WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca advances its ambition to redefine cancer care with new data across its industry-leading and diverse pipeline in hematology at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition December 7-10, 2024.

特拉华州威尔明顿（商业新闻短讯）--阿斯利康在2024年12月7日至10日举行的第66届美国血液学会（ASH）年会和博览会上，通过其行业领先和多样化的血液学管道，提出了用新数据重新定义癌症护理的雄心。

A total of 57 abstracts will feature 13 approved and potential new medicines from across AstraZeneca’s portfolio and pipeline in hematology, including from Alexion, its rare disease group, with data in key settings including chronic lymphocytic leukemia (CLL), multiple myeloma (MM), paroxysmal nocturnal hemoglobinuria (PNH) and other hematologic diseases..

共有57篇摘要将介绍阿斯利康血液学投资组合和渠道中的13种经批准和潜在的新药，包括来自其罕见疾病组Alexion的数据，其中包括慢性淋巴细胞白血病（CLL），多发性骨髓瘤（MM），阵发性夜间血红蛋白尿（PNH）和其他血液病。。

Anas Younes, Senior Vice President, Hematology R&D, AstraZeneca, said: “Our data at ASH from the AMPLIFY Phase III trial will demonstrate the efficacy and safety of our leading second-generation BTK inhibitor, CALQUENCE®, as a fixed-duration therapy in first-line CLL. In addition, new results for our novel T-cell engager, AZD0486, will reinforce its promising clinical profile in lymphomas, and data for our novel CAR T cell therapy, AZD0120, will highlight the potential of this therapy to transform treatment in multiple myeloma.”.

阿斯利康血液学研发高级副总裁Anas Younes说：“我们在ASH的AMPLIFY III期试验数据将证明我们领先的第二代BTK抑制剂CALQUENCE®作为一线CLL的固定疗程治疗的有效性和安全性。此外，我们新型T细胞接受者AZD0486的新结果将加强其在淋巴瘤中的有希望的临床表现，我们新型CAR T细胞疗法AZD0120的数据将突出这种疗法改变多发性骨髓瘤治疗的潜力。”。

Christophe Hotermans, Senior Vice President, Head of Global Medical Affairs, Alexion, said: “Our ASH presentations will highlight the transformative impact of our medicines, including new analyses from the ALPHA Phase III trial reaffirming the safety and efficacy of our first-in-class Factor D inhibitor, VOYDEYA™ as add-on to ULTOMIRIS® or SOLIRIS® for the subset of patients with PNH experiencing clinically significant extravascular hemolysis.

Alexion全球医疗事务主管高级副总裁克里斯托夫·霍特曼（ChristopheHotermans）说：“我们的ASH演讲将突出我们药物的变革性影响，包括来自ALPHA III期试验的新分析，重申我们一流的因子D抑制剂VOYDEYA™作为ULTOMIRIS®或SOLIRIS®的附加品，用于PNH患者亚组经历临床上显着的血管外溶血的安全性和有效性。

Further, new insights from our robust pipeline will enhance the understanding of several rare hematologic and cardiovascular conditions, underscoring our commitment to innovation in rare disease.”.

此外，来自我们强大渠道的新见解将增强对几种罕见血液学和心血管疾病的理解，强调我们对罕见疾病创新的承诺。”。

CALQUENCE combinations demonstrate significant benefits across CLL and MCL

CALQUENCE组合在CLL和MCL中显示出显着的优势

An oral presentation on interim results from the pivotal AMPLIFY Phase III trial will demonstrate the potential of fixed-duration CALQUENCE in combination with venetoclax, with or without obinutuzumab, in previously untreated adults with CLL compared to standard-of-care chemoimmunotherapy.1 These results will be featured during the ASH Press Briefing on Sunday, December 9..

