BOSULIF
BOSULIF (bosutinib monohydrate) tablet, film coated
[Pfizer Laboratories Div Pfizer Inc]
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

INDICATIONS AND USAGE
BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy. (1)

DOSAGE AND ADMINISTRATION
Recommended Dose: 500 mg orally once daily with food. (2.1)
Consider dose escalation to 600 mg daily in patients who do not reach complete hematologic response by week 8 or complete cytogenetic response by week 12 and do not have Grade 3 or greater adverse reactions. (2.2)
Adjust dosage for hematologic and non-hematologic toxicity. (2.3, 2.4)
Hepatic impairment (at baseline): reduce BOSULIF dose to 200 mg daily. (2.7)

DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg and 500 mg. (3)

CONTRAINDICATIONS
Hypersensitivity to BOSULIF. (4)

WARNINGS AND PRECAUTIONS
Gastrointestinal toxicity: Monitor and manage as necessary. Withhold, dose reduce, or discontinue BOSULIF. (2.3,5.1)
Myelosuppression: Monitor blood counts and manage as necessary. (2.4, 5.2)
Hepatic toxicity: Monitor liver enzymes at least monthly for the first three months and as needed. Withhold, dose reduce, or discontinue BOSULIF. (2.3,5.3)
Fluid retention: Monitor patients and manage using standard of care treatment. Withhold, dose reduce, or discontinue BOSULIF. (2.3,5.4)
Embryofetal toxicity: May cause fetal harm. Females of reproductive potential should avoid becoming pregnant while being treated with BOSULIF. (5.5)

ADVERSE REACTIONS
Most common adverse reactions (incidence greater than 20%) are diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue. (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 INTERACTIONS
CYP3A Inhibitors and Inducers: Avoid concurrent use of BOSULIF with strong or moderate CYP3A inhibitors and inducers. (2.5, 2.6, 7.1,7.2)
Proton Pump Inhibitors: May decrease bosutinib drug levels. Consider short-acting antacids in place of proton pump inhibitors. (7.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling

Revised: 09/2012
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Dose Escalation
2.3 Dose Adjustments for Non-Hematologic Adverse Reactions
2.4 Dose Adjustments for Myelosuppression
2.5 Concomitant Use With CYP3A Inhibitors
2.6 Concomitant Use With CYP3A Inducers
2.7 Hepatic Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5  WARNINGS AND PRECAUTIONS
5.1 Gastrointestinal Toxicity
5.2 Myelosuppression
5.3 Hepatic Toxicity
5.4 Fluid Retention
5.5 Embryofetal Toxicity
6 ADVERSE REACTIONS
6.1 Imatinib-Resistant or -Intolerant Ph+ Chronic Phase (CP), Accelerated Phase (AP), and Blast Phase (BP) C