5
YEARS of data in newly diagnosed adults with CP Ph + CML 1
NCCN Clinical Practice Guidelines in Oncology ( NCCN Guidelines ®) 3
Bosutinib ( BOSULIF ®) is recommended by the NCCN Guidelines as a primary treatment option for patients with newly diagnosed CML ( category 1 ).
Long-term safety profile with 5-year follow-up
• Warnings and precautions for BOSULIF include gastrointestinal toxicity , myelosuppression , hepatic toxicity , cardiovascular toxicity , fluid retention , renal toxicity , and embryo-fetal toxicity 1
Adverse reaction
Most common ( all-grade ) ARs 1
BOSULIF n = 268 (%)
Imatinib n = 265 (%)
Diarrhea 75 40 Hepatic dysfunction 45 15 Rash 40 30 Abdominal pain 39 27 Nausea 37 42
Cases of diarrhea occurred early in treatment and discontinuation rates remained low 1 , 2
• 4 days : Median time to onset of diarrhea in the BOSULIF arm 1
• 3 days : Median duration of diarrhea in the BOSULIF arm 1
• 1.5 % of patients : Discontinued due to diarrhea in the BOSULIF arm 2
Monitor and manage patients using standards of care , including antidiarrheals , antiemetics , and fluid replacement . Withhold , dose reduce , or discontinue BOSULIF as necessary .
Additional safety information 1 :
• Cardiac failure occurred in 1.9 % of patients treated with BOSULIF , compared to 0.8 % of patients treated with imatinib . Cardiac ischemic events occurred in 4.9 % of patients treated with BOSULIF , compared to 0.8 % of patients treated with imatinib
• Patients with uncontrolled or significant cardiovascular disease , including prolonged QT interval , were excluded by protocol
• Grade 3 / 4 hepatic dysfunction was reported in 27 % of patients treated with BOSULIF vs 4 % of patients treated with imatinib
Convenient , once-daily dosing
The recommended starting dose for newly diagnosed patients with CP Ph + CML is 400 mg once daily . 1
Tablet shown is not actual size .
Learn more at BosulifHCP . com
AR = adverse reaction ; BFORE = Bosutinib Trial in First-Line Chronic Myelogenous Leukemia Treatment ; MMR = major molecular response ; MR = molecular response ; NCCN = National Comprehensive Cancer Network ; Ph += Philadelphia chromosome – positive .
Fluid Retention : Fluid retention occurs with BOSULIF and may manifest as 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 .
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 . Lower starting doses are recommended for patients with renal impairment . For patients who have declining renal function while on BOSULIF or who cannot tolerate the starting dose , follow dose adjustment recommendations for toxicity .
Embryo-Fetal Toxicity : BOSULIF can cause fetal harm . Women of childbearing potential should be advised of the potential risk to the fetus and advised to use effective contraceptive measures while on treatment and for at least 2 weeks after the final dose .
Adverse Reactions : The most common adverse reactions , in ≥20 % of patients with newly diagnosed CP Ph + CML or CP , AP , or BP Ph + CML with resistance or intolerance to prior therapy ( N = 814 ) were diarrhea ( 80 %), rash ( 44 %), nausea ( 44 %), abdominal pain ( 43 %), vomiting ( 33 %),
fatigue ( 33 %), hepatic dysfunction ( 33 %), respiratory tract infection ( 25 %), pyrexia ( 24 %), and headache ( 21 %). The most common laboratory abnormalities that worsened from baseline in ≥20 % of patients were creatinine increased ( 93 %), hemoglobin decreased ( 90 %), lymphocyte count decreased ( 72 %), platelets decreased ( 69 %), ALT increased ( 58 %), calcium decreased ( 53 %), white blood cell count decreased ( 52 %), absolute neutrophil count decreased ( 50 %), AST increased ( 50 %), glucose increased ( 46 %), phosphorus decreased ( 44 %), urate increased ( 41 %), alkaline phosphatase increased ( 40 %), lipase increased ( 36 %), creatine kinase increased ( 29 %), and amylase increased ( 24 %).
CYP3A Inhibitors and Inducers : Avoid concurrent use with strong or moderate CYP3A inhibitors or strong CYP3A inducers .
Proton Pump Inhibitors ( PPIs ): Consider using short-acting antacids or H2 blockers instead of PPIs to avoid a reduction in BOSULIF exposure . Separate antacid or H2 blocker dosing and BOSULIF dosing by more than 2 hours .
Lactation : Because of the potential for serious adverse reactions in a nursing child , breastfeeding is not recommended during treatment with BOSULIF and for at least 2 weeks after the last dose .
References : 1 . BOSULIF Prescribing Information . New York , NY : Pfizer Inc . 2 . Data on file . Pfizer Inc ., New York , NY . 3 . Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology ( NCCN Guidelines ®) for Chronic Myeloid Leukemia V . 3.2021 . © National Comprehensive Cancer Network , Inc . 2021 . All rights reserved . Accessed May 1 , 2021 .
PP-BOS-USA-0762-02 © 2021 Pfizer Inc . All rights reserved . Printed in USA / June 2021