[{"data":1,"prerenderedAt":152},["ShallowReactive",2],{"drug-galcanezumab":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":21,"regimens":35,"contraindications":69,"warnings":79,"renal":80,"monitoring":81,"interactions":82,"review":83,"examples":86,"atc":87,"iran":89,"usApproval":96,"links":102,"populations":117},"galcanezumab",1,{"fa":7,"en":8},"گالکانزومب","Galcanezumab","nervous-system",{"fa":11,"en":12},"آنتی‌بادی ضد CGRP","Anti-CGRP antibody",[14],{"name":15,"market":16},"Emgality","US",[18,19,20],"emgality","امگالیتی","گالکانزوماب",[22],{"id":23,"form":24,"route":25,"label":26,"concentration":27,"markets":30,"refs":31},"pen-120","injection","sc","120 mg\u002FmL pen or syringe (100 mg\u002FmL for cluster)",{"amount":28,"unit":29,"perVolumeMl":5},120,"mg",[16],[32],{"source":33,"section":34},"fda-emgality","3",[36,54],{"id":37,"disease":38,"label":39,"population":42,"type":46,"unit":29,"dose":47,"refs":51},"mig","migraine-prophylaxis",{"fa":40,"en":41},"پیشگیری از میگرن — بارگذاری ۲۴۰ mg، سپس ۱۲۰ mg ماهانه","Migraine prevention — 240 mg load, then 120 mg monthly",{"minAge":43},{"value":44,"unit":45},18,"year","notCalculated",{"reason":48},{"fa":49,"en":50},"دوز اول ۲۴۰ mg (دو تزریق ۱۲۰)، سپس ۱۲۰ mg ماهی یک بار زیرجلدی.","First dose 240 mg (two 120 mg injections), then 120 mg SC once monthly.",[52],{"source":33,"section":53},"2.1",{"id":55,"disease":56,"label":57,"population":60,"type":46,"unit":29,"dose":62,"refs":66},"cluster","migraine-acute",{"fa":58,"en":59},"سردرد خوشه‌ای دوره‌ای — ۳۰۰ mg در شروع دوره، سپس ماهانه تا پایان دوره","Episodic cluster headache — 300 mg at onset of the cluster period, then monthly until it ends",{"minAge":61},{"value":44,"unit":45},{"reason":63},{"fa":64,"en":65},"۳۰۰ mg (سه تزریق ۱۰۰ mg) در شروع دوره خوشه‌ای و سپس ماهانه تا پایان دوره.","300 mg (three 100 mg injections) at the start of the cluster period, then monthly until the period ends.",[67],{"source":33,"section":68},"2.2",[70],{"id":71,"severity":72,"text":73,"refs":76},"hyper","block",{"fa":74,"en":75},"حساسیت جدی به گالکانزومب.","Serious hypersensitivity to galcanezumab.",[77],{"source":33,"section":78},"4",[],[],[],[],{"status":84,"reviewer":85,"date":85},"unverified",null,[],[88],"N02CD02",{"status":90,"refs":91},"not-found",[92],{"source":93,"section":94,"url":95},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Galcanezumab",{"kind":97,"refs":98,"id":101},"BLA",[99],{"source":33,"section":100},"SPL approval \u002F marketing category","BLA761063",[103,106,110,114],{"kind":104,"url":105,"label":101},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=761063",{"kind":107,"url":108,"label":109},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=33a147be-233a-40e8-a55e-e40936e28db0","FDA Emgality",{"kind":111,"url":112,"label":113},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa618063.html","Galcanezumab-gnlm Injection",{"kind":115,"url":116,"label":88},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N02CD02",{"pregnancy":118,"lactation":127,"pediatric":135,"geriatric":144},{"level":119,"text":120,"quote":123,"refs":124},"caution",{"fa":121,"en":122},"برچسب خطر مشخصی برای بارداری ذکر نکرده یا داده کافی ندارد؛ فقط در صورت لزوم و با نظر پزشک.","Label states no clear risk or has limited data; use only if needed, under medical advice.","Risk Summary There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women.",[125],{"source":33,"section":126},"8.1",{"level":119,"text":128,"quote":131,"refs":132},{"fa":129,"en":130},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There are no data on the presence of galcanezumab-gnlm in human milk, the effects on the breastfed infant, or the effects on milk production.",[133],{"source":33,"section":134},"8.2",{"level":136,"text":137,"quote":140,"refs":141},"not-established",{"fa":138,"en":139},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness in pediatric patients have not been established.",[142],{"source":33,"section":143},"8.4",{"level":119,"text":145,"quote":148,"refs":149},{"fa":146,"en":147},"برچسب: در سالمندان با احتیاط و معمولاً از دوز پایین شروع شود.","Label: use with caution in older adults, usually starting at the low end of the dose range.","Clinical studies of EMGALITY did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.",[150],{"source":33,"section":151},"8.5",1792156179967]