What is Sprycel 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 other medicines 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 been effective, or have caused unacceptable side effects.
How does dasatinib work?
Dasatinib is a type of anticancer medicine called a protein tyrosine kinase inhibitor. It 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. Acute lymphoblastic leukaemia (ALL) affects white blood cells called lymphocytes. In both these types 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.
Dasatinib works by targeting this abnormal protein produced by the abnormal Philadelphia chromosome. Dasatinib blocks the action of this protein and other similar proteins, which stops the cancerous cells from multiplying.
How do I take Sprycel?
- Sprycel tablets are usually taken once a day.
- Sprycel tablets should be swallowed 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.
- If you forget to take a dose you should just take your next scheduled dose as normal. Don't take a double dose to make up for a missed dose.
- You should not take indigestion remedies (antacids) in the two hours before or after taking your Sprycel tablets.
- You should keep taking Sprycel for as long as your doctor tells you to.
What should I know before taking Sprycel?
- This medicine may cause dizziness and blurred vision. If affected, you should take care when driving or operating machinery.
- Dasatinib 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.
- Dasatinib 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.
Sprycel should be used with caution in
- People with liver problems, including a history of hepatitis B.
- People with a history or risk of lung disease.
- People with a history of heart disease, eg heart failure, angina, previous heart attack.
- People with risk factors for heart disease, such as smoking, diabetes, high blood pressure, high cholesterol.
- People with a personal or family history of an abnormal heart beat, seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
- People taking medicines that can cause a 'prolonged QT interval' (see end of page for examples).
- People taking medicines for an abnormal heart rhythm (antiarrhythmics).
- People with a low level of potassium in the blood (hypokalaemia).
- People with a low level of magnesium in the blood (hypomagnesaemia).
- People taking medicines to prevent blood clots, eg anticoagulants such as warfarin or antiplatelets such as dipyridamole, aspirin or clopidogrel.
Who should not take Sprycel?
- People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Sprycel tablets contain lactose).
- Sprycel 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 or any of its ingredients. If you feel you have experienced an allergic reaction, inform your doctor or pharmacist immediately.
Can I take Sprycel while pregnant or breastfeeding?
- The safety of dasatinib during pregnancy has not been established. It could be harmful to a developing baby. 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.
- Dasatinib may pass into breast milk and could be harmful to a nursing infant. Mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.
What are the posible side effects of Sprycel?
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 dasatinib. 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)
- Shortness of breath.
- Fluid on the lungs (see what should I know above).
- Disturbances of the gut, eg diarrhoea, nausea and vomiting, abdominal pain.
- Excessive fluid retention in the body tissues, resulting in swelling (oedema).
- Fatigue or feeling weak.
- Skin rash.
Common (affect between 1 in 10 and 1 in 100 people)
- Feeling weak.
- Loss of appetite.
- Change in taste.
- Weight changes.
- 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).
- Inflammation of the stomach (gastritis) or bowel (colitis).
- Skin reactions, eg dermatitis, itching, dry skin, acne, hair loss, increased sweating.
- Pain in the muscles or joints, muscle weakness.
- Difficulty sleeping (insomnia).
- Nerve problems (neuropathy). Tell your doctor if you get pins and needles, burning, tingling or numb sensations.
- Decrease in the normal numbers of white blood cells, red blood cells or platelets in the blood (see what should I know above).
- Visual disturbances, eg blurred vision.
- Sensation of ringing or other noise in the ears (tinnitus).
- Heart problems, eg build-up of fluid around the heart, heart failure, abnormal heart beats, awareness of your heartbeat (palpitations).
- Increased blood pressure.
- Inflammation in the lungs, cough.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Confusion, memory loss.
- Mood swings.
- Decreased sex drive.
- Bleeding in the brain.
- Heart attack, enlarged heart, chest pain (angina).
- Low blood pressure (hypotension).
- Irregular periods.
- Breast enlargement.
- Difficulty swallowing.
- Peptic ulcer.
- Inflammation of the pancreas (pancreatitis).
- Yellowing of the skin and whites of the eyes (jaundice).
- Inflammation of the liver (hepatitis).
- Kidney failure, increased need to pass urine.
- Abnormal blood test results and possibly impaired kidney function caused by the waste products released as the cancer cells are killed (tumour lysis syndrome).
Rare (affect between 1 in 1000 and 1 in 10,000 people)
- Stroke or mini-stroke (TIA).
- Inflammation of the optic nerve.
- Lung problems such as interstitial lung disease or raised pressure in the blood vessels supplying the lungs (pulmonary arterial hypertension). Tell you doctor if you notice any unexplained shortness of breath, coughing, fatigue, dizziness or fainting while taking this medicine.
- Blood clot in a blood vessel, for example in a vein of the leg (deep vein thrombosis) or in the lungs (pulmonary embolism). Tell your doctor straight away if you experience stabbing pains and/or unusual redness or swelling in one leg, pain on breathing or coughing, coughing up blood or sudden breathlessness.
If you want any more information about the possible side effects of Sprycel you should talk to your doctor or pharmacist, or read the leaflet that comes with the medicine. If you think you have experienced a side effect, did you know you can report this using the yellow card website?
Can I take other medicines with Sprycel?
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 Sprycel. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
The following medicines may decrease the amount of dasatinib in the blood, which could make it less effective. These medicines are not recommended for people being treated with dasatinib:
- the herbal remedy St John's wort (Hypericum perforatum).
The following medicines may increase the blood level of dasatinib, which could increase the risk of its side effects. These medicines are 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, which reduce stomach acid, may reduce the absorption of dasatinib from the gut:
- antacids for indigestion or heartburn, such as aluminium hydroxide or magnesium hydroxide (antacids should not be taken in the two hours before or the two hours 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 following medicines, which may increase the risk of their side effects; these medicines should be used with caution in combination with dasatinib:
- ergot alkaloids (eg ergotamine, dihydroergotamine)
There may be an increased risk of bleeding if this medicine is used in combination with the following medicines, which reduce the ability of the blood to clot:
- antiplatelet medicines, eg aspirin, clopidogrel, dipyridamole
- anticoagulants, eg warfarin
- non-steroidal anti-inflammatory drugs, eg ibuprofen, naproxen, diclofenac.
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:
- antiarrhythmics (medicines to treat abnormal heart beats), eg amiodarone, procainamide, disopyramide, sotalol
- the antihistamines astemizole, mizolastine or terfenadine
- arsenic trioxide
- certain antidepressants, eg amitriptyline, imipramine, maprotiline
- certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine, Riamet
- certain antipsychotics, eg thioridazine, haloperidol, sertindole, pimozide
- intravenous erythromycin or pentamidine
Dasatinib is not recommended for use in combination with boceprevir, used for hepatitis C infection.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain dasatinib as the active ingredient.