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In the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy
Everyone has a distinct profile
Consider your patient.Consider BOSULIF.
( b o s u t inib)
Bosutinib (BOSULIF ® ) is recommended by the NCCN Clinical Practice Guidelines in
Oncology (NCCN Guidelines ® ) as a treatment option for patients with CML in need
of 2nd- or later-line TKI therapy. 1
Study design: BOSULIF 500 mg once-daily treatment was studied in a single-arm, Phase 1/2, open-label, multicenter
trial (N=546) in patients with CP, AP, or BP CML in second line (after imatinib) or in third line (after imatinib followed by
dasatinib and/or nilotinib). Of the 546 patients enrolled, 73% were imatinib resistant and 27% were imatinib intolerant. 2
AP=accelerated phase; BP=blast phase; CP=chronic phase.
Contraindication: History of hypersensitivity to BOSULIF. Reactions have
included anaphylaxis. Anaphylactic shock occurred in less than 0.2% of treated
patients in clinical trials.
Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain
can occur. In the clinical trial, median time to onset for diarrhea was 2 days,
median duration was 1 day, and median number of episodes per patient was 3
(range 1-221). 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 then monthly
or as clinically indicated. Withhold, dose reduce, or discontinue BOSULIF
as necessary.
Hepatic Toxicity: Twenty percent of patients experienced an increase in either
ALT or AST. Liver enzyme elevation usually occurs early in treatment. Perform
T:15
G:.5”
BOSULIF is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia
chromosome–positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.
IMPORTANT SAFETY INFORMATION
B:1
hepatic enzyme tests monthly for the first 3 months and as clinically indicated.
In patients with transaminase elevations, monitor liver enzymes more
frequently. Drug-induced liver injury has occurred. 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. Consider dose adjustment
in patients with baseline and treatment emergent renal impairment. The
recommended starting doses for patients with severe renal impairment
(CrCL <30 mL/min) or moderate renal impairment (CrCL 30-50 mL/min)
are 300 mg and 400 mg daily, respectively.
Fluid Retention: Fluid retention can occur and may cause pericardial effusion,
pleural effusion, pulmonary edema, and/or peripheral edema. Monitor
and manage patients using standards of care. Interrupt, dose reduce, or
discontinue BOSULIF as necessary.