Orilissa Disease Interactions

Compared to women with normal liver function, those with moderate hepatic impairment had approximately 3-fold higher elagolix exposures and those with severe hepatic impairment had approximately 7-fold higher elagolix exposures. Because of these increased exposures and risk for bone loss, the use of elagolix is contraindicated in women with severe hepatic impairment (Child-Pugh C). In women with moderate hepatic impairment (Child-Pugh B) elagolix 150 mg is recommended once daily with the duration of treatment limited to 6 months. No dose adjustment is needed for women with mild hepatic impairment (Child-Pugh A).

Elagolix is contraindicated in women with known osteoporosis because of the risk of further bone loss. Elagolix causes a dose-dependent decrease in bone mineral density (BMD), which is greater with increasing duration of use and may not be completely reversible after stopping treatment.

Suicidal ideation and behavior, has been reported in women treated with elagolix in the endometriosis clinical trials. Women with a history of suicidality or depression had a higher incidence of depression compared to women without such a history. Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety or other mood changes should be referred to a mental health professional. Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing elagolix if such events occur.