Elagolix
Drug Details
- Generic Name
- Elagolix
- Brand Names
- Orilissa
- Application Number
- NDA210450
- Sponsor
- AbbVie Inc.
- NDC Codes
- 4
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ELAGOLIX SODIUM, ELAGOLIX
Indications and Usage
1 INDICATIONS AND USAGE ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use: Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.2 ) ] . ORIAHNN is a combination of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. ( 1 ) Limitation of Use: Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible. ( 1 )