[{"data":1,"prerenderedAt":183},["ShallowReactive",2],{"drug-palbociclib":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":51,"contraindications":74,"warnings":75,"renal":83,"monitoring":84,"interactions":85,"review":86,"examples":89,"atc":95,"iran":97,"usApproval":117,"links":123,"populations":139},"palbociclib",1,{"fa":7,"en":8},"پالبوسیکلیب","Palbociclib","antineoplastic-immunomodulating",{"fa":11,"en":12},"مهارکننده CDK4\u002F6","CDK4\u002F6 inhibitor",[14],{"name":15,"market":16},"Ibrance","US",[18,19,7],"ibrance","ایبرنس",[21,35,43],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-75","tablet","oral","75 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},75,"mg",false,[16],[32],{"source":33,"section":34},"fda-ibrance","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-100","100 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},100,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"tab-125","125 mg tablet",{"amount":47,"unit":28,"perUnit":23,"scored":29},125,[16],[50],{"source":33,"section":34},[52],{"id":53,"disease":54,"label":55,"population":58,"type":62,"unit":28,"dose":63,"refs":64,"notes":67},"breast","breast-cancer",{"fa":56,"en":57},"سرطان پستان پیشرفته HR+\u002FHER2- (با مهارکننده آروماتاز یا فولوسترانت) — ۱۲۵ mg روزانه ۲۱ روز، سپس ۷ روز استراحت","HR+\u002FHER2- advanced breast cancer (with an aromatase inhibitor or fulvestrant) — 125 mg daily for 21 days, then 7 days off",{"minAge":59},{"value":60,"unit":61},18,"year","fixed",{"perDose":47,"dosesPerDay":5},[65],{"source":33,"section":66},"2.1",[68],{"text":69,"refs":72},{"fa":70,"en":71},"فقط زیر نظر متخصص انکولوژی؛ ادامه تا پیشرفت بیماری یا سمیت غیرقابل‌قبول. تنظیم دوز برای عوارض و تداخل‌ها طبق برچسب.","Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label.",[73],{"source":33,"section":66},[],[76],{"text":77,"refs":80},{"fa":78,"en":79},"نوتروپنی؛ بیماری بینابینی ریه یا پنومونیت؛ سمیت جنینی.","Neutropenia; interstitial lung disease or pneumonitis; embryo-fetal toxicity.",[81],{"source":33,"section":82},"5",[],[],[],{"status":87,"reviewer":88,"date":88},"unverified",null,[90],{"regimen":53,"formulation":44,"input":91,"expect":94},{"ageYears":92,"weightKg":93},55,60,{"perDose":47,"tabletsPerDoseRounded":5},[96],"L01EF01",{"status":98,"forms":99,"refs":112},"registered",[100,104,108],{"code":101,"en":102,"fa":103},"52723","PALBOCICLIB 75 mg CAPSULE","کپسول پالبوسیکلیب ۷۵ میلی‌گرم",{"code":105,"en":106,"fa":107},"50712","PALBOCICLIB 125 mg CAPSULE","کپسول پالبوسیکلیب ۱۲۵ میلی‌گرم",{"code":109,"en":110,"fa":111},"52722","PALBOCICLIB 100 mg CAPSULE","کپسول پالبوسیکلیب ۱۰۰ میلی‌گرم",[113],{"source":114,"section":115,"url":116},"darooyab-generic","G-5390\u002FPalbociclib","https:\u002F\u002Fwww.darooyab.ir\u002FG-5390\u002FPalbociclib",{"kind":118,"refs":119,"id":122},"NDA",[120],{"source":33,"section":121},"SPL approval \u002F marketing category","NDA212436",[124,127,131,134,137],{"kind":125,"url":126,"label":122},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=212436",{"kind":128,"url":129,"label":130},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=89a142d5-7e61-48bf-9e77-e2cd124c4792","FDA Ibrance",{"kind":132,"url":133,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa615013.html",{"kind":135,"url":136,"label":96},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=L01EF01",{"kind":138,"url":116,"label":8},"darooyab",{"pregnancy":140,"lactation":149,"pediatric":157,"geriatric":166,"reproductive":175},{"level":141,"text":142,"quote":145,"refs":146},"avoid",{"fa":143,"en":144},"برچسب: می‌تواند به جنین آسیب بزند. در بارداری خطرناک است.","Label: can cause fetal harm. Dangerous in pregnancy.","Risk Summary Based on findings from animal studies and its mechanism of action, IBRANCE can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] .",[147],{"source":33,"section":148},"8.1",{"level":141,"text":150,"quote":153,"refs":154},{"fa":151,"en":152},"برچسب: شیردهی توصیه نمی‌شود یا باید بین دارو و شیردهی یکی انتخاب شود.","Label: breastfeeding not recommended, or choose between the drug and breastfeeding.","Because of the potential for serious adverse reactions in breastfed infants from IBRANCE, advise a lactating woman not to breastfeed during treatment with IBRANCE and for 3 weeks after the last dose.",[155],{"source":33,"section":156},"8.2",{"level":158,"text":159,"quote":162,"refs":163},"not-established",{"fa":160,"en":161},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","The safety and effectiveness of IBRANCE in pediatric patients have not been established.",[164],{"source":33,"section":165},"8.4",{"level":167,"text":168,"quote":171,"refs":172},"caution",{"fa":169,"en":170},"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.","Of 444 patients who received IBRANCE in PALOMA-2, 181 patients (41%) were ≥65 years of age and 48 patients (11%) were ≥75 years of age.",[173],{"source":33,"section":174},"8.5",{"level":167,"text":176,"quote":179,"refs":180},{"fa":177,"en":178},"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 IBRANCE can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] .",[181],{"source":33,"section":182},"8.3",1792444710039]