100 mg, 400 mg, 500 mg film-coated tablets 
bosutinib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor. This also applies to any side effectsnot mentioned in this information. See section 4

In this leaflet you will find information about: 
1. What Bosulif is and what it is used for 
2. What you need to know before you use Bosulif 
3. How to use Bosulif 
4. Possible side effects 
5. How to store Bosulif 
6. Contents of the packaging and other information 

1. What Bosulif is and what it is used for

Bosulif contains the active substance bosutinib.

It is used to treat adult patients who have a type of leukemia called Philadelphia chromosome-positive ( Ph-positive) chronic myeloid leukemia (CML) that has been recently diagnosed, and when previous drugs for the treatment of CML have not worked or are no longer suitable to use. Ph-positive KML is a blood cancer that causes the body to produce too many of a special type of white blood cell, so-called granulocytes.

If you have any further questions on the use of Bosulif or why it has been prescribed for you, ask your doctor.

2. What you need to know before you use Bosulif

Do not use Bosulif

– if you are allergic to bosutinib or any of the other ingredients of this medicine (listed in section 6)

– if your doctor has informed you that your liver is damaged and not functioning normally.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Bosulif:

  • if you have or have had, liver problems. Tell your doctor if you have previously had liver problems such as hepatitis ( infection or inflammation of the liver) of any kind, or have had any of the following signs and symptoms of liver problems: itching, yellowing of the eyes or skin, dark urine or pain or discomfort on the right side of the upper abdomen. Your doctor should then take blood samples to examine your liver function before starting treatment with Bosulif and during the first 3 months of treatment, and whenever justified.
  • if you get diarrhea or vomiting. Tell your doctor if you get any of the following signs and symptoms: increased bowel movements per day (more than normal), more vomiting than before, blood in the vomit, stool, or urine, or if you have black stools (tar-colored). Ask your doctor if the treatment you receive for vomiting may increase the risk of developing cardiac arrhythmia (irregular heartbeat). It is especially important to consult your doctor if you want to use a medicine that contains domperidone for nausea and vomiting. If nausea and vomiting are treated with this type of medicine while taking Bosulif, the risk of dangerous cardiac arrhythmias ( arrhythmias ) may increase.
  • if you have problems with bleeding. Tell your doctor if you notice any of the following signs and symptoms e.g. abnormal bleeding or bruising without injury.
  • if you have an infection. Tell your doctor if you notice any of the following signs and symptoms e.g. fever, problems when you urinate such as a burning sensation, cough that you have not had before, or sore throat that you have not had before.
  • if you accumulate fluid. Tell your doctor if you notice any of the following signs and symptoms of fluid retention while you are being treated with Bosulif, such as swollen ankles, feet, or legs, difficulty breathing, chest pain, or cough (these may be signs of fluid retention in your lungs or chest).
  • if you have heart problems. Tell your doctor if you have any heart disease such as irregular heartbeat ( arrhythmia ) or an abnormal electrical signal, the so-called “prolonged QT interval”. This is always important, but especially if you get diarrhea often or if the diarrhea is prolonged, as described above. Tell your doctor immediately if you faint (lose consciousness) or have irregular heartbeats while taking Bosulif, as it may be a sign of a serious heart condition.
  • if you have been told that you have kidney problems. Tell your doctor if you urinate more often and produce more light-colored urine, or if you urinate less frequently and produce less urine with a darker color. Also tell your doctor if you lose weight or get swollen feet, ankles, legs, hands, and face.
  • if you have ever had or may have a hepatitis B infection. The reason for this is that Bosulif can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment.
  • if you have or have had problems with the pancreas. Tell your doctor if you experience severe pain or discomfort in your abdomen.
  • if you get any of the following symptoms: severe rash. Tell your doctor if you get signs or symptoms such as painful red or purple rashes that spread and blisters and/or other injuries to the mucous membranes (eg in the mouth or on the lips).
  • if you get any of the following symptoms: pain in the side, blood in the urine, or decreased amount of urine. If your disease is very serious, your body may not be able to get rid of all the waste products from the dying cancer cells. This is called “tumor lysis syndrome” and can lead to kidney failure and heart problems within 48 hours after the first dose of Bosulif. Your doctor is aware of this and can prevent the problem by making sure you have a good enough fluid balance as well as by giving you other medicines.

