部份中文布罗达单抗处方资料（仅供参考）
商品名：Lumicef Subcutaneous Injection
英文名：Brodalumab
中文名：布罗达单抗填充注射器
生产商：协和发酵麒麟
药品简介
新型IL-17单抗LUMICEF（Brodalumab）于2016年7月4日在日本批准上市，用于普通性银屑病、关节病性银屑病、脓疱性银屑病、银屑病性红皮病、强直性脊柱炎、不符合X线标准的体轴性脊椎关节炎.
Brodalumab是一种白细胞介素17(IL-17)受体的抑制剂，能选择性结合IL-17受体并阻止其与IL-17A、IL-17F及其它类型IL-17的结合，抑制银屑病相关炎症应答反应。该药批准的适应症为寻常型银屑病、银屑病性关节炎、脓泡型银屑病和红皮症型银屑病。Lumicef®是一种皮下注射液，每只1.5mL注射器含210mg Brodalumab。推荐剂量为每周一次，每次210mg，首次于第0、1、2周给药，此后每2周一次。
ルミセフ皮下注210mgシリンジ
药效分类名称
人型抗人IL-17受体A单克隆抗体制剂
批准日期：2016年9月
欧文商標名
LUMICEF Subcutaneous Injection 210mg Syringe
一般名
ブロダルマブ（遺伝子組換え）
Brodalumab (Genetical Recombination)
分子量
約147,000
本質
Burodarumabu是抗人白介素17受体A人IgG2单克隆抗体，在中国仓鼠卵巢细胞中产生。Burodarumabu是一个442氨基酸的H链（gamma.2链）组成的氨基酸残基2和214个由氨基酸残基的L链（κ链）的2组成的糖蛋白。
操作注意事项
1.为了避免曝光，代理能够存储并把包装盒上。此外，外箱开口后也保存挡住光线。
2，包装打开之后立即使用
条件批准
对医药风险管理计划的发展，要正确实施。
药效药理
作用机制
本制剂是针对人IL-17受体A（IL-17RA）的单克隆抗体，选择性结合IL-17RA，抑制炎症细胞因子IL-17A、IL-17F、IL-17A/F杂二聚体、IL-25（又名IL-17E）和IL-17C通过IL-17RA的信号转导。
IL-17RA抑制作用
In vitro试验显示人IL-17RA具有高的结合亲和力，与人IL-17A竞争性地结合到人IL-17RA上。
在In vitro试验中，结合到人淋巴细胞、单细胞、颗粒细胞和各种人成纤维细胞的细胞表面，抑制了通过人IL-17A、IL-17F、IL-17A/F杂二聚体、IL-25和IL-17C刺激诱导的IL-17RA的生物活性。
对牛皮癣的作用
抗小鼠IL-17RA抗体通过对小鼠牛皮癣模型腹腔内给药，抑制了牛皮癣样的皮肤症状（表皮过形成、表皮层内的嗜中性粒细胞性脓肿及角化异常引起的表皮剥离）、病变部皮肤中的各种炎症性趋化因子及细胞因子mRNA的表达。
本制剂抑制了银屑病患者病变部皮肤中IL-17A、IL-17F、IL-17C、IL-12B及IL-23A mRNA的表达、角蛋白位点的增殖及表皮肥厚及炎性T细胞的聚集（外国人数据）。
对关节炎的作用
抗小鼠IL-17RA抗体通过对小鼠炎症性关节炎模型腹腔内给药，抑制了四肢的关节炎症状（发红及肿胀）及其伴随的骨破坏和关节软骨糜烂。
适应症
现有治疗效果不充分的下述疾病
普通性银屑病、关节病性银屑病、脓疱性银屑病、银屑病性红皮病、强直性脊柱炎、不符合X线标准的体轴性脊椎关节炎
用法与用量
成人在初次、1周后、2周后皮下给药，以后每隔2周皮下给药作为溴达马布（转基因）。
包装
皮下注射：
1.5mL〔1注射器、注射针：27量规〕
制造厂商
协和发酵麒麟株式会社
注：以上中文资料不够完整，使用者以原处方资料为准。
原说明书资料附件：
https://www.info.pmda.go.jp/go/pack/3999441G1029_1_11/
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Announcement of Domestic Sales of Lumisep®for Psoriasis Treatment
Kyowa Hakko Kirin Co., Ltd. (Headquarters: Tokyo, President: Mr.Chen Yu Hui, hereinafter referred to as "Kyowa Hakko Kirin")has psoriasis vulgaris 1, arthropathic psoriasis 2, pustular psoriasis 3, psoriatic erythra We announce that we will begin selling "Lumisep® subcutaneous injection 210mg syringe"(generic name: Brodarumab (Genetical recombination), hereinafter "Lumisep ®") with indication 4 as an indication on 30th September 2016. Lumisep ® is the first company in the world to be the first to sell in Japan.
Lumisep ® is a fully human antibody against interleukin(IL)-17 receptor A Note 5. This agent has a novel mechanism of action that inhibits the function of IL-17A, IL-17F, etc., 6 by specifically binding to IL-17 receptor A. It was approved in Japan on July 4, 2016, and was listed in the drug price standard on August 31 of the same year. This product is expected to improve the clinical symptoms and quality of life(quality of life)and the satisfaction level of treatment for diseased patients who have obtained approval.
The Kyowa Hakko Kirin Group pursues progress in life science and technology and contributes to the health and abundance of people around the world by creating new value.
. (Product information) Product name Lumisep®subcutaneous injection 210 mg syringe
Common name Brodalumab (Genetical recombination)
Indications/effects The following diseases that are ineffective in existing treatments
Psoriasis vulgaris, arthropathic psoriasis, pustular psoriasis, psoriatic erythroderma
Dosage and administration In general, adults receive 210 mg once as a brodullumab (genetical recombination) subcutaneously at an interval of 2 weeks after the first dose, 1 week and 2 weeks.
Packaging Lumisep®hypodermic injection 210mg syringe: 1 syringe
Approval acquisition date July 4, 2016
Drug price listing date August 31, 2016
Note 1 Psoriasis vulgaris
Psoriasis is a type of chronic skin disorder in which clear erythema with invasion/ thickening appears in the whole body and silvery white scales are observed. Approximately 90% of psoriasis is said to be plaque psoriasis.
2 Arthroscopic psoriasis
In addition to skin symptoms it calls for a disease type accompanied by the symptoms of arthritis. It is not necessarily correlated with the degree of skin rash, it may accompany strong joint swelling and pain. Although it shows symptoms similar to rheumatoid arthritis, rheumatoid reactions are not generally recognized in blood tests.
Note 3 Pustular psoriasis
With psoriasis, it is accompanied by fever and fatigue and calls for a disease type in which many pustules appear with redness on the skin of the whole body. It is severe in psoriasis and is life-threatening systemic inflammatory disease sometimes and it is designated as intractable disease in the country.
Note 4 Psoriatic erythroderma
It means that the rash of psoriasis spreads, spreads throughout the body and becomes red. Often accompanied by fever and malaise.
Note 5 IL-17 receptor A
It forms receptors for the inflammatory cytokines IL-17A, IL-17A/F, IL-17F and IL-17C.
Note 6 IL-17A, IL-17F, etc.
It is an inflammatory cytokine that induces inflammation and immune reactions and is known to be involved in the pathogenesis of autoimmune diseases including psoriasis.