部份中文依那西普处方资料（仅供参考）
商品名称：ENBREL
英文名称：Etanercept（genetical recombination）
通用名称：依那西普预充注射笔
生产厂家：辉瑞公司
エンブレル皮下注25mgペン0.5mL／ エンブレル皮下注50mgペン1.0mL
药物分类名称
完全人溶性TNFα/LTα受体制剂
批准日期：2013年5月
商標名
ENBREL 25mg PEN 0.5mL for S.C. Injection
ENBREL 50mg PEN 1.0mL for S.C. Injection
一般名
エタネルセプト（遺伝子組換え）
Etanercept （genetical recombination）
化学名
1-235-Tumor necrosis factor receptor （human） fusion protein with 236 - 467 - immunoglobulin G1 （human γ1-chain Fc fragment）, dimer
本質
利用中国仓鼠卵巢细胞（CHO）通过遗传重组产生的分子量为75kDa（p75）的人肿瘤坏死因子II型受体（TNFR-II）的细胞外结构域亚基和人IgG1的人Fc区 糖蛋白由二聚体组成。
分子量
大约150,000
氨基酸总数
934件
处理注意事项
为避免光线照射，本产品应存放在外箱中。
此外，打开外盒后，请保持灯光不被遮挡。
药用药理学
1.关节炎抑制作用
（1）大鼠抗原诱导的关节炎模型
依那西普通过关节内给予5μg/关节或更多针对大鼠抗原诱导的关节炎模型来抑制膝关节肿胀并改善关节炎评分。
（2）II型胶原关节炎模型
依那西普通过腹膜内施用1μg/体或更多针对三型II胶原关节炎模型显示出对关节炎发作的抑制作用。此外，通过腹膜内给予150μg/体，改善了关节炎和软骨破坏的评分。对于牛II型胶原关节炎模型，通过腹膜内施用50μg/体来抑制关节炎和血清抗II型胶原抗体滴度。对于猪II型胶原关节炎模型，通过腹膜内施用10μg/体来抑制关节炎的发生率。
2.作用机制
这种药物，人TNF可溶性受体部分，过产生TNFα和LTA，捕获（受体结合反应）作为诱饵受体，通过抑制细胞表面受体，抗风湿活性的结合，抗它被认为发挥炎症作用。此外，一旦捕获TNFα和LTα再次释放，该药物与TNFα和LTα的结合是可逆的。
依那西普抑制TNF与U937细胞表面上TNF受体的结合（解离常数（Ki）=1×10 -10 M）。
3.对TNF家族的结合亲和力
依那西普对TNFα和LTα具有结合亲和力，但对LTβ没有结合亲和力。
4. TNF对细胞毒性的抑制作用（体外）
与TNF诱导的L929细胞的细胞毒性相反，依那西普抑制浓度高于10ng/mL时活细胞数量的减少。
5.对IL-1α联合TNF诱导的致死率的抑制作用（体内）
针对结合TNF（3微克/体）诱导的致死鼠IL-1α（30μg的/体），依那西普显示了超过30微克/身体的静脉内施用致死的抑制作用。
6.细胞毒活性（体外）
依那西普不诱导补体依赖性细胞毒活性。
适应症
类风湿性关节炎（包括预防关节结构损伤）在现有治疗中效果不足
用法与用量
通常，该药物每天一次皮下注射10至25毫克，一周两次，或每天一次25至50毫克，每周一次，作为成人的依那西普（遗传重组）。
包装
[试剂盒] 25mg/0.5mL×1
[试剂盒] 50mg/1.0mL×1
制造销售
辉瑞公司
联盟单位：武田薬品工業株式会社
注：以上中文资料不够完整，使用者以原资料为准。
完整说明资料附件：
1）http://www.info.pmda.go.jp/go/pack/3999424G3028_1_10/
2）https://www.enbrel.jp/guideline/pdf/enbrel_guidebook_pen.pdf 
New formulation of Enbrel ® for rheumatoid arthritis treatment
Acquired manufacturing and marketing approval for "Enbrel® subcutaneous injection 50 mg pen 1.0 mL"
- Easy administration with one click, further improving patient convenience -
Pfizer Inc. (Headquarters: Shibuya-ku, Tokyo, Representative Director: Ichiro Umeda) announced on March 22, 2013 that Takeda Pharmaceutical Co., General name: Etanercept) "New product form" Enbrel® subcutaneous injection 50 mg pen 1.0 mL "was approved for manufacturing and marketing.
"Enbrel® subcutaneous injection 50 mg pen 1.0 mL" is a pen-type injection which is filled with a chemical solution of the same composition as the conventional "Enbrel® subcutaneous injection 50 mg syringe 1.0 mL", and one button at the top of the pen It can be easily administered simply by clicking, and it is a preparation which further improved the convenience of the patient. In addition, since the injection needle is hidden in the pen, it can be administered without looking at the needle at the time of injection, it also leads to reduction of the mental burden caused by the fear of needle. In addition, it also has a needle stick prevention function after administration, and it is also expected to reduce the risk of infectious diseases.
And because "Embrel® subcutaneous injection 50 mg pen 1.0 mL" is easier to administer than the conventional syringe formulation, we believe that training time and effort for patients in medical institutions will be reduced.
"Pfizer is extremely pleased to get approval for this time," said Mark Swinkel, President of Specialty Care Business Unit, Pfizer Inc. Director of Asia-Pacific Region " Some people had been hesitant to treat from fear of self injection but some 1.0 ml of Enbrel® subcutaneous 50 mg pen this time has appeared but hesitantly hesitated to treat I expect that it will be a good opportunity for patients who had been taking a step to take a new step in treatment. " Enbrel® subcutaneous injection 50 mg pen 1.0 mL Product Overview
Product name Enbrel® subcutaneous injection 50 mg pen 1.0 mL
Common name etanercept (genetical recombination)
Indications and efficacies Rheumatoid arthritis with insufficient efficacy in existing treatments
(Including prevention of structural damage of joints)
Dosage regimen/dosage In general, for adults, 10 to 25 mg once daily, twice weekly, or 25mg to 50mg once daily, once a week, weekly, subcutaneous injection .
Manufacture and sale approval date March 22, 2013