How does it work?

Sprycel tablets contain the active ingredient dasatinib, whichis a type of anticancer medicine called a protein tyrosine kinase inhibitor. Itis used to treat cancer of the blood cells (leukaemia).

Dasatinib works by interfering with the pathways that signalcertain types of cancer cells to grow.

Leukaemia is a type of cancer that occurs when a cancerouschange in a white blood cell is produced. Chronic myeloid leukaemia (CML)affects white blood cells called granulocytes. Acute lymphoblastic leukaemia(ALL) affects white blood cells called lymphocytes. In both these types ofleukaemia, the cancerous change often involves an abnormal rearrangement of thechromosomes (genetic material) in the white blood cells. Leukaemic blood cellsoften have an abnormal chromosome called the Philadelphia chromosome (namedafter the place it was discovered), as well as other abnormal chromosomalarrangements.

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

Dasatinib works by targeting this abnormal protein produced bythe abnormal Philadelphia chromosome. Dasatinib blocks the action of thisprotein and other similar proteins, which stops the cancerous cells frommultiplying.

Sprycel tablets are usually taken once a day. They should beswallowed whole and not broken, crushed or chewed.

What is it used for?

• Newly diagnosed cancer of the blood affecting a type of white blood cell called granulocytes (Philadelphia chromosome positive chronic myeloid leukaemia (CML) in the chronic phase) in adults.

• Cancer of the blood affecting a type of white blood cell called granulocytes (chronic, accelerated or blast phase chronic myeloid leukaemia or CML) in adults, when other medicines, including imatinib, have not been successful, or when othermedicines have caused unacceptable side effects.

• Cancer of the blood affecting a type of white blood cell called lymphocytes (Philadelphia chromosome positive acute lymphoblastic leukaemia or ALL and lymphoid blast CML) in adults, when other medicines have not beeneffective, or have caused unacceptable side effects.

Warning!

• Sprycel tablets should beswallowed whole and not broken, crushed or chewed. They can be taken with or without food, but should be taken consistently either in the morning or evening.
• This medicine may cause dizziness and blurred vision. If affected, you should take care when driving or operating machinery.
• This medicine may sometimes cause a decrease in the normal amounts of healthy blood cells in the blood. For this reason, you will need to have regular blood tests during your treatment to allow your doctors to monitor the levels of blood cells in your blood. Tests should be performed weekly for the first two months and then monthly or as your doctor feels necessary. Tell your doctor immediately if you experience any of the following symptoms during treatment, as they may indicate a problem with your blood cells: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or weak, or general illness. Your doctor may want to take a blood test to check your blood cells.
• Dasatinib can sometimes cause fluid retention. Tell your doctor if you experience shortness of breath, chest pain or a cough while taking this medicine, as this could be a sign of fluid retention in the lungs or chest.
• 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 and men should use effective contraception to avoid fathering a child while taking this medicine.

Use with caution in

• Decreased liver function.
• History of heart disease, eg heart failure.
• People with risk factors for heart disease, such as high blood pressure, high cholesterol, smoking.
• People with an abnormal heart beat, seen on a heart monitoring trace (ECG) as a ‘prolonged QT interval’.
• Low level of potassium in the blood (hypokalaemia).
• Low level of magnesium in the blood (hypomagnesaemia).
• People taking medicines for an abnormal heart rhythm (antiarrhythmics).
• People taking medicines to prevent blood clots, eg anticoagulants such as warfarin or antiplatelets such as dipyridamole, aspirin or clopidogrel.

Not to be used in

• Breastfeeding.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Sprycel tablets 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 one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing 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 and men should use effective contraception to avoid fathering a child while taking this medicine. Consult your doctor for further information.
• This medicine may pass into breast milk. Mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.

Label warnings

• This medication should be swallowed whole and not broken, crushed or chewed.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

Very common (affect more than 1 in 10 people)

• Infections.
• Headache.
• Bleeding.
• Shortness of breath.
• Fluid on the lungs.
• Disturbances of the gut, eg diarrhoea, nausea and vomiting, constipation, indigestion, abdominal pain.
• Excessive fluid retention in the body tissues, resulting in swelling (oedema).
• Fever.
• Fatigue or feeling weak.
• Skin rash.

Common (affect between 1 in 10 and 1 in 100 people)

• Loss of appetite.
• Change in taste.
• Sore mouth.
• Bleeding in the gut (tell your doctor straight away if you see blood in your vomit, stools or urine, or if you have black stools).
• Skin reactions, eg rash, itching, dry skin, acne, increased sweating.
• Hair loss.
• Pain in the muscles or joints.
• Dizziness.
• Depression.
• Difficulty sleeping (insomnia).
• Pins and needles sensations.
• Decrease in the normal numbers of white blood cells, red blood cells or platelets in the blood.
• Visual disturbances, eg blurred vision.
• Sensation of ringing or other noise in the ears (tinnitus).
• Heart problems, eg heart failure, abnormal heart beats.
• Increased blood pressure.
• Inflammation in the lungs.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Confusion, memory loss.
• Anxiety.
• Bleeding in the brain.
• Conjunctivitis.
• Chest pain.
• Heart attack.
• Asthma.
• Stomach ulcer.
• Irregular periods.
• Breast enlargement.
• Inflammation of the pancreas (pancreatitis).
• Jaundice.
• Inflammation of the liver (hepatitis).
• Kidney failure.

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

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

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

The following medicines may decrease the amount of dasatinib inthe blood, which could make it less effective. These medicines are notrecommended for people being treated with dasatinib:

• carbamazepine
• dexamethasone
• phenobarbital
• phenytoin
• rifampicin
• the herbal remedy St John's wort (hypericum perforatum).

The following medicines may increase the blood level ofdasatinib, which could increase the risk of its side effects. These medicinesare not recommended for people being treated with dasatinib:

• azole antifungals such as ketoconazole or itraconazole
• the antibiotics erythromycin, clarithromycin or telithromycin
• protease inhibitors for HIV infection, eg ritonavir.

The following medicines may reduce the absorption of dasatinibfrom the gut:

• antacids for indigestion or heartburn (antacids should not be taken in the two hours before or after taking Sprycel tablets)
• H2 antagonists, eg cimetidine, famotidine, ranitidine (these are not recommended for people taking Sprycel)
• proton pump inhibitors, eg omeprazole, lansoprazole (these are not recommended for people taking Sprycel).

Dasatinib may increase the blood levels of the followingmedicines, which may increase the risk of their side effects; these medicinesshould be used with caution in combination with dasatinib:

• astemizole
• bepridil
• cisapride
• ergot alkaloids (eg ergotamine, dihydroergotamine)
• pimozide
• quinidine
• terfenadine.

There may be an increased risk of bleeding if this medicine isused in combination with the following medicines, which reduce the ability ofthe blood to clot:

• antiplatelet medicines, eg aspirin, clopidogrel, dipyridamole
• anticoagulants, eg warfarin.

There may be an increased risk of abnormal heart rhythms (prolonged QT interval on a heart monitoring trace (ECG) if this medicine is taken in combination with any of the following medicines:

• atomoxetine
• certain medicines to treat abnormal heart rhythms (antiarrhythmics), eg amiodarone, procainamide, disopyramide, sotalol
• certain antidepressants, eg amitriptyline, imipramine, maprotiline
• certain antibiotics, eg clarithromycin, erythromycin, moxifloxacin
• certain antifungals, eg ketoconazole, voriconazole
• certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine, artemether
• certain antipsychotics, eg thioridazine, chlorpromazine, pimozide, sertindole, haloperidol
• terfenadine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain dasatinib as the active ingredient.