HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 CHANGESINDICATIONS AND USAGEBOSULIF is a kinase inhibitor indicated for the treatment of adult patients with
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSTablets: 100 mg, 400 mg, and 500 mg. (3) CONTRAINDICATIONSHypersensitivity to BOSULIF. (4) WARNINGS AND PRECAUTIONS
ADVERSE REACTIONSMost 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. DRUG INTERACTIONSUSE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 6/2020 |

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BOSULIF®Highlights (bosutinib)
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