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
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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 .