Bosutinib Monohydrate
Bosutinib Monohydrate is a targeted therapy medication known as a tyrosine kinase inhibitor used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). It is specifically indicated for adult patients who have developed resistance or intolerance to prior leukemia therapies, including other tyrosine kinase inhibitors. The medication works by blocking specific proteins that drive abnormal cell growth in leukemia cells.
Bosutinib Monohydrate is a tyrosine kinase inhibitor used to treat Philadelphia chromosome-positive chronic myeloid leukemia in adults who have become resistant or intolerant to other therapies.
Key facts at a glance
- RxNorm
- 1314319
- Generic
- Bosutinib Monohydrate
- Class
- pin-variant
- Brands
- —
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- —
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
12 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks - bosutinib may cause fetal harm based on animal studies
regular fetal monitoring including ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
discontinue therapy if pregnancy occurs during treatment
regular fetal monitoring and growth assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near delivery due to potential complications
regular fetal monitoring and assessment for preterm labor
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot applicable
do not breastfeed during bosutinib therapy and for at least 2 weeks after last dose
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyno specific dose adjustment required
monitor for adverse events - elderly patients may have increased susceptibility to diarrhea and myelosuppression
regular monitoring of blood counts and gastrointestinal symptoms
Use with caution and monitor for adverse effects.
pediatric_age
adolescentsnot recommended
bosutinib is not indicated for use in patients under 18 years of age - safety and efficacy not established
not applicable for pediatric population
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild renal impairmentno adjustment needed
no dose adjustment required for mild renal impairment (CrCl 50-80 mL/min)
monitor renal function periodically
Use with caution and monitor for adverse effects.
renal_impairment
moderate renal impairmentreduce dose
dose reduction recommended for moderate renal impairment (CrCl 30-50 mL/min) - consider reducing starting dose to 400 mg once daily
regular monitoring of renal function and adverse effects
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentreduce dose significantly
dose reduction recommended for severe renal impairment (CrCl <30 mL/min) - consider reducing starting dose to 300 mg once daily
close monitoring of renal function and adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno adjustment needed
no dose adjustment required for mild hepatic impairment (Child-Pugh Class A)
monitor liver function tests periodically
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate hepatic impairmentreduce dose
dose reduction recommended for moderate hepatic impairment (Child-Pugh Class B) - consider reducing starting dose to 400 mg once daily
frequent monitoring of liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
severe hepatic impairmentavoid if possible
use with extreme caution in severe hepatic impairment (Child-Pugh Class C) - consider alternative therapy
frequent monitoring of liver function tests and clinical status
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
Drug class
Bosutinib is a Bcr-Abl tyrosine kinase inhibitor
Common uses
FDA-approved indication for treatment of chronic phase, accelerated phase, or blast phase Philadelphia chromosome-positive CML
FDA approval year
Initial FDA approval date for Bosutinib
Mechanism of action
Inhibits Bcr-Abl fusion protein to block leukemic cell proliferation
Treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adult patients with resistance or intolerance to prior tyrosine kinase inhibitor therapy.
Acts as a dual Src/Abl tyrosine kinase inhibitor that blocks the BCR-ABL oncoprotein and Src family kinases, disrupting abnormal signaling pathways that promote uncontrolled proliferation of leukemic cells.
Administered orally once daily with food. Common adverse effects include gastrointestinal symptoms (diarrhea, nausea, vomiting), fluid retention, rash, and liver enzyme elevations. Requires regular monitoring of hematologic and hepatic parameters. May interact with proton pump inhibitors and strong CYP3A4 inhibitors. Contraindicated during pregnancy due to potential fetal harm.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed August 24, 2026. · Read our editorial policy