Ann Pharmacother. 2022 Jan;56(1):93-101. doi: 10.1177/10600280211015987. Epub 2021 May 17.
Oriahnn: New Drug Approved for Treating Heavy Menstrual Bleeding in Women With Uterine Fibroids.
The Annals of pharmacotherapy
Sarah E Lynch, Danielle C Mayer
Affiliations
Affiliations
- Binghamton University School of Pharmacy and Pharmaceutical Sciences, Binghamton NY, USA.
- Jefferson College of Pharmacy, Thomas Jefferson University, Philadelphia, PA, USA.
PMID: 33998300
DOI: 10.1177/10600280211015987
Abstract
OBJECTIVE: To review data of elagolix plus estradiol and norethindrone acetate as add-back therapy for the treatment of heavy menstrual bleeding (HMB) in premenopausal women with uterine fibroids.
DATA SOURCES: Literature search of PubMed/MEDLINE and SCOPUS was performed using the search terms
STUDY SELECTION/DATA EXTRACTION: Clinical trials and articles discussing elagolix plus add-back therapy for the management of HMB in women with leiomyomas were included.
DATA SYNTHESIS: Phase 3 trials met the primary end point of menstrual blood loss (MBL) less than 80 mL at month 6 and at least a 50% reduction in MBL from baseline to the final month in 68.5% of women taking elagolix plus add-back therapy enrolled in UF-1 (8.7% placebo) and 76.5% of women in UF-2 (10% placebo). The most common adverse effects include hot flushes, nausea, headache, and night sweats.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Women with symptomatic uterine fibroids can experience significant HMB resulting in distress, depression, and anxiety. Surgical intervention remains the most commonly recommended and chosen treatment. Elagolix plus add-back therapy is a nonsurgical, oral option.
CONCLUSIONS: Elagolix plus add-back therapy is effective in reducing menstrual bleeding associated with uterine fibroids. However, there are several warnings and precautions that must be considered.
Keywords: Oriahnn; elagolix plus add-back; gonadotropin-releasing hormone antagonist; uterine fibroid treatment
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