Drug Interaction Report

Consumer information for this interaction is not currently available.

ADJUST DOSE: Coadministration with vadadustat, an inhibitor of breast cancer resistance protein (BCRP), may increase the plasma concentrations and pharmacologic effects of drugs that are substrates of BCRP such as atorvastatin, rosuvastatin, and simvastatin. The proposed mechanism involves decreased clearance due to inhibition of BCRP by vadadustat. According to product labeling, when vadadustat was coadministered with the BCRP substrates simvastatin and rosuvastatin, systemic exposure (AUC) of the substrates increased 2-fold, and 2 to 3-fold, respectively. High levels of HMG-CoA reductase inhibitory activity in plasma is associated with an increased risk of musculoskeletal toxicity, such as myopathy and rarely, rhabdomyolysis.

MANAGEMENT: When concomitant use of vadadustat is required, product labeling recommends limiting the starting dose of simvastatin to 5 mg and the daily dose to 20 mg, and the daily dose of rosuvastatin to 5 mg. The prescribing information for other BCRP substrates should be consulted for any dosage adjustments that may be required during coadministration and/or following the discontinuation of a BCRP inhibitor. Patients should be advised to monitor for signs and symptoms of adverse effects and promptly report any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.

Consumer information for this interaction is not currently 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.