尤特克单抗stelara中文说明书
合理使用阿利西尤单抗注射液
合理使用阿利西尤单抗注射液金烨 （上海中医药大学附属岳阳中西医结合医院，上海 200437）提到阿利西尤单抗这个药名的时候，细心的人会留意“单抗”二字。
由于一般肿瘤药物才会有单抗，所以不少人会误以为这是新的抗肿瘤靶向药物。
实际上，并非所有带“单抗”二字的都是抗肿瘤药物。
阿利西尤单抗是一种血脂调节剂，本文将详细介绍该药的使用知识。
什么是单抗单抗为单克隆抗体的缩写，是一类含有大分子蛋白的生物制剂。
当患者体内存在某种抗原表达时，针对此抗原的单克隆抗体药物可与之特异性结合，最终形成抗原抗体复合物，让特定抗原失活，从而达到治疗效果。
阿利西尤单抗的适应证（1）预防心血管意外事件。
如对确诊为动脉粥样硬化性心血管疾病的成人患者应用该药物，可降低卒中、心肌梗死及不稳定型心绞痛的发生风险。
（2）调节混合型血脂异常及原发性高胆固醇血症。
阿利西尤单抗的使用（1）了解注射笔的构造。
从上到下依次是绿色按钮、窗口、黄色安全帽（内部含针）、蓝帽。
每支笔只能用1次。
（2）注射前准备。
首先，查看注射笔上的标签，检查产品、剂量是否正确。
明确有效期，若超过标签上规定的使用时，则不能使用。
其次，观察窗口中的液体颜色是否澄清，无色到淡黄色属于正常。
若是窗口中显示为纯黄色，则药品已经失效，不能再使用；如在窗口中看到气泡，属正常现象。
再次，在室温下预热注射笔30~40 min，该过程中不能加热注射笔，要让其在室温下自然复温，复温过程中不能将注射笔放回冰箱。
最后，注射部位选取。
在注射前，用水和肥皂清洁双手并擦干，可选择上臂外侧、腹部（肚脐周围5 cm区域除外）、大腿。
（3）注射药物。
完成准备工作后，沿着水平的方向取下蓝帽。
握持笔的方式就像是右手比画“很棒”的手势，同时右手握住笔。
在皮肤上按压黄色安全盖，保持注射笔与皮肤之间呈90°。
按压注射笔，并让其牢牢固定在注射的身体部位，直至不能看见黄色安全盖。
如在肚皮处注射，要紧捏皮肤，确保注射部位牢固。
达雷妥尤单抗注射液说明书
核准日期：达雷妥尤单抗注射液（皮下注射）说明书本品为附条件批准上市，请仔细阅读说明书并在医师指导下使用。
【药品名称】通用名称：达雷妥尤单抗注射液（皮下注射）商品名称：兆珂速®/DARZALEX FASPRO®英文名称：Daratumumab Injection（Subcutaneous Injection）汉语拼音：Daleituoyou Dankang Zhusheye（Pixia Zhushe）【成份】主要成份：达雷妥尤单抗辅料：重组人透明质酸酶（rHuPH20）、L-组氨酸、L-组氨酸盐酸盐一水合物、L-蛋氨酸、聚山梨酯20、山梨醇（E420）和注射用水。
【性状】溶液澄清至乳白色，无色至黄色。
【适应症】本品联合硼替佐米、环磷酰胺和地塞米松适用于新诊断的原发性轻链型淀粉样变患者。
本方案不适合也不推荐用于患有NYHA IIIB级或IV级心脏疾病或Mayo IIIB期的原发性轻链型淀粉样变患者。
基于替代终点血液学完全缓解率结果附条件批准上述适应症。
本适应症的完全批准将取决于生存获益相关临床终点的结果。
【规格】1800mg（15 ml）/瓶【用法用量】本品不用于静脉给药，应仅使用规定剂量进行皮下注射给药。
本品应由医务人员给药，首次给药应在配有急救设施的条件下进行。
务必对药瓶标签进行检查，以确保按照处方给予患者适当的制剂和剂量。
应给予注射前和注射后药品，以降低达雷妥尤单抗输注相关的全身或局部反应的风险。
见下文“推荐的合并用药”和【注意事项】。
在开始本品治疗前，先对患者进行血型鉴定和红细胞抗体筛查。
用法用量与硼替佐米、环磷酰胺和地塞米松联合用药的给药方案（4周为一个周期）根据表1中的给药方案，本品建议的剂量为1,800 mg，给药时间约为3 -5分钟。
表1：本品联合硼替佐米、环磷酰胺和地塞米松（4周为一个周期）用于原发性轻链型淀粉样变的给药方案a每2周一次给药方案的首次给药时间为第9周。
依马利尤单抗注射液说明书
核准日期：修改日期：依马利尤单抗注射液说明书本品为附条件批准上市，请仔细阅读说明书并在医师指导下使用。
【药品名称】通用名称：依马利尤单抗注射液商品名称：伽蜜芬®/Gamifant®英文名称：Emapalumab Injection汉语拼音：Yimaliyou Dankang Zhusheye【成份】活性成份：依马利尤单抗依马利尤单抗是一种高亲和力全人源化IgG1 λ2型单克隆抗体，与可溶性和受体结合型的IFNγ结合，中和其生物活性。
辅料：L-组氨酸、L-组氨酸盐酸盐一水合物、氯化钠、聚山梨酯80。
【性状】澄清至微浊、无色至微黄色溶液。
【适应症】本品适用于难治性、复发性或进展性、或对常规疗法不耐受的原发性噬血细胞性淋巴组织细胞增多症（HLH）成人和儿童（新生儿及以上）患者。
本品基于境外数据获得附条件批准上市，治疗中国患者的有效性和安全性尚待上市后进一步确证。
【规格】10 mg（2 ml）/瓶。
【用法用量】安全性评估监测在开始本品治疗之前在开始本品治疗之前，通过结核菌素皮肤试验（PPD）或IFNγ释放试验进行潜伏结核感染检测，并评估患者罹患结核的危险因素。
对存在罹患结核风险或已知PPD试验结果呈阳性或IFNγ释放试验结果阳性的患者进行预防性抗结核治疗。
本品治疗期间每2周监测一次结核、腺病毒、EBV和CMV，并根据临床指征进行监测。
预防治疗及合并用药治疗前预防治疗在本品给药前，应进行带状疱疹、耶氏肺孢子虫和真菌感染预防性治疗。
治疗期间合并用药对于基线未接受地塞米松治疗的患者，在本品治疗的前一天开始给予地塞米松，日剂量至少5至10 mg/m2。
对于基线正在接受地塞米松治疗的患者，可以继续常规剂量治疗（日剂量至少为5 mg/m2）。
可以根据临床医师的评估对地塞米松进行逐渐减量（见【临床试验】）。
推荐剂量本品推荐起始剂量为1 mg/kg，静脉输注，每周2次（每3至4天一次），每次输注时间需大于1小时。
Arzerra (ofatumumab) 产品说明书
Arzerra® (ofatumumab)(Intravenous)Document Number: IC‐0208 Last Review Date: 04/04/2022Date of Origin: 08/26/2014Dates Reviewed: 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017,05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022I.Length of Authorization 1,10Coverage will be provided for 6 months with renewal subject to the following:∙CLL/SLL (first-line) may be renewed to allow for a total of 12 cycles∙CLL/SLL (relapsed) may not be renewed (unless the provisions for extended treatment have been met)∙CLL/SLL (single agent subsequent therapy) may not be renewed (unless the provisions for extended treatment have been met)∙CLL/SLL (extended treatment) may be renewed to provide for a total of 2 years of therapy ∙Waldenström’s Macroglobulinemia/Lymphoplasmacytic lymphoma may be renewed to allow for up to a total of 3 cyclesII.Dosing LimitsA.Quantity Limit (max daily dose) [NDC Unit]:∙Arzerra 100 mg/5 mL single-use vial: 3 vials Day 1∙Arzerra 1000 mg/50 mL single-use vial: 2 vials weekly x 7 doses, then 2 vials every 4 weeks, then 1 vial every 8 weeks for up to 24 monthsB.Max Units (per dose and over time) [HCPCS Unit]:CLL/SLL First‐Line▪30 billable units on day 1 and 100 billable units on day 8; then▪100 billable units every 28 days for up to 11 dosesSingle agent subsequent therapy▪30 billable units on day 1; then▪200 billable units weekly x 7 doses; then▪200 billable units every 28 days x 4 dosesRelapsed▪30 billable units on day 1 and 100 billable units on day 8; then▪100 billable units every 28 days for up to 5 dosesExtended Treatment▪30 billable units on day 1 and 100 billable units on day 8; then▪100 billable units 7 weeks later and every 8 weeks thereafterWaldenström’s Macroglobulinemia / Lymphoplasmacytic Lymphoma ▪30 billable units on day 1; then▪200 billable units every 7 days x 4 dosesIII.Initial Approval Criteria 1Coverage is provided in the following conditions:∙Patient is at least 18 years of age; ANDUniversal Criteria 1∙Patient has been screened for the presence of hepatitis B (HBV) infection (i.e., HBsAg and anti-HBc) prior to initiating therapy and patients with evidence of current or prior HBVinfection will be monitored for HBV reactivation during treatment; AND∙Must not be administered concurrently with live vaccines; ANDChronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) † Ф1-3∙Used as first-line therapy; ANDo Used in combination with chlorambucil in patients considered inappropriate for fludarabine-based therapy (Note: only applies to CLL);ORo Used in combination with bendamustine ‡; AND▪Patient does not have del(17p)/TP53 mutation (patients ≥ 65 years, or younger patients with or without significant comorbidities; excluding use in frail patients[i.e., creatine clearance (CrCl) <70 mL/min]); OR∙Used as subsequent therapy; ANDo Used as a single agent; ORo Used in combination with fludarabine and cyclophosphamide (FC) for relapsed disease (Note: only applies to CLL);OR∙Used as extended treatment in patients with complete or partial response after at least 2 lines of therapy for recurrent or progressive disease (Note: only applies to CLL) Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma ‡ 2,4∙Used as a single agent OR as part of combination therapy; AND∙Patient is intolerant to rituximab; ANDo Patient has previously failed primary therapy; ORo Patient has progressive or relapsed disease† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug IV.Renewal Criteria 1Coverage may be renewed based