。。

An updated analysis from the pivotal ECHO Phase III trial will further highlight the use of CALQUENCE in combination with bendamustine and rituximab as a first-line treatment option by demonstrating high and durable undetectable minimal residual disease (MRD) rates in previously untreated patients with mantle cell lymphoma (MCL) as well as showing the benefit of CALQUENCE across all patients including those with high-risk disease characteristics.2 Results from ECHO were first presented as a late-breaking oral presentation at the European Hematology Association (EHA) 2024 Hybrid Congress in June.3.

来自关键的ECHO III期临床试验的最新分析将进一步强调使用CALQUENCE联合苯达莫司汀和利妥昔单抗作为一线治疗选择，通过在先前未经治疗的套细胞淋巴瘤（MCL）患者中证明高且持久的不可检测的微小残留病（MRD）率，以及显示CALQUENCE对所有患者（包括具有高危疾病特征的患者）的益处。ECHO的结果首次在6月的欧洲血液学协会（EHA）2024年混合大会上作为最新的口头报告。

Results will also be shared from the ChangE Phase III trial, evaluating CALQUENCE compared with chlorambucil plus rituximab in first-line CLL in patients in China.4

ChangE III期试验的结果也将共享，评估中国一线CLL患者与苯丁酸氮芥加利妥昔单抗相比的疗效。4

New data show promise of next generation T-cell engagers and chimeric antigen receptor T-cell (CAR T) therapy

新数据显示下一代T细胞参与者和嵌合抗原受体T细胞（CAR T）疗法的前景

Two oral presentations will share results for the novel CD19xCD3 bispecific T-cell engager AZD0486, reinforcing the potential of this novel medicine as a new treatment option for B-cell malignancies.5-6 Phase I results demonstrate high response rates, with a 96% overall response rate, 85% complete response rate and high rates of undetectable MRD in patients with relapsed/refractory follicular lymphoma (R/R FL) at doses of 2.4 mg and above.5 Additionally, interim Phase I results will show the early potential of AZD0486 in patients with heavily pretreated diffuse large B-cell lymphoma (DLBCL).6 Data will also reinforce the safety profile of AZD0486, with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events effectively mitigated by the double step-up dosing schedule.7.

两次口头报告将分享新型CD19xCD3双特异性T细胞接受者AZD0486的结果，增强了这种新药作为B细胞恶性肿瘤新治疗选择的潜力。5-6 I期结果显示，高反应率，总有效率为96%，完全缓解率为85%，复发/难治性滤泡性淋巴瘤（R/R FL）患者在2.4 mg及以上剂量下检测不到MRD的比率很高。5此外，中期I期结果将显示AZD0486在重度预处理的弥漫性大B细胞淋巴瘤（DLBCL）患者中的早期潜力。6数据还将加强AZD0486的安全性AZD0486，具有细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）事件，通过双重递增给药方案有效缓解。

Early data for AZD0120 (GC012F), a novel BCMAxCD19 dual-targeting autologous CAR T developed using the Gracell FasTCAR rapid manufacturing process, will show potential as a first-line therapy for elderly patients with newly diagnosed transplant ineligible MM.8 Preliminary results from the ongoing investigator-initiated trial of AZD0120 suggest deep responses and an acceptable safety profile, with no ICANS and no ≥Grade 2 CRS events observed in this patient population.8.

AZD0120（GC012F）是一种使用Gracell FasTCAR快速制造工艺开发的新型BCMAxCD19双靶向自体CAR T的早期数据，将显示其作为新诊断的移植不合格MM的老年患者的一线治疗的潜力。正在进行的AZD0120研究者发起的试验的初步结果表明，深度反应和可接受的安全性，在该患者群体中没有观察到ICAN和≥2级CRS事件。

An oral presentation will share preclinical data demonstrating the anti-tumor activity of AZD5492, a next-generation CD8 selective, CD20-targeting T-cell engager, designed using AstraZeneca’s innovative Target Induced T-cell Activating Nanobody (TITAN) platform. AZD5492 is currently being evaluated in Phase I clinical trials in R/R Non-Hodgkin lymphoma (NHL) and CLL.9.

