Drug Interaction Report

Coadministration with CYP450 3A4 inhibitors is not expected to have clinically significant effects on the plasma concentrations of cabazitaxel, a narrow therapeutic index drug, which is primarily metabolized via the isoenzyme. A drug interaction study in patients with advanced cancers (n=13), revealed repeated administration of the moderate CYP450 3A4 inhibitor aprepitant (125 mg or 80 mg once daily) did not modify the exposure to cabazitaxel (15 mg/m2 intravenous). Clinical data with less potent CYP450 3A4 inhibitors are not available.

MONITOR: Smoking and alcohol consumption during therapy with vadadustat may increase the risk of gastrointestinal erosions. Serious erosions, including gastrointestinal bleeding and the need for red blood cell transfusions, have been reported during vadadustat clinical trials. Patients with a history of gastrointestinal erosion, peptic ulcer disease, and current tobacco smokers and alcohol drinkers may be at higher risk of gastrointestinal injury.

MANAGEMENT: Caution is advised if vadadustat is prescribed to current tobacco smokers or alcohol drinkers. Patients should be advised to contact their physician if they develop potential signs and symptoms of gastrointestinal injury such as abdominal pain, hematemesis, trouble swallowing, chest or throat pain, and/or black, tarry stools.