Elagolix/estradiol/norethindrone acetate

Elagolix/estradiol/norethindrone acetate, sold under the brand name Oriahnn, is a fixed-combination medication used to treat heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.[1] It contains elagolix, estradiol, and norethindrone acetate.[1] It is taken by mouth.[1]

Elagolix/estradiol/norethindrone acetate
Combination of
ElagolixGonadotropin-releasing hormone receptor antagonist
EstradiolEstrogen
Norethindrone acetateProgestin
Clinical data
Trade namesOriahnn
AHFS/Drugs.comOriahnn
License data
Routes of
administration		By mouth
ATC code
  • none
Legal status
Legal status

The most common side effects include hot flushes (sudden feelings of warmth), headache, fatigue and irregular vaginal bleeding.[1]

Medical uses

Fibroids are benign (non-cancerous) muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility.[1] Some women may not experience any symptoms, but many do, including heavy bleeding with periods.[1] Fibroids can occur at any age but are most common in women 35 to 49 years of age.[1] They typically resolve after menopause but are a leading reason for hysterectomy (surgical removal of the uterus) in the United States when they cause severe symptoms.[1]

Elagolix/estradiol/norethindrone acetate is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.[1]

Adverse effects

Elagolix/estradiol/norethindrone acetate may cause bone loss over time, and the loss in some women may not be completely recovered after stopping treatment.[1] Because bone loss may increase the risk for fractures, women should not take elagolix/estradiol/norethindrone acetate for more than 24 months.[1]

The drug label for the combination includes a boxed warning about the risk of vascular events (strokes) and thrombotic or thromboembolic disorders (blood clots), especially in women at increased risk for these events.[1]

History

Elagolix/estradiol/norethindrone acetate was approved for medical use in the United States in May 2020.[1][2]

The efficacy of elagolix/estradiol/norethindrone acetate was established in two clinical trials in which a total of 591 premenopausal women with heavy menstrual bleeding received the drug or placebo for six months.[1] Heavy menstrual bleeding at baseline was defined as having at least two menstrual cycles with greater than 80 mL (about a third of a cup) of menstrual blood loss (MBL).[1] The primary endpoint was the proportion of women who achieved MBL volume less than 80 mL at the final month and 50% or greater reduction in MBL volume from the start of the study (baseline) to the final month.[1] In the first study, 68.5% of participants who received elagolix/estradiol/norethindrone acetate achieved this endpoint (compared to 8.7% of participants who received placebo).[1] In the second study, 76.5% of participants who received elagolix/estradiol/norethindrone acetate achieved this endpoint (compared to 10.5% of participants who received placebo).[1]

The approval of Oriahnn was granted to AbbVie Inc.[1]

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References
  1. "FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women". U.S. Food and Drug Administration (FDA) (Press release). 29 May 2020. Retrieved 29 May 2020. This article incorporates text from this source, which is in the public domain.
  2. "FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women". AbbVie (Press release). 29 May 2020. Retrieved 29 May 2020.
  • "Elagolix". Drug Information Portal. U.S. National Library of Medicine.
  • "Estradiol". Drug Information Portal. U.S. National Library of Medicine.
  • "Norethindrone acetate". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT02654054 for "Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women" at ClinicalTrials.gov
  • Clinical trial number NCT02691494 for "Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)" at ClinicalTrials.gov
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