Applies to the following strengths: 100 mg; 500 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Chronic Myelogenous Leukemia
500 mg orally once a day with food
Duration of therapy: Until disease progression or patient intolerance
Comments: If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day.
Use: Treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
Renal Dose Adjustments
Severe renal dysfunction (CrCl less than 30 mL/min): 300 mg orally once a day
Liver Dose Adjustments
Pre-existing mild, moderate or severe hepatic impairment: 200 mg orally once a day
Dose Escalation: Dose escalation to 600 mg once a day should be considered in patients currently taking 500 mg a day, who do not reach complete hematological response (CHR) by week 8 or a complete cytogenetic response (CCyR) by week 12, who did not have Grade 3 or higher side effects.
Non-Hematologic Adverse Reactions:
-Liver transaminases greater than 5 times the upper limit of normal (5 x ULN): Drug should be withheld until recovery to less than or equal to 2.5 x ULN and resume at 400 mg once a day thereafter. If recovery takes longer than 4 weeks, discontinue use.
-Liver transaminases greater than or equal to 3 x ULN concurrently with bilirubin greater than 2 x ULN and alkaline phosphatase less than 2 x ULN (Hy's law case definition): discontinue use
-Diarrhea: For NCI CTCAE Grade 3 to 4 diarrhea (increase of greater than or equal to 7 stools/day over baseline/pretreatment): Drug should be withheld until recovery to grade less than or equal to 1. Bosutinib may be resumed at 400 mg once a day.
-For other clinically significant, moderate or severe non-hematological toxicity: Drug should be withheld until toxicity has resolved, then consider resuming bosutinib at 400 mg once a day. If clinically appropriate, consider re-escalating the dose to 500 mg once a day.
-Absolute neutrophil count (ANC less than 1000 x 10(6)/L or platelets less than 50,000 x 10(6)/L: Drug should be withheld until ANC is greater than or equal to 1000 x 10(6)/L and platelets are greater than or equal to 50,000 x 10(6)/L. Resume treatment with bosutinib at the same dose if recovery occurs within 2 weeks; reduce dose by 100 mg and resume if recovery takes longer than 2 weeks. If cytopenia recurs, reduce dose by an additional 100 mg upon recovery and resume treatment.
-Daily doses less than 300 mg have not been evaluated.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
-Data not available
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- Drug class: BCR-ABL tyrosine kinase inhibitors
Other brands: Bosulif