Interactions : אינטראקציות

9      DRUG INTERACTIONS

9.1    Effect of Other Drugs on JOENJA
Strong CYP3A4 Inhibitors
JOENJA is a substrate of CYP3A4. Leniolisib exposure was increased 2-fold when co-administered with itraconazole, a strong CYP3A4 inhibitor. Concomitant use of JOENJA with strong CYP3A4 inhibitors should be avoided [see Clinical Pharmacology (13.3)].
Strong and Moderate CYP3A4 Inducers
Concomitant use of strong and moderate CYP3A4 inducers may result in reduced leniolisib exposure and thus reduced leniolisib efficacy. Therefore, concomitant use of JOENJA with strong and moderate CYP3A4 inducers should be avoided [see Clinical Pharmacology (13.3)].


9.2    Effect of JOENJA on Other Drugs
CYP1A2 Metabolized Drugs with a Narrow Therapeutic Index
Leniolisib inhibits CYP1A2 in a time-dependent manner in vitro. Avoid concomitant use of JOENJA with drugs that are primarily metabolized by isoenzyme CYP1A2 and have a narrow therapeutic index [see Clinical Pharmacology (13.3)].
BCRP, OATP1B1, and OATP1B3 Substrates
Leniolisib inhibits BCRP, OATP1B1, and OATP1B3 in vitro. The effect of JOENJA on BCRP, OATP1B1, and OATP1B3 substrates has not been studied clinically. Due to a possible increase in systemic exposure of these substrates, avoid concomitant use of JOENJA with drugs that are BCRP, OATP1B1, and OATP1B3 substrates [see Clinical Pharmacology (13.3)].