Active Ingredient: Bosutinib
Bosutinib is indicated for the treatment of adult and paediatric patients aged 6 years and older with CP 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.
For:
In case that patient age in years is ≥ 6
Oral, 400 milligrams bosutinib, once daily to meals.
The recommended dosage of bosutinib for newly-diagnosed paediatric patients is 300 mg/m² body surface area (BSA) orally once daily and the recommended dosage for paediatric patients resistant or intolerant (R/I) to prior therapies is 400 mg/m² BSA orally once daily; dose recommendations are provided in the following table.
Dosing of bosutinib for paediatric patients with CP Ph+ CML with resistance or intolerance to prior therapy:
| BSA | ND Recommended Dose | R/I Recommended Dose |
|---|---|---|
| 0.55 – <0.63 m² | 200 mg | 250 mg |
| 0.63 – <0.75 m² | 200 mg | 300 mg |
| 0.75 – <0.9 m² | 250 mg | 350 mg |
| 0.9 – <1.1 m² | 300 mg | 400 mg |
| ≥1.1 m² | 400 mg* | 500 mg* |
* maximum starting dose (corresponding to maximum starting dose in adult indication)
Abbreviations: BSA=body surface area; CML=chronic myeloid leukaemia; Ph+=Philadelphia chromosome-positive; R/I=resistant or intolerant.
In paediatric patients with BSA <1.1 m² and an insufficient response after 3 months consider increasing dose by 50 mg increments up to maximum of 100 mg above BSA-adjusted recommended dose. In paediatric patients with BSA ≥1.1 m² and an insufficient response after 3 months consider increasing dose similarly to adult recommendations in 100 mg increments. If there is inadequate clinical response and further dose escalation cannot be performed in paediatric patients, treatment will be stopped.
The maximum dose in paediatric patients is 600 mg once daily in previously treated CML.
Doses greater than 600 mg/day have not been studied and, therefore, should not be given.
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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