Summary

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• Orilissa (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
• This summary is based on the review of five systematic review(s)/meta-analysis(es). ^[1-5]
• Endometriosis-associated pain: Elagolix 400 mg was effective in reducing pelvic pain, dysmenorrhea, and dyspareunia in premenopausal women with moderate to severe endometriosis-associated pain. It was comparable to ASP1707 15 mg and relugolix 40 mg in reducing these symptoms.
• Uterine fibroids: Elagolix, along with other GnRH antagonists like relugolix and linzagolix, was effective in reducing menstrual blood loss, discomfort, and uterine/leiomyoma sizes, improving health-related quality of life in premenopausal women with symptomatic uterine fibroids.
• Elagolix 250 mg had the highest rates of TEAEs-related discontinuation and significantly decreased spinal BMD in premenopausal women with endometriosis-associated pain.
• Elagolix was associated with adverse events such as hot flush, headache, liver function test abnormalities, endometrial hyperplasia, bone mineral density loss, and ovarian hypoestrogenic effects, particularly at higher doses or in comparison to placebo and other treatments.
• Studies involved premenopausal women with moderate to severe endometriosis-associated pain or symptomatic uterine fibroids with heavy menstrual bleeding, where elagolix, particularly at a 400 mg dosage, was effective in these specific populations. The addition of estradiol/norethindrone acetate helped mitigate hypoestrogenism-related side effects in premenopausal women with uterine fibroids.