部份中文阿巴西普处方资料（仅供参考）
英文名：Abatacept
商品名：ORENCIA FOR I.V.
中文名：阿巴西普注射剂
生产商：百时美施贵宝
オレンシア点滴静注用250mg
药用分类名称
T细胞选择性共刺激调节剂
批准日期：2010年9月
欧文商標名
ORENCIA FOR I.V. INFUSION
一般名：
アバタセプト（遺伝子組換え）
Abatacept（Genetical Recombination）
本質：
阿巴塔塞普特是一种基因重组融合蛋白，1至125th是人细胞毒性T淋巴细胞抗原-4，126-358th由从人类IgG1衍生的修饰Fc区域组成，131，137， 140和149个氨基酸残基被Ser所取代。 阿巴塔塞普特是由中国仓鼠卵巢细胞产生的。 阿巴塔塞普托是一种糖蛋白，由由358个氨基酸残基组成的亚单位2分子组成（分子量：约92，000）。
批准条件
制定并适当实施药品风险管理计划。
风湿性关节炎
1. 进行大规模生产销售后调查，充分考虑本剂的安全性，并考虑长期给药的安全性、感染表达等。
2. 在制造和销售后进行双盲比较临床试验，进行适当的对照组，以验证该药物的有效性（包括对防止关节断裂进展的评估）和安全。
药效药理
1. 作用机制
阿巴受体通过CD28抑制共刺激信号，与抗原呈现细胞表面的CD80/CD86结合。 因此，抑制参与风湿性关节炎发展的T细胞的活化和细胞因子生产，基质金属蛋白酶通过激活其他免疫细胞或联合缔带组织细胞，被认为抑制了炎症介质的产生。
2. 药理作用
阿巴塔塞普汀减少抗原特异性天真T细胞和记忆T细胞在体外的生长，抑制炎症细胞因子的产生，如IL-2、TNF-α和IFN-α。 此外，在胶原蛋白诱导的关节炎大鼠中，病理进展，抑制了抗胶原蛋白抗体的产生和关节破坏。
适应症
以下疾病在现有治疗中效果不足
风湿性关节炎
具有多关节活动性青少年特发性关节炎
用法与用量
风湿性关节炎
通常，以下剂量作为阿巴塔塞普托（基因重组）在成人滴注中作为一次剂量。 首次给药后，2周，4周施用，然后每隔4周进行给药。
患者体重：小于60公斤
剂量：500毫克
小瓶数：2小瓶
患者体重：60公斤或以上100公斤以下
剂量：750mg
小瓶数：3小瓶
患者体重：超过100公斤
剂量： 1g
小瓶数：4小瓶
具有多关节活动性青少年特发性关节炎
通常，一次10mg/kg（体重）作为阿巴塔塞普托（基因重组）滴注。 首次给药后，2周，4周施用，然后每隔4周进行给药。
然而，如果体重超过75公斤或100公斤以下，则一次750毫克，如果超过100公斤体重，则滴注1g一次。
与使用和剂量相关的使用注意事项
1. 制备方法
（1）根据患者体重准备所需的小瓶数。
（2）使用专用的可处置注射器和18-21G注射针，不应用附加到本剂的硅油，每瓶10mL的日站注射水（也可使用日站生理盐溶液） 在浓度为阿巴塔塞普托（基因重组）25mg/mL溶解后，用日站生理盐水稀释所需量[当使用涂有硅油的注射器制备时，由于在溶液中可能发生漂浮物，则丢弃。
2. 如何管理
（1）将本剂的稀释剂总量滴入30分钟。
（2）这种药物通过内联过滤器施用，使用0.2至1.2微米的膜过滤器，不含无菌和无火焰，蛋白质结合性低。
（3）本剂应由独立线施用，不得与其他注射剂或输液等混合。
包装
静脉输液
250mg：1小瓶
制备注射器：1件
制造商
百时美施贵宝有限公司
プロモーション提携
小野薬品工業株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整资料附件：
https://www.info.pmda.go.jp/go/pack/3999429D1021_1_09/
ORENCIA FOR I.V.INFUSION(Abatacept[Genetical Recombination])
Brand name :ORENCIA FOR I.V.INFUSION[Active polyarticular juvenile idiopathic arthritis]
Active ingredient:Abatacept(Genetical Recombination)
Dosage form:
Color, diameter mm, thick mm
Print on wrapping:
Effects of this medicine
This medicine blocks co-stimulatory signal between antigen presenting cells and T cells, resulting in blocking T-cell activation and cytokine production related to rheumatoid arthritis.
It is usually used to treat active polyarticular juvenile idiopathic arthritis which conventional treatments showed insufficient results.
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 serious infectious disease.
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))
In general, administer intravenously at an interval of 2 weeks for the first 3 doses and then every 4 weeks.
Intravenous infusion takes about 30 minutes.
Precautions while taking this medicine
If you feel something is wrong such as breathlessness or itch during or after administration, consult with your doctor or nurse immediately.
Chest X-ray or other examination should be done periodically in order to prevent severe adverse drug reaction during or after administration. However, if you have prolonged cough or fever, contact with your doctor before the next consultation day and see your doctor as soon as possible.
Wash hands and gargle and regulate your daily life to prevent infectious disease. If you notice any unusual signs with your physical condition such as phlegm, sore throat, nasal discharge, congested nose, malaise, rash, itching of skin, shortness of breath or breathing difficulty, consult with your doctor, nurse or pharmacist.
If you notice any unusual signs other than those above or notice any changes in your physical conditions, consult with your doctor, nurse or pharmacist.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include headache, blood pressure elevation, decreased blood pressure, hypertension, upper respiratory infection (including nasopharyngitis), upper respiratory tract inflammation, nausea, stomatitis, constipation, gastroenteritis, rash (including eczema, prurigo, erythema) ,sore throat, oral candidiasis, oral herpes and hypopyrexia.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.
phlegm, sore throat, nasal discharge, congested nose, malaise[serious infection disease (sepsis, pneumonia, bronchitis, cellulitis, urinary-tract infection)]
malaise, rash, itching of skin, shortness of breath, breathing difficulty[serious hypersensitivity(shock, anaphylactoid symptoms)]
fever, dry cough, breathing difficulty, shortness of breath[interstitial pneumonia]
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
Consult with your doctor before you receive vaccination.
Injection
Published: 4/2018
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.