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IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR PATIENTS
Do not take BOSULIF if you are allergic to bosutinib or any of the ingredients in BOSULIF.
Before you take BOSULIF, tell your doctor if you:
- have liver problems
- have heart problems
- have kidney problems
- have high blood pressure
- have diabetes
- are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. Tell your doctor right away if you become pregnant while taking BOSULIF
- Females who are able to become pregnant should have a pregnancy test before starting treatment with BOSULIF and should use effective birth control (contraception) during treatment with BOSULIF and for at least 2 weeks after the last dose. Talk to your doctor about birth control methods that may be right for you
- are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. Do not breastfeed during treatment with BOSULIF and for at least 2 weeks after the last dose
Tell your doctor about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. BOSULIF and certain other medicines can affect each other.
BOSULIF may cause serious side effects, including:
- Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, vomiting, or blood in your stools. Get medical help right away for any stomach problems
- Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection
- Liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice), or you have dark “tea color” urine
- Heart problems. BOSULIF may cause heart problems, including heart failure and decreased blood flow to the heart, which can lead to heart attack. Get medical help right away if you get shortness of breath, weight gain, chest pain, or swelling in your hands, ankles, or feet
- Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Get medical help right away if you get any of the following symptoms during your treatment with BOSULIF:
- shortness of breath and cough
- chest pain
- swelling in your hands, ankles, or feet
- swelling all over your body
- weight gain
- Kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
- you urinate more or less often than normal
- you make a much larger or smaller amount of urine than normal
The most common side effects of BOSULIF in adults and children with CML include diarrhea, stomach (abdominal) pain, vomiting, nausea, rash, tiredness, liver problems, headache, fever, decreased appetite, respiratory tract infections (infections in nose, throat, or lungs), constipation, and changes in certain blood tests. Your doctor may do blood tests during treatment with BOSULIF to check for changes.
Tell your doctor or get medical help right away if you get respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, rash, or itching while taking BOSULIF. These may be symptoms of a severe allergic reaction.
Your doctor may change your dose, temporarily stop, or permanently stop treatment with BOSULIF if you have certain side effects.
BOSULIF may cause fertility problems in both female and male patients. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of BOSULIF. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.
INDICATIONS
BOSULIF is a prescription medicine used to treat:
- adults and children 1 year of age and older who have a certain type of leukemia called chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who are newly diagnosed or who no longer benefit from or did not tolerate other treatment
- adults with accelerated phase (AP) or blast phase (BP) Ph+ CML who can no longer benefit from or did not tolerate other treatment
It is not known if BOSULIF is safe and effective in children less than 1 year of age with CP Ph+ CML who are newly diagnosed or who no longer benefit from or did not tolerate other treatment or in children with AP Ph+ CML or BP Ph+ CML.
