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HomeAboutAboutMechanism of ActionNCCN Guidelines® Recommendations for CMLTreatment ConsiderationsEfficacyEfficacyAdult: Newly Diagnosed Patients with CP Ph+ CMLBFORE EfficacyBFORE Study DesignAdult: Ph+ CML in Patients with Resistance or Intolerance to Prior TherapyStudy 200 EfficacyStudy 200 Study DesignPediatric: CP Ph+ CML in Patients Who Are Newly Diagnosed or Resistant or Intolerant to Prior TherapyBCHILD EfficacyBCHILD Study DesignSafetySafetyAdult: Newly Diagnosed Patients with CP Ph+ CMLBFORE SafetyAdult: Ph+ CML in Patients with Resistance or Intolerance to Prior TherapyStudy 200 SafetyPediatric: CP Ph+ CML in Patients Who Are Newly Diagnosed or Resistant or Intolerant to Prior TherapyBCHILD SafetyDosingDosingAdult Dosing and AdministrationPediatric Dosing and AdministrationTherapy ManagementSupport & ResourcesSupport & ResourcesEventsMaterialsVideosCo-pay, Access, and Patient SupportDownloadable Resources
Prescribing Information Indication Patient Site
Therapy ManagementManagement considerations for selected adverse reactions associated with BOSULIF® (bosutinib)

Diarrhea

Liver enzyme elevations

Myelosuppression

Fluid retention

Tab Number 5

Cases of diarrhea occurred early in treatment, with frequency and severity typically lessening over time175% of newly diagnosed adults with CP Ph+ CML experienced diarrhea2
  • 9% experienced grade 3/4 diarrhea
85% of adults with CP CML resistant or intolerant to prior therapy experienced diarrhea2
  • 10% experienced grade 3/4 diarrhea
76% of adults with AdvP CML resistant or intolerant to prior therapy experienced diarrhea2
  • 4% experienced grade 3/4 diarrhea
Diarrhea experienced by newly diagnosed adult patients​​​​Diarrhea experienced by adult patients with resistance or intolerance to prior therapy2,3Management strategies for diarrhea2

Diarrhea, nausea, vomiting, and abdominal pain occur with BOSULIF. Monitor and manage patients using standards of care, including:

Dose adjustments for diarrhea2
  • Withhold, dose reduce, or discontinue BOSULIF as necessary
Communication to patients5
  • Diet modifications may help limit diarrhea, such as avoiding:

Advise patients to seek medical attention promptly if symptoms persist.

AdvP=advanced phase; AE=adverse event; CP=chronic phase; CP-CML=chronic phase chronic myeloid leukemia; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; Ph+=Philadelphia chromosome–positive. Expert Panel reviewManagement of AEs for bosutinib

In 2018, an expert review panel of 7 hematologists discussing how they use BOSULIF as 1L or ≥2L in patients with CP-CML was published in the Journal of Hematology & Oncology. The full article, “Management of Adverse Events Associated With Bosutinib Treatment of Chronic-Phase Chronic Myeloid Leukemia: Expert Panel Review,” can be viewed on the journal site, linked below. A guide highlighting key takeaways is also available here for download. The FDA has not reviewed the recommendations contained in this reprint.

 Download guide Loading

Click to view the publication on the journal site (open access; no subscription required)

AE=adverse event.

References Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomized BFORE trial. J Clin Oncol. 2018;36(3):231-237. BOSULIF Prescribing Information. New York, NY: Pfizer Inc. Data on file. Pfizer Inc., New York, NY. Supplement to: Brümmendorf TH, Cortes JE, Milojkovic D, et al; BFORE study investigators. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial. Leukemia. 2022;36(7):1825-1833. Accessed October 25, 2023. https://www.nature.com/articles/s41375-022-01589-y.PDQ® Supportive and Palliative Care Editorial Board. PDQ Gastrointestinal Complications. National Cancer Institute. Updated August 24, 2023. Accessed October 18, 2023. https://www.cancer.gov/about-cancer/treatment/side-effects/constipation/GI-complications-hp-pdq.
In newly diagnosed adults
  • The incidence of ALT elevation was 68%, and AST elevation was 56%; the incidence of grade 3/4 elevations was 26% and 13%, respectively
  • Of patients who experienced transaminase elevations of any grade, 73% experienced their first event within the first 3 months
    • The median time to onset of increased ALT and AST was 29 and 56 days, respectively, and the median duration was 19 and 15 days, respectively

In adults with resistance or intolerance to prior therapy1

  • 60% of patients experienced an increase in either ALT or AST
  • Most cases of transaminase elevations occurred early in treatment
  • Of patients who experienced transaminase elevations of any grade, more than 81% experienced their first event within the first 3 months
    • The median time to onset of increased ALT and AST was 22 and 29 days, respectively, and the median duration for each was 21 days

