In the BFORE Trial of BOSULIF vs imatinib
47% of patients receiving BOSULIF achieved MMR
at 12 months vs 37% with imatinib (P=0.0200)
1,a
BOSULIF significantly improved CCyR by 12 months vs imatinib
(77% vs 66%, respectively; P=0.0075) 1,a
BFORE: A two-arm, open-label, randomized, multicenter trial conducted to investigate the efficacy and
safety of BOSULIF 400 mg once daily compared with imatinib 400 mg once daily in adult patients with
newly diagnosed chronic phase Ph+ CML (N=487)
The most common adverse reactions reported in patients receiving BOSULIF
(all grades vs imatinib) were diarrhea (70% vs 34%), nausea (35% vs 38%),
thrombocytopenia (35% vs 20%), rash (34% vs 21%), increased ALT (31% vs 6%),
abdominal pain (25% vs 15%), and increased AST (23% vs 6%)
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) 2 :
Bosutinib (BOSULIF) is recommended by the NCCN Guidelines® as a primary treatment
option (category 1) for newly diagnosed patients with CML in need of TKI therapy.
Visit BosulifHCP.com to learn more about BOSULIF
Fluid Retention: Fluid retention can occur with BOSULIF and may cause pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Among 546
patients in a single-arm study of patients with Ph+ CML who were resistant or intolerant to prior therapy, Grade 3/4 fluid retention was reported in 26 patients (5%).
Monitor and manage patients using standards of care. Interrupt, dose reduce, or discontinue BOSULIF as necessary.
Embryofetal Toxicity: BOSULIF can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised of the potential
hazard to the fetus. Advise females of reproductive potential to use effective contraceptive measures to prevent pregnancy while being treated with BOSULIF and for at
least 1 month after the final dose.
Adverse Reactions: The most common adverse reactions observed in greater than or equal to 20% of patients with newly diagnosed CML were diarrhea, nausea,
thrombocytopenia, rash, increased ALT, abdominal pain, and increased AST. The most common Grade 3/4 adverse reactions and laboratory abnormalities observed in
greater than 10% of newly diagnosed CML patients were thrombocytopenia and increased ALT. The most common adverse reactions observed in greater than or equal to
20% of patients with CML who were resistant or intolerant to prior therapy were diarrhea, nausea, abdominal pain, rash, thrombocytopenia, vomiting, anemia, fatigue,
pyrexia, cough, headache, ALT, and edema. The most common Grade 3/4 adverse reactions and laboratory abnormalities observed in greater than 10% of patients who
were resistant or intolerant to prior therapy were thrombocytopenia, neutropenia, and anemia.
CYP3A Inhibitors and Inducers: Avoid concurrent use with strong or moderate CYP3A inhibitors or strong CYP3A inducers.
Proton Pump Inhibitors (PPIs): Use 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 serio