Bosulif
bosutinib
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What Bosulif is and what it is used for
What you need to know before you take Bosulif
How to take Bosulif
Possible side effects
How to store Bosulif
Content of the pack and other information
Bosulif contains the active substance bosutinib. It is used to treat adult patients who have a type of leukaemia called Philadelphia chromosome-positive (Ph-positive) Chronic Myeloid Leukaemia (CML) and are newly-diagnosed or for whom previous medicines to treat CML have either not worked or are not suitable. Ph-positive CML is a cancer of the blood which makes the body produce too many of a specific type of white blood cell called granulocytes.
If you have any questions about how Bosulif works or why this medicine has been prescribed for you, ask your doctor.
if you are allergic to bosutinib or any of the other ingredients of this medicine (listed in section 6).
if your doctor has told you that your liver has been damaged and is not working normally.
Talk to your doctor, pharmacist or nurse before taking Bosulif:
3 months of treatment with Bosulif, and as clinically indicated.
You may become more sensitive to the sun or UV rays while taking bosutinib. It is important to cover sunlight-exposed areas of skin and use sunscreen with high sun protection factor (SPF).
Bosulif is not recommended for people whose age is under 18 years. This medicine has not been studied in children and adolescents.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, vitamins, and herbal medicines. Some medicines can affect the levels of Bosulif in your body. You should inform your doctor if you are taking medicines containing active substances such as those listed below:
ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole, used to treat fungal infections.
clarithromycin, telithromycin, erythromycin, and ciprofloxacin, used to treat bacterial infections.
nefazodone, used to treat depression.
mibefradil, diltiazem and verapamil, used to lower blood pressure in people with high blood pressure.
ritonavir, lopinavir/ritonavir, indinavir, nelfinavir, saquinavir, atazanavir, amprenavir, fosamprenavir and darunavir, used to treat human immunodeficiency virus (HIV)/AIDS.
boceprevir and telaprevir, used to treat hepatitis C.
aprepitant, used to prevent and control nausea (feeling sick) and vomiting.
imatinib, used to treat a type of leukaemia.
crizotinib, used to treat a type of lung cancer called non-small cell lung cancer.
rifampicin, used to treat tuberculosis.
phenytoin and carbamazepine, used to treat epilepsy.
bosentan, used to lower high blood pressure in the lungs (pulmonary artery hypertension).
nafcillin, an antibiotic used to treat bacterial infections.
St. John’s Wort (a herbal preparation obtained without a prescription), used to treat depression.
efavirenz and etravirine, used to treat HIV infections/AIDS.
modafinil, used to treat certain types of sleep disorders.
These medicines should be avoided during your treatment with Bosulif. If you are taking any of them, tell your doctor. Your doctor may change the dose of these medicines, change the dose of Bosulif, or switch you to a different medicine.
amiodarone, disopyramide, procainamide, quinidine and sotalol used to treat heart disorder.
chloroquine, halofantrine used to treat malaria.
clarithromycin and moxifloxacin antibiotics used to treat bacterial infections.
haloperidol, used to treat psychotic disease such as schizophrenia.
domperidone, used to treat nausea and vomiting or to stimulate breast milk production.
methadone, used to treat pain.
These medicines should be taken with caution during your treatment with Bosulif. If you are taking any of them, tell your doctor.
The medicines listed here may not be the only ones that could interact with Bosulif.
Do not take Bosulif with grapefruit or grapefruit juice, as it may increase the risk of side effects.
Bosulif is not to be used during pregnancy, unless clearly necessary, because Bosulif could harm an unborn baby. Ask your doctor for advice before taking Bosulif if you are pregnant or might become pregnant.
Women taking Bosulif will be advised to use effective contraception during treatment and for at least 1 month after the last dose. Vomiting or diarrhoea may reduce the effectiveness of oral contraceptives.
There is a risk that treatment with Bosulif will lead to decreased fertility and you may wish to seek advice about sperm storage before the treatment starts.
If you are breast-feeding, tell your doctor. Do not breast-feed during treatment with Bosulif as it could harm your baby.
If you experience dizziness, have blurred vision or feel unusually tired, do not drive or operate machines until these side effects have gone away.
This medicine contains less than 1 mmol sodium (23 mg) per 100 mg, 400 mg, or 500 mg tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Bosulif will only be prescribed to you by a doctor with experience in medicines to treat leukaemia.
The recommended dose is 400 mg once daily for patients with newly-diagnosed CML. The recommended dose is 500 mg once daily for patients whose previous medicines to treat CML have either not worked or are not suitable. In the event that you have moderate or severe kidney problems, your doctor will reduce your dose by 100 mg once daily for moderate kidney problems and by an additional 100 mg once daily for severe kidney problems. Your doctor may adjust the dose using the 100 mg tablets depending upon your medical conditions, upon your response to treatment and/or on any side effect you may experience. Take the tablet(s) once a day with food. Swallow the tablet(s) whole with water.