Sun / UV protection

You may become more sensitive to sun or UV rays while taking bosutinib. It is important to protect skin exposed to the sun and to use a sunscreen with a high sun protection factor (SPF).

Children and young people

Bosulif is not recommended for people under 18 years of age. The drug has not been studied in children and adolescents.

Other medicines and Bosulif

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 amount of Bosulif in your body. Tell your doctor if you are taking medicines containing the active substances listed below:

The following active substances may increase the risk of side effects from Bosulif:

  • ketoconazole , itraconazole, voriconazole, posaconazole and fluconazole used against fungal infections
  • clarithromycin, telithromycin, erythromycin and ciprofloxacin , used against bacterial infections
  • nefazodone, an antidepressant
  • mibefradil, diltiazem and verapamil, which are used to lower blood pressure in people with high blood pressure
  • ritonavir, lopinavir / ritonavir, indinavir, nelfinavir, saquvinavir, atazanavir, amprenavir, fosamprenavir and darunavir, used to treat HIV infections / AIDS
  • boceprevir and telaprevir, which are used to treat hepatitis C.
  • aprepitant, which is used to prevent and control nausea and vomiting
  • imatinib, which is used for a specific type of leukemia
  • crizotinib, which is used to treat a type of lung cancer called non-small cell lung cancer .

The following active substances may reduce the effect of Bosulif:

  • rifampicin used to treat tuberculosis
  • phenytoin and carbamazepine used for epilepsy
  • bosentan , which is used to lower high blood pressure in the lungs ( pulmonaryarterial hypertension )
  • nafcillin, an antibiotic for bacterial infections
  • St. John’s wort (a traditional herbal medicine), is used for mild depression
  • efavirenz and etravirine, which are used to treat HIV infections / AIDS
  • modafinil, which is used in certain sleep disorders.

These medicines should be avoided when you are treated with Bosulif. Tell your doctor if you are taking any of these medicines. Your doctor may change the dose ofone of these medicines, change the dose of one of Bosulif or give you another medicine.

The following active substances may affect the heart rhythm:

  • amiodarone , disopyramide , procainamide , quinidine and sotalol, used in heart disease
  • chloroquine and halofantrine used against malaria
  • clarithromycin and moxifloxacin, which are antibiotics for bacterial infections
  • haloperidol , which is used in psychotic diseases such as schizophrenia
  • domperidone, which is used to treat nausea and vomiting or to stimulate the production of breast milk
  • methadone , a painkiller.

These medicines should be taken with caution when you are being treated with Bosulif. Tell your doctor if you are taking any of these medicines.

There may also be other medicines than those mentioned here that can affect or be affected by Bosulif.

Bosulif with food, drink and alcohol

Do not take Bosulif with grapefruit or grapefruit juice, as it may increase the risk of side effects .

Pregnancy, breastfeeding, and fertility

Bosulif should not be used during pregnancy unless clearly necessary because it can harm the unborn baby.

Talk to your doctor before taking Bosulif if you are pregnant or could become pregnant

pregnant.

Women taking Bosulif are advised to use effective contraception during treatment and for at least 1 month after the last dose . Vomiting and diarrhea can reduce the effect of birth control pills .

There is a risk that treatment with Bosulif will lead to reduced fertility and you can therefore consult a doctor regarding the preservation of semen before starting treatment.

Tell your doctor if you are breast-feeding. You should not breast-feed while you are being treated with Bosulif as it may harm your baby

Driving and using machines

If you feel dizzy, blurred or unusually tired, do not drive or use machines until these side effects have disappeared.

Bosulif contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per 100 mg, 400 mg or 500 mg tablet, ie it is essentially ‘sodium-free’.

