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Elagolix/estradiol/norethisterone acetate: Difference between revisions

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{{Short description|Combination drug}}
{{Use American English|date=July 2020}}
{{Use dmy dates|date=May 2020}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Infobox drug
| drug_name =
| type = combo
| image =
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| component2 = Estradiol
| class2 = [[Estrogen (medication)|Estrogen]]
| component3 = NorethindroneNorethisterone acetate
| class3 = [[Progestogen (medication)|Progestin]]
 
<!-- Clinical data -->
| pronounce =
| tradename = Oriahnn
| Drugs.com = {{Drugs.com|ppa|elagolix-estradiol-and-norethindrone}}
| MedlinePlus = a620042
| licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) -->
| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| DailyMedID = Oriahnn
| licence_US = Oriahnn
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_US = <!-- A / B / C / D / X / N -->
| pregnancy_US_comment =
| pregnancy_category=
| dependency_liability =
| addiction_liability =
| routes_of_administration = [[Oral administration|By mouth]]
| ATCvet ATC_prefix = H01
| ATC_prefixATC_suffix = NoneCC53
| ATC_suffix =
| ATC_supplemental =
 
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| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Oriahnn FDA label">{{cite web | title=Oriahnn- elagolix and estradiol and norethisterone kit | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=99f6eee7-7e52-6999-7eb8-488d06dd1710 | access-date=3 August 2021}}</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
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<!-- Identifiers -->
| PubChem =
| PubChemSubstance =
| IUPHAR_ligand =
| DrugBank =
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}}
 
'''Elagolix/estradiol/norethindronenorethisterone acetate''', sold under the brand name '''Oriahnn''', is a [[fixed-dose combination]] medication used to treat heavy [[menstrual bleeding]] associated with uterine [[leiomyoma]]s ([[Uterine fibroid|fibroids]]) in premenopausal women.<ref name="Oriahnn FDA label" /><ref name="FDA PR">{{cite press release | title=FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women | website=U.S. [[Food and Drug Administration]] (FDA) | date=29 May 2020 | url=https://www.fda.gov/news-events/press-announcements/fda-approves-new-option-treat-heavy-menstrual-bleeding-associated-fibroids-women | access-date=29 May 2020}} {{PD-notice}}</ref><ref name="Ali_2021">{{cite journal | vauthors = Ali M, Sara AR, Al Hendy A | title = Elagolix in the treatment of heavy menstrual bleeding associated with uterine fibroids in premenopausal women | journal = Expert Review of Clinical Pharmacology | volume = 14 | issue = 4 | pages = 427–437 | date = April 2021 | pmid = 33682578 | doi = 10.1080/17512433.2021.1900726 | pmc = 8262561 }}</ref> It contains [[elagolix]], a gonadotropin-releasing hormone (GnRH) receptor antagonist, [[estradiol]], an [[Estrogen (medication)|estrogen]], and [[norethindronenorethisterone acetate]], a [[Progestogen (medication)|progestin]].<ref name="Oriahnn FDA label" /><ref name="FDA PR" /> It is taken [[Oral administration|by mouth]].<ref name="Oriahnn FDA label" /><ref name="FDA PR" /> Oriahnn is co-packaged as a combination of elagolix/estradiol/norethindronenorethisterone acetate capsules with elagolix capsules.<ref name="Oriahnn FDA label" />
 
The most common side effects include hot flushes (sudden feelings of warmth), headache, fatigue and irregular vaginal bleeding.<ref name="FDA PR" />
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Fibroids are benign (non-cancerous) muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility.<ref name="FDA PR" /> Some women may not experience any symptoms, but many do, including heavy bleeding with periods.<ref name="FDA PR" /> Fibroids can occur at any age but are most common in women 35 to 49 years of age.<ref name="FDA PR" /> 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.<ref name="FDA PR" />
 
Elagolix/estradiol/norethindronenorethisterone acetate is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.<ref name="FDA PR" />
 
== Adverse effects ==
Elagolix/estradiol/norethindronenorethisterone acetate may cause bone loss over time, and the loss in some women may not be completely recovered after stopping treatment.<ref name="FDA PR" /> Because bone loss may increase the risk for fractures, women should not take elagolix/estradiol/norethindronenorethisterone acetate for more than 24 months.<ref name="FDA PR" />
 
The drug label for the combination includes a boxed warning about the risk of vascular events (strokes) and [[Thrombosis|thrombotic]] or [[thromboembolic]] disorders (blood clots), especially in women at increased risk for these events.<ref name="FDA PR" />
 
== History ==
Elagolix/estradiol/norethindronenorethisterone acetate was approved for medical use in the United States in May 2020.<ref name="FDA PR" /><ref name="AbbVie PR">{{cite press release | title=FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women | website=AbbVie | date=29 May 2020 | url=https://news.abbvie.com/news/press-releases/fda-approves-first-oral-medication-for-management-heavy-menstrual-bleeding-due-to-uterine-fibroids-in-pre-menopausal-women.htm | access-date=29 May 2020}}</ref>
 
The efficacy of elagolix/estradiol/norethindronenorethisterone 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.<ref name="FDA PR" /> 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).<ref name="FDA PR" /> 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.<ref name="FDA PR" /> In the first study, 68.5% of participants who received elagolix/estradiol/norethindronenorethisterone acetate achieved this endpoint (compared to 8.7% of participants who received placebo).<ref name="FDA PR" /> In the second study, 76.5% of participants who received elagolix/estradiol/norethindronenorethisterone acetate achieved this endpoint (compared to 10.5% of participants who received placebo).<ref name="FDA PR" />
 
The approval of Oriahnn was granted to AbbVie Inc.<ref name="FDA PR" />
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== External links ==
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/elagolix | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Elagolix }}
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/estradiol | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Estradiol }}
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/norethindrone%20acetate | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Norethindrone acetate }}
* {{ClinicalTrialsGov|NCT02654054|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}}
* {{ClinicalTrialsGov|NCT02691494|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)}}
 
{{Portal bar | Medicine}}
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{{DEFAULTSORT:Elagolix Estradiol NorethindroneNorethisterone Acetate}}
[[Category:AbbVieDrugs brandsdeveloped by AbbVie]]
[[Category:Combination sex hormone drugs]]
[[Category:CYP3A4 inducers]]
[[Category:Estrogens]]
[[Category:GnRH antagonists]]
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