新一代人源化抗人IL-17A的单克隆抗体制剂TALTZ Subcutaneous Injection（Ixekizumab（Genetical Recombination））在日本获批用于适合系统治疗（systemic therapy，即全身疗治）的中度至重度斑块型银屑病（plaque psoriasis）成人患者的治疗.

トルツ皮下注80mgオートインジェクター／トルツ皮下注80mgシリンジ

治疗类别名称
人源化抗人IL-17A的单克隆抗体制剂
商標名
Taltz Subcutaneous Injection
Taltz Subcutaneous Injection
一般名：
イキセキズマブ（遺伝子組換え）（JAN）
Ixekizumab（Genetical Recombination）
本　質：
Ikisekizumabu是重组人源化单克隆抗体，小鼠抗人白细胞介素17抗体的互补性决定部分，以及由H链的一个框架部分和人IgG4的恒定部分，227位的Ser残基的取代有临，赖氨酸在C末端已被删除。Ikisekizumabu由中国仓鼠卵巢细胞产生的。Ikisekizumabu是，445片组成的氨基酸残基的H链（γ4链）2和由糖蛋白组成的219个氨基酸残基（κ链）具有两个L链（分子量：约149,000）。
条件批准
在建立药品风险管理计划，要正确使用。
药效药理
1.作用机制
这种药物是人源化的IgG4单克隆抗体白细胞介素（IL）-17A炎性细胞因子，结合行为与IL-17A，这被认为是参与自身免疫疾病的IL-17A的发展它被认为。
2.药理作用
(1) 这种药物以高亲和力与人IL-17A（解离常数：小于3时）的约束，不结合IL-17B，IL-17C，IL-17D，IL-17E和IL-17F。
(2) 在施用在体外研究和IL-17A的小鼠，该药物抑制由IL-17A诱导的趋化因子生成。
(3) 在皮肤银屑病患者的活检物中I期临床试验，皮肤厚度以及角化细胞的增殖，T细胞和树突状细胞数目的剂量依赖性下降趋势是从第1天观察到43天进行。
适应病症
寻常型银屑病，关节病型银屑病，脓疱型银屑病，红皮病牛皮癣
用法与用量
通常，在成人160mg皮下施用首次作为Ikisekizumabu（基因重组），是从两周后直到12周后在2周的时间间隔，4周间隔皮下给药一次80毫克一次80毫克和更高在皮下施用。
包装规格
注射笔
80毫克/1毫升：1支

预充注射器
80毫克/1毫升：1支

制造厂商
礼来日本有限公司
提携
鳥居薬品株式会社
完整处方资料附件[注：使用以原处方为准]：
http://www.info.pmda.go.jp/go/pack/3999442G1023_1_02/
TALTZ Subcutaneous Injection injector（Ixekizumab (genetical recombination)）
Humanized anti-human IL-17A monoclonal antibody preparation
Japan Eli Lilly Co., Ltd. and Torii Pharmaceutical Co., Ltd. launched the psoriasis treatment "Tortz subcutaneous injection 80 mg autoinjector" and "Toruzu subcutaneous injection 80 mg syringe" on November 21.
"Tortz" is a humanized anti-human IL-17A monoclonal antibody preparation. Both dosage forms are indications for "patients with psoriasis poorly effective in existing treatments, arthropathic psoriasis, pustular psoriasis, psoriatic erythroderma".
Afflicted people in the world reaching 125 million people Psoriasis
Psoriasis is a chronic non-infectious autoimmune disease that appears on the skin. The immune system develops by sending the wrong signal to accelerate the growth cycle of skin cells. It develops in every part of the body and is also associated with other serious diseases such as diabetes and heart disease. It is a common inflammatory disease with as many as 7.5 million patients in the United States, with more than 125 million people suffering in the world.
"Toluz" is a monoclonal antibody that binds with high affinity to neutrophils interleukin-17A (IL-17A), which is deeply involved in the pathology of psoriasis and arthropathic psoriasis. In July this year we have obtained domestic manufacturing and marketing approval.
It surely delivers to patients who need treatment。
TALTZ Subcutaneous Injection 80 mg auto injector（トルツ皮下注80mgオートインジェクター） 
Brand name : TALTZ Subcutaneous Injection 80 mg auto injector
　Active ingredient: Ixekizumab (genetical recombination)
　Dosage form: injection
　Print on wrapping:
TALTZ Subcutaneous Injection 80 mg syringe（トルツ皮下注80mgシリンジ） 
Brand name : TALTZ Subcutaneous Injection 80 mg syringe
　Active ingredient: Ixekizumab (genetical recombination)
　Dosage form: injection
　Print on wrapping: 
Effects of this medicine
This medicine inhibits interleukin(IL)-17A, which is one of the causes of inflammatory response that plays a role in the development of psoriasis, and psoriatic arthritis.
It is usually used to treat plaque psoriasis, psoriatic arthritis, pustular psoriasis and erythrodermic psoriasis with inadequate response to conventional therapies.
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 infections or suspected of them, active tuberculosis or a history of tuberculosis. If you have inflammatory bowel disease (Crohn's Disease or ulcerative colitis). If you are scheduled for vaccination with a live vaccine.
•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))
•For adults, inject 2 syringes subcutaneously at the first time, followed by one syringe every 2 weeks for 12 weeks. After 12 weeks, inject one syringe every 4 weeks.
•Depending on your response to the treatment, this medicine may be administered over a long period of time.
•If you miss the doctor's appointment to receive the injection, contact your prescribed doctor when you realize it.
Precautions while taking this medicine
•Preventing from any infections such as common cold or influenza, washing hands and gargling is important to keep your health condition better.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include injection site reaction (erythema, pain etc.), nasopharyngitis, and upper respiratory tract infection. 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.
•fever, cold-like symptoms, general malaise [serious infections]
•fever, hives, swelling around the lips [serious hypersensitivity reaction]
•fever, sore throat [neutropenia]
•abdominal pain, chronic diarrhea, feces with mucus or blood [inflammatory bowel disease (ulcerative colitis, Crohn's disease) ]
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
•This medicine has immuno-suppressive effect, avoid receiving live vaccines during the treatment.
Eli Lilly Japan K.KInjection
Published: 12/2016
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.