BOSULIF (bosutinib) tablet Contraindications

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Canada
 

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Do not use BOSULIF (bosutinib) in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.  Cases of Grade 3 or 4 drug hypersensitivity were reported in patients treated with BOSULIF  in single-agent cancer studies.

Two cases (less than 0.2%) of Grade 4 drug-related anaphylactic shock were reported in patients treated with BOSULIF (see ADVERSE REACTIONS).  For a complete listing of ingredients, see the Dosage Forms, Composition and Packaging section of the product monograph.

Do not use BOSULIF in patients with a known history of long QT syndrome or with a persistent QT interval of >480 ms (see ADVERSE REACTIONS).

Do not use BOSULIF in cases of uncorrected hypokalemia or hypomagnesemia (see ADVERSE REACTIONS ).

Do not use BOSULIF in hepatically impaired patients. Higher risk of QT prolongation has been seen in patients with declining hepatic function (see ACTION AND CLINICAL PHARMACOLOGY, WARNINGS AND PRECAUTIONS, Special Populations, and ACTION AND CLINICAL PHARMACOLOGY, Other Considerations).