Interactions : אינטראקציות

7      DRUG INTERACTIONS
This section describes clinically relevant drug interactions with ORLADEYO. Drug interaction studies are described elsewhere in the labeling [see Clinical Pharmacology (12.3)].
7.1   Potential for Other Drugs to Affect ORLADEYO
P-gp Inducers
Berotralstat is a substrate of P-gp and BCRP. P-gp inducers (e.g., rifampin, St. John’s wort) may decrease berotralstat plasma concentration, leading to reduced efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.
7.2   Potential for ORLADEYO to Affect Other Drugs
CYP2D6 and CYP3A4 Substrates
ORLADEYO at a dose of 150 mg is a moderate inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a narrow therapeutic index that are predominantly metabolized by CYP2D6 (e.g., thioridazine, pimozide) or CYP3A4 (e.g., cyclosporine, fentanyl), appropriate monitoring and dose titration is recommended [see Clinical Pharmacology (12.3)].
Desogestrel
In a drug interaction study conducted in healthy women of childbearing potential (N=22), co- administration of ORLADEYO at a dose of 150 mg at steady state with a single dose of 0.15 mg/0.03 mg desogestrel/ethinyl estradiol resulted in increased exposure to etonogestrel, the active metabolite of desogestrel. If ORLADEYO is co-administered with desogestrel, any potential risk of concurrent use of desogestrel should be weighed against benefit [see Clinical Pharmacology (12.3)].


P-gp Substrates
ORLADEYO at a dose of 300 mg is a P-gp inhibitor. Appropriate monitoring and dose titration is recommended for P-gp substrates (e.g., digoxin) when co-administering with ORLADEYO [see Clinical Pharmacology (12.3)].