Nilotinib capsules

About nilotinib

Nilotinib is a medicine which is given to treat leukaemia. Leukaemia is cancer of cells in the bone marrow - these are the cells which develop into blood cells. Nilotinib is given for the type of leukaemia called chronic myeloid leukaemia (CML).

In cancer, certain cells in the body grow and multiply in a way that is 'out of control'. Chemotherapy (anti-cancer) medicines work by inhibiting the way cells grow and increase in number. Nilotinib belongs to a group of anti-cancer medicines known as tyrosine kinase inhibitors. These medicines work by blocking the chemical messengers (called tyrosine kinases) which send signals to cells to grow. This stops the production of cancer cells.

Before taking nilotinib

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking nilotinib it is important that your doctor knows:

• If you have an infection or feel particularly unwell.

• If you have a heart condition or an unusual heart rhythm.

• If you have any problems with the way your liver works or if you have ever had hepatitis B infection.

• If you have ever had a disorder of your pancreas, called pancreatitis.

• If you are pregnant or breastfeeding.

• If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.

• If you have ever had an allergic reaction to a medicine.

How to take nilotinib

• Before you start the treatment, read any printed information you have been given by your doctor and the printed manufacturer's leaflet from inside the pack of capsules. These will give you more information about nilotinib and will provide a full list of the side-effects which you may experience from taking it.

• Nilotinib will be prescribed for you by a specialist doctor who is experienced in treating your condition. It is important that you take the capsules exactly as you are told to. It is usual to take two capsules twice daily (morning and evening), although your dose may be different to this. There are two strengths of capsule available (150 mg and 200 mg) - you will be given the strength that is most suitable for your condition. The directions for taking the capsules will be printed on the label of the pack to remind you what your doctor has told you to do, but if you have any concerns or questions, you should contact your doctor or hospital clinic for further advice.

• Swallow the capsules with a full glass of water. Do not chew the capsules. If you have difficulties swallowing capsules, you can mix the content of each capsule with a teaspoon of apple sauce (puréed apple). Swallow the mixture straightaway. Do not use more than one teaspoon of apple sauce per capsule, and do not mix nilotinib with any other foods.

• You should take the capsules when your stomach is empty of food, which means taking your doses an hour before a meal, or waiting until two hours afterwards. This is because food interferes with the way your body absorbs nilotinib and may increase the risk of harmful effects.

• Do not drink grapefruit juice while you are on nilotinib. This is because a chemical in grapefruit juice can interfere with the amount of nilotinib in your bloodstream.

• If you forget to take a dose, make sure that you remember to take your next dose when it is due. Do not take two doses together to make up for a missed dose.

Getting the most from your treatment

• You must try to keep your regular appointments with your doctor or hospital. This is so your doctor can check on your progress. You will need to have regular check-ups during treatment and your doctor may also want you to check your own blood sugar levels.

• Nilotinib can lower the number of white cells in your blood and this increases the chance that you may get an infection. You should take precautions to reduce the risk of infection whenever you can. So, if possible, avoid other people with infections and let your doctor know straightaway if you think you are getting a sore throat or if you have a high temperature.

• If you buy or take any other medicines, check with a pharmacist that they are suitable to take alongside nilotinib.

• If you are having an operation or dental treatment, always tell the person carrying out the treatment which medicines you are taking.

• It is important that you do not get pregnant while you are taking nilotinib. If this could be a possibility for you, make sure you discuss with your doctor which types of contraception are suitable for you and your partner.

Can nilotinib cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with nilotinib. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

If you experience other symptoms which you think may be due to the capsules, ask your doctor or pharmacist for further advice.

How to store nilotinib

• Keep all medicines out of the reach and sight of children.

• Store in a cool, dry place, away from direct heat and light.

• Please return any unused or unwanted capsules to your clinic or pharmacy to destroy.

Important information about all medicines