口头报告将分享临床前数据，证明AZD5492的抗肿瘤活性，AZD5492是一种下一代CD8选择性CD20靶向T细胞参与者，使用阿斯利康创新的靶向诱导T细胞活化纳米体（TITAN）平台设计。AZD5492目前正在R/R非霍奇金淋巴瘤（NHL）和CLL的I期临床试验中进行评估。

VOYDEYA (danicopan) as add-on to ULTOMIRIS (ravulizumab-cwvz) or SOLIRIS (eculizumab) demonstrates low rate of mild or moderate BTH events and improves quality-of-life measures in patients with PNH and clinically significant EVH

VOYDEYA（danicopan）作为ULTOMIRIS（ravulizumab cwvz）或SOLIRIS（eculizumab）的附加品，表现出轻度或中度BTH事件发生率低，并改善了PNH和临床显着EVH患者的生活质量

Data will be presented detailing events of breakthrough hemolysis (BTH), a key indicator of intravascular hemolysis and PNH disease control, reported in the ALPHA trial evaluating VOYDEYA as add-on to ULTOMIRIS or SOLIRIS in patients with PNH experiencing clinically significant extravascular hemolysis (EVH) and separately in the PEGASUS Phase III trial evaluating pegcetacoplan in patients with PNH previously treated with SOLIRIS.

数据将详细介绍突破性溶血（BTH）事件，这是血管内溶血和PNH疾病控制的关键指标，在ALPHA试验中报告，该试验评估VOYDEYA作为ULTOMIRIS或SOLIRIS的附加品，用于PNH患者经历临床显着的血管外溶血（EVH），并在PEGASUS III期试验中单独评估先前用SOLIRIS治疗的PNH患者的pegcetacoplan。

Data will show that 5/84 patients (6.0%) in the ALPHA trial and 19/80 patients (23.8%) in the PEGASUS trial experienced one or more BTH events. Moreover, most BTH events (6/7 or 85.7%) in the ALPHA trial were either mild or moderate, and all events were resolved without transfusion, dose modification or treatment withdrawal.10.

。此外，ALPHA试验中大多数BTH事件（6/7或85.7%）为轻度或中度，所有事件均在无输血，剂量调整或停药的情况下得到解决。

Separately, final long-term patient-reported outcomes from the ALPHA trial will demonstrate VOYDEYA as add-on to ULTOMIRIS or SOLIRIS resulted in sustained improvements in fatigue, quality-of-life and physical function for up to 72 weeks in the subset of patients with PNH who experience clinically significant EVH.11.

另外，ALPHA试验的最终长期患者报告结果将证明VOYDEYA作为ULTOMIRIS或SOLIRIS的附加品，在PNH患者亚组中持续改善疲劳，生活质量和身体功能长达72周，具有临床意义的EVH.11。

Advancing understanding of life-threatening rare diseases

提高对危及生命的罕见疾病的认识

A US, retrospective chart review will provide real-world evidence showing hematologic and renal improvements in adults with atypical hemolytic uremic syndrome (aHUS) who switched to ULTOMIRIS after short-term use of SOLIRIS, with early responses and continued improvements through one year of treatment with ULTOMIRIS.12.

。

Additionally, two presentations on amyloid light chain (AL) amyloidosis will highlight unmet medical needs in this progressive, debilitating disease, reinforcing the importance of bringing forward novel therapies to improve cardiovascular outcomes and organ function.13-14

此外，关于淀粉样轻链（AL）淀粉样变性的两篇演讲将突出这种进行性，衰弱性疾病中未满足的医疗需求，加强提出新疗法以改善心血管结局和器官功能的重要性.13-14

Key presentations during the 66th ASH Annual Meeting and Exposition

第66届ASH年会和博览会期间的关键演讲

Lead Author

主要作者

Abstract Title

摘要标题

Presentation details (PST)

演示文稿详细信息（PST）

CALQUENCE® (acalabrutinib)

calsequence® （阿卡拉布替尼）

Brown, JR et al.

