[{"data":1,"prerenderedAt":191},["ShallowReactive",2],{"drug-fingolimod":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":77,"warnings":87,"renal":96,"monitoring":97,"interactions":98,"review":99,"examples":101,"atc":112,"iran":114,"usApproval":126,"links":132,"populations":148},"fingolimod",1,{"fa":7,"en":8},"فینگولیمود","Fingolimod","antineoplastic-immunomodulating",{"fa":11,"en":12},"تعدیل‌کننده گیرنده S1P (MS)","S1P receptor modulator (MS)",[14],{"name":15,"market":16},"Gilenya","US",[18,19,7],"gilenya","ژیلنیا",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"cap-025","capsule","oral","0.25 mg capsule",{"amount":27,"unit":28,"perUnit":23,"scored":29},0.25,"mg",false,[16],[32],{"source":33,"section":34},"fda-gilenya","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"cap-05","0.5 mg capsule",{"amount":39,"unit":28,"perUnit":23,"scored":29},0.5,[16],[42],{"source":33,"section":34},[44],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":62,"notes":65},"ms","multiple-sclerosis",{"fa":48,"en":49},"MS عودکننده (۱۰ سال به بالا) — وزن >۴۰ kg: ۰٫۵ mg؛ ≤۴۰ kg: ۰٫۲۵ mg یک بار در روز","Relapsing MS (≥10 y) — >40 kg: 0.5 mg; ≤40 kg: 0.25 mg once daily",{"minAge":51},{"value":52,"unit":53},10,"year","weightBand",{"weightBands":56},[57,60],{"minWeightKg":58,"maxWeightKg":59,"perDose":27,"dosesPerDay":5},0,40,{"minWeightKg":59,"maxWeightKg":61,"perDose":39,"dosesPerDay":5},null,[63],{"source":33,"section":64},"2.3",[66],{"text":67,"refs":70},{"fa":68,"en":69},"دوز اول با پایش ۶ ساعته (نبض و فشار هر ساعت، ECG قبل و بعد) برای برادی‌کاردی؛ شروع مجدد پس از قطع بیش از ۱۴ روز هم همین‌طور. CBC، آنزیم کبد و معاینه ته چشم.","First dose with 6-hour monitoring (hourly pulse and BP, ECG before and after) for bradycardia; same when restarting after >14 days off. CBC, liver enzymes and fundus exam.",[71,73,75],{"source":33,"section":72},"2.4",{"source":33,"section":74},"2.1",{"source":33,"section":76},"2.5",[78],{"id":79,"severity":80,"text":81,"refs":84},"ci","block",{"fa":82,"en":83},"در ۶ ماه گذشته MI، آنژین ناپایدار، سکته، TIA یا نارسایی قلبی جبران‌نشده؛ بلوک AV موبیتز II یا درجه ۳ یا سینوس بیمار بدون پیس‌میکر؛ QTc پایه ≥۵۰۰؛ ضدآریتمی کلاس Ia یا III؛ حساسیت.","Within 6 months: MI, unstable angina, stroke, TIA or decompensated heart failure; Mobitz II\u002F3rd-degree AV block or sick sinus without pacemaker; baseline QTc ≥500 ms; class Ia or III antiarrhythmics; hypersensitivity.",[85],{"source":33,"section":86},"4",[88],{"text":89,"refs":92},{"fa":90,"en":91},"برادی‌کاردی دوز اول؛ عفونت و PML؛ ادم ماکولا؛ آسیب کبدی.","First-dose bradycardia; infections and PML; macular oedema; liver injury.",[93,95],{"source":33,"section":94},"5",{"source":33,"section":72},[],[],[],{"status":100,"reviewer":61,"date":61},"unverified",[102,107],{"regimen":45,"formulation":36,"input":103,"expect":106},{"ageYears":104,"weightKg":105},30,65,{"perDose":39,"tabletsPerDoseRounded":5},{"regimen":45,"formulation":22,"input":108,"expect":111},{"ageYears":109,"weightKg":110},12,35,{"perDose":27,"tabletsPerDoseRounded":5},[113],"L04AE01",{"status":115,"forms":116,"refs":121},"registered",[117],{"code":118,"en":119,"fa":120},"18099","FINGOLIMOD 0.5MG CAP","کپسول فینگولیمود ۰٫۵ میلی‌گرم",[122],{"source":123,"section":124,"url":125},"darooyab-generic","G-4753\u002FFingolimod","https:\u002F\u002Fwww.darooyab.ir\u002FG-4753\u002FFingolimod",{"kind":127,"refs":128,"id":131},"NDA",[129],{"source":33,"section":130},"SPL approval \u002F marketing category","NDA022527",[133,136,140,143,146],{"kind":134,"url":135,"label":131},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=022527",{"kind":137,"url":138,"label":139},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=cc9e1c8c-0e2b-44e2-878b-27057f786be9","FDA Gilenya",{"kind":141,"url":142,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa611006.html",{"kind":144,"url":145,"label":113},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AE01",{"kind":147,"url":125,"label":8},"darooyab",{"pregnancy":149,"lactation":158,"pediatric":167,"geriatric":175,"reproductive":183},{"level":150,"text":151,"quote":154,"refs":155},"avoid",{"fa":152,"en":153},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Based on findings from animal studies, GILENYA may cause fetal harm when administered to a pregnant woman.",[156],{"source":33,"section":157},"8.1",{"level":159,"text":160,"quote":163,"refs":164},"caution",{"fa":161,"en":162},"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 fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.",[165],{"source":33,"section":166},"8.2",{"level":159,"text":168,"quote":171,"refs":172},{"fa":169,"en":170},"برچسب برای کودکان شرط، محدودیت سنی یا نکته دارد؛ جمله برچسب در زیر آمده است.","The label has conditions, age limits or notes for children; the label sentence is quoted below.","Safety and effectiveness of GILENYA in pediatric patients below the age of 10 years have not been established.",[173],{"source":33,"section":174},"8.4",{"level":159,"text":176,"quote":179,"refs":180},{"fa":177,"en":178},"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.","GILENYA should be used with caution in patients aged 65 years and over, reflecting the greater frequency of decreased hepatic, or renal, function and of concomitant disease or other drug therapy.",[181],{"source":33,"section":182},"8.5",{"level":159,"text":184,"quote":187,"refs":188},{"fa":185,"en":186},"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 Before initiation of GILENYA treatment, females of reproductive potential should be counseled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with GILENYA [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1)] .",[189],{"source":33,"section":190},"8.3",1792156178724]