HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BOSULIF safely and effectively. See full prescribing information for BOSULIF.
BOSULIF® (bosutinib) tablets, for oral use
Initial U.S. Approval: 2012
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 400 mg, and 500 mg. (3)
Hypersensitivity to BOSULIF. (4)
WARNINGS AND PRECAUTIONS
Most common adverse reactions in patients with newly-diagnosed CML (incidence ≥20%) are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, increased aspartate aminotransferase. (6)
Most common adverse reactions in patients with CML who were resistant or intolerant to prior therapy (incidence ≥20%) are diarrhea, nausea, abdominal pain, rash, thrombocytopenia, vomiting, anemia, fatigue, pyrexia, cough, headache, alanine aminotransferase, and edema. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.