Brown，JR等人。

Fixed-Duration Acalabrutinib plus Venetoclax with or without Obinutuzumab versus Chemoimmunotherapy for First-Line Treatment of Chronic Lymphocytic Leukemia: Interim Analysis of the Multicenter, Open-label, Randomized, Phase 3 AMPLIFY Trial

固定持续时间阿卡鲁替尼联合Venetoclax联合或不联合Obinutuzumab与化学免疫疗法治疗慢性淋巴细胞白血病的一线治疗：多中心、开放标签、随机、3期AMPLIFY试验的中期分析

Abstract #1009

摘要#1009

Oral Session 642: Chronic Lymphocytic Leukemia: Clinical and Epidemiological:

口腔会议642：慢性淋巴细胞白血病：临床和流行病学：

Frontline Targeted Therapy Combinations

一线靶向治疗组合

December 9, 2024

2024年12月9日

4:30 PM

4： 下午30点

Qiu, L et al.

邱，L等人。

Acalabrutinib Versus Chlorambucil Plus Rituximab in Patients with Previously

Acalabrutinib与苯丁酸氮芥联合利妥昔单抗治疗先前患有

Untreated Chronic Lymphocytic Leukemia: A Randomized, Multicenter, Open Label, Phase 3 Study

未经治疗的慢性淋巴细胞白血病：一项随机，多中心，开放标签的3期研究

Abstract #3251

摘要#3251

Poster Session 642: Chronic Lymphocytic Leukemia: Clinical and Epidemiological:

海报会议642：慢性淋巴细胞白血病：临床和流行病学：

Poster II

海报II

December 8, 2024

2024年12月8日

6:00 – 8:00 PM

6： 00–8:00 PM

Dreyling, M et al.

Dreyling，M等人。

High-risk Subgroups and MRD: An Updated Analysis of the Phase 3 ECHO Trial of Acalabrutinib with Bendamustine/Rituximab in Previously Untreated Mantle Cell Lymphoma

高危亚组和MRD：阿卡鲁替尼联合苯达莫司汀/利妥昔单抗治疗先前未治疗的套细胞淋巴瘤的3期ECHO试验的最新分析

Abstract #1626

摘要#1626

Poster Session 623. Mantle Cell, Follicular, Waldenstrom’s and Other Indolent B

海报课程623。套细胞，滤泡，Waldenstrom和其他惰性B

Cell Lymphomas: Clinical and Epidemiological: Poster I

细胞淋巴瘤：临床和流行病学：海报I

December 7, 2024

2024年12月7日

5:30 – 7:30 PM

5： 下午30-7:30

Simon, F et al.

西蒙，F等人。

Efficacy and Safety of Acalabrutinib Treatment in Very Old (≥80y) and/or Frail

阿卡拉鲁替尼治疗高龄（≥80岁）和/或体弱的疗效和安全性

Patients with Chronic Lymphocytic Leukemia (CLL) – Primary Endpoint Analysis of the Phase II CLL-Frail Trial

慢性淋巴细胞白血病（CLL）患者–II期CLL Frail试验的主要终点分析

Abstract #4618

摘要#4618

Poster Session 642: Chronic Lymphocytic Leukemia: Clinical and Epidemiological:

海报会议642：慢性淋巴细胞白血病：临床和流行病学：

Poster III

海报III

December 9, 2024

2024年12月9日

6:00 – 8:00 PM

6： 00–8:00 PM

Swaminathan, M et al.

Swaminathan，M等人。

Early Obinutuzumab Significantly Increases Bone Marrow Undetectable MRD (10-4 sensitivity) (uMRD4) Rate when Combined with Acalabrutinib and Venetoclax in a Randomized Phase II Trial for Treatment Naïve CLL

Abstract #1855

Poster Session 642: Chronic Lymphocytic Leukemia: Clinical and Epidemiological:

海报会议642：慢性淋巴细胞白血病：临床和流行病学：

Poster I

海报I

December 7, 2024

2024年12月7日

5:30 – 7:30 PM

5： 下午30-7:30

Jerkeman, M et al.

