Nilotinib (Tasigna)

Nilotinib is a 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 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 twice a day.

You swallow the capsules whole with water. You take nilotinib on an empty stomach. This means taking your capsules at least 2 hours after 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 or miss a dose of a cancer drug.

How often do you have nilotinib?

You take nilotinib for as long as it is helping you and the side effects aren't too bad.

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.

You also have an ECG before you start this treatment, and regularly while you have treatment. ECG stands for electrocardiogram. It is a test to check the electrical activity of your heart.

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. 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, spotty and swollen. Or you might develop non cancerous growths such as warts.

Skin problems usually go back to normal when your treatment finishes. Your doctor, nurse or pharmacist will tell you what products you can use on your skin to help.

Headaches or migraines

It’s common with nilotinib to get headaches. It can also cause a severe headache, often called a migraine, but this is rare.

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

Low number of white blood cells

Having a low number of white blood cells can increase your risk of getting an infection. Symptoms include a change in temperature, aching muscles, headaches, feeling cold and shivery and generally unwell. You might have other symptoms depending on where the infection is.

Infections can sometimes be life threatening. You should contact your advice line urgently if you think you have an infection. 

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.

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.

Pain in different parts of the body

Nilotinib commonly causes pain in your muscles and tummy (abdomen). It can also cause pain in other areas of the body such as bones and joints. Let your doctor or nurse know if you have any pain so that they can give you painkillers.

Liver changes

You might have liver changes that are usually mild and unlikely to cause symptoms. They usually go back to normal when treatment finishes.

Rarely your liver might stop working properly. This can cause symptoms such as yellowing of the whites of the eyes and skin, 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.

Changes in the levels of fats in the blood

This drug can raise the amount of cholesterol and triglycerides in your blood. You will have regular blood tests to check this.

Changes to the levels of substances in the blood

You may have changes in levels of minerals, salts and enzymes in your blood. Commonly you might have a low phosphate level.

There may be other changes such as to your levels of magnesium, potassium, sodium, and calcium.

You have regular blood tests to check these levels.

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.

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 might include itchy or dry eyes or swelling around the eye. You might notice blood in the whites of your eyes. Rarely you might have eyesight changes such as blurring, double vision, loss of sight or sensitivity to light. Let your nurse know if you notice any changes with your eyesight
• numbness or tingling in fingers and toes that can make it difficult to do fiddly things such as doing up buttons (peripheral neuropathy)
• difficulty opening your bowels (constipation)
• loose or watery poo (diarrhoea)
• fluid build up in your legs, and arms. Rarely you might get swelling of the face
• swollen abdomen
• indigestion - symptoms include heartburn, bloating or burping
• changes in blood sugar levels
• taste changes
• loss of appetite, but rarely you may have an increase in appetite
• weight gain or loss
• dizziness or a feeling as if everything around you is spinning (vertigo)
• heart problems such as chest pain or changes to your heart rhythm and rate. Rarely heart problems include fluid build up around the heart or a heart attack. Some of these signs include your lips, tongue and skin having a bluish colour
• high blood pressure
• needing to pass urine very often. Rarely you might notice when you pass urine that it burns, stings or tingles or you might have an urgency to go
• changes to how your kidneys are working
• sweating more than usual but it’s not related to heat or exercise. You might also get night sweats
• sudden reddening and warmth of the neck, upper chest and face (flushing)
• difficulty sleeping
• wind (flatulence)
• feeling very low in mood or sad (depression)
• muscle cramps (spasms) and weakness. Your muscles may feel stiff but this is rare
• feeling more worried or panicky than usual
• stiff joints and rarely joint swelling
• generally feeling unwell
• breathlessness and looking pale due to a low number of red blood cells in the blood (anaemia)
• changes to your voice such as sounding hoarse, raspy or weak
• difficulty breathing or a cough – let your doctor know so they can check the cause
• a reduced blood flow to the legs or arms. Symptoms include pain or cramps during activity such as walking or climbing the stairs

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:

• flu-like symptoms such as headaches, muscle aches, a high temperature and shivering
• mouth problems such as ulcers, sores, dry mouth or sensitive teeth
• low or high levels of thyroid hormones in your body
• lack of fluid in the body (dehydration)
• problems getting an erection (impotence)
• fainting
• shaking or trembling
• digestive system  problems such as inflammation of the lining of the stomach, passing black or bloody poo, or pain in your food pipe (oesophagus)
• 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

Other side effects

There isn't enough information to work out how often these side effects might happen. You might have one or more of them. They include:

• 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, alert your nurse or doctor if notice any of these symptoms
• hearing problems such as difficulty hearing or ringing in the ears (tinnitus)
• a virus called hepatitis B to 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 I need to know?

Other medicines, foods and drink

Cancer drugs can interact with some other medicines and herbal products. Tell your doctor or pharmacist about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies.

Grapefruit and grapefruit juice

You should not eat grapefruit or drink grapefruit juice when you are taking this drug because it can react with the drug.

Lactose intolerance

This drug contains lactose (milk sugar). If you have an intolerance to lactose, contact your doctor before taking this medicine.

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 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.

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.

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.