Interaction entre Bosentan et Mifépristone

Co-administration of such combinations of a CYP2C9 inhibitor plus a strong or moderate CYP3A inhibitor with TRACLEER is not recommended.

Hormonal contraceptives: TRACLEER use decreases contraceptive exposure and reduces effectiveness ( 7.2 ).

Concomitant administration of both a CYP2C9 inhibitor (such as fluconazole or amiodarone) and a strong CYP3A inhibitor (e.g., ketoconazole, itraconazole) or a moderate CYP3A inhibitor (e.g., amprenavir, erythromycin, fluconazole, diltiazem) with TRACLEER will likely lead to large increases in plasma concentrations of bosentan.

An interaction study demonstrated that co-administration of bosentan and a combination oral hormonal contraceptive produced average decreases of norethindrone and ethinyl estradiol levels of 14% and 31%, respectively.

Effect of other drugs on bosentan Figure 1 Figure 2 7.2 Hormonal Contraceptives Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable when TRACLEER is co-administered.

CYP3A inducers: Do not use mifepristone with CYP3A inducers ( 7.3 ).

Avoid co-administration of mifepristone and CYP3A inducers such as rifampin, rifabutin, rifapentin, phenobarbital, phenytoin, carbamazepine, and St.

The dose of mifepristone should be limited to 900 mg, and strong inhibitors of CYP3A should be used only when necessary. [See Dosage and Administration ( 2.4 ), Warnings & Precautions ( 5.6 ), and Clinical Pharmacology ( 12.3 )] 7.3 CYP3A Inducers No medications that induce CYP3A have been studied when co-administered with mifepristone.