Safety

In a Phase 1/2 trial in adults with CP, AP, or BP Ph+ CML resistant or intolerant to prior therapy 

Long-term safety data

The most common adverse reactions with BOSULIF are well-established1
Warnings and precautions for BOSULIF include gastrointestinal toxicity, myelosuppression, hepatic toxicity, fluid retention, renal toxicity, and embryofetal toxicity
The long-term follow-up data analysis was based on a minimum of 60 months for patients with CP CML treated with 1 prior TKI (imatinib) and a minimum of 48 months for patients with CP CML treated with imatinib and at least 1 additional TKI and for patients with advanced phase CML.1
Learn more about select adverse reactions, including therapy management suggestions and dose adjustments.
ALT=alanine aminotransferase; AP=accelerated phase; ARs=adverse reactions; BP=blast phase; Ph+=Philadelphia chromosome–positive.
Diarrhea
Diarrhea (all grades) was the most common adverse reaction, occurring in 82% of patients receiving BOSULIF (N=450)1,2
90% (406 out of 450) of patients who developed diarrhea had a maximum severity of Grade 1 or 2, and there were no Grade 4 cases2
More than half of these patients (249 out of 450) had a maximum severity of Grade 12
Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and fluid replacement. For NCI CTCAE Grade 3/4 diarrhea (increase of ≥7 stools/day over baseline/pretreatment), withhold BOSULIF until recovery to Grade ≤1. BOSULIF may be resumed at 400 mg once daily1
Patients experiencing diarrhea (n=450)2
Learn more about select adverse reactions, including therapy management suggestions and dose adjustments.
NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.
Fluid retention1
5% (n=26) of patients had severe (Grade 3/4) fluid retention
4% (n=21) of patients experienced Grade 3 or 4 pleural effusion
1% (n=7) of patients experienced Grade 3 or 4 pericardial effusion
1% (n=6) of patients experienced Grade 3 edema
How to manage fluid retention1
To manage fluid retention, monitor and manage patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF as necessary
Learn more about select adverse reactions, including therapy management suggestions and dose adjustments.
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
2.
Data on file. Pfizer Inc, New York, NY.

Cardiac and vascular data

BOSULIF has long-term cardiac and vascular safety data
Patients with uncontrolled or significant cardiovascular disease, including prolonged QT interval, were excluded by protocol.1
Long-term follow-up of adult patients with CP Ph+ CML and with advanced leukemias
Total extended safety population (N=570) included patients with CP Ph+ CML (n=403) and advanced Ph+ leukemias (AP CML [n=79], BP CML [n=64], and ALL [n=24])1,2,a
QTcF prolongation: 1 out of 546 patients (0.2%) experienced QTcF interval >500 ms in the Phase 1/2 study.
The long-term follow-up data analysis was based on a minimum of 60 months for patients with CP CML treated with 1 prior TKI (imatinib) and a minimum of 48 months for patients with CP CML treated with imatinib and at least 1 additional TKI and for patients with advanced phase CML.1
aBOSULIF is not indicated for the treatment of ALL.1
ALL=acute lymphoblastic leukemia; AP=accelerated phase; BP=blast phase; ECG=electrocardiogram; Ph+=Philadelphia chromosome–positive; QTcF=QT interval corrected for heart rate using the Fridericia formula; TKI=tyrosine kinase inhibitor.
Patients with known risk factors for cardiac and vascular events tend to have the highest incidence of cardiac and vascular complications3
Close monitoring, particularly in high-risk patients, and proactive management should be standard of care before starting therapy.3
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
2.
Data on file. Pfizer Inc, New York, NY.
3.
Cortes JE, Khoury HJ, Kantarjian H, et al. Long-term evaluation of cardiac and vascular toxicity in patients with Philadelphia chromosome-positive leukemias treated with bosutinib. Am J Hematol. 2016;91(6):606-616. doi:10.1002/ajh.24360.