Overall, the most common serious adverse events reported for subjects treated with ORILISSA in the two placebo-controlled clinical trials (Studies EM-1 and EM-2) included appendicitis (0.3%), abdominal pain (0.2%), and back pain (0.2%). In these trials, 0.2% of subjects treated with ORILISSA 150 mg once daily and 0.2% of subjects treated with ORILISSA 200 mg twice daily discontinued therapy due to serious adverse reactions compared to 0.5% of those given placebo.
Discontinuations for both dosage forms were most commonly due to hot flush or night sweats and nausea.
|150 mg QD|
|200 mg BID|
|Hot Flush or Night Sweats||24%||46%||9%|
|Mood altered, mood swings||6%||5%||3%|
|Depressed mood, depression, depressive symptoms and/or tearfulness||3%||6%||2%|
ORILISSA leads to a reduction in serum estradiol levels that causes a dose-dependent decrease in bone mineral density (BMD)
|Concomitant Drug Class:|
|Effect on Concentration of ORILISSA or Concomitant Drug||Clinical Comments|
|Antiarrhythmics: digoxin||↑ digoxin||Clinical monitoring is recommended for digoxin when co-administered with ORILISSA.|
|Antimycobacterial: rifampin||↑ elagolix||Concomitant use of ORILISSA 200 mg twice daily and rifampin is not recommended. Limit concomitant use of ORILISSA 150 mg once daily and rifampin to 6 months.|
|Benzodiazepines: oral midazolam||↓ midazolam||Consider increasing the dose of midazolam and individualize therapy based on patient’s response.|
|Statins: rosuvastatin||↓ rosuvastatin||Consider increasing the dose of rosuvastatin.|
No clinically significant changes in ORILISSA exposures were observed when co-administered with rosuvastatin (20 mg once daily), sertraline (25 mg once daily) or fluconazole (200 mg single dose).
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