Jerkeman，M等人。

Acalabrutinib and Rituximab in Elderly Patients with Newly Diagnosed Mantle Cell Lymphoma Including a Matched Population-Based External Comparator- the Nordic Lymphoma Group NLG-MCL8 (ALTAMIRA) Phase II Trial

Acalabrutinib和利妥昔单抗治疗老年新诊断套细胞淋巴瘤患者，包括基于人群的匹配外部比较-北欧淋巴瘤组NLG-MCL8（ALTAMIRA）II期试验

Abstract #747

Oral Session 623: Mantle Cell, Follicular, Waldenstrom’s and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Updates on Drug Treatments for Mantle Cell Lymphoma, and CAR-T and Transplants for Indolent Lymphomas

口腔会议623：套细胞、滤泡性、Waldenstrom和其他惰性B细胞淋巴瘤：临床和流行病学：套细胞淋巴瘤药物治疗、CAR-T和惰性淋巴瘤移植的最新进展

December 9, 2024

2024年12月9日

11:00 AM

11： 上午00点

Christofyllakis, K et al.

Christophyllicis，K等人。

Toxicity of R-mini-CHOP with or without Acalabrutinib in Older Adults with Untreated DLBCL – An Interim Analysis of Serious Adverse Events in the ARCHED / GLA 2022-1 Randomized, Open-Label, Phase 3 Trial

R-mini-CHOP联合或不联合阿卡鲁替尼对未经治疗的DLBCL老年人的毒性-ARCHED/GLA 2022-1随机、开放标签、3期试验中严重不良事件的中期分析

Abstract #4498

摘要#4498

Poster Session 627: Aggressive Lymphomas: Pharmacologic Therapies: Poster III

海报会议627：侵袭性淋巴瘤：药物治疗：海报III

December 9, 2024

2024年12月9日

6:00 – 8:00 PM

6： 00–8:00 PM

AZD0486

AZD0486

Gaballa, S et al.

Gaballa，S等人。

Evaluation of AZD0486, a Novel CD19xCD3 T-Cell Engager, in Relapsed/Refractory Diffuse Large B-cell Lymphoma in an Ongoing First-in-Human Phase 1 Study: High Complete Responses Seen in CAR-T–naive and CAR-T–exposed Patients

在正在进行的人类第一阶段研究中，对新型CD19xCD3 T细胞接受者AZD0486在复发/难治性弥漫性大B细胞淋巴瘤中的评估：在未接受CAR-T和接触CAR-T的患者中观察到高完全反应

Abstract #868

摘要#868

Oral Session 627: Aggressive Lymphomas: Pharmacologic Therapies: Novel Monotherapies or Novel Disease Indications

口腔会议627：侵袭性淋巴瘤：药物治疗：新型单一疗法或新型疾病适应症

December 9, 2024

2024年12月9日

3:30 PM

3： 下午30点

Hou, J et al.

侯，J等人。

Escalating Doses of AZD0486, a Novel CD19xCD3 T-cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma

AZD0486是一种新型CD19xCD3 T细胞接受者，剂量的增加可导致复发/难治性滤泡性淋巴瘤患者的高度完全缓解，并迅速清除微小残留疾病

Abstract #341

摘要#341

Oral Session 623: Mantle Cell, Follicular, Waldenstrom’s and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Novel Treatment Strategies and New Data on Old Standards for Follicular Lymphoma

口腔会议623：套细胞、滤泡性、Waldenstrom氏和其他惰性B细胞淋巴瘤：临床和流行病学：新的治疗策略和滤泡性淋巴瘤旧标准的新数据

December 7, 2024

2024年12月7日

5:00 PM

5： 下午00点

Zhu, X et al.

