EXPANDED APPROVAL
NOW INDICATED FOR ADULT PATIENTS WITH
NEWLY DIAGNOSED CHRONIC PHASE Ph+ CML
BOSULIF® (bosutinib) is indicated for the treatment of adult patients with
• Newly diagnosed chronic phase Ph+ chronic myelogenous leukemia (CML).
This indication is approved under accelerated approval based on molecular
and cytogenetic response rates. Continued approval for this indication may
be contingent upon verification and confirmation of clinical benefit in an
ongoing long-term follow-up trial
• Chronic phase, accelerated phase, or blast phase Ph+ CML with resistance
or intolerance to prior therapy
IMPORTANT SAFETY INFORMATION
Contraindication: History of hypersensitivity to BOSULIF. Reactions have included anaphylaxis. Anaphylactic shock occurred in less than 0.2% of treated patients in
single-agent cancer studies with BOSULIF.
Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain can occur. In the randomized clinical trial of patients with newly diagnosed Ph+ CML, the
median time to onset for diarrhea (all grades) among patients in the BOSULIF treatment group (n=268) was 3 days and the median duration per event was 3 days.
Among 546 patients in a single-arm study of patients with CML who were resistant or intolerant to prior therapy, median time to onset of diarrhea (all grades) was
2 days, median duration was 2 days, and the median number of episodes per patient was 3 (range 1-268). Monitor and manage patients using standards of care,
including antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce, or discontinue BOSULIF as necessary.
Myelosuppression: Thrombocytopenia, anemia, and neutropenia can occur. Perform complete blood counts weekly for the first month and monthly thereafter, or as
clinically indicated. Withhold, dose reduce, or discontinue BOSULIF as necessary.
Hepatic Toxicity: Elevations in serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) can occur. Perform hepatic enzyme tests
at least monthly for the first 3 months and as clinically indicated. In patients with transaminase elevations, monitor liver enzymes more frequently. One case consistent
with drug-induced liver injury occurred without alternative causes in a trial of BOSULIF in combination with letrozole. Withhold, dose reduce, or discontinue BOSULIF as
necessary. In patients with mild, moderate, or severe hepatic impairment, the recommended starting dose is 200 mg daily.
Renal Toxicity: An on-treatment decline in estimated glomerular filtration rate has occurred in patients treated with BOSULIF. Monitor renal function at baseline and
during therapy, with particular attention to patients with preexisting renal impairment or risk factors for renal dysfunction. Consider dose adjustment in patients with
baseline and treatment-emergent renal impairment.
Reduce the BOSULIF starting dose in patients with moderate (creatinine clearance [CLcr] 30 to 50 mL/min) or severe (CLcr less than 30 mL/min) renal impairment at
baseline. For patients who have declining renal function while on BOSULIF who cannot tolerate the starting dose, follow dose adjustment recommendations for toxicity.