow it immediately and don't use any food other than apple sauce. 

Whether you have a full or empty stomach can affect how much of a drug gets into your bloodstream.

You should take the right dose, not more or less.

Talk to your healthcare team before you stop taking a cancer drug, or if you have missed a dose.

How often do you have nilotinib?

You take nilotinib twice a day about 12 hours apart.

You take nilotinib for as long as it is working and you are not experiencing too many side effects.

Your doctor may stop nilotinib if your CML has been very well controlled for a number of years.

Tests

You have blood tests before and during your treatment. They check your levels of blood cells and other substances in the blood. They also check how well your liver and kidneys are working.

Before treatment starts you may have a blood test to check for viruses such as hepatitis B, hepatitis C, and HIV . This is called a viral screen.

It’s important for your doctor to know if you have had any of these viruses. This is because this treatment can weaken your immune system and can cause the virus to become active again (reactivation). 

You also have an ECG before you start this treatment, and regularly while you have treatment.

What are the side effects of nilotinib?

Side effects can vary from person to person. They also depend on what other treatments you're having. 

When to contact your team

Your doctor, nurse or pharmacist will go through the possible side effects. They will monitor you during treatment and check how you are at your appointments. Contact your advice line as soon as possible if:

• you have severe side effects 

• your side effects aren’t getting any better

• your side effects are getting worse

Early treatment can help manage side effects better. 

We haven't listed all the side effects here. Talk to your healthcare team if you have any new symptoms that you think might be a side effect of your treatment.

Remember it is very unlikely that you will have all of these side effects. But you might have some of them at the same time.

Common side effects

These side effects happen in more than 10 in 100 people (more than 10%). You might have one or more of them. They include:

Skin problems 

Skin problems include a skin rash and itching. Less commonly nilotinib can make your skin dry, red, cracked, sore, and spotty.

Rarely your skin can have areas that feel thinner or thicker. You might develop cysts, lumps and have patchy areas where your skin is lighter or darker in colour. Your skin might also be more sensitive to light.

Let your doctor, nurse or pharmacist know of any skin changes. They can let you know what you can use to help.

Infection of the upper parts of the body involved in breathing

The upper part of your breathing system includes the mouth, nose, nose passages, throat and voice box.

There is a chance you can get an infection whilst on nilotinib to this part of the body. Symptoms can include a sore throat, runny or stuffy nose, sneezing, cough, high temperature, lack in energy and generally feeling unwell.

Let your healthcare team know if you have any of these symptoms

Headaches or migraines

Nilotinib can cause headaches. It can also cause a severe headache, often called a migraine, but this happens less often.

Tell your doctor or nurse so they can give you painkillers to help.

Liver changes

Nilotinib can cause liver changes. These are usually picked up on blood tests and are mild and unlikely to cause symptoms.

Rarely your liver might get bigger or stop working properly. This can cause symptoms such as yellowing of the skin and whites of the eyes, passing dark coloured urine or you might feel sick.

You have regular blood tests to check for any changes in the way your liver is working. Let your healthcare team know if you have any of these symptoms.

Pain, stiffness and swelling in different parts of the body

Nilotinib commonly causes pain in your muscles, joints, back and tummy (abdomen). It can also cause pain in other areas of the body such as your mouth, throat, chest and bones but this is less common.

Rarely your breasts can hurt. Your body may also feel stiff and you might have joint swelling.

Let your doctor or nurse know if you are in any pain so that they can give you painkillers.

Tiredness and weakness (fatigue)

Tiredness and weakness (fatigue) can happen during and after treatment. Doing gentle exercises each day can keep your energy up. Don't push yourself, rest when you start to feel tired and ask others for help.

Feeling or being sick

Feeling or being sick is usually well controlled with anti sickness medicines. It might help to avoid fatty or fried foods, eat small meals and snacks and take regular sips of water. Relaxation techniques might also help.

It is important to take anti sickness medicines as prescribed even if you don’t feel sick. It is easier to prevent sickness rather than treat it once it has started.

Bruising and bleeding

This is due to a drop in the number of platelets in your blood. These blood cells help the blood to clot when we cut ourselves. You may have nosebleeds or bleeding gums after brushing your teeth. Or you may have lots of tiny red spots or bruises on your arms or legs (known as petechiae).

Let you team know straight away if you have any of these symptoms.

Breathlessness and looking pale

You might be breathless and look pale due to a drop in red blood cells. This is called anaemia.

Hair thinning or loss

You may have some hair loss or hair thinning. This can be upsetting. It is almost always temporary and your hair will grow back when you finish your treatment.

Changes to how well your pancreas is working

Blood tests might show your pancreas isn’t working very well. Nilotinib can cause inflammation of the pancreas (pancreatitis), but this is less common.