How to use Bosulif

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Bosulif is only prescribed by a doctor who has experience in the treatment of leukemia.

Dosage and administration

The recommended dose is 400 mg once daily in patients with newly diagnosed CML. The recommended dose is 500 mg once daily in patients whose previous KML medications have not worked or are no longer suitable for use. If you have moderate or severe renal impairment, your doctor will reduce your dose by 100 mg once daily for moderate renal impairment and by an additional 100 mg once daily for severe renal impairment. Your doctor may adjust the dose using the 100 mg tablets depending on how you feel, how you react to the treatment and / or any side effects.are. Take the tablet (s) in the morning with food. Swallow the tablets whole with water.

If you use more Bosulif than you should 

If you happen to take too many Bosulif tablets or a higher dose than you need, contact your doctor immediately for advice. Show the package or this information to your doctor, if possible. You may need medical attention.

If you forget to use Bosulif

If you forget to take a dose and it has not been 12 hours since you should have taken it, you should take your recommended dose . If more than 12 hours have passed, take the next dose the following day at the usual time.

Do not take a double dose to make up for a forgotten tablet.

If you stop using Bosulif

Do not stop taking Bosulif unless your doctor tells you to. If you can not take the medicine as prescribed by your doctor or if you no longer need it, contact your doctor immediately.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must contact your doctor immediately if you get any of these serious side effects(see also section 2, “What you need to know before taking Bosulif”):

Blood diseases. Tell your doctor immediately if you get any of the following symptoms: bleeding, fever, or bruising easily (you may have a blood disorder or lymphatic system disease ).

Liver disease. Tell your doctor immediately if you get any of the following symptoms: itching , yellowing of the eyes or skin, dark urine and pain or discomfort in the upper right part of the stomach, or fever.

Diseases of the stomach / intestines. Tell your doctor immediately if you get stomach pain, heartburn, diarrhea, constipation, nausea or vomiting.

Heart problems. Tell your doctor if you have any heart disease such as an abnormal electrical signal, so-called “prolonged QT interval”, or if you faint (lose consciousness) or have irregular heartbeats while taking Bosulif.

Hepatitis B reactivation. Recurrence (reactivation) of hepatitis B infection when you have previously had hepatitis B (a liver infection).

Severe skin reactions. Tell your doctor immediately if you get any of these symptoms: painful red or purple rash that spreads, blisters and / or other damage to the mucous membranes (eg in the mouth or on the lips).

Side effects of Bosulif may include:

Very common side effects (may affect more than 1 in 10 people):

  • decreased number of platelets , red blood cells and / or neutrophils (a type of white blood cell )
  • diarrhea, vomiting, abdominal pain, nausea
  • fever, swollen hands, feet or swollen face, fatigue, weakness
  • respiratory tract infection
  • inflammation of the nose and throat ( nasopharyngitis )
  • change of blood samples taken to see if Bosulif is affecting your liver and / or pancreas
  • reduced appetite
  • joint pain, back pain
  • headache
  • skin rash, which may be itchy and / or spread throughout the body
  • cough
  • shortness of breath

Common side effects (may affect up to 1 in 10 people):

  • low white blood cell count ( leukopenia )
  • irritation of the stomach ( gastritis ), bleeding in the stomach or intestines
  • chest pain, pain
  • liver damage, abnormal liver function and liver disease
  • lung infection ( pneumonia ), influenza , bronchitis
  • abnormal heart rhythm that can lead to fainting, dizziness and palpitations
  • increased blood pressure
  • high potassium content in the blood, low phosphorus content in the blood, large fluid losses (dehydration)
  • muscle aches
  • a feeling of instability (dizziness), altered taste sensations ( dysgeusia )
  • acute renal failure , renal failure , renal impairment
  • fluid around the lungs (fluid shedding in the alveoli)
  • fluid around the heart (fluid outflow into the pericardium)
  • tinnitus ( tinnitus )
  • itching , hives , acne
  • photosensitivity reactions (sensitivity to UV rays from the sun and other light sources).

