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BOSULIF®Drug Interactions (bosutinib)

7 DRUG INTERACTIONS

7.1 Effect of Other Drugs on BOSULIF

Strong or Moderate CYP3A Inhibitors

Concomitant use with a strong or moderate CYP3A inhibitor increased bosutinib Cmax and AUC compared to BOSULIF alone [see Clinical Pharmacology (12.3)] which may increase the risk of toxicities. Avoid the concomitant use of strong or moderate CYP3A inhibitors with BOSULIF.

Strong CYP3A Inducers

Concomitant use with a strong CYP3A inducer decreased bosutinib Cmax and AUC compared to BOSULIF alone [see Clinical Pharmacology (12.3)] which may reduce BOSULIF efficacy. Avoid the concomitant use of strong CYP3A inducers with BOSULIF.

Proton Pump Inhibitors (PPI)

Concomitant use with a PPI decreased bosutinib Cmax and AUC compared to BOSULIF alone [see Clinical Pharmacology (12.3)] which may reduce BOSULIF efficacy. As an alternative to PPIs, use short-acting antacids or H2 blockers and separate dosing by more than 2 hours from BOSULIF dosing.

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