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BOSULIF®(bosutinib)
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BOSULIF® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
BOSULIF is indicated for the treatment of adult patients with:
- Newly-diagnosed chronic phase (CP) Philadelphia chromosome-...
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Dosage and Administration
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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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
- 100 mg tablets: yellow, oval, biconvex, film-coated tablets debossed with "Pfizer" on one side and "100" on the other.
- 400 mg tablets: orange, oval, biconvex, film-coated tablets...
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Contraindications
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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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Gastrointestinal toxicity [see...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on BOSULIF
Strong or Moderate CYP3A Inhibitors...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from animal studies and its...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
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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Clinical Studies
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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How Supplied/Storage and Handling
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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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
- ...
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Report Adverse Event
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