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Treatment Name: Bosutinib (Bosulif®)

Bosutinib (Bosulif®) is a Chemotherapy Regimen for Chronic Myeloid Leukemia (CML)

How does bosutinib work?
Bosutinib is designed to stop Chronic Myeloid Leukemia (CML) cells from growing and dividing. It may also permit non-cancerous blood cells in the bone marrow to resume normal growth.

Goals of therapy:
Bosutinib is taken to reduce symptoms from CML or prevent CML-related symptoms from ever occurring. Bosutinib is usually taken continuously to prevent CML from progressing to more aggressive phases. Bosutinib is not commonly given with the goal of cure, but all signs of the CML may become undetectable after taking bosutinib continuously.


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Usual starting dose for chronic phaseaccelerated phase, or blast phase:

  • Bosutinib 500 mg oral tablet by mouth once daily, every day with food

Bosutinib is dispensed by a pharmacy and taken at home. Some patients may require hospitalization when initially diagnosed and begin treatment with bosutinib before leaving the hospital. Typical duration of therapy is usually life-long. Some patients may need to switch to a similar medication if bosutinib is causing unacceptable side effects.

Dose reductions and treatment interruptions are common. It is important that you do NOT miss doses if possible, unless your doctor tells you it is okay. Missing more doses per month than your doctor advises may prevent you from achieving a remission and increase the risk of bosutinib no longer working.

 Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability


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Side Effects

In clinical studies, the most commonly reported side effects with bosutinib are shown here:

Some of the side effects listed may be due to CML, rather than bosutinib. Also, some side effects may go away with continued treatment, such as diarrhea. Severe side effects are rare and occur in less than 12% of patients.

The percentage of patients that stopped using bosutinib due to unacceptable side effects is about 25%. The majority of patients who need to stop using bosutinib because of side effects typically do so in the first nine months of treatment. Although diarrhea is common, most patients do not have to stop using bosutinib due to diarrhea. Side effects may be balanced by the effectiveness of bosutinib. Compared to imatinib, a smaller percent of patients stopped using bosutinib because it was no longer working.

Side effect videos Side Effect Videos
DiarrheaDiarrheaNausea and VomitingNausea and VomitingBleedingBleedingAnemiaAnemiaNeutropenic FeverNeutropenic FeverPainPainFatigue Fatigue


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How often is monitoring needed?
Labs (blood tests) may be checked before treatment, once weekly during the first month, then every other week during the second month, and monthly thereafter until stable. Most patients achieve a complete hematologic (blood) response within four weeks of beginning therapy with bosutinib. Labs at diagnosis often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), lactate dehydrogenase (LDH), magnesium, phosphate, and uric acid, plus any others your doctor may order. Tumor lysis syndrome is usually not seen after the first two weeks of therapy.

Importantly, your doctor will order a test known as BCR/ABL. Your doctor uses the BCR/ABL% to monitor your response to bosutinib.

How do I know if I am responding to Bosutinib?
It is important for you to know what your BCR/ABL% is. This way, if it begins to increase, you will know and can look for reasons why. Missed doses and drug interactions are the most common reasons for an increasing BCR/ABL%.

How often is imaging needed?
Imaging may be checked before treatment, and periodically thereafter. Imaging may include: a chest X-ray, or CT scan of the lungs. These are most often done to look for fluid in the lungs or an infection causing pneumonia.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to interrupt bosutinib therapy for a short period of time (several days), increase the dose if the BCR/ABL% is increasing, decrease the dose if the normal blood cells are too low, or switch therapy if goals of therapy are not being met.


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ChemoExperts Tips

  • Diarrhea, if it occurs, usually presents by the third day of treatment and becomes less frequent after the first month of treatment. Diarrhea is usually managed using over-the-counter medications such as loperamide (Imodium®)
  • A chemical in grapefruit juice, star fruit, and pomegranate can decrease the body’s ability to break down bosutinib and increase the amount of drug in your body. This may lead to an increase in side effects, therefore it is best to avoid grapefruit, star fruit, and pomegranate
  • Compared to imatinib, bosutinib causes less swelling around the eyes, muscle cramps, or bone pain
  • Although rash is common, it is rarely severe. When rash occurs, it usually appears on the forearms, chest, abdominal area, and occasionally on the face. In most cases, therapy with bosutinib can be continued and the rash will go away on its own, or with topical creams or lotions recommended by your doctor
  • Bring all your pill bottles to every clinic visit! This will make it easier for your healthcare team to make sure bosutinib can be taken safely with all other medications. A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • If you are having trouble paying for bosutinib, there are many patient assistance programs available to help. Ask your doctor or pharmacist to help you with this before you run out!
  • Clinical trials may exist for CML. Ask your doctor if any studies are currently enrolling in your area. If not, go to to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Bosutinib (Bosulif®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Bosutinib (Bosulif®). Depending upon your income, they may be able to help cover the cost of:

  • Bosutinib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Bosutinib (Bosulif®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Bosutinib (Bosulif®)

Individual Drug Label Information

Bosutinib (Bosulif®)

