Indications for ORILISSA:
Moderate to severe pain associated with endometriosis.
Exclude pregnancy prior to starting or begin within 7 days from onset of menses. Use lowest effective dose. Initiate at 150mg once daily for up to 24 months. If dyspareunia: consider initiating with 200mg twice daily for up to 6 months. Concomitant strong CYP3A inhibitors, rifampin, or if moderate hepatic impairment: limit to 150mg once daily for up to 6 months.
<18yrs: not established.
Pregnancy. Osteoporosis. Severe hepatic impairment. Concomitant strong OATP 1B1 inhibitors (eg, cyclosporine, gemfibrozil).
Risk of decrease in bone mineral density (BMD). Assess BMD at baseline and periodically thereafter. Consider treatment benefits/risks in those with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss; supplementation with calcium and Vit.D may be beneficial. History of suicidality or depression. Evaluate if new onset or worsening depression, anxiety, other mood changes occur. Evaluate if signs/symptoms of liver injury (eg, jaundice, elevated liver tests) occurs. Reduced ability to recognize pregnancy. Perform pregnancy testing if suspected; discontinue if confirmed. Advise women to use non-hormonal contraceptives during therapy and for 1 week after discontinuation. Nursing mothers.
See Adults and Contraindications. May potentiate P-gp substrates (eg, digoxin; monitor), CYP2C19 substrates (eg, omeprazole; limit doses to ≤40mg daily). May antagonize CYP3A substrates. Antagonizes oral midazolam, rosuvastatin: consider increasing their doses. May be antagonized by CYP3A inducers. Reduced efficacy with estrogen-containing contraceptives.
Hot flushes, night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, mood changes; bone loss, elevated hepatic transaminase.
Generic Drug Availability:
Tabs 150mg—28; 200mg—56