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
ビジンプロ錠15mg/ビジンプロ錠45mg
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
商標名
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
構造式
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。
完整说明书附件：http://www.info.pmda.go.jp/go/pack/4291056F1025_1_02/
VIZIMPRO Tablets 45mg（dacomitinib）
Brand name:VIZIMPRO Tablets 45mg
Active ingredient:Dacomitinib hydrate
Dosage form:blue tablet, diameter: approx. 9.0mm, thickness:
approx. 4.5mm
Print on wrapping:VIZIMPRO, ビジンプロ, 45mg, DCB 45
Effects of this medicine
This 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 medicinal
effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription
medicines.)
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 1 tablet (45 mg of dacomitinib) at a time, once a day. The dosage may be decreased
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 two
doses 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 medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, paronychia, stomatitis (oral ulceration, aphthous
ulcer, etc.), acneiform dermatitis and rash/ maculopapular rash/ erythematous eruption. If any of these symptoms
occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse
reactions indicated in brackets. If any of these symptoms occur, stop taking this
medicine 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 other
than 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 or the
medical institution how to discard them.
Internal
Published: 02/2019
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,
patients should understand their medication and cooperate with the treatment.