简介:
部份中文阿巴西普处方资料(仅供参考)
英文名:Abatacept
商品名:ORENCIA
中文名:阿巴西普冻干粉注射剂
生产商:百时美施贵宝公司
药品简介
Orencia(abatacept,阿巴西普)静脉输液(IV)和皮下注射剂(SC),联合氨甲喋呤(MTX),用于既往未接受MTX治疗(MTX初治)的类风湿性关节炎(RA)成人患者高度活动性和进展性疾病的治疗。
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:
Abatacept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。Abatacept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. 操作机制
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,以及基质金属蛋白酶,通过激活其他免疫细胞或激活关节中的结缔组织细胞,它被认为是抑制炎症介质的产生。
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Abatacept(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Abatacept(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。
包装
输注
250mg:1小瓶[制备注射器:1件]
制造供应商
百时美施贵宝公司
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。
完整说明资料附件:
http://www.info.pmda.go.jp/go/pack/3999429D1021_1_09/
ORENCIA FOR I.V. INFUJION(オレンシア点滴静注用250mg)
Brand name : ORENCIA FOR I.V. INFUJION
Active ingredient: Abatacept(Genetical Recombination)
Dosage form: injection
Print on wrapping:
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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 rheumatoid 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, for adults, 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 sputum, sore throat, nasal discharge, congested nose, lassitude, rash, itching of skin, shortness of breath or breathlessness, 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, rash (including eczema, prurigo, erythema) and sore throat. 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.
•sputum, sore throat, nasal discharge, congested nose, lassitude [serious infection desease(sepsis, pneumonia, bronchitis, cellulitis, urinary-tract infection)]
•lassitude, rash, itching of skin, shortness of breath, breathlessness[serious hypersensitivity (shock, anaphylactoid symptoms)]
•fever, dry cough, breathlessness, 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. |