英文药名：Alecensa Capsule(Alectinib Hydrochloride) 中文药名：盐酸阿雷替尼胶囊 生产厂家：中外制药 アレセンサカプセル20mg／アレセンサカプセル40mg 治疗类别名称 抗肿瘤药，ALK注1）抑制剂注1）ALK：间变性淋巴瘤激酶（间变性淋巴瘤激酶） 欧文商標名 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 它是一种白色粉末与白色粉末黄色发红或质量。它是易溶略微2,2,2-三氟乙醇，乙醇（99.5），以溶解，不溶于水的小乙腈和丙酮非常轻微。 融　点約 302℃(分解) 药效药理 在ALK融合基因阳性的非小细胞肺癌，ALK酪氨酸激酶活性异常上升，并参与恶性转化和肿瘤生长 抗肿瘤作用 Arekuchinibu和主要代谢物（M-4）抑制人的非小细胞肺癌的来自ALK融合基因阳性的NCI-H2228细胞系的细胞生长。此外，Arekuchinibu，在NCI-H2228细胞系皮下注入严重联合免疫缺陷的小鼠，表现出对肿瘤生长的抑制效果。 作用机序 Arekuchinibu是通过抑制ALK酪氨酸激酶活性，抑制ALK融合基因阳性的肿瘤细胞的生长 适应症 对不能手术切除的晚期或ALK融合复发基因阳性非小细胞肺癌 用法用量 成人每日口服两次，每次300毫克。 包装规格 胶囊：20毫克*14胶囊（瓶） 胶囊：40毫克*98胶囊（瓶） 生产商：中外制药 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/4291032M1029_1_05/4291032M1029_1_05?view=body www.120ty.net Alecensa (Alectinib Hydrochloride) 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: ALECENSA Capsule 40mg（アレセンサカプセル40mg） Brand name : ALECENSA Capsule 40mg 　Active ingredient: Alectinib hydrochloride 　Dosage form: pale purplish red to dull purplish red, long diameter: approximately 18 mm 　Print on wrapping: Effects of this medicine This medicine suppress cancer cell growth by selective inhibition of ALK fusion protein essential for cancer cell growth. It is usually used to treat ALK fusion gene-positive unresectable, recurrent or advanced 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 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 40mg) contains 40 mg of Alectinib per capsule. Strictly follow the instructions. •In order to avoid food effect, take this medicine on an empty stomach (2 or more hours after meals and 1 or more hours before meals) as much as possible. •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 medicine The 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.Internal Published: 9/2014 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.