Uncommon side effects (may affect up to 1 in 100 people):

  • fever associated with low white blood cell count (febrile neutropenia )
  • acute pancreatitis ( acute pancreatitis )
  • liver damage
  • life-threatening allergic reaction (anaphylactic shock )
  • abnormal fluid accumulation in the lungs ( acute pulmonary edema )
  • respiratory failure
  • allergic reaction
  • abnormally high blood pressure in the pulmonary artery ( pulmonaryhypertension )
  • rash
  • inflammation of the pericardium (pericarditis).
  • significant decrease in the number of granulocytes (a type of white blood cell ).

Rare side effects (may affect up to 1 in 1,000 people):

  • severe skin disease (erythema multiforme, Stevens-Johnson syndrome , toxic epidermal necrolysis ) due to an allergic reaction , scaly rash.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Bosulif

  • 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 and carton after “EXP”. The expiration date is the last day of the specified month.
  • No special storage instructions.
  • Do not use this medicine if the package is damaged or appears to have been tampered with.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is bosutinib. Bosulif film-coated tablets are available 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 film coating of the tablet contains polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b) and yellow iron oxide (E172, in Bosulif 100 mg and 400 mg) or red iron oxide (E172, in Bosulif 400 mg and 500 mg).

What the medicine looks like and the contents of the pack

Bosulif 100 mg film-coated tablets are yellow, oval, biconvex, with “Pfizer” debossed on one side and “100” on the other.

Bosulif 100 mg comes in blister packs of either 14 or 15 film-coated tablets in cartons of 28, 30 or 112 film-coated tablets.

Bosulif 400 mg film-coated tablets are orange, oval, biconvex, with “Pfizer” debossed on one side and “400” on the other.

Bosulif 400 mg comes in blister cards of 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, with “Pfizer” debossed on one side and “500” on the other.

Bosulif 500 mg comes in blister packs of either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Company Freiburg

Mooswaldallee 1

79090 Freiburg

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgique / België / BelgienPfizer SA / NVTel: +32 (0) 2 554 62 11 LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000
BulgariaPfizer Luxembourg SAARЛ, Clone of BulgariaTel: +359 2 970 4333 Luxembourg / LuxemburgPfizer SATel: +32 (0) 2 554 62 11
Czech RepublicPfizer, spol.sroTel .: + 420-283-004-111 HungaryPfizer Kft.Tel .: + 36-1-488-37-00
DenmarkPfizer ApSTel: +45 44 20 11 00 MaltaVivian Corporation Ltd.Tel: +356 21344610
GermanyPfizer Pharma GmbHTel: +49 (0) 30 550055 51000 The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01
EestiPfizer Luxembourg SARL Eesti subsidiaryTel .: +372 666 7500 NorwayPfizer ASTel: +47 67 52 61 00
GreecePfizer Aλλάς AE:Ηλ: +30 210 6785 800 AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0
SpainPfizer, SLTel: +34 91 490 99 00 PolandPfizer Polska Sp. z oo Tel: +48 22 335 61 00
FrancePfizerTel: +33 (0) 1 58 07 34 40 PortugalPfizer Laboratories, Lda.Tel: +351 21 423 5500
CroatiaPfizer Croatia dooTel: +385 1 3908 777 RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00
IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 SloveniaPfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel .: + 386 (0) 1 52 11 400
IcelandIcepharma hf.Phone: +354 540 8000 Slovak RepublicPfizer Luxembourg SARL, organizerTel .: + 421 2 3355 5500
ItalyPfizer SrlTel: +39 06 33 18 21 Finland / FinlandPfizer OyPuh./Tel: +358 (0) 9 43 00 40
ΎπροςPfizer Αλλάς Α.Ε. (Cyprus Branch)Tηλ .: + 357 22 81 7690
LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775 United KingdomPfizer LimitedTel: +44 (0) 1304 616161

Muhammad Nadeem

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