Tell your doctor straight away if you have sudden and severe pain in your abdomen, feeling or being sick, diarrhoea or a high temperature.

Cough and breathing changes

You may get a cough while you are having treatment. Less commonly you may feel short of breath with or without physical activity. 

Rarely nilotinib can cause other changes to your breathing such as a wheeze, painful breathing, chest pain, hiccups, and breathing faster.

Let your healthcare team know straight away if you have changes in your breathing.

Constipation

Constipation is easier to sort out if you treat it early. Drink plenty and eat as much fresh fruit and vegetables as you can. Try to take gentle exercise, such as walking. Tell your healthcare team if you think you are constipated. They can give you a laxative if needed.

Diarrhoea

Contact your advice line if you have diarrhoea. For example, in one day you have 2 or more loose bowel movements than usual. If you have a stoma , you might have more output than normal. Your doctor may give you anti diarrhoea medicine to take home with you after treatment.

Try to eat small meals and snacks regularly. It’s best to try to have a healthy balanced diet if you can. You don’t necessarily need to stop eating foods that contain fibre. But if your diet is normally very high in fibre, it might help to cut back on high fibre foods such as beans, nuts, seeds, dried fruit, bran and raw vegetables. 

Drink plenty to try and replace the fluid lost. Aim for 8 to 10 glasses per day.

High temperature

Tell your healthcare team straightaway if you get a high temperature. Ask them if you can take paracetamol to help lower your temperature.

Occasional side effects

These side effects happen in between 1 and 10 out of every 100 people (between 1 and 10%). You might have one or more of them. They include:

• eye problems – symptoms can include dry, itchy, redness, or swelling of the eyes. Your vision might also be blurred. Rarely you might have eyesight changes such as double vision, loss of sight or sensitivity to light. Let your nurse know if you notice any changes with your eyesight
• nerve changes including numbness, prickling or a tingling feeling in fingers and toes that can make it difficult to do fiddly things such as doing up buttons. Rarely you may have an unpleasant feeling when touched
• fluid build up (oedema) in your legs and arms. You might also have swelling of the face but this is rare
• swelling and bloating of the abdomen
• indigestion - symptoms include heartburn, bloating or burping
• changes in blood sugar levels. Symptoms can include feeling thirsty, changes in appetite and weight, peeing more often, tiredness, fast heartbeat, feeling anxious, nervous and dizzy
• loss of appetite or you may feel hungrier, but this is rare
• gaining or losing weight
• dizziness or a feeling as if everything around you is spinning (vertigo)
• heart problems – symptoms can include chest pain, fast, slow or irregular heartbeat, tiredness, shortness of breath, feeling lightheaded, dizzy or fainting, a bluish, grey or white change to the colour of your lips, tongue and skin, sweating, heartburn or indigestion. Rarely this drug can cause a heart attack.  
• high blood pressure - symptoms can include blurred vision, nosebleeds, dizziness, headaches, shortness of breath and chest pain. Rarely your blood pressure might drop this can make you feel dizzy, lightheaded or faint
• needing to pee very often, this can happen at night but it is rare. When you pee it might burn, sting or tingle. Rarely you might have an urgency to go or go without knowing (incontinence). Your pee might be an abnormal colour or you might have blood in it
• sweating more than usual but it’s not related to heat or physical activity. You might also get night sweats
• sudden reddening and warmth of the neck, upper chest and face (flushing)
• difficulty sleeping (insomnia)
• wind (flatulence)
• mood changes including feeling very low in mood or sad (depression) and anxious.
• muscle cramps (spasms) and weakness. Rarely you may experience muscle pain only when you are active and not when resting
• generally feeling unwell
• a reduced blood flow to the legs or arms. Symptoms include pain or cramps during activity such as walking or climbing the stairs
• low levels of thyroid hormones in your body. Rarely they may go up. Symptoms can include changes in your weight, feeling tired or cold, hair loss, fast heartbeat or neck swelling
• changes to the levels of minerals, salts and uric acid in your blood. You have regular bloods tests to check this
• high levels of fats in your blood. You have blood tests to check this
• hearing changes can include ear pain or hearing a ringing or humming sound (tinnitus). This treatment can also cause difficulty hearing, but this is rare
• digestive system problems - commonly nilotinib can cause inflammation of the lining of the stomach. Rarely you might pass black or bloody poo, pain, heartburn, feeling bloated, feeling or being sick, difficulty swallowing
• mouth problems such as ulcers, sores or dry mouth. Rarely nilotinib can cause sensitive teeth
• swollen veins in or around your bottom (piles) – symptoms can include pain, passing blood after you poo and feeling as you still have to poo
• problems getting an erection
• heavy bleeding with your periods
• flu-like symptoms such as headaches, muscle aches, a high temperature and shivering
• chills
• low levels of white blood cells this can increase your risk of developing infections. Rarely you might have a high number of a type of white blood cell
• painful or swollen joints (gout)

