Drug updated on 5/17/2024
Dosage Form | Tablet (oral: 150 mg, 200 mg) |
Drug Class | Gonadotropin-releasing hormone receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the management of moderate to severe pain associated with endometriosis.
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Summary
- 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.
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 |
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 |
Oral gonadotropin-releasing hormone antagonists for treating endometriosis-associated pain: a systematic review and network meta-analysis. | 2022 | Fertility and Sterility |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
A clinician's guide to the treatment of endometriosis with elagolix. | 2021 | Journal of Women's Health |