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
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Dosage and Administration (2) |
09/2015 |
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Dosage and Administration, Recommended Starting Dosage with Hepatic Impairment or Renal Impairment (2.7) |
11/2014 |
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Warnings and Precautions, Renal Toxicity (5.5) |
11/2014 |
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
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Recommended Dose: 500 mg orally once daily with food. (2.1)
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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)
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Adjust dosage for toxicity and organ impairment (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg and 500 mg. (3)
CONTRAINDICATIONS
Hypersensitivity to BOSULIF. (4)
WARNINGS AND PRECAUTIONS
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Gastrointestinal Toxicity: Monitor and manage as necessary. Withhold, dose reduce, or discontinue BOSULIF. (2.3, 5.1)
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Myelosuppression: Monitor blood counts and manage as necessary. (2.4, 5.2)
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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)
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Fluid Retention: Monitor patients and manage using standard of care treatment. Withhold, dose reduce, or discontinue BOSULIF. (2.3, 5.4)
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Renal Toxicity Monitor patients for renal function at baseline and during therapy with BOSULIF (5.5)
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Embryofetal Toxicity: May cause fetal harm. Females of reproductive potential should avoid becoming pregnant while being treated with BOSULIF. (5.6)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥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.
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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)
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Proton Pump Inhibitors: May decrease bosutinib drug levels. Consider short-acting antacids in place of proton pump inhibitors. (7.2)
USE IN SPECIFIC POPULATIONS
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Nursing Mothers: Discontinue nursing if drug is important to mother.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 9/2015
