Safety profile

Long-term safety data: BOSULIF has a distinct safety profile that was established in 5- and 4-year follow-up1
  • The safety population consisted of 546 CML patients who received at least 1 dose of BOSULIF
  • Warnings and precautions for BOSULIF include gastrointestinal toxicity, myelosuppression, hepatic toxicity, fluid retention, renal toxicity, and embryofetal toxicity. Please click here for full Important Safety Information
Adverse reactions observed in ≥20% of patients in the Phase 1/2 safety population based on long-term follow-up (N=546)
Advanced phase CML includes patients with accelerated phase and blast phase CML.
Data are based on: a minimum follow-up of 60 months for patients with CP CML treated with one prior TKI (imatinib), and a minimum follow-up of 48 months for patients with CP CML treated with imatinib and at least one additional TKI and for patients with advanced phase CML.
Diarrhea occurrence
Diarrhea (all grades) was the most common side effect, occurring in 82% of patients taking BOSULIF1
  • 90% (n=406 of 450) of all patients who developed diarrhea had a maximum severity of Grade 1 or 2, and there were no cases of Grade 42
  • More than half of these patients (n=249 of 450) had a maximum severity of Grade 12
The majority of episodes of diarrhea were both transient and manageable1,2
  • 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 daily
 

 

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 retention
  • To manage fluid retention, monitor and manage patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF as necessary
QTcF prolongation1
1 out of 546 patients (0.2%) experienced QTcF prolongation (interval >500 ms) in the Phase 1/2 study
  • Patients with uncontrolled significant cardiovascular disease, including QT interval prolongation, were excluded by protocol
To learn more about managing adverse reactions, click here.

References
  1. BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
  2. Data on file. Pfizer Inc, New York, NY.
BOSULIF has a distinct cardiac and vascular toxicity profile1
At baseline, 22% of enrolled patients had a medical history of cardiac events; 33% of enrolled patients had a medical history of vascular events.a Patients with uncontrolled or significant cardiovascular disease, including QT interval prolongation, were excluded by protocol1

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

References
  1. Data on file. Pfizer Inc, New York, NY.
  2. BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
  3. Cortes JE, Jean Khoury H, 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.