on the following criteria:∙Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performancestatus, etc.identified in section III; AND∙Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND∙Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: Hepatitis B virus reactivation/infection, progressive multifocal leukoencephalopathy, severe infusion reactions, tumor lysis syndrome, cytopenias (neutropenia, anemia, andthrombocytopenia), etc.V.Dosage/Administration 1,10CLL/SLL (First-line)Administer 300 mg on Day 1, then 1,000 mg on Day 8, followed by 1,000 mg on Day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or amaximum of 12 cyclesCLL/SLL (Single agent subsequent therapy)Administer 300 mg on Day 1, followed 1 week later by 2,000 mg given weekly x 7 doses (infusions 2 through 8), followed 4 weeks later by 2,000 mg every 4 weeks for 4 doses (infusions 9 through 12) for a total of 12 dosesCLL/SLL (Relapsed) Administer 300 mg on Day 1, then 1,000 mg on Day 8, followed by 1,000 mg on Day 1 of subsequent 28-day cycles for a maximum of 6 cyclesCLL/SLL (Extended treatment)Administer 300 mg on Day 1, then 1,000 mg on Day 8, followed by 1,000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 yearsWaldenström’s/ Lymphoplasmacytic lymphoma Cycle 1:∙Administer 300 mg on day 1, then 1,000 mg weekly for weeks 2 through 4; OR∙Administer 300 mg on day 1, then 2,000 mg weekly for weeks 2 through 5Cycle 2-3:∙Patients with stable disease or a minor response at week 16 of cycle 1 are eligible to receive a re-dosing cycle of 300 mg on day 1, then 2,000 mg for weeks 2 through5.Patients responding to cycle 1 or the redosing cycle who developed diseaseprogression within 36 months can receive treatment with 300 mg on day 1, then2,000 mg for weeks 2 through 5.VI.Billing Code/Availability InformationHCPCS Code:•J9302 – Injection, ofatumumab, 10 mg; 1 billable unit = 10 mgNDC:•Arzerra 1000 mg/50 mL single-use vial: 00078-0690-xx•Arzerra 100 mg/5 mL single-use vial: 00078-0669-xxVII.References1.Arzerra [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation, August2016. Accessed March 2022.2.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium®) ofatumumab. National Comprehensive Cancer Network, 2022. The NCCNCompendium® is a derivative work of the NCCN Guidelines®. NATIONALCOMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® aretrademarks owned by the National Comprehensive Cancer Network, Inc. To view the mostrecent and complete version of the Compendium, go online to . Accessed March2022.3.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium®) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Version2.2022. National Comprehensive Cancer Network, 2022. The NCCN Compendium® is aderivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCERNETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the NationalComprehensive Cancer Network, Inc. To view the most recent and complete version of theCompendium, go online to . Accessed March 2022.4.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium®) Waldenstrom’s Macroglobulinemia/Lymphoplasmacytic Lymphoma. Version2.2022. National Comprehensive Cancer Network, 2022. The NCCN Compendium® is aderivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCERNETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the NationalComprehensive Cancer Network, Inc. To view the most recent and complete version of theCompendium, go online to . Accessed March 2022.5.Furman RR, Eradat H, DiRienzo CG, et al. A phase II trial of ofatumumab in subjects withWaldenstrom's macroglobulinemia. Blood. 2011;118:37016.Wierda WG, Kipps TJ, Mayer J, et al. Ofatumumab as single-agent CD20 immunotherapyin fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol 2010;28:1749-17557.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium®) B-Cell Lymphomas. Version 1.2022. National Comprehensive CancerNetwork, 2022. The NCCN Compendium® is a derivative work of the NCCN Guidelines®.2NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCNGUIDELINES® are trademarks owned by the National Comprehensive Cancer Network,Inc. To view the most recent and complete version of the Compendium, go online to. Accessed March 2022.8.Rosenbaum CA, Jung SH, Pitcher B, et al. Phase 2 multicentre study of single-agentofatumumab in previously untreated follicular lymphoma: CALGB 50901 (Alliance). Br JHaematol. 2019 Feb 5.9.Van Imhoff GW, McMillan A, Matasar MJ et al. Ofatumumab Versus Rituximab SalvageChemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: TheORCHARRD Study. J Clin Oncol 2017;35 (5):544-551.10.Furman RR, Eradat HA, DiRienzo CG, et al. Once-weekly ofatumumab in untreated orrelapsed Waldenström's macroglobulinaemia: an open-label, single-arm, phase 2 study.Lancet Haematol. 2017 Jan;4(1):e24-e34. doi: 10.1016/S2352-3026(16)30166-1. Epub 2016Dec 1.11.Hillmen P, Robak T, Janssens A, et al. Chlorambucil plus ofatumumab versus chlorambucilalone in previously untreated patients with chronic lymphocytic leukaemia(COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015 May 9;385(9980):1873-83. doi: 10.1016/S0140-6736(15)60027-7. Epub 2015 Apr 14.12.Robak T, Warzocha K, Govind Babu K, et al. Ofatumumab plus fludarabine andcyclophosphamide in relapsed chronic lymphocytic leukemia: results from theCOMPLEMENT 2 trial. Leuk Lymphoma. 2017 May;58(5):1084-1093. doi:10.1080/10428194.2016.1233536. Epub 2016 Oct 12.13.van Oers MH, Kuliczkowski K, Smolej L, et al. Ofatumumab maintenance versusobservation in relapsed chronic lymphocytic leukaemia (PROLONG): an open-label,multicentre, randomised phase 3 study. Lancet Oncol. 2015 Oct;16(13):1370-9. doi:10.1016/S1470-2045(15)00143-6. Epub 2015 Sep 13.14.Lemery SJ, Zhang J, Rothmann MD, et al. U.S. Food and Drug Administration Approval:Ofatumumab for the Treatment of Patients with Chronic Lymphocytic Leukemia Refractory to Fludarabine and Alemtuzumab. 10.1158/R-10-0570 Published September2010.15.Chen L, Shah R, Cwynarski K. et al. Ofatumumab is a feasible alternative anti-CD20therapy in patients intolerant of rituximab. Br J Haematol. 