If you accidentally take too many Bosulif tablets or a higher dose than you need, contact a doctor for advice right away. If possible, show the doctor the pack, or this leaflet. You may require medical attention.
If dose is missed by less than 12 hours, take your recommended dose. If a dose is missed by more than 12 hours, take your next dose at your regular time on the following day.
Do not take a double dose to make up for the forgotten tablets.
Do not stop taking Bosulif unless your doctor tells you to do so. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor right away.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must immediately contact your doctor if you experience any of those serious side effects (see also section 2 “What you need to know before you take Bosulif”):
(e.g. mouth and lips).
Side effects with Bosulif may include:
reduction in the number of platelets, red blood cells and/or neutrophils (type of white blood cells).
diarrhoea, vomiting, stomach pain, nausea.
fever, swelling of hands, feet or face, fatigue, weakness.
respiratory tract infection.
nasopharyngitis.
changes in blood test to determine if Bosulif is affecting your liver and/or pancreas, kidneys.
decrease of appetite.
joint pain, back pain.
headache.
skin rash, which may be itchy and/or generalised.
cough.
shortness of breath.
feeling of instability (dizziness).
fluid in the lungs (pleural effusion).
itching.
low white blood cells count (leukopenia).
stomach irritation (gastritis), bleeding from the stomach or intestine.
chest pain, pain.
toxic damage to the liver, abnormal hepatic function including liver disorder.
infection of the lung (pneumonia), influenza, bronchitis.
defect in cardiac rhythm that predisposes to fainting, dizziness and palpitation.
increase in blood pressure.
high level of potassium in the blood, low level of phosphorus in the blood, excessive loss of body fluid (dehydration).
pain in the muscles.
alteration of the sense of taste (dysgeusia).
acute kidney failure, kidney failure, kidney impairment.
fluid around the heart (pericardial effusion).
ringing in the ears (tinnitus).
urticaria (hives), acne.
photosensitivity reaction (sensitivity to UV rays from the sun and other light sources).
allergic reaction.
abnormally high blood pressure in the arteries of the lungs (pulmonary hypertension).
acute inflammation of the pancreas (acute pancreatitis).
respiratory failure.
fever associated with low white blood cell count (febrile neutropenia).
damage to the liver.
life-threatening allergic reaction (anaphylactic shock).
abnormal build-up of fluid in the lungs (acute pulmonary oedema).
skin eruption.
inflammation of the sac-like covering of the heart (pericarditis).
a marked decrease in the number of granulocytes (a type of white blood cells).
severe skin disorder (erythema multiforme).
nausea, shortness of breath, irregular heartbeat, muscular cramps, seizure, clouding of urine and tiredness associated with abnormal laboratory test results (high potassium, uric acid and phosphorous levels and low calcium levels in the blood) that can lead to changes in kidney function and acute renal failure –(Tumour lysis syndrome (TLS) ).
severe skin disorder (Stevens-Johnson syndrome, toxic epidermal necrolysis) due to an allergic reaction, exfoliative (scaly, peeling) rash.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly viathenationalreporting systemlistedinAppendixV. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister foil and carton after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is bosutinib. Bosulif film-coated tablets come in different strengths.
Bosulif 100 mg: each film-coated tablet contains 100 mg bosutinib (as monohydrate). Bosulif 400 mg: each film-coated tablet contains 400 mg bosutinib (as monohydrate). Bosulif 500 mg: each film-coated tablet contains 500 mg bosutinib (as monohydrate).
The other ingredients are: microcrystalline cellulose (E460), croscarmellose sodium (E468), poloxamer 188, povidone (E1201) and magnesium stearate (E470b). The tablet film-coating contains polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) and iron oxide yellow (E172, for Bosulif 100 mg and 400 mg) or iron oxide red (E172, for Bosulif 400 mg and 500 mg).
Bosulif 100 mg film-coated tablets are yellow, oval biconvex, debossed with “Pfizer” on one side and “100” on the other side.
Bosulif 100 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets or 112 film-coated tablets.
Bosulif 400 mg film-coated tablets are orange, oval biconvex, debossed with “Pfizer” on one side and “400” on the other side.
Bosulif 400 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.
Bosulif 500 mg film-coated tablets are red, oval biconvex, debossed with “Pfizer” on one side and “500” on the other side.
Bosulif 500 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.
Not all pack sizes may be marketed.
1050 Bruxelles Belgium
Pfizer Manufacturing Deutschland GmbH Betriebsstӓtte Freiburg
Mooswaldallee 1
79090 Freiburg Germany
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