[{"data":1,"prerenderedAt":180},["ShallowReactive",2],{"drug-elagolix":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":82,"warnings":92,"renal":99,"monitoring":100,"interactions":101,"review":102,"examples":105,"atc":114,"iran":116,"links":123,"populations":140,"usApproval":175},"elagolix",1,{"fa":7,"en":8},"الاگولیکس","Elagolix","systemic-hormones",{"fa":11,"en":12},"آنتاگونیست GnRH خوراکی","Oral GnRH antagonist",[14],{"name":15,"market":16},"Orilissa","US",[18,19,7],"orilissa","اوریلیسا",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-150","tablet","oral","150 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},150,"mg",false,[16],[32],{"source":33,"section":34},"fda-orilissa","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-200","200 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},200,[16],[42],{"source":33,"section":34},[44,70],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":56,"allowedFormulations":59,"notes":60},"std","endometriosis",{"fa":48,"en":49},"درد آندومتریوز — ۱۵۰ mg یک بار در روز (حداکثر ۲۴ ماه)","Endometriosis pain — 150 mg once daily (max 24 months)",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[57],{"source":33,"section":58},"2.1, Table 1",[22],[61],{"text":62,"refs":65},{"fa":63,"en":64},"پیش از شروع بارداری رد شود یا ظرف ۷ روز از شروع قاعدگی شروع شود. نارسایی متوسط کبد: فقط ۱۵۰ mg و حداکثر ۶ ماه.","Exclude pregnancy or start within 7 days of menses. Moderate hepatic impairment: 150 mg only, max 6 months.",[66,68],{"source":33,"section":67},"2.1",{"source":33,"section":69},"2.2",{"id":71,"disease":46,"label":72,"population":75,"type":54,"unit":28,"dose":77,"refs":79,"allowedFormulations":81},"dysp",{"fa":73,"en":74},"درد آندومتریوز با دیسپارونی — ۲۰۰ mg دو بار در روز (حداکثر ۶ ماه)","Endometriosis pain with dyspareunia — 200 mg twice daily (max 6 months)",{"minAge":76},{"value":52,"unit":53},{"perDose":39,"dosesPerDay":78},2,[80],{"source":33,"section":58},[36],[83],{"id":84,"severity":85,"text":86,"refs":89},"ci","block",{"fa":87,"en":88},"بارداری؛ استئوپوروز؛ نارسایی شدید کبد؛ مهارکننده‌های قوی OATP1B1؛ حساسیت.","Pregnancy; osteoporosis; severe hepatic impairment; strong OATP1B1 inhibitors; hypersensitivity.",[90],{"source":33,"section":91},"4",[93],{"text":94,"refs":97},{"fa":95,"en":96},"کاهش تراکم استخوان وابسته به دوز و مدت؛ مدت مصرف محدود شود.","Dose- and duration-dependent bone loss; limit duration of use.",[98],{"source":33,"section":67},[],[],[],{"status":103,"reviewer":104,"date":104},"unverified",null,[106,111],{"regimen":45,"formulation":22,"input":107,"expect":110},{"ageYears":108,"weightKg":109},30,60,{"perDose":27,"tabletsPerDoseRounded":5},{"regimen":71,"formulation":36,"input":112,"expect":113},{"ageYears":108,"weightKg":109},{"perDose":39,"tabletsPerDoseRounded":5},[115],"H01CC03",{"status":117,"refs":118},"not-found",[119],{"source":120,"section":121,"url":122},"darooyab-generic","G-5571\u002FElagolix","https:\u002F\u002Fwww.darooyab.ir\u002FG-5571\u002FElagolix",[124,128,132,135,138],{"kind":125,"url":126,"label":127},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=210450","NDA210450",{"kind":129,"url":130,"label":131},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=a86757b3-09c5-fd3b-1223-244e94f50a66","FDA Orilissa",{"kind":133,"url":134,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa618044.html",{"kind":136,"url":137,"label":115},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=H01CC03",{"kind":139,"url":122,"label":8},"darooyab",{"pregnancy":141,"lactation":149,"pediatric":158,"reproductive":167},{"level":142,"text":143,"quote":146,"refs":147},"contraindicated",{"fa":144,"en":145},"برچسب: در بارداری منع مصرف دارد.","Label: contraindicated in pregnancy.","ORILISSA is contraindicated in women: Who are pregnant [see Use in Specific Populations ( 8.1 )] .",[148],{"source":33,"section":91},{"level":150,"text":151,"quote":154,"refs":155},"caution",{"fa":152,"en":153},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.",[156],{"source":33,"section":157},"8.2",{"level":159,"text":160,"quote":163,"refs":164},"not-established",{"fa":161,"en":162},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of ORILISSA in pediatric patients have not been established.",[165],{"source":33,"section":166},"8.4",{"level":150,"text":168,"quote":171,"refs":172},{"fa":169,"en":170},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Contraception Advise women to use effective non-hormonal contraception during treatment with ORILISSA and for 28 days after discontinuing ORILISSA [see Warnings and Precautions ( 5.5 )] .",[173],{"source":33,"section":174},"8.3",{"kind":176,"refs":177,"id":127},"NDA",[178],{"source":33,"section":179},"SPL approval \u002F marketing category",1792111452733]