BOSULIF® What are the possible side effects of BOSULIF?

(bosutinib)

What are the possible side effects of BOSULIF?

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:
o
shortness of breath and cough
o
chest pain
o
swelling in your hands, ankles, or feet
o
swelling all over your body
o
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:
o
you urinate more often than normal
o
you urinate less often than normal
o
you make a much larger amount of urine than normal
o
you make a much 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
•
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 females and males. 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Health Professional Information

What are the possible side effects of BOSULIF?

What are the possible side effects of BOSULIF?

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:
o
shortness of breath and cough
o
chest pain
o
swelling in your hands, ankles, or feet
o
swelling all over your body
o
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:
o
you urinate more often than normal
o
you urinate less often than normal
o
you make a much larger amount of urine than normal
o
you make a much 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
•
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 females and males. 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Prescribing Information
Download Prescribing Information

Health Professional Information

What are the possible side effects of BOSULIF?

What are the possible side effects of BOSULIF?

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:
o
shortness of breath and cough
o
chest pain
o
swelling in your hands, ankles, or feet
o
swelling all over your body
o
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:
o
you urinate more often than normal
o
you urinate less often than normal
o
you make a much larger amount of urine than normal
o
you make a much 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
•
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 females and males. 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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