[{"data":1,"prerenderedAt":185},["ShallowReactive",2],{"drug-siponimod":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":50,"contraindications":80,"warnings":90,"renal":98,"monitoring":99,"interactions":100,"review":101,"examples":104,"atc":110,"iran":112,"usApproval":119,"links":125,"populations":141},"siponimod",1,{"fa":7,"en":8},"سیپونیمود","Siponimod","antineoplastic-immunomodulating",{"fa":11,"en":12},"تعدیل‌کننده گیرنده S1P","S1P receptor modulator",[14],{"name":15,"market":16},"Mayzent","US",[18,19,7],"mayzent","مایزنت",[21,35,42],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-2","tablet","oral","2 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},2,"mg",false,[16],[32],{"source":33,"section":34},"fda-mayzent","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":39,"refs":40},"tab-1","1 mg tablet",{"amount":5,"unit":28,"perUnit":23,"scored":29},[16],[41],{"source":33,"section":34},{"id":43,"form":23,"route":24,"label":44,"concentration":45,"markets":47,"refs":48},"tab-0-25","0.25 mg tablet (titration)",{"amount":46,"unit":28,"perUnit":23,"scored":29},0.25,[16],[49],{"source":33,"section":34},[51],{"id":52,"disease":53,"label":54,"population":57,"type":61,"unit":28,"dose":62,"refs":63,"allowedFormulations":66,"notes":67},"ms","multiple-sclerosis",{"fa":55,"en":56},"ام‌اس عودکننده بزرگسال (CYP2C9 *1\u002F*1، *1\u002F*2، *2\u002F*2) — نگهدارنده ۲ mg یک بار از روز ۶ پس از تیتراسیون ۵ روزه","Relapsing MS, adults (CYP2C9 *1\u002F*1, *1\u002F*2, *2\u002F*2) — maintenance 2 mg once daily from day 6 after a 5-day titration",{"minAge":58},{"value":59,"unit":60},18,"year","fixed",{"perDose":27,"dosesPerDay":5},[64],{"source":33,"section":65},"2.2",[22],[68],{"text":69,"refs":72},{"fa":70,"en":71},"پیش از شروع ژنوتیپ CYP2C9. *1\u002F*3 یا *2\u002F*3: ۱ mg از روز ۵ پس از تیتراسیون ۴ روزه. قرص کامل. وقفه ۴ روز یا بیشتر: تیتراسیون از روز ۱. برادیکاردی یا بلوک AV یا سابقه MI\u002Fنارسایی قلب: پایش ۶ ساعته دوز اول.","Genotype CYP2C9 first. *1\u002F*3 or *2\u002F*3: 1 mg from day 5 after a 4-day titration. Swallow whole. Interruption ≥4 days: restart titration. Bradycardia, AV block or prior MI\u002FHF: 6-hour first-dose monitoring.",[73,74,76,78],{"source":33,"section":65},{"source":33,"section":75},"2.3",{"source":33,"section":77},"2.5",{"source":33,"section":79},"2.4",[81],{"id":82,"severity":83,"text":84,"refs":87},"ci","block",{"fa":85,"en":86},"در ۶ ماه اخیر: MI، آنژین ناپایدار، سکته، TIA، نارسایی قلب جبران‌نشده یا کلاس III\u002FIV؛ بلوک AV موبیتز II یا درجه ۳ یا سندرم سینوس بیمار بدون پیس‌میکر؛ ژنوتیپ CYP2C9*3\u002F*3؛ حساسیت به سیپونیمود.","Within 6 months: MI, unstable angina, stroke, TIA, decompensated or class III\u002FIV heart failure; Mobitz II or third-degree AV block or sick sinus syndrome without a pacemaker; CYP2C9*3\u002F*3 genotype; hypersensitivity to siponimod.",[88],{"source":33,"section":89},"4",[91],{"text":92,"refs":95},{"fa":93,"en":94},"عفونت و PML؛ ادم ماکولا؛ برادی‌آریتمی در شروع؛ اثر تنفسی؛ آسیب کبد؛ سرطان پوست؛ افزایش فشار خون؛ خطر جنینی؛ تشدید شدید ناتوانی پس از قطع.","Infections and PML; macular oedema; bradyarrhythmia at initiation; respiratory effects; liver injury; skin cancer; raised blood pressure; fetal risk; severe disability increase after stopping.",[96],{"source":33,"section":97},"5",[],[],[],{"status":102,"reviewer":103,"date":103},"unverified",null,[105],{"regimen":52,"formulation":22,"input":106,"expect":109},{"ageYears":107,"weightKg":108},40,65,{"perDose":27,"tabletsPerDoseRounded":5},[111],"L04AE03",{"status":113,"refs":114},"registered",[115],{"source":116,"section":117,"url":118},"darooyab-generic","G-5546\u002FSiponimod","https:\u002F\u002Fwww.darooyab.ir\u002FG-5546\u002FSiponimod",{"kind":120,"refs":121,"id":124},"NDA",[122],{"source":33,"section":123},"SPL approval \u002F marketing category","NDA209884",[126,129,133,136,139],{"kind":127,"url":128,"label":124},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=209884",{"kind":130,"url":131,"label":132},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=44492772-5aed-4627-bd85-e8e89f308bb3","FDA Mayzent",{"kind":134,"url":135,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa619027.html",{"kind":137,"url":138,"label":111},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L04AE03",{"kind":140,"url":118,"label":8},"darooyab",{"pregnancy":142,"lactation":151,"pediatric":160,"geriatric":169,"reproductive":177},{"level":143,"text":144,"quote":147,"refs":148},"avoid",{"fa":145,"en":146},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Based on animal data and its mechanism of action, MAYZENT can cause fetal harm when administered to a pregnant woman ( see Data ).",[149],{"source":33,"section":150},"8.1",{"level":152,"text":153,"quote":156,"refs":157},"caution",{"fa":154,"en":155},"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 siponimod in human milk, the effects of MAYZENT on the breastfed infant, or the effects of the drug on milk production.",[158],{"source":33,"section":159},"8.2",{"level":161,"text":162,"quote":165,"refs":166},"not-established",{"fa":163,"en":164},"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.",[167],{"source":33,"section":168},"8.4",{"level":152,"text":170,"quote":173,"refs":174},{"fa":171,"en":172},"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.","In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.",[175],{"source":33,"section":176},"8.5",{"level":152,"text":178,"quote":181,"refs":182},{"fa":179,"en":180},"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 Females Before initiation of MAYZENT treatment, women of childbearing potential should be counseled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with MAYZENT [see Use in Specific Populations (8.1)] .",[183],{"source":33,"section":184},"8.3",1792191566584]