Summary

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• Elagolix (Orilissa) is indicated for the management of moderate to severe pain associated with endometriosis and has been evaluated for efficacy in managing symptoms related to uterine fibroids, including heavy menstrual bleeding.
• The information was derived from five systematic reviews/meta-analyses that compared Orilissa primarily to other Gonadotropin-Releasing Hormone (GnRH) antagonists, such as relugolix, ASP1707, and linzagolix.
• In terms of effectiveness against endometriosis-associated pain and dysmenorrhea, elagolix demonstrated significant efficiency over other GnRH antagonists, especially at a dose of 400 mg.
• For managing symptoms of uterine fibroids like heavy menstrual bleeding, elagolix showed considerable improvement over placebo and similar effectiveness when combined with estradiol/norethindrone acetate.
• Adverse effects were noted, particularly with certain doses; common side effects include hot flushes and changes in liver function, while specific concerns regarding bone mineral density loss were observed especially at a dose of 250mg. These adverse effects can be mitigated by combining elagolix with hormonal add-back therapy such as estradiol/norethindrone acetate.
• The treatment efficacy and safety have mainly been evaluated in premenopausal women suffering from either endometriosis-associated pain or uterine fibroids, indicating that its benefit-risk profile may vary across different patient subpopulations.