朱，X等人。

Exposure-Response analysis and Quantitative Systems Pharmacology modelling for an optimal dose selection of AZD0486 in follicular lymphoma patients

滤泡性淋巴瘤患者AZD0486最佳剂量选择的暴露-反应分析和定量系统药理学建模

Abstract #2794

摘要#2794

Poster Session 605: Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Poster II

海报会议605：分子药理学和耐药性：淋巴肿瘤：海报II

December 8, 2024

2024年12月8日

6:00 – 8:00 PM

6： 00–8:00 PM

AZD0120

AZD0120

Du, J et al.

杜，J等人。

A phase I study of dual targeting BCMA and CD19 FasTCAR-T cells (GC012F)

双靶向BCMA和CD19 FasTCAR-T细胞（GC012F）的I期研究

as first-line therapy for transplant-ineligible newly diagnosed multiple myeloma

作为移植不合格的新诊断多发性骨髓瘤的一线治疗

Abstract #2072

摘要#2072

Poster Session 704: Cellular Immunotherapies: Early Phase Clinical Trials and

海报课程704：细胞免疫疗法：早期临床试验和

Toxicities: Poster I

毒性：海报I

December 7, 2024

2024年12月7日

5:30 – 7:30 PM

5： 下午30-7:30

AZD5492

AZD5492

Lawrence, R et al.

劳伦斯，R等人。

Pre-Clinical Evaluation of AZD5492, a Novel CD8-Guided T Cell Engager, for B-Non-Hodgkin Lymphoma Indications

新型CD8引导的T细胞接受者AZD5492对B非霍奇金淋巴瘤适应症的临床前评估

Abstract #959

摘要#959

Oral Session 605: Molecular Pharmacology and Drug Resistance: Lymphoid Neoplasms: Novel Therapeutic Approaches in Lymphoma

口腔会议605：分子药理学和耐药性：淋巴肿瘤：淋巴瘤的新治疗方法

December 9, 2024

2024年12月9日

5:30 PM

5： 下午30点

VOYDEYA™ (danicopan)

旅行者™ （丹麦）

Schrezenmeier, H

施雷森梅尔，H

Breakthrough Hemolysis Events in Patients with Paroxysmal Nocturnal Hemoglobinuria: Data from Danicopan and Pegcetacoplan Trials

阵发性夜间血红蛋白尿患者的突破性溶血事件：来自Danicopan和Pegcetacoplan试验的数据

Abstract #2694

摘要#2694

Poster Session 508: Bone Marrow Failure: Acquired: Poster II

海报课程508：骨髓衰竭：获得性：海报II

December 8, 2024

2024年12月8日

6:00 PM

6： 下午00点

Piatek, C

星期五，C

Danicopan as Add-On Therapy to Ravulizumab or Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria: Long-Term Patient-Reported Outcomes from the Phase 3 ALPHA Trial

Danicopan作为Ravulizumab或Eculizumab的附加疗法治疗阵发性夜间血红蛋白尿症：3期ALPHA试验的长期患者报告结果

Abstract #2692

摘要#2692

Poster Session 508: Bone Marrow Failure: Acquired: Poster II

海报课程508：骨髓衰竭：获得性：海报II

December 8, 2024

2024年12月8日

6:00 PM

6： 下午00点

ULTOMIRIS® (ravulizumab-cwvz) and SOLIRIS® (eculizumab)

到期® （拉武利珠单抗cwvz）和SOLIRIS® （艾库珠单抗）

Griffiths, E

格里菲斯，E

Real-World Drug Adherence, Persistence, and Healthcare Resource Utilization in Patients with Paroxysmal Nocturnal Hemoglobinuria in the USA: The ADVANTAGE Study

美国阵发性夜间血红蛋白尿患者的现实世界药物依从性，持久性和医疗资源利用：优势研究

Abstract #5074

摘要#5074

Poster Session 905: Outcomes Research: Non-Malignant Conditions Excluding Hemoglobinopathies

