Therapy management

Adverse event management strategies for patients taking BOSULIF1
  • The following information can help you manage specific adverse events your patients may experience while taking BOSULIF
Diarrhea in the Phase 1/2 study (N=546)
82% of patients experienced diarrhea (all grades)2,3
  • No Grade 4 occurrences
  • 8% of patients experienced Grade 3 diarrhea
  • 1% of patients discontinued due to diarrhea

Management strategies for diarrhea2

Diarrhea, nausea, vomiting, and abdominal pain can occur. Monitor and manage patients using standards of care, including:

Dose adjustment for diarrhea2
  • Withhold, dose reduce, or discontinue BOSULIF as necessary
Communication to patients2,4

Adaptations in diet may help limit diarrhea, such as avoiding:

Advise patients to seek medical attention promptly if symptoms persist.
Management strategies for liver enzyme elevations
Liver enzyme elevations in the Phase 1/2 study2
  • Twenty percent of patients experienced an increase in either ALT or AST
  • Most cases of transaminase elevations occurred early in treatment
  • Of patients who experienced transaminase elevations of any grade, more than 80% experienced their first event within the first 3 months
  • The median time to onset of increased ALT and AST was 35 and 33 days, respectively, and the median duration for each was 21 days
Perform monthly hepatic enzyme tests for the first 3 months of treatment with BOSULIF and as clinically indicated. In patients with transaminase elevations, liver enzymes should be monitored more frequently.
Dose adjustments for elevated liver transaminases2
Communication to patients2
  • Explain to patients that their liver enzymes will be monitored for the first 3 months of treatment with BOSULIF and as clinically indicated, and the reasons for these assessments
  • Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice
Management strategies for myelosuppression
Dose adjustments for myelosuppression2
  • Dose reductions are recommended for severe or persistent neutropenia and thrombocytopenia
  • A complete blood count should be performed weekly for the first month and then monthly or as clinically indicated
  • Withhold, dose reduce, or discontinue BOSULIF as necessary
Dose adjustments for myelosuppression: neutropenia and thrombocytopenia2
Communication to patients2
  • Explain to patients that a complete blood count will be performed weekly for the first month of initiating BOSULIF and as clinically indicated to check for myelosuppression
  • Advise patients of the possibility of developing low blood cell counts and to immediately report fever, any suggestion of infection, or signs or symptoms suggestive of bleeding or easy bruising
Management strategies for fluid retention
  • Fluid retention can occur and may cause pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema
Fluid retention in the Phase 1/2 study2
  • Overall, severe fluid retention was reported in 26 (5%) patients from the total safety population (N=546)
    — 4% (n=21) of patients had Grade 3 or 4 pleural effusion
    — 1% (n=7) of patients experienced Grade 3 or 4 pericardial effusions
    — 1% (n=6) of patients experienced Grade 3 edema
Dose adjustments for fluid retention2
  • To manage fluid retention, monitor and manage patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF as necessary
 

References
  1. Welch MA, Kaled ES. Ensuring optimal adherence to BCR-ABL1 tyrosine kinase inhibitor therapy for chronic myeloid leukemia. Commun Oncol. 2013;10:138-146.
  2. BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
  3. Data on file. Pfizer Inc, New York, NY.
  4. Leukemia & Lymphoma Society. Digestive Disorders. http://www.lls.org/treatment/managing-side-effects/digestive-disorders. Accessed August 15, 2017.