Interactions : אינטראקציות

4.5     Interaction with other medicinal products and other forms of interaction

NITYR tablet is metabolized in vitro by CYP 3A4 and dose-adjustment may therefore be needed when nitisinone is co-administered with inhibitors or inducers of this enzyme.
Based on data from a clinical interaction study with 80 mg nitisinone at steady-state, nitisinone is a moderate inhibitor of CYP2C9 (2.3-fold increase in tolbutamide AUC), therefore nitisinone treatment may result in increased plasma concentrations of co-administered medicinal products metabolized primarily via CYP2C9 (see section 4.4).
Nitisinoneis a weak inducer of CYP2E1 (30% decrease in chlorzoxazone AUC) and a weak inhibitor of OAT1 and OAT3 (1.7-fold increase in AUC of furosemide), whereas nitisinone did not inhibit CYP2D6 (see section 5.2).No formal food interactions studies have been performed with NITYR tablets.
However, NITYR tablets has been co-administered with food during the generation of efficacy and safety data. Therefore, it is recommended that treatment with NITYR tablets is initiated with food, this should be maintained on a routine basis. See section 4.2.