Rare side effects

These side effects happen in fewer than 1 in 100 people (less than 1%). You might have one or more of them. They include:

• changes to your voice such as sounding hoarse, raspy or weak
• taste changes
• lack of fluid in the body (dehydration)
• shaking or trembling with no control (tremor)
• a stroke - symptoms include numbness or weakness on one side of your body, difficulty talking, headache or dizziness
• unable to concentrate
• breast swelling in men
• nipple swelling
• an allergic reaction that can cause a rash, shortness of breath, redness or swelling of the face and dizziness - some allergic reactions can be life threatening. Tell your nurse or doctor if you notice any of these symptoms
• you may have an irresistible urge to move your legs and an uncomfortable sensation such as crawling and creeping sensation (restless legs syndrome)
• loss of muscle control on one side of your face (facial paralysis)
• narrowing of the blood vessels to your arms and legs, symptoms can include cramping or pain in one or both hips, thighs or calf muscles after being active. Or you may have numbness or weakness in your limbs
• fat build up in the blood vessels that can cause a blockage (arteriosclerosis)
• blood clots that can be life threatening; signs are pain, redness and swelling where the clot is. Feeling breathless can be a sign of a blood clot in the lung. Call 999 or go straight to Accident and Emergency (A & E) if you have any of these symptoms
• inflammation of the gums making them tender, swollen and you may notice some blood
• memory loss (amnesia)
• fainting
• infections such as hepatitis B can become active again if you've had it in the past

Coping with side effects

We have more information about side effects and tips on how to cope with them.

What else do you need to know?

Other medicines, foods and drink

Cancer drugs can interact with medicines, herbal products, and some food and drinks. We are unable to list all the possible interactions that may happen. An example is grapefruit or grapefruit juice which can increase the side effects of certain drugs.

Tell your healthcare team about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies. Also let them know about any other medical conditions or allergies you may have.

Loss of fertility 

It is not known whether this treatment affects fertility in people. Talk to your doctor before starting treatment if you think you may want to have a baby in the future.

Pregnancy and contraception

This drug may harm a baby developing in your womb. It is important not to become pregnant or get someone pregnant while you are having treatment with this drug and for at least 2 weeks afterwards.

Talk to your doctor or nurse about effective contraception before starting treatment. Let them know straight away if you or your partner become pregnant while having treatment.

Breastfeeding

It is not known whether this drug comes through into the breast milk. Doctors usually advise that you don’t breastfeed during this treatment and for 2 weeks after your last dose.

Treatment for other conditions

If you are having tests or treatment for anything else, always mention your cancer treatment. For example, if you are visiting your dentist.

Immunisations

Don’t have immunisations with live vaccines while you’re having treatment and for up to 12 months afterwards. The length of time depends on the treatment you are having. Ask your doctor or pharmacist how long you should avoid live vaccinations.

In the UK, live vaccines include rubella, mumps, measles, BCG, yellow fever and one of the shingles vaccines called Zostavax.

You can have:

• other vaccines, but they might not give you as much protection as usual
• the flu vaccine (as an injection)
• the coronavirus (COVID-19) vaccine - talk to your doctor or pharmacist about the best time to have it in relation to your cancer treatment

Members of your household who are aged 5 years or over are also able to have the COVID-19 vaccine. This is to help lower your risk of getting COVID-19 while having cancer treatment and until your immune system recovers from treatment.

Contact with others who have had immunisations - You can be in contact with other people who have had live vaccines as injections. Avoid close contact with people who have recently had live vaccines taken by mouth (oral vaccines) such as the oral typhoid vaccine. Sometimes people who have had the live shingles vaccine can get a shingles type rash. If this happens they should keep the area covered.

If your immune system is severely weakened, you should avoid contact with children who have had the flu vaccine as a nasal spray as this is a live vaccine. This is for 2 weeks following their vaccination.

Babies have the live rotavirus vaccine. The virus is in the baby’s poo for about 2 weeks and could make you ill if your immunity is low. Get someone else to change their nappies during this time if you can. If this isn't possible, wash your hands well after changing their nappy.

More information about this treatment

For further information about this treatment and possible side effects go to the electronic Medicines Compendium (eMC) website. You can find the patient information leaflet on this website.

You can report any side effect you have to the Medicines Health and Regulatory Authority (MHRA) as part of their Yellow Card Scheme.