2019 Feb;184(3):462-465.doi: 10.1111/bjh.15110. Epub 2018 Jan 24.Appendix 1 – Covered Diagnosis Codes1010C83.00 Small cell B-cell lymphoma, unspecified siteC83.01 Small cell B-cell lymphoma, lymph nodes of head, face and neckC83.02 Small cell B-cell lymphoma, intrathoracic lymph nodes1010C83.03 Small cell B-cell lymphoma, intra-abdominal lymph nodesC83.04 Small cell B-cell lymphoma, lymph nodes of axilla and upper limbC83.05 Small cell B-cell lymphoma, lymph nodes of inguinal region and lower limbC83.06 Small cell B-cell lymphoma, intrapelvic lymph nodesC83.07 Small cell B-cell lymphoma, spleenC83.08 Small cell B-cell lymphoma, lymph nodes of multiple sitesC83.09 Small cell B-cell lymphoma, extranodal and solid organ sitesC88.0 Waldenström macroglobulinemiaC91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remissionC91.12 Chronic lymphocytic leukemia of B-cell type in relapseAppendix 2 – Centers for Medicare and Medicaid Services (CMS)Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Article (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https:///medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/AJurisdiction Applicable State/US Territory ContractorE (1) CA, HI, NV, AS, GU, CNMI Noridian Healthcare Solutions, LLCF (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC5 KS, NE, IA, MO Wisconsin Physicians Service Insurance Corp (WPS)6 MN, WI, IL National Government Services, Inc. (NGS)H (4 & 7) LA, AR, MS, TX, OK, CO, NM Novitas Solutions, Inc.8 MI, IN Wisconsin Physicians Service Insurance Corp (WPS) N (9) FL, PR, VI First Coast Service Options, Inc.J (10) TN, GA, AL Palmetto GBA, LLCM (11) NC, SC, WV, VA (excluding below) Palmetto GBA, LLCNovitas Solutions, Inc.L (12) DE, MD, PA, NJ, DC (includes Arlington &Fairfax counties and the city of Alexandria in VA)K (13 & 14) NY, CT, MA, RI, VT, ME, NH National Government Services, Inc. (NGS)15 KY, OH CGS Administrators, LLC。
Keytruda中文说明书(2017.03版)
注射用Keytruda(派姆单抗)使用说明书处方信息的强调部分这些重点不包括所有需要使用Keytruda安全有效的信息。
Keytruda详细信息请见完整处方信息。
注射用Keytruda®（派姆单抗），静脉使用Keytruda®（派姆单抗）注射液，静脉使用美国FDA初次批准：2014.9----------------------------最近的重大更新---------------------------适应症与用法（1）03/2017剂量和用法（2）03/2017警告和注意事项（5）03/2017---------------------------适应症及用法-------------------------------Keytruda是一种人程序性死亡受体-1（PD-1）阻断抗体。
用于治疗：•不能手术切除的或转移性的黑色素瘤。
（1.1）•经FDA批准检测方法检测转移性非小细胞肺癌（NSCLS）患者其肿瘤高表达PD-L1（肿瘤比例TPS≥50%），该患者没有EGFR或ALK肿瘤基因突变，且化疗方案治疗无效。
（1.2）•转移性NSCLS患者其肿瘤表达PD-L1（肿瘤比例TPS≥1%），该患者已接受或正接受含铂化疗后疾病进展。
对于已有EGFR或ALK肿瘤基因突变的患者，其必须在突变前获得FDA批准用药治疗疾病进展。
（1.2）•复发或转移性头部和颈部鳞状细胞癌(HNSCC)患者，该患者已接受或正接受含铂化疗后疾病进展。
批准此适应证基于肿瘤反应率和持久性，对这个适应证的继续批准取决于后续临床验证和验证试验中的患者临床获益情况。
（1.3）•对于成人或儿科难治性经典霍奇金淋巴瘤（cHL）患者，或者既往接受过3种或3种以上方案治疗后病情复发的cHL患者，加速批准此适应证基于肿瘤反应率和持久性，尚未确定在生存或疾病相关症状中改善。
对这个适应证的继续批准取决于后续临床验证和验证试验中的患者临床获益情况。
Stelara靶点及其药物研究
3、Ilumya（tildrakizumab）
靶点：IL-23 公司：默沙东/太阳制药（Sun Pharmaceutical） Ilumya（tildrakizumab）是默沙东（MSD）和太阳制药公 司开发的一款IL-23特异性抗体，可以选择性结合IL-23的p19亚基， 并抑制其与IL-23受体作用，从而抑制促炎细胞因子和趋化因子的 释放。2018年3月，Ilumya获得美国FDA批准，治疗适合接受全 身治疗或光疗的中度至重度斑块型银屑病成人患者。
4、Mirikizumab
靶点：IL-23 公司：礼来（Eli Lilly and Company） Mirikizumab是礼来公司开发的一款靶向IL-23的p19亚基的全人源化单克隆抗体。目前，礼来 公司已经开展多项3期临床试验，评估mirikizumab治疗银屑病、克罗恩病和溃疡性结肠炎的效果。 根据礼来在2019年美国消化疾病周（DDW）医学会议上公布的结果，mirikizumab在治疗中重度克 罗恩病患者的2期临床试验中获得了积极结果：与安慰剂相比，mirikizumab在治疗12周后显著降低 临床和内镜检测到的疾病活动。治疗银屑病的关键性3期临床试验有望在2020年获得结果。 在中国，mirikizumab注射液已获得6项临床试验默示许可，针对中重度活动性溃疡性结肠炎、 中 重 度 活 动 性 克 罗 恩 病 适 应 症 。 此 外 ， 礼 来 产 品 管 线 中 还 有 一 款 靶 向 I L - 2 3 的 抑 制 剂 LY - 9 0 0 0 2 1 ， 和 一款靶向IL-23/CGRP的双抗，目前正在1期临床研究阶段。
在中国，乌司奴单抗注射液于2017年11月首次获批，用于治疗中重度斑 块状银屑病，是中国国内获批的首个全人源“双靶向”IL-12和IL-23抑制剂。 2019年5月，乌司奴单抗在中国被加入到第二批临床急需境外新药名单中。
尤特奇手册2
E U D R A G I T®(尤特奇)药用丙烯酸树脂长达50多年的标准化生产，使得众多知名制药企业在它们的口服制剂中选用EUDRAGIT®尤特奇——世界著名品牌的药用辅料尤特奇(EUDRAGIT)是合成药用辅料的商品名，它包括甲基丙烯酸共聚物和甲基丙烯酸酯共聚物，在中国通称为丙烯酸树脂。
尤特奇广泛用于药物物剂的胃溶包衣、肠溶包衣、缓控释包衣、保护隔离包衣、缓释骨架材料和经皮给药制剂的骨架胶粘材料。
尤特奇自从第一个产品问世至今已有半多个世纪，广泛用于各种药物制剂，成为许多国际名牌制剂产品的重要辅料。
尤特奇以其优良稳定的质量和真诚的应用技术服务，正在被越来越多的中国用户所采用。
尤特奇产品种类商品名化学组成注册名称USP/NF*尤特奇E 100甲基丙烯酸丁酯、甲基丙烯酸二甲胺基乙酯和甲基丙烯酸甲酯(1:2:1)共聚物甲基丙烯酸氨烷基酯共聚物E型尤特奇E PO*尤特奇L 100-55甲基丙烯酸和丙烯酸乙酯(1:1)共聚物甲基丙烯酸共聚物C型Methacrylic Acid Copolymer， Type C*尤特奇L 30D-55甲基丙烯酸－丙烯酸乙酯共聚物水分散体Methacrylic Acid Copolymer， Dispersion*尤特奇L 100甲基丙烯酸和甲基丙烯酸甲酯(1:1)共聚物甲基丙烯酸共聚物A型Methacrylic Acid Copolymer， Type A *尤特奇S 100甲基丙烯酸和甲基丙烯酸甲酯(1:2)共聚物甲基丙烯酸共聚物B型Methacrylic Acid Copolymer， Type B*尤特奇RL 100丙烯酸乙酯、甲基丙烯酸甲酯和甲基丙烯酸氯化三甲胺基乙酯(1:2:0.2)共聚物季胺基甲基丙烯酸酯共聚物A型Ammonio Methacrylate Copolymer，Type A□尤特奇RL PO □尤特奇RL 30D*尤特奇RS 100丙烯酸乙酯、甲基丙烯酸甲酯和甲基丙烯酸氯化三甲胺基乙酯(1:2:0.1)共聚物季胺基甲基丙烯酸酯共聚物B型Ammonio Methacrylate Copolymer，Type B*尤特奇RS PO 季胺基甲基丙烯酸酯共聚物B型□尤特奇RS 30D*尤特奇NE 30D丙烯酸乙酯和甲基丙烯酸甲酯(2:1)共聚物丙烯酸乙酯－甲基丙烯酸甲酯共聚物水分散体尤特奇FS 30D 甲基丙烯酸、丙烯酸甲酯和甲基丙烯酸甲酯(1:1:1)共聚物*已获得SFDA进口药品注册证；□正在注册中各种尤特奇均由几种单体聚合而成。
OriCell SD Rat Cortical Astrocytes用户手册说明书
OriCell TM Sprague-Dawley (SD) Rat Cortical AstrocytesCat. No. SCCAC-00001Table of ContentsContents and Storage (3)Product Introduction (3)Product Applications (3)General Handling Principles (4)Culture OriCell TM SD Rat Cortical AstrocytesThawing and Establishing OriCell TM SD Rat Cortical Astrocytes (4)Passaging of OriCell TM SD Rat Cortical Astrocyte s (6)Cryopreservation of OriCell TM SD Rat Cortical Astrocytes (7)Appendix (8)Related Products (8)References (8)Technical Support (8)CONTENTS AND STORAGECAUTION:Please handle this product as a potentially biohazardous material. Thisproduct contains Dimethyl Sulfoxide (DMSO), a hazardous material, in the freezingmedium.PRODUCT INTRODUCTIONAstrocytes are characteristic star-shaped glial cells in the brain and spinal cord. They are crucial in forming the blood-brain barrier through biochemical support ofendothelial cells, providing nutrients to the nervous tissue, maintaining ofextracellular ion balance and healing of the brain and spinal cord from traumaticinjuries.OriCell TM Fisher 344（F344）Rat Cortical Astrocytes are derived from the cortex ofnewborn F344rats. They are tested negative for bacteria, fungi and mycoplasma.Activity of CyagenOriCell TM SD Rat Cortical Astrocytes∙Recovery Viability ≥80%∙Can be passaged at least 2 times.Purity of