阿雷替尼,盐酸阿雷替尼胶囊Alectinib(Alecensa Capsule 20mg)

药店国别:

产地国家:日本

处方药:

所属类别: 20毫克/胶囊 14胶囊/瓶

包装规格: 20毫克/胶囊 14胶囊/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Chugai Pharmaceutical Co

原产地英文商品名:ALECENSA(アレセンサカプセル)20ng/Caps 14Caps/bottle

原产地英文药品名:alectinib hydrochloride

中文参考商品译名:ALECENSA(アレセンサカプセル)

中文参考药品译名:盐酸阿雷替尼

曾用名:AP26113

简介

部份中文盐酸阿雷替尼处方资料(仅供参考)

商品名:ALECENSA

英文名:Alectinib Hydrochloride

中文名:盐酸阿雷替尼胶囊

生产商:中外制药

药品介绍

新一代抗癌新药盐酸阿雷替尼胶囊ALECENSA(Alectinib Hydrochloride,アレセンサカプセル20mg)在日本批准上市。为肺癌突破性治疗药物.アレセンサカプセル20mg/アレセンサカプセル40mg药用类别名称抗恶性肿瘤药物/lk注 1) 抑制剂注 1) ALK: 再生性淋巴瘤激酶 (未分化淋巴瘤激酶)

批准日期:2015年11月

商标名:ALECENSA一般名アレクチニブ塩酸塩(Alectinib Hydrochloride)(JAN)化学名9-Ethyl-6,6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile monohydrochloride構造式分子式C30H34N4O2・HCl分子量519.08

性状:白色到黄色的红色是一种带有白色粉末或肿块的粉末。微溶于2, 2, 2-三氟乙醇, 很难溶于乙醇 (99.5), 水, 几乎不溶于乙腈和丙酮。熔点约 302°c

药用药理学

在ALK融合基因阳性的非小细胞肺癌中, ALK酪氨酸激酶活性异常增强, 并参与癌变和肿瘤增殖。

1. 抗肿瘤作用Arechinibu和主要代谢物(M-4)抑制了人的非小细胞肺癌NCI-H2228细胞系的细胞增殖, 这些细胞系来源于ALK融合基因阳性。此外, Arechienibu, 在重症复杂型免疫缺陷小鼠皮下移植NCI-H2228细胞系显示肿瘤生长的抑制作用。

2. 作用机制Altininib 通过抑制ALK酪氨酸激酶活性来抑制ALK融合基因阳性肿瘤细胞的增殖。适应症·ALK融合基因阳性的非小细胞肺癌无法切除的进展和复发

用法与用量:通常情况下, 成人每天口服两次300毫克一次。

包装胶囊:150毫克:28 胶囊(PTP14胶囊x2)

制造和销售来源:中外制药

英文版说明书

ALECENSA Capsule 20mg(アレセンサカプセル20mg)Brand name : ALECENSA Capsule 20mg Active ingredient: Alectinib hydrochloride Dosage form: pale yellow, long diameter: approximately 18 mm Print on wrapping:Effects of this medicineThis medicine suppress cancer cell growth by selective inhibition of ALK fusion protein essential for cancer cell growth.It is usually used to treat unresectable progressive / recurrent non-small cell lung cancer positive for ALK infusion gene.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 have a history of it.If you have liver dysfunction.•If you are pregnant, possibly 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 300 mg of Alectinib (7 capsules of ALECENSA Capsule 40mg and 1 capsule of ALECENSA Capsule 20mg) at a time, twice a day.This preparation (ALECENSA Capsule 20mg) contains 20 mg of Alectinib per capsule.Strictly follow the instructions.•If you miss a dose, skip the missed dose and continue 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. The disease may become worse by discontinuing the medicine, or adjusting the dose on your own judgment because you feel better.Precautions while taking this medicine•This medicine may cause serious adverse reactions. You should be informed of precautions, etc. until you fully understand them.•Since this medicine may cause interstitial lung disease, chest CT examination will be performed. Pulmonary function test may be performed, if needed.•Since this medicine may cause liver dysfunction or blood disorder (neutropenia, leukopenia, etc.), periodic blood test will be performed while taking this medicine.•Avoid pregnancy if you have possibility of it.Possible adverse reactions to this medicineThe most commonly reported adverse reactions include taste disorder and rash. 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, breathing difficulty, dry cough, fever [interstitial lung disease]•yellowing of the skin and the white of eyes, darkly-colored urine, nausea, vomiting, loss of appetite, general malaise, itch [liver dysfunction]•fever, sore throat [neutropenia, leukopenia]•severe stomachache, nausea, vomiting [perforation of the digestive tract]•chest pain, chest constriction, chest tightness, severe leg pain, abdominal bloating, severe stomachache, nausea, vomiting, vomiting of blood, bleeding, anesthesia [thromboembolism]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 the reach of children. Store at room temperature (1 to 30°C), away from direct sunlight and moisture.•Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.Chugai Pharmaceutical Co., Ltd.InternalRevised: 10/2015The 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.

 

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