海报会议905：结果研究：不包括血红蛋白病的非恶性疾病

December 9, 2024

2024年12月9日

6:00 PM

6： 下午00点

Chaturvedi, S

查图维迪，S

Real-World Effectiveness of Ravulizumab Among Adults with Atypical Hemolytic Uremic Syndrome (aHUS) who Switched to Ravulizumab Within 3 Months of Eculizumab Treatment: A Physician Panel-Based Chart Review Study (aHUS IMPACT)

在依库利珠单抗治疗3个月内改用Ravulizumab的非典型溶血性尿毒症综合征（aHUS）成人中，Ravulizumab的真实有效性：一项基于医师小组的图表审查研究（aHUS IMPACT）

Abstract #2613

摘要#2613

Poster Session 330: Vascular Biology, Thrombosis, and Thrombotic Microangiopathies: Basic and Translational

海报课程330：血管生物学，血栓形成和血栓性微血管病：基础和转化

December 8, 2024

2024年12月8日

6:00 PM

6： 下午00点

Iori, AP

美联社，伊奥里

REACTION - Real Life Use of Ravulizumab in Italian PatiEnts with PAroxysmal NoCturnal Hemoglobinuria a MulTicenter ObservatIONal Retrospective and Prospective Cohort Study, Final Results

反应-意大利阵发性夜间血红蛋白尿患者现实生活中使用Ravulizumab的多中心观察性回顾性和前瞻性队列研究，最终结果

Abstract #2464

摘要#2464

Poster Session 101: Red Cells and Erythropoiesis, Excluding Iron

海报课程101：红细胞和红细胞生成，不包括铁

December 8, 2024

2024年12月8日

6:00 PM

6： 下午00点

PNH

PNH

Wagner-Ballon, O

瓦格纳-气球，O

High Proportion of PNH Type II Neutrophils, l.e Relative Percentage 3%, Is Associated with Thrombosis in Patients Displaying a PNH Clone >1%: Evidence from Analysis of the 5-Year French Nation-Wide Multicenter Observational Study

在显示PNH克隆>1%的患者中，高比例的PNH II型中性粒细胞（即相对百分比3%）与血栓形成有关：来自法国为期5年的全国性多中心观察性研究分析的证据

Abstract #4080

摘要#4080

Poster Session 508: Bone Marrow Failure: Acquired: Poster III

海报课程508：骨髓衰竭：获得性：海报III

December 9, 2024

2024年12月9日

6:00 PM

6： 下午00点

HSCT-TMA

HSCT-ma

Dandoy, C

丹多伊，C

Survival Outcomes in Adult and Pediatric Patients Who Experienced Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant: A Systematic Review and Meta-Analysis

造血干细胞移植后发生血栓性微血管病的成人和儿科患者的生存结果：系统评价和荟萃分析

Abstract #7286

摘要#7286

Online Publication

Amyloidosis

淀粉样变性

Laires, P

莱尔斯，p

Comparison Of Alternative Mayo Staging Classification Systems Used in Light-Chain Amyloidosis

Abstract #6887

摘要#6887

Online Publication

在线出版物

Thompson, J

汤普森，J

Evaluation of Functional Cardiac Measures and Response to Treatment Initiation in Patients with Systemic Light-Chain (AL) Amyloidosis: Results from a Single Site Retrospective Study

系统性轻链（AL）淀粉样变性患者心脏功能测量和治疗开始反应的评估：单点回顾性研究的结果

Abstract #4677

摘要#4677

Poster Session 652: MGUS, Amyloidosis, and Other Non-Myeloma Plasma Cell

海报会议652：MGUS，淀粉样变性和其他非骨髓瘤浆细胞

Dyscrasias: Clinical and Epidemiological

恶液质症：临床和流行病学

December 9, 2024

2024年12月9日

6:00 PM

6： 下午00点

INDICATIONS AND USAGE

适应症和用法

CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

。

This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

根据总体回复率，该适应症在加速批准下获得批准。继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。

CALQUENCE is also indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

CALQUENCE也适用于治疗成人慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）患者。

IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib) tablets

关于CALQUENCE®（acalabrutinib）片剂的重要安全信息

Serious and Opportunistic Infections

严重和机会性感染

Fatal and serious infections, including opportunistic infections, have occurred in patients with hematologic malignancies treated with CALQUENCE.

