Drug updated on 4/17/2024
| Dosage Form | Tablet (oral: 150 mg, 200 mg) |
| Drug Class | Gonadotropin-releasing hormone receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- To manage the moderate to severe pain associated with endometriosis.
Summary
- Elagolix (Orilissa) is indicated for the management of moderate to severe pain associated with endometriosis.
- Four systematic reviews/meta-analyses were reviewed, providing evidence on the efficacy and safety of elagolix in treating conditions such as endometriosis-associated pain and heavy menstrual bleeding caused by uterine fibroids.
- In a network meta-analysis, elagolix was found effective in reducing pelvic pain, dysmenorrhea, and dyspareunia associated with moderate-to-severe endometriosis; however, it also showed higher rates of treatment-emergent adverse events (TEAEs) related discontinuation compared to other oral nonpeptide GnRH antagonists like relugolix or ASP1707.
- A review focusing on symptomatic uterine fibroids suggested that gonadotropin-releasing hormone antagonists including elagolix could be preferred oral treatment options due to their confirmed therapeutic efficacy and milder adverse effect profile compared to drugs like mifepristone.
- Another study reported that while elagolix effectively reduced heavy menstrual bleeding caused by uterine fibroid in premenopausal women when compared against placebo; its combination with estradiol/norethindrone acetate helped alleviate hypoestrogenism side effects such as hot flushes and bone mineral density loss observed during monotherapy.
- The final study highlighted that among oral GnRH antagonists used for symptomatic uterine fibroids - relugolix, linzagolix along with Orilissa demonstrated significant improvement over placebo regarding reduction in discomfort levels & leiomyoma sizes besides improving quality of life parameters but called for more randomized clinical trials for long-term benefits confirmation.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Orilissa (elagolix) Prescribing Information. | 2021 | AbbVie Inc., North Chicago, IL |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of oral gonadotropin-releasing hormone antagonists in moderate-to-severe endometriosis-associated pain: a systematic review and network meta-analysis. | 2023 | Archives of Gynecology and Obstetrics |
| Systematic review of oral pharmacotherapeutic options for the management of uterine fibroids. | 2022 | Journal of the American Pharmacists Association |
| Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis. | 2022 | BMC Women’s Health |
| Efficacy and safety of oral GnRh antagonists in patients with uterine fibroids: a systematic review. | 2022 | Journal of Obstetrics and Gynecology Canada |
| Elagolix for treating endometriosis. | 2018 | ICER |