CyagenOriCell TM SD Rat Cortical Astrocytes∙GFAP positive cells ≥ 80%∙β-tubulin IIIpositive cells ≤ 10%∙GalCpositive cells ≤ 10%This product is intended for laboratory research use only. It is not intended fordiagnostic, therapeutic, clinical, household, or any other applications.PRODUCT APPLICATIONSOriCell TM Sprague-Dawley (SD) Rat Cortical Astrocytes can be used to studyneurobiology such as the maintenance of the extracellular environment in the CNSand the maintenance of neuronal metabolism and neurotransmitter synthesis, aswell as drug discovery in the areas of Parkinson’s, Huntington's and Alzheimer’sDisease.GENERAL HANDLING PRINCIPLES1.Aseptic handling of the product is necessary throughout.2.For general maintenance of cells, we recommend the seeding density to be3.0-4.0×104cells/cm2.3.For all studies, it is strongly recommended to use cells that are at, or under, anoriginal passage number of 5.4.For general maintenance of cells, we recommend that the medium is changed if itbecomes acidic (the pH indicator in medium appears yellow). In general, changethe growth medium every three days.5.Do not let OriCell TM SD Rat Astrocyte overgrow as it will result in contact inhibition.When the cells are 80-90% confluent, subculturing the cells is stronglyrecommended.Note: We strongly recommend the use of OriCell TM culture media and other relatedreagents for optimal results.THAWING AND ESTABLISHING OriCell TM Sprague-Dawley (SD) RAT CORTICAL ASTROCYTESMaterials Required:OriCell TM Astrocyte Growth Medium(Cat. No. GXXAC-90011)Thawing and EstablishingSDRatCortical Astrocytes1.Pre-warm OriCell TM Astrocyte Growth Medium to 37°C.2.Add 9mlL of OriCell TM Astrocyte Growth Medium to a 15mL conical tube.3.Remove the cryovial of OriCell TM SD Rat Cortical Astrocytes from liquid nitrogen.4.Quickly thaw the vial in a 37°C water bath until the last ice crystal disappears, andfinish the thawing procedure within 3 minutes. Be careful not to submerge theentire vial. Maximum cell viability is dependent on the rapid and complete thawingof frozen cells.Note:Results will be less than optimal if the cells are thawed for more than 3 minutes.5.As soon as the cells are completely thawed, disinfect the outside of the vial with70% v/v ethanol.e a pipette to transfer the cells to the 15mL conical tube containingOriCell TM Astrocyte Growth Medium inside a biosafety cabinet. Be careful not to introduce any bubbles during the transfer process.7.Rinse the vial with 1mL of medium to reduce the loss of cell and then transfer this1mL of cell suspension to the conical tube.8.Gently mix the cell suspension by slowly pipetting up and down. Be careful not tointroduce any bubbles.9.Centrifuge the cell suspension at 250 x g for 5 minutes.10.Carefully aspirate off as much of the supernatant as possible and add 2-3mL offresh OriCell TM Astrocyte Growth Medium (pre-warmed to 37°C).11.Gently re-suspend the cells in OriCell TM Astrocyte Growth Medium.12.Seed the cells into a T25 flask and add a sufficient OriCell TM Astrocyte GrowthMedium. Gently rock the culture flask to evenly distribute the cells.13.Incubate the flask at 37°C in a 5% CO2 humidified incubator.14.The next day, change the medium with fresh OriCell TM Astrocyte Growth Medium(pre-warmed to 37°C).15.Change the growth medium every three days thereafter.16.When the cells are approximately 80-90% confluent, they can be dissociated withTrypsin-EDTAand passaged.Note: Changing Medium1.Warm an appropriate amount of medium to 37°C in a sterile container. Remove themedium and replace it with the warmed, fresh medium and return the flask to the incubator.2.Avoid repeated warming and cooling of the medium. If the entire contents are notneeded for a single procedure, transfer only the required volume to a sterilesecondary container.Fig. 1 OriCell TM Sprague-DawleyRat Cortical Astrocytesare establishedPASSAGING OriCell TM Sprague-Dawley (SD) RAT CORTICAL ASTROCYTESMaterials Required:∙Trypsin-EDTA(Cat. No. TEDTA-10001)∙Phosphate-Buffered Saline (1×PBS) (Cat. No. PBS-10001)∙OriCell TM Sprague-DawleyRat Cortical Astrocytes(Cat. No. SCCAC-00001)∙OriCell TM Astrocyte Growth Medium(Cat. No. GXXAC-90011)Passaging of OriCell TM SD Rat Cortical Astrocytes1.Pre-warm the OriCell TM Astrocyte Growth Medium, 1×PBS, Trypsin-EDTA solution to37°C.2.Carefully aspirate spent medium from the 80-90% confluent monolayer ofOriCell TM SD Rat Cortical Astrocytes.3.Add 1×PBS (6mL for T75 flask, 3mLfor T25 flask). Be careful not to disturb themonolayer. Gently rock the flask back and forth to rinse the monolayer.4.Aspirate 1×PBS and discard.5.Repeat the step 3-4 two or three times.6.Add Trypsin-EDTA solution (1.5mL for T75 flask, 0.5mL for T25 flask). Gently rocktheflask back and forth to ensure that the entire monolayer is covered with theTrypsin-EDTAsolution. Allow the trypsinization to continue until the majority of thecells (approximately80%) are rounded up. At this point, gently tap the side of theflask to release themajority of cells from the culture surface.Note:Avoid leaving cells exposed to the trypsin longer than necessary. Care shouldalso be taken that the cells are not forced to detach prematurely as this may result inclumping.7.After the cells are visibly detached, immediately add the pre-warmed OriCell TMAstrocyte Growth Medium (6mL for T75 flask, 3mL for T25 flask) to neutralize thetrypsinization.8.Gently pipet the medium over the cells to dislodge and resuspend the cells. Repeat5-6 times until all the cells are dissociated from the flask and evenly dispersed intoa single cell suspension.Note:Care should be taken to avoid introducing bubble during pipetting.9.Transfer the dissociated cells into a 15mL conical tube.10.Centrifuge at 250 x g for 5 minutes to pellet the cells.11.Carefully aspirate off as much of the supernatant as possible.12.Add 2ml of OriCell TM Astrocyte Growth Medium to the conical tube and gently re-suspend the cells thoroughly.13.Plate the cells into appropriate flasks. OriCell TM SD Rat Cortical Astrocytes can besplitat 1:2 or other