Bosulif Warnings and Precautions

Reviewing the warnings and precautions associated with Bosulif before starting chemotherapy with this drug can help prevent potentially dangerous complications. Although it can be an effective medicine in many cases, Bosulif may not be the best choice for people who have liver disease, heart problems, or certain allergies. Other risks also apply to women who are pregnant or nursing.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Bosulif® (bosutinib) if you have:
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Heart problems
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings for Bosulif

Some warnings and precautions to be aware of prior to taking this medication include the following:
  • Bosulif can cause stomach problems, including abdominal (stomach) pain, diarrhea, nausea, and vomiting. Your healthcare provider may give you other medicines to prevent or treat these side effects. If you experience severe or persistent stomach problems, your healthcare provider may recommend you skip a dose, reduce your dose, or stop Bosulif treatment altogether.
  • This medication may cause low blood cell counts, including low platelets (thrombocytopenia), low red blood cells (anemia), and low white blood cells (neutropenia). A low platelet count increases the risk for dangerous bleeding, while a low white blood cell count increases the risk for infections. Your healthcare provider will monitor your blood cell counts (using blood tests) routinely during treatment. Let him or her know right away if you develop problems, such as:
    • Fever
    • Signs of infection
    • Unusual bleeding or bruising.
  • Bosulif has been reported to increase liver enzymes and cause liver problems. Your healthcare provider will use blood tests to check your liver function routinely for the first three months of treatment, and then on an as-needed basis thereafter. Let your healthcare provider know right away if you have signs of liver problems, such as:
    • Yellowing of your skin or whites of your eyes (jaundice)
    • Dark-colored urine
    • Upper-right abdominal (stomach) pain.
  • Bosulif can cause the body to retain fluid, which could lead to potentially serious problems, especially if the fluid builds up around the lining of the heart, lungs, or stomach. Let your healthcare provider know if you develop any signs of fluid retention (known as edema), such as:
    • Unexplained weight gain
    • Swelling in any area of your body
    • Shortness of breath
    • Cough
    • Chest pain.
  • Bosulif is a pregnancy Category D medication, which means it may harm an unborn child. Talk to your healthcare provider about the risks and benefits of using this medication during pregnancy (see Bosulif and Pregnancy).
  • It is not known whether Bosulif passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Bosulif and Breastfeeding).
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