Drug updated on 10/29/2024
Dosage Form | Tablet (oral; 150 mg, 200 mg) |
Drug Class | Gonadotropin-releasing hormone (GnRH) receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the management of moderate to severe pain associated with endometriosis.
Latest News
Summary
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Elagolix 400 mg demonstrated effectiveness in reducing pelvic pain, dysmenorrhea, dyspareunia, and non-menstrual pelvic pain in premenopausal women with moderate to severe endometriosis-associated pain, with no significant differences in effectiveness among different population types or subgroups noted in the studies.
- When compared to other treatments, Elagolix 400 mg was found to be comparable to ASP1707 15 mg for reducing pelvic pain and dysmenorrhea but less effective than relugolix 40 mg for dysmenorrhea. Other treatments, such as dienogest and GnRH analogues, ranked higher for pelvic pain reduction at 3 and 6 months, respectively.
- Elagolix 400 mg had a lower incidence of treatment-emergent adverse events (TEAEs) compared to relugolix 40 mg, but it was still associated with significant adverse events, including hot flush and headache, particularly at higher doses. Elagolix 250 mg was linked to significantly decreased spinal bone mineral density (BMD).
- There was a significant incidence of ovarian hypoestrogenic effects associated with both GnRH analogues and elagolix, expressed in a dose-dependent manner.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Orilissa (elagolix) Prescribing Information. | 2023 | 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 |
Oral gonadotropin-releasing hormone antagonists for treating endometriosis-associated pain: a systematic review and network meta-analysis | 2022 | Fertility and Sterility |
Medical therapy options for endometriosis related pain, which is better? A systematic review and network meta-analysis of randomized controlled trials | 2021 | Journal of Gynecology Obstetrics and Human Reproduction |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
A Clinician's Guide to the Treatment of Endometriosis with Elagolix | 2020 | Journal of Women's Health |