Skip to Content

Bosutinib Dosage

Applies to the following strength(s): 100 mg ; 500 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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 Adjustments

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.

Myelosuppression:
-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.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

-Data not available

Hide