ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in patients less than 18 years of age have not been established.
US-ORIL-200330
For more information, please click here for full Prescribing Information.
1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc.
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis. Limit the duration of use based on the dose and coexisting condition.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in pediatric patients have not been established.
US-ORIL-210045
For more information, please click here for full Prescribing Information.
1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc.
US-ORIL-210523
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.
*Dysmenorrhea responder threshold was ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder threshold was ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2.
†In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to month 6 were secondary endpoints.
‡In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to each month (except month 6) were non-ranked secondary endpoints. Appropriate multiplicity adjustments were not applied.
§Baseline and monthly visit values were based on a 35-day mean.
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.