罗氏抗炎药Actemra单剂量预充式自动注射器ACTPen获美国FDA批准,治疗4种炎症性疾病 2018年11月27日,瑞士制药巨头罗氏(Roche)近日宣布,美国食品和药物管理局(FDA)已批准ACTPen(162mg/0.9mL),这是抗炎药物...
Actemra/RoActemra通过阻断白细胞介素6(IL-6),从而发挥免疫抑制作用。IL-6是一种促炎蛋白细胞因子,在多种疾病发生发展过程中发挥关键作用。 雅美罗获批基于罗氏公司赞助的focuSSced试验(NCT02453256),这是一项在212名成年硬皮病患者中进行的3期临床研究。受试者被随机分配每周皮下注射162 mg 雅美罗或者安慰剂,持续给药...
该研究入组了51例年龄在1-17岁、之前对非类固醇抗炎药(NSAIDs)和皮质类固醇治疗反应不佳、未接受Actemra治疗或正在接受Actemra静脉输液(IV)治疗并实现完全疾病控制的sJIA患者。 研究中,Actemra SC根据基于患者体重的给药方案进行开放标签治疗:体重<30kg的sJIA患者中Actemra用药方案为每2周或10天一次162mg,体重≥30kg的...
约80%的系统性硬皮病患者可能患上间质性肺病,是由肺部瘢痕组织沉积和炎症引起的,严重影响患者的呼吸功能。 雅美罗获批基于罗氏公司赞助的focuSSced试验(NCT02453256),这是一项在212名成年硬皮病患者中进行的3期临床研究。受试者被随机分配每周皮下注射162 mg 雅美罗或者安慰剂,持续给药48周——差不多一年的时间,之后...
prefilled syringe (PFS) with a needle safety device. Each device delivers 0.9 mL (162 mg) ...
The recommended dose of Actemra is 162 mg injected once a week. Actemra must be used on the same day each week. Choose the day of the week that best fits your schedule. The syringe is designed to deliver 162 mg per injection when used according to the instructions given here. ...
162 mg/0.9 mL Actemra subcutaneous solution from$1,246.57 for 0.9 milliliters QuantityPer unitPrice 0.9 milliliters$1,385.08$1,246.57 Important: When there is a range of pricing, consumers should normally expect to pay the lower price. However, due to stock shortages and other unknown variabl...
In October of 2013, a SC dosage form of Actemra was released for the RA indication. The SC form of Actemra contains 162 mg of Actemra in 0.9 mL.Original Effective Date
-Weight less than 30 kg: 12 mg/kg IV over 60 minutes every 2 weeks -Weight 30 kg or more: 8 mg/kg IV over 60 minutes every 2 weeks SUBCUTANEOUS formulation: -Weight less than 30 kg: 162 mg subcutaneously once every 2 weeks -Weight 30 kg or more: 162 mg subcutaneously once a wee...
“A method of treating rheumatoid arthritis (RA) in a patient comprising subcutaneously administering an anti-IL-6 receptor (IL-6R) antibody to the patient, wherein the anti-IL-6R antibody is administered as a fixed dose of 162 mg per dose every week or every two weeks, and wherein the...