达克替尼，ビジンプロ錠 达克替尼片dacomitinib （Vizimpro Tablets 15mg）

药店国别：无 产地国家：日本 处方药：是 所属类别： 15毫克/片 30片/盒 包装规格： 15毫克/片 30片/盒 计价单位：盒 生产厂家中文参考译名：无 生产厂家英文名：Pfizer 原产地英文商品名：VIZIMPRO（ビジンプロ錠）15mg/Tablets 30Tablets/box 原产地英文药品名：dacomitinib 中文参考商品译名：VIZIMPRO（ビジンプロ錠）15毫克/片 30片/盒 中文参考药品译名：达克替尼 曾用名：无

简介

部分中文达克替尼处方资料（仅供参考） 英文名：dacomitinib 商标名：VIZIMPRO Tablets 中文名：达克替尼 生产商：辉瑞公司 药用类别名称：抗恶性肿瘤琼脂糖/酪氨酸激酶抑制剂 批准日期：2019年3月 商标名：VIZIMPRO Tablets 一般名：ダコミチニブ水和物 化学名：（2E）-N-{4-［（3-Chloro-4-fluorophenyl）amino］-7-methoxy-quinazolin-6-yl}-4-（piperidin-1-yl）but-2-enamide monohydrate 分子式：C24H25ClFN5O2・H2O 分子量：487.95 性状：本产品为白色至细黄色粉末。分布系数 (日志 D)4.2 (pH7.4, 1-octanol/水)批准条件制定药品风险管理计划并加以实施。 药用药理学 抗肿瘤作用该制剂, 体外试验, 人类非小细胞肺衍生的Nci-h125细胞系与野生类型EGFR, 人类非小细胞肺癌衍生HCC827和HCC400细胞系与EGFR活性突变(Ex19 del), 并抑制人的非小细胞肺衍生的nci-h1975细胞系与EGFR主动突变 (L858R) 的增殖。 该制剂在体内试验中, 分别在重复杂型免疫缺陷(SCID)小鼠体内进行NCI-H125和NCI-H1975细胞系植入, 显示出肿瘤生长抑制作用。 作用机制 该制剂, 通过抑制酪氨酸激酶活性, 如EGFR有一个活跃的突变(Ex19 Del和L858R), 被认为可以抑制肿瘤的生长。 适应症 EGFR基因突变阳性的非小细胞肺癌无法操作或复发 用法与用量 通常情况下, 成人口服一次, 每天45毫克。另外, 根据患者的病情酌情减肥。 包装片剂：15mg:30 片 (PTP) 10片/片 x3片45mg:10 片 (PTP) 10片/片x1片 制造和销售：辉瑞公司 注：以上中文处方资料不够完整，使用者以原处方资料为准。

英文版说明

VIZIMPRO Tablets 15mg（dacomitinib）Brand name:VIZIMPRO Tablets 15mgActive ingredient:Dacomitinib hydrateDosage form:blue tablet, diameter: approx. 6.4mm, thickness:approx. 3.1mmPrint on wrapping:VIZIMPRO, ビジンプロ, 15mg, DCB 15Effects of this medicineThis medicine suppresses tumor growth by inhibiting active mutated epidermal growth factor receptor (EGFR)tyrosine kinase.It is usually used to treat EGFR mutation positive inoperable or recurrent non-small cell lung cancer.Before using this medicine, be sure to tell your doctor and pharmacist• If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.If you have: interstitial lung disease or its history and liver dysfunction.• If you are pregnant or breastfeeding.• If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects. Beware of over-the-counter medicines and dietary supplements as well as other prescriptionmedicines.)Dosing schedule (How to take this medicine)• Your dosing schedule prescribed by your doctor is (( to be written by a healthcare professional ))• In general, for adults, take 3 tablets (45 mg of dacomitinib) at a time, once a day. The dosage may bedecreased according to the condition. Strictly follow the instructions.• If you miss a dose, skip the missed dose and follow your regular dosing schedule. You should never take twodoses at one time.• If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.• Do not stop taking this medicine unless your doctor instructs you to do so.Precautions while taking this medicinePossible adverse reactions to this medicineThe most commonly reported adverse reactions include diarrhea, paronychia, stomatitis (oral ulceration, aphthousulcer, etc.), acneiform dermatitis and rash/ maculopapular rash/ erythematous eruption. If any of these symptomsoccur, consult with your doctor or pharmacist.The symptoms described below are rarely seen as initial symptoms of the adversereactions indicated in brackets. If any of these symptoms occur, stop taking thismedicine and see your doctor immediately.• shortness of breath, respiratory distress, fever [interstitial lung disease]• muddy or watery stool, abdominal pain, dehydration [severe diarrhea]• acne-like rash, pain/heat sensation/redness/swelling around nails [severe dermopathy]• general malaise, loss of appetite, yellowing of the skin and the white of eyes [liver dysfunction]The above symptoms do not describe all the adverse reactions to this medicine.Consult with your doctor or pharmacist if you notice any symptoms of concern otherthan those listed above.Storage conditions and other information• Keep out of reach of children. Store away from direct sunlight, heat and moisture.• Discard the remainder. Do not store them. If you dispose of unused medicines, ask the pharmacist and themedical institution how to discard them.Published: 02/2019The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,patients should understand their medication and cooperate with the treatment.