It can be taken with or without food.Elagolix is approved only for the treatment of endometriosis. Other approved and off-label uses of GnRH antagonists in general are the same as those of GnRHR desensitization therapy with GnRH agonists such as leuprorelin, and include uterine fibroids and breast cancer in premenopausal women, prostate cancer in men, precocious puberty in children, and hormone therapy in transgender adolescents and adults, among others. Available forms
Elagolix is available in the form of Orilissa 150 and 200 mg oral tablets. The 150 mg tablets are light pink, oblong, and film-coated with "EL 150" debossed on one side, while the 200 mg tablets are light orange, oblong, and film-coated with "EL 200" debossed on one side. The inactive ingredients in the tablets include mannitol, sodium carbonate monohydrate, pregelatinized starch, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and a distinct color additive (carmine high tint in the 150 mg tablets and iron oxide red in the 200 mg tablets). Contraindications
Contraindications of elagolix include pregnancy, known osteoporosis, severe hepatic impairment, and concomitant use with strong organic anion-transporting polypeptide (OATP) 1B1 inhibitors such as ciclosporin and gemfibrozil. Elagolix may increase the risk of miscarriage in early pregnancy. Women should avoid pregnancy while taking elagolix, for instance by using birth control, and should discontinue the medication if they become or wish to become pregnant. Elagolix should not be used in women with osteoporosis because it may increase the risk of further bone loss.
It was the first new medication to be approved by the FDA for the treatment of endometriosis in more than a decade. Elagolix was the first member of a new class of GnRH modulators described as "second-generation" due to their non-peptide and small-molecule nature and oral activity to be marketed. A second member of this group, relugolix (brand name Relumina), was introduced in Japan in January 2019. In addition to endometriosis, elagolix is under development for the treatment of uterine fibroids and menorrhagia. It is in phase III clinical trials for these indications. Society and culture
Generic names
Elagolix is the generic name of the drug and its INN and USAN. It is also known by its former developmental code names NBI-56418 and ABT-620. Brand names
Elagolix is marketed under the brand name Orilissa. Availability
Elagolix is available in the United States and Canada. A similar medication, relugolix, is available in Japan. Economics
Prior to its introduction, elagolix was estimated to cost about US$850 per month. It is not available as a generic medication. Research
As of November 2018, elagolix in phase III clinical trials for the treatment of uterine fibroids (uterine leiomyoma) and menorrhagia (abnormally heavy bleeding during menstruation) in women. An efficacy and safety study of elagolix in combination with add-back estradiol, an estrogen, and norethisterone acetate, a progestin, for the treatment of menorrhagia associated with uterine fibroids in premenopausal women has been published.