Drug Interaction Report

GENERALLY AVOID: Coadministration of topical tacrolimus with other immunosuppressive agents may potentiate the immunosuppressive effects of topical tacrolimus. However, data concerning its safety and efficacy in combination with immunosuppressants are not available. According to the prescribing information, rare cases of skin malignancy and lymphoma have been reported in patients who have received treatment with topical calcineurin inhibitors, including topical tacrolimus. On the other hand, systemic exposure from topical tacrolimus is reported to be less than 1 ng/mL. In addition, the lowest tacrolimus blood concentration from topical application at which systemic effects can be observed is unknown.

MANAGEMENT: According to the manufacturer, use of topical tacrolimus in immunocompromised patients is not recommended. Therefore, until further information is available, it may be advisable to avoid its concomitant use with other immunosuppressants. Screening for the development of malignancy during and after treatment may also be considered.

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of umbralisib. When a single oral dose of umbralisib was administered with a high-fat, high-calorie meal (approximately 917 calories; 171 calories from protein, 232 calories from carbohydrate, 502 calories from fat) in healthy subjects, umbralisib peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 115% and 61%, respectively, compared to administration under fasted conditions.

MANAGEMENT: Umbralisib should be administered with food at approximately the same time each day.