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Bosulif Generic Name & Formulations
Legal Class
Rx
General Description
Bosutinib 100mg, 400mg, 500mg; tabs.
Pharmacological Class
Tyrosine kinase inhibitor.
How Supplied
Tabs 100mg—120; 400mg, 500mg—30
Manufacturer
Generic Availability
NO
Bosulif Indications
Indications
Newly-diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.
Bosulif Dosage and Administration
Adult
Take with food. Swallow whole. Continue until disease progression or patient intolerance. Newly-diagnosed: 400mg once daily. Renal impairment (CrCl 30–50mL/min): initially 300mg daily; (CrCl <30mL/min): initially 200mg daily. With resistance/intolerance to prior therapy: 500mg once daily. Renal impairment (CrCl 30–50mL/min): initially 400mg daily; (CrCl <30mL/min): initially 300mg daily. Both: hepatic impairment: initially 200mg daily. Dose escalation or dose adjustments for toxicity: see full labeling.
Children
<18yrs: not established.
Bosulif Contraindications
Not Applicable
Bosulif Boxed Warnings
Not Applicable
Bosulif Warnings/Precautions
Warnings/Precautions
Monitor and manage GI toxicity, cardiac failure/ischemia, fluid retention; withhold, reduce dose, or discontinue as necessary. Coronary artery disease risk factors (including history of diabetes, BMI >30, hypertension, vascular disorders): higher occurrence of cardiac ischemic events. Perform CBC weekly for first month, then monthly; hepatic enzyme tests monthly for first 3 months (more frequently if transaminase elevations occur); withhold, reduce dose, or discontinue as necessary. Monitor renal function at baseline and during therapy; consider adjusting dose if renal impairment occurs. Dialysis: not studied. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥2 weeks after the last dose. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).
Bosulif Pharmacokinetics
See Literature
Bosulif Interactions
Interactions
Potentiated by strong or moderate CYP3A inhibitors (eg, ketoconazole, aprepitant, grapefruit products); avoid concomitant use. Antagonized by strong CYP3A inducers (eg, rifampin, St. John’s wort); avoid concomitant use. Antagonized by proton pump inhibitors (eg, lansoprazole); consider short-acting antacids or H2 blockers instead; separate dosing by >2hrs.
Bosulif Adverse Reactions
Adverse Reactions
Diarrhea, rash, nausea, abdominal pain, vomiting, fatigue, hepatic dysfunction, respiratory tract infection, pyrexia, headache, lab abnormalities; myelosuppression, pneumonia, pleural effusion, coronary artery disease, gastroenteritis.
Bosulif Clinical Trials
See Literature
Bosulif Note
Not Applicable
Bosulif Patient Counseling
See Literature
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