英文药名：LASERPHYRIN FOR INJECTION（Talaporfin Sodium） 中文药名：注射用他拉泊芬钠 生产厂家：明治制果制药 注射用レザフィリン100mg 治疗类别名称 光动力疗法 开发与上市厂商 本品由日本明治制果公司研制， 2004年6月在日本首次上市。 欧文商標名 LASERPHYRIN 100mg FOR INJECTION 性　状 他拉泊芬钠是一种深蓝绿色粉末。 此产品易溶于水，乙酸（100），以促进微溶，微溶于甲醇，乙醇（99.5）非常微溶，并在乙腈中几乎不溶。 旋光[α]20546：约+1000°（0.02克那些转化为脱水，水，500毫升为100mm）。 本产品是吸湿 一般名 タラポルフィンナトリウム　Talaporfin Sodium 化学名 （＋）-tetrasodium（2S，3S）-18-carboxylato-20-［N-（S）-1,2-dicarboxylatoethyl］carbamoylmethyl-13-ethyl-3,7,12,17-tetramethyl-8-vinylchlorin-2-propanoate 分子式 C38H37N5Na4O9 分子量 799.69 構造式 融　点 約150℃（分解点） 分配係数 （log10　1-オクタノール層／水層） （下表参照） pH2  pH4  pH6  pH8～12  ＞3.00  2.08  －1.58  ＜－3.00  条件批准 在制定药品风险管理计划，要正确实施。 1.早期肺癌 1）所有的管理情况下尽可能多地从审批受制于上市后监测的三年中，复发按照本药，生存等，光动力疗法施行后要考虑长期预后。对调查结果，它被提交的总结的结果与在外科手术等的其它处理结果进行比较。 2）根据药物接收的训练为光动力学治疗，如所使用的唯一的医生具有足够的知识和经验相关的治疗，采取必要的措施。 2. 原发性恶性脑肿瘤 收到的光动力学治疗的训练根据药物，如所使用的唯一的医生具有足够的知识和经验相关的治疗，采取必要的措施。 3）放化疗或局部复发持续食管癌放射治疗后 收到的光动力学治疗的训练根据药物，如所使用的唯一的医生具有足够的知识和经验相关的治疗，采取必要的措施。 适应证 本品适用于不能接受手术等根除 性治疗或有必要保留肺功能而不能接 受其他治疗方法的早期肺癌。 用法用量 1.早期肺癌，化疗和放射治疗，或本地持久复发食道癌放射治疗后 通常，为40mg/m 2至单次静脉内注射如成人他拉泊芬钠。激光照射到静脉注射4-6小时后的病变部位。 2. 原发性恶性脑肿瘤 通常，为40mg/m 2至单次静脉内注射如成人他拉泊芬钠。静脉内注射22-26小时后的激光照射到病变部位。 药效药理 1. 薬理作用 此疗法，裸鼠移植人肺癌（5-10mg/ kg，静脉给药），人成胶质细胞瘤来源的细胞系（T98G，A172和U251）和人食管癌来源的细胞系（TE-5和TE-10这表明针对抗肿瘤作用）。 2.作用机制 通过照射激光束到他拉泊芬钠的单线态氧产生。这单线态氧具有对肿瘤细胞的直接的损伤，或通过破坏肿瘤血管，它被认为是显示出抗肿瘤作用。 包装规格 1瓶：100毫克 制造厂商 明治制果制药 注：以上部份资料仅供参考，使用时请仔细阅读[附件]：http://www.info.pmda.go.jp/go/pack/4299404D1028_1_08/ LASERPHYRIN 100mg FOR INJECTION（注射用レザフィリン100mg） Brand name : LASERPHYRIN 100mg FOR INJECTION 　Active ingredient: Talaporfin sodium 　Dosage form: injection 　Print on wrapping:   Effects of this medicine This medicine gathers in and around tumor cells and reacts to laser light to exert an antitumor effect. It is usually used to treat early-stage lung cancer, primary malignant brain tumor (only when surgical removal of the tumor is performed) and local failure after chemoradiotherapy or radiotherapy for esophageal cancer eligible for laser irradiation. Thus, this is a local treatment and is ineffective on non-irradiated laser site. 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 porphyria. •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>> •Early-stage lung cancer, local failure after chemoradiotherapy or radiotherapy for esophageal cancer: In general, this medicine is injected once intravenously. The target lesion is then irradiated by laser light 4 to 6 hours after the injection. Primary malignant brain tumor: In general, this medicine is injected once intravenously. The target lesion is then irradiated by laser light 22 to 26 hours after the injection. •The treatment period with this medicine is determined based on the response to the treatment. Ask the doctor about the treatment span. Precautions while taking this medicine •In treatment of local failure in patients with esophageal cancer, dietary intake may cause intense inflammation and weakening of the tissues, resulting in esophageal perforation. For this reason, the patients should fast from the morning on the day of administration until the following day of laser irradiation and receive nutritional care with fluid replacement. •This medicine may cause photosensitivity. Avoid direct sunlight and stay in rooms conditioned at lighting intensity of 500 lux or less by using shade curtains for 2 weeks after the injection. Wear sunglasses for 3 days after the injection. Possible adverse reactions to this medicine The most commonly reported adverse reactions include increased sputum, bloody sputum, cough, sore throat, fever and esophageal pain. 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. •breathing difficulty, shortness of breath on exertion [respiratory distress] •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. Meiji Seika Pharma Co., Ltd.Injection Revised: 8/2015 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. Light Sciences宣布，其先导化合物LS11(在日本称为Laserphyrin)的授权公司—Meiji Seika获得了日本厚生省Pharmaceutical Affairs and Food Sanitation Council的批准推荐。该药物将获准用于早期支气管癌的光动力疗法。 日本政府对全球第二大保健市场决策的出台，是缘于Light Sciences成功地完成了其先导化合产品Litx(TM)用于实体癌晚期患者的第一和第二阶段研究。 Litx System关键成分之一就是具有光活性的LS11药物。 Light Sciences的总裁兼首席执行官Albert Luderer博士表示：“我们的先导药物在日本获得批准推荐之时，正值我们的肿瘤学项目第二阶段在全球启动之际。LS11杰出的安全性使我们深受鼓舞。我们相信这一里程碑式的政府决策将为Litx下一阶段的评估树立积极的基调。” Light Sciences在2000年初从日本石化公司(Nippon Petrochemicals)和日本明治制果株式会社(Meiji Seika Kaisha)获得了LS11的授权，同时获得了开发、制造和出售该化合物，用于日本以外世界其他地区的光力学治疗的多种疗法应用的专有权。 Litx以新一代光活性药物为基础，这种药物在治疗场所由微小且成本低廉的发光二极管为其制造并传输光能。Litx主要用于治疗局部疾病，并初步用于对手术、放疗或化疗等疗法均告失败的实体瘤患者的研究。 美国癌症学会(American Cancer Society)预测，今年将有超过550,000名病情已到达这种程度的癌症患者死亡，即每天死亡1,500多人。Litx还被作为针对心血管疾病的介入疗法正在进行前临床实验，而针对眼疾的第一阶段研究也正在进行中。