Bosulif Disease Interactions

Cardiovascular events, including arterial vascular occlusive events, peripheral arterial occlusive events and ischemic cerebrovascular events have been reported in patients receiving tyrosine kinase inhibitors. If acute signs or symptoms of cardiovascular events occur, patients should seek immediate medical attention. The cardiovascular status and risk factors of patients should be evaluated prior to therapy and cardiovascular monitoring and management should take place during treatment.

Fluid retention occurs with BCR-ABL tyrosine kinase inhibitors therapy and may manifest as pericardial effusion, pleural effusion, pulmonary edema, and/or peripheral edema. Caution should be taken when using these drugs in patients with preexisting fluid retention or congestive heart failure. Monitor and manage patients using standards of care. Interrupt, reduce dose or discontinue therapy as necessary.

Thrombocytopenia, aplastic anemia, agranulocytosis and neutropenia occur with BCR-ABL tyrosine kinase inhibitors. Therapy with these drugs should be administered cautiously in patients with preexisting bone marrow suppression. A complete blood count should be performed every 1-2 weeks for the first month of therapy and then monthly thereafter, or as clinically indicated. To manage myelosuppression, withhold, reduce dose, or discontinue therapy as necessary.

Adequate hydration might be necessary during therapy with bosutinib as diarrhea, nausea, vomiting, and abdominal pain occur with treatment. Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and fluid replacement. To manage gastrointestinal toxicity, withhold, dose reduce, or discontinue bosutinib as necessary.

Bosutinib is primarily metabolized by the CYP 450 3A4. Therapy with bosutinib should be administered cautiously in patients with hepatic impairment and the starting dose should be 200 mg daily in patients with baseline hepatic impairment. The manufacturer recommends performing hepatic enzyme tests monthly for the first three months of bosutinib treatment and as clinically indicated. In patients with transaminase elevations, monitor liver enzymes more frequently. Withhold, reduce dose, or discontinue bosutinib as necessary.

An on-treatment decline in estimated glomerular filtration rate (eGFR) has occurred in patients treated with bosutinib. The manufacturer recommends reducing the bosutinib starting dose in patients with severe (CrCl) less than 30 mL/min) or moderate (CrCl 30 to 50 mL/min) renal impairment at baseline. Consider dose adjustment in patients with baseline and treatment emergent renal impairment. It is recommended to monitor patients for renal function at baseline and during therapy with bosutinib, with particular attention to those patients who have preexisting renal impairment or risk factors for renal dysfunction.