


Reminder: The outer packaging is for reference only, please purchase and use under the guidance of a pharmacist. For read by medical and pharmaceutical professionals only.
Oriahnn is a combination oral therapy containing three active ingredients: elagolix (a gonadotropin-releasing hormone [GnRH] receptor antagonist), estradiol (an estrogen), and norethindrone acetate (a synthetic progestin). Elagolix suppresses pituitary GnRH receptors, reducing the secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), thereby lowering ovarian production of estrogen and progesterone.
This supplemental approval addresses an alternative blister pack configuration to simplify packaging, enhancing patient usability. While the document does not specify the approved indication, elagolix-based therapies are historically indicated for conditions such as endometriosis-associated pain, where hormonal modulation is critical. The combination of estradiol and norethindrone acetate suggests a targeted approach to balance efficacy and tolerability.
ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis.
1. Normal liver function or mild hepatic impairment:150 mg once daily for up to 24 months,200 mg twice daily for up to 6 months;
2. Moderate hepatic impairment (Child-Pugh B):150 mg once daily for up to 6 months,200 mg twice daily is not recommended;
3. Severe hepatic impairment (Child-Pugh C):Contraindicated.
