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
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 400 mg, and 500 mg. (3)
Hypersensitivity to BOSULIF. (4)
WARNINGS AND PRECAUTIONS
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
Lactation: Advise women not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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