Drug Interaction Report

MONITOR: Coadministration of daclizumab with other agents known to induce hepatotoxicity may increase the risk of liver injury. Serious drug-related hepatic injury, including liver failure and autoimmune hepatitis, has been reported across controlled and open-label studies in 1.7% of daclizumab-treated patients and may occur at any time during treatment and up to 5 months after treatment cessation. Fatal cases have occurred. In addition, cases of hepatic injury have occurred in patients taking daclizumab concomitantly with other hepatotoxic drugs; however, the contributory role of these other medicines has not been established.

MANAGEMENT: Caution is advised if daclizumab is used with other potentially hepatotoxic agents, including non-prescription products and herbal supplements. Patients treated with daclizumab should have serum transaminase levels and total bilirubin measured prior to initiation of treatment and monthly during treatment in accordance with the manufacturer's recommendations, and the dosing adjusted or interrupted as necessary. Patients should be advised to seek medical attention if they experience potential signs and symptoms of hepatotoxicity such as fever, rash, itching, anorexia, nausea, vomiting, fatigue, malaise, right upper quadrant pain, dark urine, pale stools, and jaundice.

ADJUST DOSING INTERVAL: Coadministration with a high-fat meal may increase the plasma concentrations of olutasidenib. According to the product labeling, administration of a single 150 mg dose with a high-fat meal (approximately 800 to 1000 calories, with approximately 50% of those calories from fat) increased olutasidenib peak plasma concentration (Cmax) and systemic exposure (AUC) by 191% and 83%, respectively, in healthy subjects.

MANAGEMENT: Olutasidenib should be administered at about the same time each day, on an empty stomach at least 1 hour before or 2 hours after a meal.