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The content of this website has been produced in line with the BOSULIF® (bosutinib) Summary of Product Characteristics for Great Britain and Northern Ireland. For BOSULIF® (bosutinib) Prescribing Information Click here. Adverse event reporting information can be found at the bottom of the page.

Safety Data

A well defined and manageable safety profile1

<1% of the overall patient population discontinued due to diarrhoea​​​​​​​1

Example

y-axis: AE, x-axis: patients, %
*Patients in the overall safety population include 1372 patients from SmPC with newly-diagnosed CP CML or who were resistant or intolerant to prior therapy with chronic, accelerated, or blast phase CML or Ph+ ALL. Patients within the safety population received one or more doses of BOSULIF®.1

†19 patients discontinued bosutinib due to neutropenia

No new cardiac or vascular safety signals at 36 months in newly diagnosed patients2​​​​​​​​​​​​​​

Safety events for study population exposed to bosutinib/imatinib

Example

*Patients who received ≥1 dose of study drug.
†Includes one Grade 5 event (cardiac failure) unrelated to the study drug.
‡Includes one Grade 5 event (cerebrovascular accident) unrelated to the study drug. Further information

 Please refer to the BOSULIF SmPC for full details of adverse events

 BOSULIF SmPC Loading

AE, adverse event; ALL, acute lymphoblastic leukaemia; ALT, alanine aminotransferase; AP, accelerated phase; AST, aspartate aminotransferase; BP, blast phase; CML, chronic myeloid leukaemia; CP, chronic phase; Ph+, Philadelphia chromosome-positive; SmPC, Summary of Product Characteristics.

References:

BOSULIF Summary of Product Characteristics for Great Britain click here. BOSULIF Summary of Product Characteristics for Northern Ireland click here.Brümmendorf T, et al. Presented at the 24th Congress of the European Hematology Association (EHA), 2019; Poster PF413.
PP-BOS-GBR-1613. June 2022
Quick links

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store


Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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