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Diarrhea
Liver enzyme elevations
Myelosuppression
Fluid retention
Tab Number 5
Diarrhea, nausea, vomiting, and abdominal pain occur with BOSULIF. Monitor and manage patients using standards of care, including:
Advise patients to seek medical attention promptly if symptoms persist.
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.
Click to view the publication on the journal site (open access; no subscription required)
AE=adverse event.
In adults with resistance or intolerance to prior therapy1
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
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.
Click to view the publication on the journal site (open access; no subscription required)
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.
Click to view the publication on the journal site (open access; no subscription required)
Interrupt, dose reduce, or discontinue BOSULIF as necessary
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.
Click to view the publication on the journal site (open access; no subscription required)
The Therapy Management Guide provides guidance for monitoring and managing the most common adverse reactions in adult patients receiving bosutinib. Considerations on what to communicate to patients are also included.
Download guide
To report an adverse event, please call 1-800-438-1985
Pfizer for Professionals 1-800-505-4426
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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
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