appropriate ratio.14.Add an appropriate amount of medium to the cells. Incubate the cells at 37°C in a5% CO2 humidified incubator.Additional TipsTime to Change MediumIt is recommended tochange the culture medium whenever themediumbecomesacidic, even ifthecellsdonotreach80-90%confluency.In general, change the growth medium every three days.Time to SubcultureWhenOriCell TM SD RatCorticalAstrocytes are 80-90%confluent, itisrecommended that the cells be subcultured. Do not let OriCell TM SD Rat Cortical Astrocytes overgrow as it will result in contact inhibition.CRYOPRESERVATION OF OriCell TM F344 RAT CORTICAL ASTROCYTESNote:Change the culture medium with fresh growth medium 24 hours beforefreezing.1.Collect cells that are in logarithmic growth phase. Perform a cell count to determinethe viable cell density.2.Centrifuge the cells 3-5 minutes at 250 x g, 20°C. Remove and discard thesupernatant using a pipette.3.Resuspend the cell pellet in the OriCell TM Cryopreservation Medium(Cat.No.CRYO-10001) at a cell density of 105-106cells/mL.4.Dispense aliquots of the cell suspension into cryogenic storage vials that areproperly labeled.5.Place the vials in a programmed controlled-rate freezing apparatus and make surethe cooling rate is 1°C/min.6.After 24 hours, transfer the frozen vials to liquid nitrogen for long-termpreservation.APPENDIXRelated productsProduct Catalog NumberTrypsin-EDTA TEDTA-10001Phosphate-Buffered Saline (1 × PBS) PBS-10001OriCell TM SD Rat Cortical Astrocytes SCCAC-00001OriCell TM Astrocyte Growth Medium GXXAC-90011 ReferencesFedoroff, G. and Richardson, A. (1992) Protocols for Neural Cell Cultures. HumanaPress, Totowa, N.J.Jeffrey W. Allen,Lysette A. Mutkus, and Michael Aschner.(2001) Isolation of NeonatalRat Cortical Astrocytes for Primary Cultures.Current Protocols in Toxicology 12. Cyagen Biosciences reserves all rights on the technical documents of its OriCell TM cell culture products. No part of this document may be reproduced or adapted for other purposes without written permission from Cyagen Biosciences.。
阿特珠单抗中文说明书
【药物名】Atezolizumab【商品名】Tecentriq（阿特珠单抗）【美国上市时间】膀胱癌，2016年5月【类别】抑制剂【靶点】PD-L1【分子结构】人源化抗体，lgG1亚型，分子量145kDa【生产公司】Genentech，Inc. 罗氏子公司基因泰克【购买地】美国【剂型和规格】注射液，1200mg/20mL(60mg/mL)无色至浅黄色溶液在单剂量小瓶中(NDC50242-917-01)。
【本质】20mL/支：含有1200mg Atezolizumab，16.5mg冰醋酸，62mg L-组氨酸，821.6mg 蔗糖，8mg吐温20，PH5.8。
【作用机理】阿特珠单抗与PD-L1相结合，从而阻断它与T细胞上的PD-1、B7.1受体的相互作用。
这个释放PD-L1/PD-1介导的免疫反应的抑制作用，包括抗肿瘤免疫反应的活化与诱导抗体依赖细胞细胞毒性。
在同源小鼠肿瘤模型中，阻断PD-L1活性导致肿瘤生长减低。
【适应症和用途】阿特珠单抗是适用为有局部晚期或转移尿路上皮癌患者的治疗患者：含铂化疗期间或化疗后有疾病进展：（1）用含铂化疗新辅助或辅助治疗12个月内有疾病进展有疾病进展；（2）这个适应证在加快批准下根据肿瘤反应率和反应时间被批准的。
【用法用量】1200mg，不少于1小时静脉滴注给药，每3周给药一次；并在静脉输注前稀释。
如果首次输注后患者对药物耐受，则在随后的给药在30分钟左右完成静脉滴注。
不要作为静脉推注和丸注给药；不要和其他药物同时给药。
计量调整：对以下情况停止阿特珠单抗给药:（1）2级肺炎；（2）谷草转氨酶(AST)或谷丙转氨酶(ALT)大于3和至5倍正常上限(ULN)或总胆红素大于1.5和至3倍ULN；（3）2或3级腹泻或结肠炎；（4）症状性垂体炎，肾上腺功能不全，甲状腺功能减退症，甲状腺功能亢进症，或3或4级高血糖；（6）2级眼炎症毒性；（7）2或3级胰腺炎，或淀粉或脂肪酶水平3或4级增加(大于2.0倍ULN)；（8）3或4级感染；（9）2级输注相关反应；（10）3级皮疹：在患者其不良反应恢复至0–1级阿特珠单抗可能被恢复。
制药工艺学美国FDA批准运用细胞培养新药种类
近5年，美国FDA1207342
细胞培养
细胞培养是指从体内组织取出细胞摹 全国就业现状 拟体内出现环境，在无菌、适当温度 及酸碱度和一定营养条件下，使期生 制药工程概述 长繁殖，并维持其结构和功能的一种 培养技术。
2009-2013年FDA批准药物种类
重组蛋白
重组蛋白的产生是应用了重组 DNA或重组RNA的技术通过细胞 培养从而获得的蛋白质。
重组蛋白
Ilaris（人抗白介素-1β）
CAPS是一种终身性自身免疫性疾病， 由人体内白介素1-B ( IL-1B)过剩引起 的。Ilaris 能够靶向阻断白介素1β( IL-1β)从而减少患者体内IL-1β 的产生[12 。
• Stelara是模拟人体自身免疫系统由CHO经过体外培养产 生具有人源化的单克隆抗体anti- IL12/23， • 由于特异性的抗IL-12和IL-23的p40亚基， Stelara能够 抑制细胞因子IL-12和IL-23这两种促皮肤细胞过度生长 和炎症发生蛋白的活性从而达到治疗牛皮癣的目的。
其他 14% 疫苗 16% 酶 23%
重组蛋白 20% 单克隆抗体 27%
单克隆抗体
单抗是指经过特定的抗原处理过的效 应B细胞和骨髓瘤细胞杂交得到的杂交 瘤细胞产生的具有特异性识别某抗原 上的某一个特定抗原决定簇的抗体。
单克隆抗体
Stelara（优特克单抗）
牛皮癣是一种免疫介导的慢性疾病，由 皮肤细胞增生并积聚在皮肤表面形成的 鳞屑性红斑。
酶
酶是指生物体重具有生物 催化功能的高分子物质， 可以由细胞培养得到。
美国 FDA 于 2012 年 1 月 17 日批准 glucarpidase( 羧肽酶，商品名为 Voraxaze) 用于治疗因肾功能衰竭而导致的甲氨蝶呤中毒( 血液中甲 氨蝶呤水平过高) 。
CHO Tet-On 3G Cell Line商品说明书
Certificate of Analysis Clontech Laboratories, Inc.A Takara Bio Company1290 Terra Bella Avenue, Mountain View, CA 94043, USA U.S. Technical Support: *****************United States/Canada 800.662.2566 Asia Pacific+1.650.919.7300Europe+33.(0)1.3904.6880Japan+81.(0)77.543.6116Page 1 of 2(080714) CHO Tet-On® 3G Cell LineCatalog No(s). Lot Number631196 (Not sold separately) Specified on product label.DescriptionCHO Tet-On 3G is a an epithelial-like cell line derived from Chinese hamster ovary (CHO-K1 clone) that expresses the tetracycline (Tet)-regulated transactivator Tet-On 3G (1, 2). Inducible expression of any gene can be achieved by transfecting or transducing this cell line with a vector containing your gene of interest under the control of a tetracycline-responsive promoter. Expression is induced by the addition of doxycycline (Dox) to the culture medium.Package Contents∙ 1 ml CHO Tet-On 3G Cell Line (2.0 x 106 cells/tube)Storage Conditions∙Store cells in liquid nitrogen (–196°C) or in a –150°C freezer.Shelf Life∙ 1 year from date of receipt under proper storage conditions.Storage Medium∙Recommended cell culture medium/FBS/DMSOShipping Conditions∙Dry ice (–70°C)Product DocumentsDocuments for Clontech® products are available for download at /manualsThe following documents apply to this product:∙Tet-On 3G Inducible Expression Systems User Manual∙Tet Cell Lines Protocol-at-a-GlanceCell Type InformationCHO Tet-On 3G is an epithelial-like cell line derived from Chinese hamster ovary (CHO-K1 clone), stably transfected with pEF1-Tet3G. This cell line is G418-resistant.Recommended Cell Culture MediumGrow the cells in 90% Ham’s F-12 Medium (Kaighn's Modification of Ham's F-12 Medium) 10% Tet System Approved Fetal Bovine Serum (FBS), 100 units/ml penicillin G sodium & 100 μg/ml streptomycin sulfate, 100 μg/ml G418, in the presence of 5% CO2.Certificate of Analysis Cat. No. 631196 CHO Tet-On 3G Cell Line (Not sold separately)References1.Zhou, X. et al. (2006) Gene Ther.13(19):1382–1390.2.Löw, R. et al. (2010) BMC Biotechnology10:81.Quality Control DataFunctional TestsCHO Tet-On 3G cells were transiently transfected with pTRE3G-Luc. Luciferase activity in the presence andabsence of doxycycline (Cat. No. 631311) was measured 48 hr later as described in the Tet-On 3G Inducible Gene Expression System User Manual. Induction was observed to be at least 500-fold when cells were grown inmedium containing Clontech's Tet System Approved FBS.Mycoplasma Contamination TestThis lot of cells has been tested and found to be free of mycoplasma contamination.