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BOSULIF® (bosutinib)

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BOSULIF® Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

BOSULIF is indicated for the treatment of adult patients with:

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Newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).
...
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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

The recommended dose is taken orally once daily with food. The tablet is to be swallowed whole and should not be...

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3 DOSAGE FORMS AND STRENGTHS

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100 mg tablets: yellow, oval, biconvex, film-coated tablets debossed with "Pfizer" on one side and "100" on the other.
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400 mg tablets: orange, oval, biconvex, film-coated...
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4 CONTRAINDICATIONS

BOSULIF is contraindicated in patients with a history of hypersensitivity to BOSULIF. Reactions have included anaphylaxis [see Adverse Reactions (6.1)]....

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5 WARNINGS AND PRECAUTIONS

5.1 Gastrointestinal Toxicity

Diarrhea, nausea, vomiting, and abdominal pain occur with BOSULIF treatment. Monitor and manage patients...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

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Gastrointestinal toxicity [see...
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7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on BOSULIF

Strong or Moderate CYP3A Inhibitors...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from animal studies and its...

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10 OVERDOSAGE

Experience with BOSULIF overdose in clinical studies was limited to isolated cases. There were no reports of any serious adverse events associated with the overdoses. Patients who take an overdose of BOSULIF...

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11 DESCRIPTION

Bosutinib is a kinase inhibitor. The chemical name for bosutinib monohydrate is 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Bosutinib is a TKI. Bosutinib inhibits the BCR-ABL kinase that promotes CML; it is also an inhibitor of Src-family...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Bosutinib was not carcinogenic in rats or transgenic mice. The rat 2-year...

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14 CLINICAL STUDIES

14.1 Newly-Diagnosed CP Ph+ CML

The efficacy of BOSULIF in patients with newly-diagnosed chronic phase Ph+ CML was evaluated in the...

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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

BOSULIF (bosutinib) tablets are supplied for oral administration in 3 strengths: a 100...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

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Resources

Pfizer Oncology Together
For questions regarding the Pfizer Oncology Together program, please call (877) 744-5675.
website
Bosulif Website for Consumers and Patients
 
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Call (800) 438-1985

Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985

Report Adverse Event
Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.