Perform monthly hepatic enzyme tests for the first 3 months of treatment with BOSULIF and as clinically indicated. In patients with transaminase elevations, liver enzymes should be monitored more frequently.1

Dose adjustments for elevated liver transaminases1Communication to patients1
  • Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice
AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CP-CML=chronic phase chronic myeloid leukemia; ULN=upper limit of normal.
ReferenceBOSULIF Prescribing Information. New York, NY: Pfizer Inc.
  • Thrombocytopenia, anemia, and neutropenia occur with BOSULIF treatment1
  • Perform complete blood counts weekly for the first month of therapy and then monthly thereafter, or as clinically indicated1
  • To manage myelosuppression, withhold, dose reduce, or discontinue BOSULIF as necessary1
Dose adjustments for myelosuppression: neutropenia and thrombocytopeniaCommunication to patients1
  • Advise patients of the possibility of developing low blood cell counts and to immediately report fever, any suggestion of infection, or signs or symptoms suggestive of bleeding or easy bruising
AE=adverse event; ANC=absolute neutrophil count; CP-CML=chronic phase chronic myeloid leukemia.
ReferenceBOSULIF Prescribing Information. New York, NY: Pfizer Inc.
  • Fluid retention occurs with BOSULIF and may cause pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema1
  • Monitor and manage patients using standards of care1
Dose adjustments for fluid retention1

Interrupt, dose reduce, or discontinue BOSULIF as necessary

Communication to patients1
  • Advise patients of the possibility of developing fluid retention (swelling, weight gain, or shortness of breath) and to seek medical attention promptly if these symptoms arise
AE=adverse event; CP-CML=chronic phase chronic myeloid leukemia.
Reference BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
Header
DosingDownloadable resource Expert Panel review
Management of AEs for bosutinib

In 2018, an expert review panel of 7 hematologists discussing how they use BOSULIF as 1L or ≥2L in patients with CP-CML was published in the Journal of Hematology & Oncology. The full article, “Management of Adverse Events Associated With Bosutinib Treatment of Chronic-Phase Chronic Myeloid Leukemia: Expert Panel Review,” can be viewed on the journal site, linked below. A guide highlighting key takeaways is also available here for download. The FDA has not reviewed the recommendations contained in this reprint.

 View Publication Loading Download therapy guideLoading

Click to view the publication on the journal site (open access; no subscription required)

Downloadable resource Expert Panel review
Management of AEs for bosutinib

In 2018, an expert review panel of 7 hematologists discussing how they use BOSULIF as 1L or ≥2L in patients with CP-CML was published in the Journal of Hematology & Oncology. The full article, “Management of Adverse Events Associated With Bosutinib Treatment of Chronic-Phase Chronic Myeloid Leukemia: Expert Panel Review,” can be viewed on the journal site, linked below. A guide highlighting key takeaways is also available here for download. The FDA has not reviewed the recommendations contained in this reprint.

Download guide

LoadingDownloadable resource

Expert Panel review
Management of AEs for bosutinib

In 2018, an expert review panel of 7 hematologists discussing how they use BOSULIF as 1L or ≥2L in patients with CP-CML was published in the Journal of Hematology & Oncology. The full article, “Management of Adverse Events Associated With Bosutinib Treatment of Chronic-Phase Chronic Myeloid Leukemia: Expert Panel Review,” can be viewed on the journal site, linked below. A guide highlighting key takeaways is also available here for download. The FDA has not reviewed the recommendations contained in this reprint.

 Download guide Loading

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PP-BOS-USA-1062
INDICATIONSBOSULIF is indicated for the treatment of:

  • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy 

  • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy
Important Safety Information Contraindications: History of hypersensitivity to BOSULIF. Reactions have included anaphylaxis. Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain occur with BOSULIF. In the study of adults with newly diagnosed CP Ph+ CML, the median time to onset for diarrhea (all grades) was 4 days and the median duration per event was 3 days. In the study of adults with CML who were resistant or intolerant to prior therapy, median time to onset of diarrhea (all grades) was 2 days, median duration was 2 days, and the median number of episodes per patient was 3 (range 1-268). Among 49 pediatric patients with CP Ph+ CML that was newly diagnosed or resistant or intolerant to prior therapy, the median time to onset of diarrhea (all grades) was 2 days, median duration was 2 days, and the median number of episodes was 2 (range, 1–198). Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce, or discontinue BOSULIF as necessary. Myelosuppression: Thrombocytopenia, anemia, and neutropenia occur with BOSULIF. Perform complete blood counts weekly for the first month and then monthly thereafter, or as clinically indicated. Withhold, dose reduce, or discontinue BOSULIF as necessary. Hepatic Toxicity: In adults with mild, moderate, or severe hepatic impairment, the recommended starting dose is 200 mg daily. BOSULIF may cause elevations in serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]). Out of 1711 adults in BOSULIF clinical trials, 2 cases consistent with drug-induced liver injury have occurred without alternative causes. In the study of adults with newly diagnosed CP Ph+ CML, the incidence of ALT and AST elevations was 68% and 56%, respectively. In adults with CML who were resistant or intolerant to prior therapy, the incidence of ALT and AST elevations was 53% and 47%, respectively; 60% of these patients experienced an increase in either ALT or AST. Among 49 pediatric patients with CP Ph+ CML that was newly diagnosed or resistant or intolerant to prior therapy, the incidence of ALT and AST elevations was 59% and 51%, respectively; 76% of patients experienced an increase in either ALT or AST.Perform hepatic enzyme tests at least monthly for the first 3 months and as clinically indicated. In patients with transaminase elevations, monitor liver enzymes more frequently. Withhold, dose reduce, or discontinue BOSULIF as necessary.  Cardiovascular Toxicity: BOSULIF can cause cardiovascular toxicity, including cardiac failure, left ventricular dysfunction, and cardiac ischemic events. Cardiac failure events occurred more frequently in previously treated adults than in those with newly diagnosed CML and were more frequent in patients with advanced age or risk factors, including previous medical history of cardiac failure. Cardiac ischemic events occurred in both previously treated adults and in those with newly diagnosed CML and were more common in adults with coronary artery disease risk factors, including history of diabetes, body mass index greater than 30, hypertension, and vascular disorders. In a randomized study of adults with newly diagnosed CML, cardiac failure occurred in 1.9% of adults treated with BOSULIF compared to 0.8% of those treated with imatinib. Cardiac ischemic events occurred in 4.9% of adults treated with BOSULIF compared to 0.8% of those treated with imatinib. In a single-arm study of adults with CML who were resistant or intolerant to prior therapy, cardiac failure was observed in 5.3% of patients and cardiac ischemic events were observed in 5.1% of patients treated with BOSULIF. Among 49 pediatric patients with CP Ph+ CML that was newly diagnosed or resistant or intolerant to prior therapy, 4 patients (8%) had Grade 1-2 cardiac events, including tachycardia (n=2), angina pectoris, right bundle branch block, and sinus tachycardia (n=1 each). Monitor patients for signs and symptoms consistent with cardiac failure and cardiac ischemia and treat as clinically indicated. Interrupt, dose reduce, or discontinue BOSULIF as necessary. Fluid Retention: Fluid retention occurs with BOSULIF and may manifest as pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Monitor and manage patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF as necessary. Renal Toxicity: An on-treatment decline in estimated glomerular filtration rate has occurred in patients treated with BOSULIF. Monitor renal function at baseline and during therapy, with particular attention to patients with preexisting renal impairment or risk factors for renal dysfunction. Lower starting doses are recommended for patients with renal impairment. For patients who have declining renal function while on BOSULIF or who cannot tolerate the starting dose, follow dose adjustment recommendations for toxicity. Embryo-Fetal Toxicity: BOSULIF can cause fetal harm. Women of childbearing potential should be advised of the potential risk to the fetus and advised to use effective contraceptive measures while on treatment and for at least 2 weeks after the final dose. Adverse Reactions: The most common adverse reactions (≥20%), in adult and pediatric patients with CML are diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, respiratory tract infection, and constipation. The most common laboratory abnormalities (≥20%) in adult and pediatric patients are creatinine increased, hemoglobin decreased, lymphocyte count decreased, platelets decreased, ALT increased, calcium decreased, white blood cell count decreased, AST increased, absolute neutrophil count decreased, glucose increased, phosphorus decreased, urate increased, alkaline phosphatase increased, lipase increased, creatine kinase increased, and amylase increased. CYP3A Inhibitors and Inducers: Avoid concurrent use with strong or moderate CYP3A inhibitors or strong CYP3A inducers. Proton Pump Inhibitors (PPIs): Consider using short-acting antacids or H2 blockers instead of PPIs to avoid a reduction in BOSULIF exposure. Separate antacid or H2 blocker dosing and BOSULIF dosing by more than 2 hours. Lactation: Because of the potential for serious adverse reactions in a nursing child, breastfeeding is not recommended during treatment with BOSULIF and for at least 2 weeks after the last dose. Indications

BOSULIF is indicated for the treatment of:

  • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy 

  • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy
 Please see full Prescribing Information.