(080714) Page 2 of 2CATALOG NO.631196NOTICE TO PURCHASER:Our products are to be used for research purposes only. They may not be used for any other purpose, including, but not limited to, use in drugs, in vitro diagnostic purposes, therapeutics, or in humans. Our products may not be transferred to third parties, resold, modified for resale, or used to manufacture commercial products or to provide a service to third parties without prior written approval of Clontech Laboratories, Inc.Your use of this product is also subject to compliance with the licensing requirements listed below and described on the product´s web page at. It is your responsibility to review, understand and adhere to any restrictions imposed by these statements.STATEMENT 42Use of the Tetracycline controllable expression systems (the "Tet Technology") is covered by a series of patents including U.S. Patent Nos. 6087166, 6271341, 7541446, 8383364, European Patents: EP 0990030, 1954811,2050818, 2352833 and corresponding patent claims outside these regions which are proprietary to TET Systems GmbH & Co. KG. Academic research institutions are granted an automatic license with the purchase of this product to use the Tet Technology only for internal, academic research purposes, which license specifically excludes the right to sell, or otherwise transfer, the Tet Technology or its component parts to third parties. Notwithstanding the above,academic and not-for profit research institutions whose research using the Tet Technology is sponsored by for profit organizations, which shall receive ownership to all data and results stemming from the sponsored research, shall need a commercial license agreement from TET Systems in order to use the Tet Technology. In accepting this license, all users acknowledge that the Tet Technology is experimental in nature. TET Systems GmbH & Co. KG makes no warranties, express or implied or of any kind, and hereby disclaims any warranties, representations, or guarantees of any kind as to the Tet Technology, patents, or products. All others are invited to request a license from TET Systems GmbH & Co. KG prior to purchasing these reagents or using them for any purpose. Clontech is required by its licensing agreement to submit a report of all purchasers of the Tet-controllable expression system to TET Systems.For license information, please contact: GSF/CEO TET Systems GmbH & Co. KG, Im Neuenheimer Feld 582 69120HeidelbergGermanyTel:+4962215880400Fax:+4962215880404email:***************************electronic licensing request form via /main_inquiry.htmTRADEMARKS:All other marks are the property of their respective owners. Certain trademarks may not be registered in all jurisdictions. Clontech is a Takara Bio Company. ©2015 Clontech Laboratories, Inc. This document has beenreviewed and approved by the Clontech Quality Assurance Department.。
Stelara（ustekinumab）商品说明书
Stelara® (ustekinumab)*IH*Document Number: IH-0117 Last Review Date: 03/29/2016Date of Origin: 02/15/2011Dates Reviewed: 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 03/2013, 06/2013, 09/2013, 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015,09/2015, 12/2015, 03/2016I.Length of AuthorizationCoverage will be provided for 6 months and may be renewedII.Dosing LimitsA.Quantity Limit (max daily dose) [Pharmacy Benefit]:Plaque Psoriasis and Psoriatic arthritis with co-existent plaque psoriasisLoading:Stelara 90 mg: 1 prefilled syringe at weeks 0 & 4; then begin maintenance dose 12 weeks later Maintenance:Stelara 90 mg: 1 prefilled syringe every 84 daysPsoriatic arthritisLoading:Stelara 45 mg: 1 prefilled syringe at weeks 0 & 4; then begin maintenance dose 12 weeks later Maintenance:Stelara 45 mg: 1 prefilled syringe every 84 daysB.Max Units (per dose and over time) [Medical Benefit]:Plaque Psoriasis and Psoriatic arthritis with co-existent plaque psoriasisLoading:Male: 90 billable units at weeks 0 & 4; then begin maintenance dose 12 weeks laterFemale 90 billable units at weeks 0 & 4; then begin maintenance dose 12 weeks laterMaintenance:Male: 90 billable units every 84 daysFemale: 90 billable units every 84 daysPsoriatic arthritisLoading:Male: 45 billable units at weeks 0 & 4; then begin maintenance dose 12 weeks laterFemale 45 billable units at weeks 0 & 4; then begin maintenance dose 12 weeks laterMaintenance:Male: 45 billable units every 84 daysFemale: 45 billable units every 84 daysIII.Initial Approval CriteriaCoverage is provided in the following conditions:•Adult patient (18 years or older); AND•Patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment; AND•Patient is free of any clinically important active infections; AND•Stelara will not be administered concurrently with live vaccines; AND•Patient is not on concurrent treatment with any other biological response modifier or biologic DMARD; ANDPlaque Psoriasis†•Patient has Moderate to severe plaque psoriasis for at least 6 months with at least 1 of the following:−Involvement of at least 10% of body surface area (BSA); OR−Psoriasis Area and Severity Index (PASI) score of 12 or greater; OR−Incapacitation due to plaque location (i.e. head and neck, palms, soles or genitalia);AND•Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial to topical agents (i.e. Anthralin, Coal Tar preparations, corticosteroids, emollients,immunosuppressives, keratolytics, retinoic acid derivatives, and/or Vitamin D analogues);ANDo Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of at least 1 systemic agent (i.e. immunosuppressives, retinoic acid derivatives,and/or methotrexate); ORo Patient did not respond adequately (or is not a candidate) to a 3 month minimum trial of phototherapy (i.e. Psoralens with UVA light (PUVA) OR UVB with coal taror dithranol)Client Specific Information•If medication is being self-injected (i.e. Pharmacy Benefit) patient must have tried and failed to respond to treatment with Enbrel and Humira or a documented contraindicationexists.Psoriatic Arthritis (PsA) †•Documented moderate to severe active disease; ANDo For patients with predominantly axial disease OR active enthesitis and/or dactylitis, an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory agents(NSAIDs), unless use is contraindicated; ORo For patients with peripheral arthritis, a trial and failure of at least a 3 month trial of ONE oral disease-modifying anti-rheumatic agent (DMARD) such as methotrexate,azathioprine, sulfasalazine, or hydroxychloroquineClient Specific Information•If medication is being self-injected (i.e. Pharmacy Benefit) patient must have tried and failed to respond to treatment with Enbrel and Humira or a documented contraindicationexists.