Main use Active ingredient Manufacturer
Leukaemia  Nilotinib hydrochloride monohydrate Novartis

How does it work?
Tasigna capsules contain the active ingredient nilotinib, which is a type of anticancer medicine called a protein tyrosine kinase inhibitor. It is used to treat cancer of the blood cells (leukaemia).

Nilotinib works by interfering with the pathways that signal certain types of cancer cells to grow.

Leukaemia is a type of cancer that occurs when a cancerous change in a white blood cell is produced. Chronic myeloid leukaemia (CML) affects white blood cells called granulocytes. In this type of leukaemia, the cancerous change often involves an abnormal rearrangement of the chromosomes (genetic material) in the white blood cells. Leukaemic blood cells often have an abnormal chromosome called the Philadelphia chromosome (named after the place it was discovered), as well as other abnormal chromosomal arrangements

The abnormal chromosomes disturb the normal control of the way the blood cells divide and multiply. They cause an abnormal protein to be produced on the blood cells, called Bcr-Abl tyrosine kinase. This protein makes the white blood cells multiply without restraint and dramatically increases the number produced by the bone marrow.

Nilotinib works by targeting this abnormal protein produced by the abnormal Philadelphia chromosome. Nilotinib blocks the action of this protein, which stops the cancerous cells from multiplying. The cancerous cells then die.

Nilotinib only acts on cancerous cells because these are the only cells that carry the abnormal tyrosine kinase. This means nilotinib stops the growth of the abnormal cancerous cells, while having little effect on the growth of normal healthy cells.

What is it used for?
Cancer of the blood affecting a type of white blood cell called granulocytes (Philadelphia chromosome positive chronic myeloid leukaemia in adults).
Warning!
This medicine should be taken without food on an empty stomach. You should not eat for two hours before and for at least one hour after taking the capsules.
The capsules should be swallowed whole with water. People who have difficulty swallowing Tasigna capsules can open them up and mix the contents in one teaspoon of apple sauce or puree. If you do this, the apple sauce and medicine mixture should be swallowed immediately without chewing. It should not be kept for later use. Only one teaspoon of apple sauce should be used and no other types of foods other than apple sauce should be used. This is because food can affect the absorption of nilotinib.
You should avoid drinking grapefruit juice while taking this medicine, as it may increase the level of this medicine in your blood and hence increase the risk of side effects.
This medicine may cause dizziness and blurred vision. If affected, caution is required when driving or operating machinery.
This medicine can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
Your doctor may want to check your heart function with an ECG and a take a blood test to measure the level of salts such as potassium and magnesium in your blood, before you start treatment with this medicine.
Your doctor may also want you to have regular blood tests during treatment to check for a side effect called pancreatitis (inflammation of the pancreas). You should let your doctor know if you experience sudden unexplained stomach or abdominal pain, nausea or vomiting while taking this medicine, as these could be symptoms of pancreatitis.
This medicine may potentially be harmful to an unborn baby. Women who could get pregnant should use a reliable method of contraception to prevent pregnancy while taking this medicine.
Use with caution in
People with decreased liver function.
History of heart disease, eg heart failure, heart attack, unstable angina.
People with a slow heart rate (bradycardia).
People with an abnormal heart rhythm, seen on a heart monitoring trace (ECG) as a ‘prolonged QT interval’.
People with a low level of magnesium in their blood (hypomagnesaemia).
People with a low level of potassium in their blood (hypokalaemia).
People taking medicines for an abnormal heart rhythm (antiarrhythmics -see end of factsheet for examples).
People with a history of pancreatitis.
Not to be used in
Breastfeeding.
Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Tasigna capsules contain lactose).
This medicine is not recommended for children and adolescents under 18 years of age, as its safety and effectiveness have not been studied in this age group.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

The safety of this medicine during pregnancy has not been established. For this reason, it should not be used during pregnancy unless considered essential by your doctor, and only if the potential benefit to the mother outweighs any risks to the developing baby.
Women who could get pregnant should use a reliable method of contraception to avoid getting pregnant while taking this medicine. Consult your doctor for further information.
It is not known if this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.
Label warnings
Take this medication an hour before food or on an empty stomach.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)
Headache.
Nausea.
Rash.
Itching.
Muscle pain.
Fatigue.
Common (affect between 1 in 10 and 1 in 100 people)
Disturbances of the gut, such as constipation, diarrhoea, vomiting, abdominal pain and bloating.
Difficulty sleeping
Dizziness.
Hair loss.
Skin reactions such as dry skin, redness, dermatitis, night sweats, acne and excessive sweating.
Eye problems such as dry eyes, itchy eyes and infection.
Difficulty breathing and cough.
High blood pressure.
Flushing.
Palpitations.
Joint pain (arthralgia).
Back pain.
Chest pain.
Muscle spasms.
Weakness or loss of strength (asthenia).
Increased levels of fats called cholesterol and triglycerides in the blood.
Increased blood sugar levels and diabetes.
Fever.
Swelling of the legs and ankles due to excess fluid retention (peripheral oedema).
Decrease in the number of platelets in the blood.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
Upper respiratory tract infection.
Decreased numbers of all types of blood cells in the blood pancytopenia).
Decreased appetite.
Anxiety.
Pins and needles sensations (paraesthesia).
Inflammation of the liver (hepatitis).
Inflammation of the pancreas (pancreatitis).
Bluish discoloration of lips and tongue (cyanosis).
Changes in taste.
Decrease in the number of white blood cells or red blood cells in the blood.
Unknown frequency
Swelling of the face.
Nosebleeds.
Runny or blocked nose.
Migraine.
Fainting.
Skin discoloration.
Gout.
Abnormal enlargement of breasts in men (gynaecomastia).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

The medicines listed below may increase the blood level ofnilotinib, which could increase the risk of its side effects. These medicines should be avoided where possible while you are taking nilotinib:

the antibiotic medicines clarithromycin and telithromycin
the antifungal medicines ketoconazole, itraconazole and voriconazole
the HIV protease inhibitors atazanavir, nelfinavir, ritonavir, saquinavir and indinavir
lapatinib
nefazodone.
The medicines listed below may decrease the blood level of nilotinib, which could make it less effective. These medicines should also be avoided where possible while you are taking nilotinib:

carbamazepine
phenobarbital
phenytoin
rifabutin
rifampicin(should not be taken together with Tasigna capsules).
the herbal remedy St John’s wort (Hypericum perforatum).
There may be an increased chance of an abnormal heart rhythm, seen as a ‘prolonged QT interval’ on an ECG, if this medicine is taken in combination with other medicines that can have this side effect, such as the following:

atomoxetine
medicines to treat abnormal heart rhythms (antiarrhythmics), eg amiodarone, procainamide, quinidine, disopyramide, sotalol
certain antihistamines astemizole, terfenadine or mizolastine
certain antidepressants, eg maprotiline, amitriptyline, imipramine
certain antipsychotics, eg thioridazine, chlorpromazine, sertindole, haloperidol, pimozide
certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine
certain antimicrobials, eg erythromycin by injection, voriconazole, moxifloxacin or pentamidine
cisapride.
Nilotinib may potentially increase the blood levels of the following medicines:

ergot alkaloids (eg ergotamine, dihydroergotamine)
midazolam
pimozide
quinidine
terfenadine.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK thatcontain nilotinib as the active ingredient.