Indication

Endometriosis

Administration

Take at approximately the same time each day, with or without food

Adult Dose

Endometriosis\r\nIndicated for management of moderate-to-severe pain associated with endometriosis\r\n\r\nInitiate with 150 mg PO qDay for up to 24 months\r\n\r\nHepatic impairment\r\nMild (Child-Pugh A): No dosage adjustment required\r\nModerate (Child-Pugh B): Only the 150-mg qDay regimen is recommended for women with moderate hepatic impairment, and the duration of treatment should be limited to 6 months\r\nSevere (Child-Pugh C): Contraindicated

Renal Dose

Renal impairment\r\nNo dosage adjustment required with any degree of renal impairment or end-stage renal disease (including dialysis)

Contraindication

Pregnancy\r\n\r\nKnown osteoporosis\r\n\r\nSevere hepatic impairment\r\n\r\nCoadministration of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (eg, cyclosporine and gemfibrozil)

Mode of Action

Oral gonadotropin-releasing hormone (GnRH) receptor antagonist; inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland\r\n\r\nAdministration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone

Precaution

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Side Effect

>10%\r\nHot flush or night sweats (24-36%)\r\n\r\nHeadache (17-20%)\r\n\r\nNausea (11-16%)\r\n\r\n1-10%\r\nInsomnia (6-9%)\r\n\r\nMood altered, mood swings (5-6%)\r\n\r\nAmenorrhea (4-7%)\r\n\r\nDepressed mood, depression, depressive symptoms and/or tearfulness (3-6%)\r\n\r\nHypersensitivity reactions (5.8%)\r\n\r\nAnxiety (3-5%)\r\n\r\nArthralgia (3-5%)

Pregnancy Category Note

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