†FDA Approved Indication(s)IV.Renewal CriteriaCoverage can be renewed based upon the following criteria:•Patient continues to meet criteria identified in section III; AND•Absence of unacceptable toxicity from the drug; AND•Ongoing monitoring for TB; ANDPlaque Psoriasis•Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement.Psoriatic Arthritis (PsA)•Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts.V.Dosage/AdministrationVI.Billing Code/Availability InformationJcode:•J3357 – Stelara (Janssen Biotech) 45 mg, 90 mg Injection: 1 billable unit = 1mgNDC:•Stelara 45 mg vial – 57894-0060-02 (Janssen Biotech)•Stelara 45 mg prefilled syringe – 57894-0060-03 (Janssen Biotech)•Stelara 90 mg vial– 57894-0061-02 (Janssen Biotech)•Stelara 90 mg prefilled syringe – 57894-0061-03 (Janssen Biotech)VII.References1.Stelara [package insert]. Horsham, PA; Janssen Biotech, Inc; March 2014. AccessedFebruary 2016.2.Leonardi CL, Kimball AB, Papp KA, et al, “Efficacy and Safety of Ustekinumab, a HumanInterleukin-12/23 Monoclonal Antibody, in Patients With Psoriasis: 76-Week Results from a Randomised, Double-Blind, Placebo-Controlled Trial (PHOENIX 1),” Lancet, 2008,371(9625): 1665-74.3.Papp KA, Langley RG, Lebwohl M, et al, “Efficacy and Safety of Ustekinumab, a HumanInterleukin-12/23 Monoclonal Antibody, in Patients With Psoriasis: 52-Week Results from a Randomised, Double-Blind, Placebo-Controlled Trial (PHOENIX 2),” Lancet, 2008,371(9625): 1675-84.4.Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaquepsoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.5.Papp KA, Griffiths CE, Gordon K, et al. Long-term safety of ustekinumab in patients withmoderate-to-severe psoriasis: final results from 5 years of follow-up. Br J Dermatol. 2013 Apr;168(4):844-54.6.Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasisand psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for thetreatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50. doi:10.1016/j.jaad.2008.02.039.7.Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS,Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for themanagement of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol2008 May;58(5):851-64.8.Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR)recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec 7. pii: annrheumdis-2015-208337. doi:10.1136/annrheumdis-2015-208337.Appendix 1 – Covered Diagnosis CodesICD-10 ICD-10 DescriptionL40.0 Psoriasis vulgarisL40.50 Arthropathic psoriasis, unspecifiedL40.51 Distal interphalangeal psoriatic arthropathyL40.52 Psoriatic arthritis mutilansL40.53 Psoriatic spondylitisL40.54 Psoriatic juvenile arthropathyL40.59 Other psoriatic arthropathyAppendix 2 – Centers for Medicare and Medicaid Services (CMS)Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: /medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):。
尤特克单抗(stelara)中文说明书
STELARA?(ustekinumab)使用说明书2009年12月第二版译自：/drugsatfda_docs/label/2009/125261s001lbl.pdf 以下是处方资料的重点这些重点不包括安全和有效使用STELARA?全部资料。
见STELARA?完整处方资料。
STELARA? (ustekinumab)注射剂，为皮下使用美国2009年初次批准最近重要修改。
汤教授注：以下用红色标记剂量和给药方法，对给药的一般考虑 (2.2) 11/2009剂量和给药方法, 为STELARA?给药指导装配针头安全保护预装注射器 (2.3) 11/2009适应证和用途STELARA?是一种人白介素-12和-23拮抗剂适用于治疗成年患者(18岁或以上)有中度至严重斑块性银屑病是光疗和全身治疗的备选者。
(1)剂量和给药方法STELARA? 是通过皮下注射给药。
(2)对患者体重 <100 kg (220 lbs)，推荐剂量是最初45 mg和4周后，接着每12周45 mg。
(2.1) 对患者体重 >100 kg (220 lbs), 推荐剂量最初是90 mg和4周后，接着每12周90 mg。
(2.1)剂型和规格45 mg/0.5 mL在单次使用预装注射器中(3)90 mg/1 mL在单次使用预装注射器中(3)45 mg/0.5 mL在单次使用小瓶中(3)90 mg/1 mL在单次使用小瓶中(3)禁忌证无(4)警告和注意事项感染：曾发生严重感染。
任何临床上重要活动性感染是不要开始用STELARA?。
如发生严重感染停止STELARA?直至感染解决。
(5.1)特殊感染的理论风险：遗传上缺乏IL-12/IL-23患者曾报道来自分枝杆菌、沙门氏菌和卡介苗(BCG)免疫接种严重感染。
临床情况指示应考虑诊断检验。
(5.2)结核(TB)评价：开始用STELARA?治疗前评价患者TB。
给STELARA?前开始潜伏TB治疗。
FDA批准Stelara上市治疗中度到重度斑块状银屑病
FDA批准Stelara上市治疗中度到重度斑块状银屑病
佚名
【期刊名称】《齐鲁药事》
【年(卷),期】2009(28)11
【总页数】1页(P655-655)
【关键词】斑块状银屑病;FDA批准;治疗;上市;T淋巴细胞反应;IL-23;IL-12;调节免疫反应
【正文语种】中文
【中图分类】R758.63;R97
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4.强生子公司银屑病治疗新药Stelara获FDA批准 [J], 王思思
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可善挺（司库奇尤单抗注射液）
可善挺（司库奇尤单抗注射液）药品提示：可善挺(司库奇尤单抗注射液) ：银屑病用于治疗符合系统治疗或光疗指征的中度至重度斑块状银屑病的成年患者。
强直性脊柱炎用于常规治疗疗效欠佳的强直性脊柱炎的成年患者。
以下关于可善挺(司库奇尤单抗注射液)的作用机理、疗效、药理作用、适应症、用法用量、不良反应、副作用、效果、禁忌症、注意事项及其价格等信息由诺本专科新特药房专业药师为您介绍，药师同时提醒您：为了您的健康，请正确选药，合理用药。
【可善挺药物名称】通用名称: 司库奇尤单抗注射液商品名称: 可善挺英文名称: Cosentyx（Secukinumab Injection）拼音全码：SiKuQiYouDanKangZhuSheYe【可善挺成份】活性成份：司库奇尤单抗司库奇尤单抗是在中国仓鼠卵巢细胞系（CHO-HPT1）中表达的，具有高亲和性的全人源单克隆抗体，属于IgG1/κ同种型亚类，可选择性结合人白介素-17A（IL-17A）并中和该细胞因子的生物活性。
分子量约为 151 kDa；两条重链均含有寡聚糖链。
辅料：海藻糖二水合物、L-组氨酸/组氨酸盐酸盐一水合物、L-蛋氨酸、聚山梨酯 80、注射用水。
【可善挺性状】无色至淡黄色液体【可善挺适应症】银屑病用于治疗符合系统治疗或光疗指征的中度至重度斑块状银屑病的成年患者。
强直性脊柱炎用于常规治疗疗效欠佳的强直性脊柱炎的成年患者。
【可善挺规格】1支/盒(1ml:150mg)(预装试自动注射笔）【可善挺用法用量】须由在治疗方面有经验的医生指导和监督下使用本品。
用量银屑病本品的推荐剂量为每次 300 mg，分别在第 0、1、2、3、4 周进行皮下注射初始给药，随后维持该剂量每 4 周给药一次。
300 mg 剂量分 2 针给药，每针 150 mg。
同时，对于体重低于 60 kg 的患者，给药剂量可以考虑 150 mg。
强直性脊柱炎本品的推荐剂量为每次 150 mg，在第 0、1、2、3 和 4 周皮下注射初始给药，随后维持该剂量每 4 周给药一次。
司库奇尤单抗操作方法
司库奇尤单抗操作方法司库奇（Siglec-7）尤单抗是一种人源化的嵌合单克隆抗体，用于治疗一些类型的癌症，特别是血液系统恶性肿瘤。
以下是司库奇尤单抗的操作方法的详细描述。
一、前处理1.1确保所有操作在无菌的条件下进行。
准备无菌的操作台和工具。
1.2根据需要，准备生长因子和细胞因子的培养基和溶液。
使用无菌技术准备培养基，并检查是否消毒完全。
1.3准备好细胞培养板或瓶。
首先用70%乙醇清洗，然后用无菌PBS 洗涤3次。
