Orencia(abatacept) 是第一个选择性的T细胞共刺激调节剂，是一种治疗类风湿性关节炎的全新类别药物，该药可以减轻患者体征，包括主要的临床反应，减缓骨骼损伤的进程
Generic Name and Formulations:
Abatacept 250mg/vial; pwd for IV infusion after reconstitution and dilution; 125mg/mL prefilled syringe; soln for SC inj; Both: preservative-free. IV form: contains maltose.

Company:
Bristol-Myers Squibb
Indications for ORENCIA:
To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in patients with moderately-to-severely active rheumatoid arthritis; may be used alone or with DMARDS other than TNF antagonists. To reduce signs/symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients ≥6 years of age; may be used alone or with methotrexate.

Adult:
IV regimen: give as IV infusion over 30 mins at weeks 0, 2, and 4, then every 4 weeks thereafter. <60kg: 500mg. 60–100kg: 750mg. >100kg: 1g. SC regimen: following a single IV loading dose, give the first 125mg SC inj within a day, followed by 125mg SC inj once weekly. Patients who are unable to receive IV infusion, may begin weekly SC inj without an IV loading dose. Switching from IV to SC regimen: give the first SC dose instead of the next scheduled IV dose.

Children:
Give as an IV infusion over 30 mins at weeks 0, 2, and 4, then every 4 weeks thereafter. <6yrs: not recommended. 6–17yrs: (<75kg): 10mg/kg; (≥75kg): use adult dose; max 1g.

Pharmacological Class:
Selective costimulation modulator.

Warnings/Precautions:
Chronic or history of recurring infections. Conditions that predispose to infection. Test for tuberculosis, treat TB first. Monitor closely if new infection develops; discontinue if serious infection occurs. Screen for viral hepatitis prior to initiation. COPD (monitor). Immunosuppression. Juvenile arthritis: follow up on current immunizations before starting therapy. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
Concomitant TNF antagonists, other biologics (eg, anakinra), live vaccines: not recommended (see full labeling).

Adverse Reactions:
Headache, upper respiratory tract infection, nasopharyngitis, nausea, infusion site reactions; infections (may be serious), malignancies (eg, lymphoma, lung cancer), hypersensitivity reactions (discontinue if occurs). Children: pyrexia, abdominal pain.

Note:
Reconstitute with silicone-free disposable syringes only.

How Supplied:
Single-use vial—1 (w. silicone-free disposable syringe); Single-dose prefilled syringe—4

类风湿性关节炎治疗药Orencia的新型皮下制剂可由患者自行给药
2011年7月29日，百时美施贵宝公司宣布美国食品药品管理局(FDA)已批准Orencia(阿巴西普)的皮下(SC)制剂。Orencia适用于缓解中重度类风湿性关节炎(RA)患者的症状和体征，诱导主要临床应答，抑制结构损坏的进展，及改善躯体功能。该药先前获准的是静脉注射剂型。
这种新型可自行注射的皮下制剂为125 mg的固定剂量，用法为继单次静脉注射约10 mg/kg的负荷剂量后，每周用药1次。对于无法接受输注的患者，可以在未静脉注射负荷剂量的情况下开始每周注射1次Orencia皮下制剂。由Orencia静脉注射治疗过渡到皮下用药的患者首次应该使用皮下注射剂量，而不是下一个规定的静脉注射剂量。
Orencia既可用作单药治疗，亦可与除肿瘤坏死因子(TNF)拮抗剂以外的病情缓解性抗风湿药物(DMARD)联用。在临床试验中，接受TNF拮抗剂与Orencia联合用药的患者感染发生率较高，另外，不推荐将Orencia与其他RA生物性治疗(如阿那白滞素)联用。
Orencia皮下制剂研发计划包括4项临床试验，涉及近2,000例患者，其中一项3期比较试验纳入1,457例患者，另外3项研究主要评估了该药在以下3种临床情况下的安全性和免疫原性：Orencia单药治疗，停药后又重新开始Orencia皮下注射治疗，以及由Orencia静脉注射转为Orencia皮下注射治疗。
Orencia皮下制剂的安全性和免疫原性与其静脉注射治疗一致。接受Orencia皮下注射+甲氨蝶呤治疗的患者中有2.6%发生了局部皮下注射部位反应，这一比例在接受安慰剂皮下注射+MTX的患者中为2.5%。所有的注射部位反应(包括血肿、瘙痒和红斑)均为轻微至中度，均无需停药。在这些研究中，Orencia皮下注射组或静脉注射组最常报告的(报告率>5%)不良事件为头痛、鼻咽炎、上呼吸道感染、腹泻和恶心。
Orencia皮下注射制剂于2011年9月在美国上市。