Class: Biological Therapy

Generic Name: bosutinib

Trade Name: Bosulif®

How is this drug used? Bosulif is used for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults with resistance or intolerance to prior therapy.

What is the mechanism of action? Bosulif is a kinase inhibitor. It limits cancer growth by interfering with certain signaling pathways in cells.

How is Bosulif given (administered)? Bosulif is administered orally (by mouth) in the form of a tablet.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Bosulif. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Bosulif?

• Diarrhea
• Nausea
• Low platelet count
• Vomiting
• Abdominal pain
• Rash
• Anemia
• Fever
• Fatigue

What are some of the potentially serious side effects of treatment with Bosulif?

• Stomach problems
• Low blood cell counts
• Liver problems
• Fluid retention (sometimes involving the heart or lungs)

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• If possible, avoid large crowds or people who are sick or not feeling well.
• Wash hands often to reduce the risk of infection.
• Avoid activities that may cause injury or bruising.
• Avoid grapefruit and grapefruit products during treatment with Bosulif.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interact with treatment.
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may harm an unborn child. Women should avoid becoming pregnant while being treated with Bosulif.
• Patients should inform their physician about all other medical conditions, including liver problems and heart problems.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor if you experience stomach problems, signs of an infection (such as fever), signs of bleeding problems (such as such unexpected bleeding or bruising or blood in the urine or stools), signs of liver problems (such as yellowing of the skin or the whites of the eyes or dark urine), or signs of fluid retention (such as shortness of breath or cough; chest pain; swelling in the hands, ankles, feet, or entire body; or weight gain). Also tell your doctor if you notice respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, or itching.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 09/16.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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