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EfficacyBOSULIF efficacy​​​​​​​EfficacyLinkLinkLinkLinkBFORE studyBYOND studyStudy 200SafetySafety dataDosingBosulif Dosing informationSupport & ResourcesSupport and ResourcesMaterials

Click here for BOSULIF® (bosutinib) Prescribing Information. Adverse event reporting information can be found at the bottom of the page.

EfficacyA breadth of clinical research1-8 BOSULIF® (bosutinib) has been studied in a large number of CML patients and a wide range of patient types Third- and fourth-line subgroups comprise of patients with CP CML that were imatinib resistant or imatinib intolerant and ≥1 of the following: dasatinib resistant or dasatinib intolerant, nilotinib resistant, nilotinib intolerant or resistant/intolerant to dasatinib and nilotinib.5,7 Consider BOSULIF for your adult Ph+ CML patients1 BFORE study: View study Loading BYOND study: View study Loading Study 200 View study Loading Recommended starting dose in first-line1

400 mg BOSULIF once daily for adult patients with newly diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)


Recommended starting dose in second-line and beyond1

500 mg BOSULIF once daily for adult patients with CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib, and dasatinib are not considered appropriate treatment options

Dose Adjustment1

Dose escalation or reduction by 100mg may be considered depending on patients response and tolerability. Doses greater than 600 mg/day have not been studied and, therefore, should not be given. Doses less than 300 mg/day have been used in patients; however, efficacy has not been established. 

Consider BOSULIF when you make a TKI switch1AP=accelerated phase; BP=blast phase; CML=chronic myelogenous leukemia; CP=chronic phase; Ph+=Philadelphia chromosome-positive; TKI=tyrosine kinase inhibitor. Please refer to the BOSULIF SmPC for full details of adverse events BOSULIF Summary of Product Characteristics  Loading
References:BOSULIF (bosutinib) Summary of Product Characteristics.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.Brümmendorf TH, Cortes JE, Milojkovic D, et al. Bosutinib (BOS) versus imatinib for newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML): final 5-year results from the Bfore trial. Oral presentation at American Society of Hematology; December 5, 2020; San Diego, CA.Cortes JE, Kantarjian HM, Brümmendorf TH, et al. Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome–positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood. 2011;118(17):4567-4576.Cortes JE, Khoury HJ, Kantarjian HM, et al. Long-term bosutinib for chronic phase chronic myeloid leukemia after failure of imatinib plus dasatinib and/or nilotinib. Am J Hematol. 2016;91(12):1206-1214.Gambacorti-Passerini C, Kantarjian HM, Kim D-W, et al. Long-term efficacy of bosutinib in patients with advanced leukemia following resistance/intolerance to imatinib and other tyrosine kinase inhibitors. Am J Hematol. 2015;90(9):755-768.Hochhaus A, Gambacorti-Passerini C, Abboud C, et al; BYOND Study Investigators. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study. Leukemia. 2020;34(8) identifier: NCT02228382. Updated March 11, 2021. Accessed December 2022.
Efficacy Safety

The safety profile of BOSULIF is well established and includes long-term, cardiac, and vascular data1

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PP-BOS-IRL-0175. Date of Preparation December 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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