bosutinib monohydrate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
bosutinib monohydrate: clinical details
Prescribing considerations
- Treatment should be initiated and supervised by a clinician experienced in CML therapy.
- Review renal, cardiovascular and gastrointestinal comorbidity, pancreatitis history, infection risk and interacting medicines.
- Correct clinically significant dehydration and hyperuricaemia before initiation because tumour lysis syndrome can occur.
- Test for hepatitis B before treatment and obtain specialist input for positive serology.
- Assess pregnancy potential, contraception and fertility-preservation needs.
- Advise sun protection because photosensitivity can occur.
Contraindications and cautions
- Hypersensitivity to bosutinib or a formulation excipient.
- Hepatic impairment.
Monitoring
- Check full blood count, liver function and renal function before and during treatment.
- Monitor for diarrhoea, vomiting, dehydration, fluid retention, infection, pancreatitis, cardiovascular toxicity and severe skin reactions.
- Consider ECG and electrolyte assessment where QT prolongation or cardiovascular risk is present.
- Monitor hepatitis B carriers during and after treatment.
Clinical pharmacology
Bosutinib is an oral inhibitor of BCR-ABL and Src-family kinases. It is principally affected by CYP3A-mediated interactions, and raised gastric pH reduces its absorption.
Formulation and product differences
- Film-coated tablets must be swallowed whole and not cut, crushed, broken or chewed.
- Hard capsules may be swallowed whole or opened and mixed with applesauce or yoghurt for immediate consumption without chewing.
- Both formulations are taken with food; opened-capsule soft food does not replace the accompanying meal.
bosutinib monohydrate preparations and strengths
Capsule
Route: Oral
Strengths: 50 mg, 100 mg
Tablet
Route: Oral
Strengths: 100 mg, 400 mg, 500 mg
bosutinib monohydrate interactions
A full medicines review is needed before treatment and whenever another medicine is started or stopped.
Strong or moderate CYP3A inhibitors, including clarithromycin, azole antifungals, ritonavir, verapamil and diltiazem
These can increase bosutinib exposure and adverse effects, so combined use should generally be avoided or managed by the specialist.
Strong or moderate CYP3A inducers, including rifampicin, carbamazepine, phenytoin and St John's wort
These can substantially reduce bosutinib exposure and may make treatment less effective, so combined use should generally be avoided.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.