Orilissa Instructions?

Indications

It is an oral, non-peptide gonadotropin-releasing hormone (GnRH) antagonist that combines elagolix and estradiol/quinolone acetate (E2/NETA), an estrogen and progestin combination.

elagolix causes a dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), resulting in reduced blood concentrations of the ovarian sex hormones estradiol and progesterone, and a reduction in bleeding associated with uterine fibroids.

Orilissa is used to treat moderate to severe pain associated with endometriosis and heavy menstrual bleeding associated with uterine leiomyomas (fibromas) in premenopausal women.

Two similar, double-blind, randomized, 6-month phase 3 trials were conducted to evaluate the efficacy of two doses of elagog sodium, low dose (150 mg once daily) and high dose (200 mg twice daily), plus placebo, in patients with surgically diagnosed endometriosis and moderate or severe endometriosis pain.

At 3 months, a significantly higher proportion of patients who received elagoxa met clinical response criteria compared with placebo. In Elaris EM-I, 46.4% of patients in the low-dose Elagog sodium group and 75.8% of patients in the high-dose Elagog sodium group had a clinical response to dysmenorrhea, compared with 19.6% in the placebo group. In Elaris EM-II, they are 43.4% and 72.4% respectively.

In Elaris EM-I, the percentage of women with a clinical response to nonmenstrual pelvic pain was 50.4% in the low-dose Elagog sodium group and 54.5% in the high-dose Elagog sodium group, compared with 36.5% in the placebo group. Reactions to dysmenorrhea and nonmenstrual pelvic pain persist until 6 months.

Over a 6-month period, both high- and low-dose aragog sodium was effective in improving endometriosis-related pain and nonmenstrual pelvic pain. Elagog sodium provides pain-free benefits to women with endometriosis and improves clinically meaningful outcomes for patients.

Medication Guide

Take one capsule (300 mg) in the morning and one capsule (300 mg) in the evening. Take the capsules at approximately the same time each morning and evening, with or without food. The recommended duration of treatment is 24 months.

Rule out pregnancy before starting Orilissa or start within 7 days of the start of menstruation.

side effects

The most common are nausea, headache, hair loss, uterine bleeding, menorrhagia, hot flashes, insomnia, irritability, mood changes, anxiety, joint pain, and fatigue. Serious side effects mainly include thromboembolic disease and vascular events, suicidal ideation, suicidal behavior, worsening of mood disorders, increased liver transaminases, increased blood pressure, effects on carbohydrate and lipid metabolism, and hair loss.

References:

Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19. PMID: 28525302.

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