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Label Changes for:

Bosulif (bosutinib) Tablets, 100 mg and 500 mg

September 2013

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


September 2013


8.7 Renal Impairment
  • Reduce the BOSULIF dose in patients with CLcr less than 30 mL/min at baseline. For patients with CLcr 30 to 50 mL who cannot tolerate a 500 mg dose, follow dose adjustment recommendations for toxicity. In a dedicated renal impairment trial, compared to volunteers with normal renal function, the exposure (AUC) of bosutinib increased by 60% and 35% in subjects with CLcr less than 30 mL/min and CLcr 30 to 50 mL/min, respectively [see Dosing and Administration (2.8) and Clinical Pharmacology (12.3)]. BOSULIF has not been studied in patients undergoing hemodialysis.


Before you take BOSULIF, tell your doctor if you:

  • have kidney problems

note: also see section 2.8 Renal Impairment