  • Bosutinib Is an oral tablet that comes in either 100 mg or 500 mg strengths 
  • It is usually taken with food and with a large glass of water
  • If you miss a dose, and it is within 12 hours from the regular time you take it, you may still take it. If it is more than 12 hours late, skip it, and take the next scheduled dose at the regular time. Do not take two doses at the same time 
  • Bosutinib should be stored at room temperature: 68°F to 77°F (20°C to 25°C)
  • Dosage adjustments may be required for liver problems or if good white blood cells (neutrophils), red blood cells, or platelets fall below the normal range 
  • Women of child-bearing potential should avoid becoming pregnant while taking bosutinib or taking it in the first trimester of pregnancy as it may harm the unborn baby. Women wanting to become pregnant should consult their doctor regarding the safest way to balance this with bosutinib therapy 
  • May interact with a steroid known as dexamethasone (Decadron), or a variety of anti-seizure medicines. A dosage increase is sometimes required to avoid losing response to bosutinib 
  • A chemical in grapefruit juice decreases the body’s ability to break down bosutinib so it is best to avoid grapefruit and grapefruit juice to help prevent an increase in side effects 
  • May interact with medicine taken for heartburn or those that reduce stomach acid. It is recommended that short-acting antacids (example: Tums®, famotidine, ranitidine) be considered instead of proton pump inhibitors (example: omeprazole (Prilosec®)) and that they are not taken within 2 hours of bosutinib
General Bosutinib (Bosulif) Side Effects:
  • Diarrhea is common and often resolves with continued treatment. Diarrhea usually presents by the third day of treatment and becomes less frequent after the first month of treatment. Diarrhea is usually managed using over-the-counter medications such as loperamide (Imodium®)
  • Muscle cramps can sometimes be treated with electrolytes such as potassium or magnesium prescribed by your doctor
  • Skin rash often resolves with continued treatment. Tell your doctor immediately if you develop a rash
  • Fatigue
  • Bruising or bleeding
  • Fever may be a sign of infection. Keep a thermometer at home and report any fevers immediately
  • Trouble sleeping
  • Click on the bosutinib (Bosulif) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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1. Gambacorti-Passerini C, Cortes JE, Lipton JH, et al. Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. Am J Hematol. 2014;89:947-953.

Created: August 29, 2015 Updated: November 20, 2016

What is Chronic Myeloid Leukemia (CML)?

A disease of the white blood cells found in the bone marrow that results when 2 chromosomes trade small sections of their DNA forming what is known as the “Philadelphia Chromosome.” When this happens within a white blood cell, it may grow and divide without being able to stop.

CML is a relatively rare condition and represents about 10% of diagnosed leukemias. CML is not thought to be an inherited disorder and most of the time, the cause is unknown. The average age at diagnosis is about 65 years old.

CML can present in one of three phases: Chronic Phase, Accelerated Phase, or Blast Crisis

Without treatment, CML may evolve over time causing aggressive disease. This may lead to symptoms such as weight loss, abdominal discomfort, decreased appetite, fever, bruising or bleeding, among others. The stage of CML can vary at diagnosis and throughout treatment. The effectiveness of the treatment may depend upon the phase of CML at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is Chronic Phase?

When a patient with CML has a bone marrow biopsy that shows less than 10% blasts, they are said to be in chronic phase. Patients in chronic phase have few or no symptoms from CML.

What is Accelerated Phase?

When a patient with CML has a bone marrow biopsy that shows between than 11 – 20% blasts, they are said to be in accelerated phase. Patients with accelerated phase usually have symptoms such as poor appetite, weight loss, an enlarged spleen, or fever.

What is Blast Phase?

When a patient with CML has a bone marrow biopsy that shows more than 20% blasts, they are said to be in blast phase, or blast crisis. Patients with blast phase usually have symptoms similar to acute leukemia such as: easy bruising or bleeding, fever, poor appetite, weight loss, or an enlarged spleen.

What is BCR/ABL?

A gene mutation within CML cells. The percent of cells that have the BCR/ABL mutation goes down by taking bosutinib therapy. The goal is that the percentage will become undetectable. This happens in the many patients and is known as a complete molecular response, or 0.000%. At diagnosis, the BCR/ABL % is often very high, sometimes exceeding 100%. This is because the test is based upon the average BCR/ABL% from patients in one of the earliest clinical studies with imatinib. Having a BCR/ABL% greater than 100% at diagnosis does not usually affect the response to bosutinib.

Responding to Bosutinib?

The optimal response to bosutinib depends upon how long you have been taking it for. Ultimately, the goal is an undetectable BCR/ABL%, or 0.0000%, but a level less than 1% usually predicts long-term survival as well. Patients who have a BCR/ABL of 10% or more after three months of bosutinib (without missing doses) may need to switch therapy to another medication that treats CML.

Goal BCR/ABL% (International Scale, IS) while taking Bosutinib therapy:

  • Newly Diagnosed (No Bosutinib therapy): [~80 - more than 100%]
  • Complete Hematologic Response (CHR): Less than 10%
  • Complete Cytogenetic Response (CCyR): Less than 1%
  • Major Molecular Response (MMR): Less than 0.1%
  • Complete Molecular Response (CMR): 0.0000%

What is Tumor Lysis Syndrome?

This occurs when many cancer cells die quickly and release their contents into the bloodstream. Many times the body has the ability to flush these substances out through the kidneys or metabolize them via the liver. However, sometimes the body needs medicines to help eliminate these substances and to prevent organ damage.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

14) Serum calcium