Active Ingredient: Bosutinib
Bosutinib is indicated for the treatment of adult patients with accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 500 milligrams bosutinib, once daily to meals.
The recommended dose is 500 mg bosutinib once daily.
In clinical studies for both indications, treatment with bosutinib continued until disease progression or intolerance to therapy.
In adult patients with CML who are resistant or intolerant to prior therapy, doses can be escalated to 600 mg in those with unsatisfactory response or with signs of progression and in the absence of any Grade 3 or 4 or persistent Grade 2 adverse events.
If clinically significant moderate or severe non-haematological toxicity develops, bosutinib should be interrupted, and may be resumed at a dose reduced by 100 mg taken once daily after the toxicity has resolved. If clinically appropriate, re-escalation to the dose prior to the dose reduction taken once daily should be considered. Doses less than 300 mg/day have been used in patients; however, efficacy has not been established.
If a dose is missed by more than 12 hours, the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day.
Bosutinib should be taken orally once daily with food.
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