1.4消毒试剂和实验仪器，如离心管、移液器等。
二、细胞培养2.1选择适当的细胞系进行培养。
监测细胞的生长状态和纯度。
细胞应保持在对刺激物敏感的状态。
2.2按照预定的批量生产计划种植细胞。
2.3使用无菌技术，将细胞传入预先消毒的培养皿中，并根据细胞种类的不同进行不同的处理。
2.4保持细胞培养皿在恒温恒湿的培养箱中。
根据细胞类型，设置适当的温度和CO2浓度。
三、抗体的制备3.1取出冷藏的抗体，并将其缓慢推入培养基中。
不要使抗体与空气接触过长时间。
3.2使用洁净的移液器进行抗体的稀释。
将抗体稀释到预定的浓度。
3.3使用过滤器过滤稀释后的抗体溶液，以确保无菌状态。
四、细胞治疗的操作方法4.1用离心将细胞离心沉淀，去除上清液。
4.2将细胞重悬于预备的细胞培养基中，使细胞浓度达到所需浓度。
4.3将稀释后的抗体加入细胞悬液中。
注意避免抗体的高浓度与细胞直接接触，以免损害细胞活力。
4.4轻轻摇动培养皿，使抗体均匀地与细胞混合。
保持培养皿在恒温恒湿的培养箱中进行培养。
4.5根据实验计划，设置合适的刺激时间和刺激浓度。
五、细胞的采样与检测5.1在设定的时间点，从培养皿中取出细胞样品。
5.2使用适当的方法，如显微镜观察细胞的形态、生长情况和增殖能力。
5.3使用流式细胞仪检测细胞的表面标志物表达情况和细胞数量。
5.4使用细胞培养技术，进行细胞的亚细胞分析、细胞周期、凋亡和增殖等方面的分析。
六、数据分析与结果呈现6.1收集和整理实验数据。
度伐利尤单抗药物说明书
AstraZeneca plc （阿斯利康）
日本
AstraZeneca plc （阿斯利康）
韩国
AstraZeneca plc （阿斯利康）
美国
AstraZeneca plc （阿斯利康）
新加坡
AstraZeneca plc （阿斯利康）
巴西
AstraZeneca plc （阿斯利康）
欧洲
AstraZeneca plc （阿斯利康）
适应症
治疗领域 ATC分类 分子式 分子量 化学名称 CAS登记号
Acute myelogenous leukemia（急性骨髓性白血病） A d e n o c a r c i n o m a （ 腺癌） Anaplastic t h yr o id cancer（甲状腺未分化癌） Biliary cancer（胆管癌） Bladder cancer（膀胱癌） Breast t u m o r （乳腺肿瘤） Cholangiocarcinoma（胆管癌） Chronic lym p h o cyt ic leukemia（慢性淋巴细胞白血病） Colorectal t u m o r （大肠癌） Diffuse large B-cell lym p h o m a （ 弥漫性大B细胞淋巴瘤） Endometrioid carcinoma（子宫内膜癌） Esophagus t u m o r （食道肿瘤） Fallopian t u b e cancer（输卵管癌） Female genital t r a ct t u m o r （女性生殖器官肿瘤） Follicle center lym p h o m a （滤泡中心淋巴瘤） Gallbladder t u m o r （ 胆囊肿瘤） Gastrointestinal t u m o r （胃肠道肿瘤） G e r m cell a n d e m b r yo n ic cancer（生殖细胞和胚胎癌） Glioblastoma（胶质母细胞瘤） Hepatocellular carcinoma（肝细胞癌） Ho r m o n e refractory prostate cancer（激素抵抗性前列腺癌） L ym p h o m a （淋巴瘤） Male genital t r a ct t u mo r（男性生殖道肿瘤） Mantle cell lym p h o m a （套细胞淋巴瘤） M e s o t h e l i o m a （ 间皮瘤） Metastatic bladder cancer（转移性膀胱癌） Metastatic breast cancer（转移性乳腺癌） Metastatic colon cancer（转移性结肠癌） Metastatic colorectal cancer（转移性结直肠癌） Metastatic esophageal cancer（转移性食管癌） Metastatic n o n small cell lung cancer（转移性非小细胞肺癌） Metastatic o va r y cancer（转移性卵巢癌） Metastatic pancreas cancer（转移性胰腺癌） Metastatic prostate cancer（转移性前列腺癌） Metastatic st o m a ch cancer（转移性胃癌） M o u t h t u m o r （口腔肿瘤） Multiple m ye lo m a （ 多发性骨髓瘤） Myelodysplastic syndrome（骨髓增生异常综合征） Nasopharyngeal carcinoma（鼻咽癌） Neoplasm （ 肿瘤） Neuroendocrine t u m o r （神经内分泌肿瘤） Non-Hodgkin lym p h o m a （非霍奇金淋巴瘤） Non-small-cell lung cancer（非小细胞肺癌） Ovary t u m o r （卵巢肿瘤） Pancreas t u m o r （胰腺肿瘤） Peripheral T-cell lym p h o m a （ 外周T细胞淋巴瘤） Peritoneal t u m o r （腹膜肿瘤） Pharynx t u m o r （咽喉部肿瘤） Renal cell carcinoma（肾细胞癌） Small-cell lung cancer（小细胞肺癌） Soft tissue sarcoma（软组织肉瘤） Solid t u m o r （实体瘤） Squamous cell carcinoma（鳞状细胞癌） Stage IV melanoma（IV期黑色素瘤） Stomach t u m o r （胃肿瘤） T-cell lym p h o m a （T细胞淋巴瘤） Urinary t r a ct t u m o r （ 尿路肿瘤） Uterine cervix t u m o r （子宫颈癌） Vaginal t u m o r （阴道肿瘤）
纳武利尤单抗说明书（主要包括适应症、用法用量以及不良反应）
纳武利尤单抗说明书（主要包括适应症、⽤法⽤量以及不良反应）纳武利尤单抗是NMPA批准上市的PD-1类抗癌药物，它也叫欧狄沃。
纳武利尤单抗的相关研究有不少，但它⽬前获批的适应症只有⼀个，即⽤于治疗不可耐受的晚期转移性⾮⼩细胞肺癌（NSCLC）。
纳武利尤单抗的上市，具有划时代的意义，它开启了中国肿瘤治疗新篇章，为经治NSCLC患者提供新的治疗选择。
⽽它能在国内上市，也确实经历了⼤型国内临床试验的考验，在疗效、安全性等⼏个⽅⾯是得到认可的。
接下来，五唸为⼤家带来纳武利尤单抗适应症、⽤法⽤量以及不良反应说明书纳武利尤单抗适⽤范围本品适⽤于EGFR（-）ALK（-）且接受过含铂化疗后疾病进展或不可耐受的NSCLC患者。
纳武利尤单抗规格40 mg/4ml和100 mg/10 ml纳武利尤单抗⽤法⽤量本品推荐剂量为3mg/kg，由于其剂型是40mg/4mL和100mg/10mL两种，患者的体重通常为60kg以上，因此⼀般每次的⽤量是200-240mg，患者每隔两周⽤药⼀次，每次⽤药的时间不少于30分钟。
展开剩余51%纳武利尤单抗不良反应在多个临床研究的汇总数据中，纳武利尤单抗单药治疗的常见副作⽤（≥ 10%）为疲劳（30%）、⽪疹（17%）、瘙痒（13%）、腹泻（13%）和恶⼼（12%）。
⼤多数不良反应为轻⾄中度（1级或2级）。
纳武利尤单抗可引起免疫相关性的严重不良反应，但发病率不⾼，具体如下：1.免疫介导性肺炎免疫介导性肺炎发⽣率为3.1%，对于严重(3级)或危及⽣命的(4级)肺炎，应永久停⽤纳武利尤单抗；对于中度(2级)肺炎，应停⽤直到症状消失。
2.免疫介导性结肠炎发⽣免疫介导性结肠炎的可能性为2.9%，2级或3级结肠炎应停⽤纳武利尤单抗。
4级或重新开始治疗后结肠炎复发的应永久停⽌本品治疗。
3.免疫介导性肝炎在接受纳武利尤单抗单药治疗的患者中，免疫介导性肝炎发⽣率为1.8% ，在治疗前和治疗期间定期监测患者的肝脏指标。
古塞奇尤单抗注射液Guselkumab-详细说明书与重点
古塞奇尤单抗注射液Guselkumab 英文名：Guselkumab injection汉语拼音：gu sai qi you dan kang Zhu She Ye【成份】主要成份：古塞奇尤单抗。
辅料：L-组氨酸、L-组氨酸盐酸盐一水合物、聚山梨酯80、蔗糖、注射用水。
【性状】透明的无色至浅黄色液体。
【适应症】本品适用于适合系统性治疗的中重度斑块状银屑病成人患者。
【规格】100mg/1mL/支【用法用量】本品应在医生的指导及监督下使用，医生应具备斑块状银屑病的诊断及治疗经验。
剂量：本品推荐剂量为第0周和第4周时皮下给药100mg,之后每8周接受一次相同剂量维持。
治疗16周后仍未应答的患者应考虑停止用药。
肾功能/肝功能损伤：尚未在这些患者群中研究过本品。
因此无法提供推荐剂量。
给药方法：皮下给药。
应尽量避免在出现银屑病症状的皮肤区域注射。
经过适当的皮下注射技术培训后，若医生认为适合，患者可自行注射本品。
然而，医生仍要确保对患者进行适当的医学随访。
应按照纸盒中提供的“使用指南”指导患者进行本品全剂量注射。
【不良反应】安全性特征总结：最常见的药物不良反应（ADR）是上呼吸道感染。
不良反应列表：表1列出了银屑病临床研究及上市后经验中报告的药物不良反应。
不良反应按MedDRA 系统器官分类和频率分类，使用以下规则：十分常见(≥1/10)、常见(≥1/100至<1/10)、偶见(≥1/1,000至<1/100)、罕见(≥1/10,000至<1/1,000)、十分罕见(<1/10,000)、未知(无法从现有数据估算)。
表1：不良反应列表特定的不良反应的描述胃肠炎：在两项III期临床研究的安慰剂对照期内，古塞奇尤单抗治疗组（1.1%）胃肠炎的发生率高于安慰剂治疗组（0.7%）。
至第156周，接受古塞奇尤单抗治疗的受试者中有4.9%报告了胃肠炎。
不良反应胃肠炎为非严重事件，156周内未导致古塞奇尤单抗停药。
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尤特克单抗stelara中文说明
书
STELARA?(ustekinumab)使用说明书12月第二版译自：/drugsatfda_docs/label/ /125261s001lbl.pdf
以下是处方资料的重点这些重点不包括安全和有效使用STELARA?全部资料。
见STELARA?完整处方资料。
STELARA? (ustekinumab) 注射剂，为皮下使用美国初次批准最近重要修改。
汤教授注：以下用红色标记剂量和给药方法，对给药的一般考虑(2.2) 11/ 剂量和给药方法, 为STELARA?给药指导装配针头安全保护预装注射器(2.3) 11/
适应证和用途STELARA?是一种人白介素-12和-23拮抗剂适用于治疗成年患者(18岁或以上)有中度至严重斑块性银屑病是光疗和全身治疗的备选者。
(1)
剂量和给药方法STELARA? 是经过皮下注射给药。
(2) 对患者体重 <100 kg (220 lbs)，推荐剂量是最初45 mg和4周
后，接着每12周45 mg。
(2.1) 对患者体重 >100 kg (220 lbs), 推荐剂量最初是90 mg和4周后，接着每12周90 mg。
(2.1)
剂型和规格45 mg/0.5 mL在单次使用预装注射器中(3) 90 mg/1 mL在单次使用预装注射器中(3) 45 mg/0.5 mL在单次使用小瓶中(3) 90 mg/1 mL在单次使用小瓶中(3)
禁忌证无(4)
警告和注意事项感染：曾发生严重感染。
任何临床上重要活动性感染是不要开始用STELARA?。
如发生严重感染停止STELARA?直至感染解决。
(5.1)
特殊感染的理论风险：遗传上缺乏IL-12/IL-23患者曾报道来自分枝杆菌、沙门氏菌和卡介苗(BCG)免疫接种严重感染。
临床情况指示应考虑诊断检验。
(5.2)
结核(TB)评价：开始用STELARA?治疗前评价患者TB。
给STELARA?前开始潜伏TB治疗。
(5.3)
恶性病：STELARA?可能增加恶性病风险。
尚未评价有恶性病史或已知恶性病患者用STELARA?。
(5.4)
可逆性后脑白质脑病综合征(RPLS)：报道1例。
如怀疑立即治疗和停用STELARA?。
(5.5)
不良反应最常见不良反应(发生率>3%和大于安慰剂)：鼻咽炎、上呼吸道感染、头痛、和疲劳。
(6.1)
为报告怀疑不良反应，请联系Centocor Ortho Biotech公司或FDA
药物相互作用活疫苗：用STELARA?不应给予活疫苗。
(7.1)
同时治疗：尚未评价STELARA?与免疫抑制剂或光疗联用的安全性。
(7.2)
完整处方资料
1 适应证和用途STELARA?适用于治疗有中度至严重斑块性银屑病的成年患者(18岁或以上)是光疗和全身治疗的备选者。
2 剂量和给药方法2.1 给药STELARA? 是经过皮下注射给药。
1)对患者体重<100 kg(220 lbs)，推荐剂量最初是45 mg和4周后，接着每12周45 mg。
2)对患者体重>100 kg(220 lbs)，推荐剂量最初是90 mg和4周后，接着每12周90 mg。
受试者体重>100 kg，45 mg也显示有效。
然而，这些受试者中90 mg导致更高疗效[见临床研究(14)]。
尚未评价超过2年时STELARA?的安全性和有效性。
2.2 对给药的一般考虑STELARA?是意向在医生监督下皮下给药。
给药前，应肉眼观测STELARA?是否有颗粒物质和变色。
STELARA?是无色至淡黄色和可能含少许小半透明或白色颗粒。
STELARA?如。