The content of this website has been produced in line with the BOSULIF®▼ (bosutinib) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. BOSULIF▼ Prescribing Information for Great Britain and for Northern Ireland, and adverse event reporting information can be found at the bottom of the page.
Understand the differences between the 2013 and 2020 Guideline
BOSULIF (bosutinib) is approved as an option, within its marketing authorisation, for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults, when:
they have previously had 1 or more tyrosine kinase inhibitor and
imatinib, nilotinib and dasatinib are not appropriate and
the company provided bosutinib with the discount agreed in the patient access scheme (as revised in 2016)
** This is an optional area where footnotes can live.
Statement from Scottish Medicines Consortium website on Bosulif
Following a re-submission considered under the ultra-orphan medicine process1:
Bosutinib (Bosulif) is accepted for use within NHS Scotland.
Indication under review: Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (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.
Major cytogenetic response was achieved in 23/52 patients who represented “unmet medical need” within a non-comparative phase I/II study, in which the full population included 546 patients with CP, AP or BP imatinib pre-treated Ph+ CML.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bosutinib. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
For Great Britain
Bosulif (bosutinib) Prescribing Information - 100mg Tablets
Bosulif (bosutinib) Prescribing Information - 400mg Tablets
Bosulif (bosutinib) Prescribing Information - 500mg Tablets
For Northern Ireland
Bosulif (bosutinib) Prescribing Information
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