Table 1.

Identifying Patients Who May Benefit from Elagolix

Candidates for Elagolixa
Premenopausal women with surgically or clinically diagnosed endometriosis, who:
Have endometriosis-associated pain,
Have not responded to or have intolerable side effects with first-line treatments (e.g., NSAIDs, combined hormonal contraceptives, and progestins),
Have progestin-resistant disease, and/or
Have had side effects from oral contraceptive in the past

Considerations/cautions
Not recommended for patients with a history of or nonresponse to GnRH agonists or antagonists
Limit concomitant use with strong CYP3A inhibitors (≤1 month with elagolix 200 mg twice daily and ≤6 months with elagolix 150 mg once daily)
Clinical monitoring is recommended when coadministered with digoxin
Concomitant use with rifampin is not recommended with elagolix 200 mg twice daily and should be limited to 6 months with elagolix 150 mg once daily
Dose increases of midazolam and rosuvastatin may be considered when used concomitantly with elagolix

Contraindications
Pregnancy
Known osteoporosis
Severe hepatic impairment (Child-Pugh C)
Concomitant use of strong OATP1B1 inhibitors (e.g., cyclosporine and gemfibrozil)

^aThese criteria reflect expert opinion. Pivotal elagolix clinical trials enrolled patients with a surgical diagnosis of endometriosis and who were experiencing moderate-to-severe endometriosis-associated pain; treatment history was not a factor for study eligibility.

CYP, cytochrome P450; GnRH, gonadotropin-releasing hormone; NSAIDs, nonsteroidal anti-inflammatory drugs; OATP, organic anion-transporting polypeptide.