用CALQUENCE治疗的血液系统恶性肿瘤患者发生了致命和严重的感染，包括机会性感染。

Serious or Grade 3 or higher infections (bacterial, viral, or fungal) occurred in 19% of 1029 patients exposed to CALQUENCE in clinical trials, most often due to respiratory tract infections (11% of all patients, including pneumonia in 6%). These infections predominantly occurred in the absence of Grade 3 or 4 neutropenia, with neutropenic infection reported in 1.9% of all patients.

在临床试验中暴露于CALQUENCE的1029名患者中，有19%发生严重或3级或更高级别的感染（细菌，病毒或真菌），最常见的原因是呼吸道感染（占所有患者的11%，包括6%的肺炎）。这些感染主要发生在没有3级或4级中性粒细胞减少症的情况下，据报道所有患者中有1.9%患有中性粒细胞减少症。

Opportunistic infections in recipients of CALQUENCE have included, but are not limited to, hepatitis B virus reactivation, fungal pneumonia, Pneumocystis jirovecii pneumonia, Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocal leukoencephalopathy (PML). Consider prophylaxis in patients who are at increased risk for opportunistic infections.

CALQUENCE受者的机会性感染包括但不限于乙型肝炎病毒再激活，真菌性肺炎，肺囊虫肺炎，爱泼斯坦-巴尔病毒再激活，巨细胞病毒和进行性多灶性白质脑病（PML）。考虑对机会性感染风险增加的患者进行预防。

Monitor patients for signs and symptoms of infection and treat promptly..

监测患者的感染体征和症状，并及时治疗。。

Hemorrhage

出血

Fatal and serious hemorrhagic events have occurred in patients with hematologic malignancies treated with CALQUENCE. Major hemorrhage (serious or Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 3.0% of patients, with fatal hemorrhage occurring in 0.1% of 1029 patients exposed to CALQUENCE in clinical trials.

用CALQUENCE治疗的血液系统恶性肿瘤患者发生致命和严重的出血事件。3.0%的患者发生大出血（严重或3级或更高级别出血或任何中枢神经系统出血），在临床试验中暴露于CALQUENCE的1029名患者中，有0.1%发生致命出血。

Bleeding events of any grade, excluding bruising and petechiae, occurred in 22% of patients..

22%的患者发生任何程度的出血事件，不包括瘀伤和瘀斑。。

Use of antithrombotic agents concomitantly with CALQUENCE may further increase the risk of hemorrhage. In clinical trials, major hemorrhage occurred in 2.7% of patients taking CALQUENCE without antithrombotic agents and 3.6% of patients taking CALQUENCE with antithrombotic agents. Consider the risks and benefits of antithrombotic agents when co-administered with CALQUENCE.

同时使用抗血栓药物可能会进一步增加出血风险。在临床试验中，服用不含抗血栓药物的CALQUENCE的患者中有2.7%发生大出血，服用抗血栓药物的患者中有3.6%发生大出血。考虑与CALQUENCE共同给药时抗血栓药物的风险和益处。

Monitor patients for signs of bleeding..

监测患者是否有出血迹象。。

Consider the benefit-risk of withholding CALQUENCE for 3-7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

根据手术类型和出血风险，考虑手术前后3-7天停止计算的益处风险。

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (23%), anemia (8%), thrombocytopenia (7%), and lymphopenia (7%), developed in patients with hematologic malignancies treated with CALQUENCE. Grade 4 neutropenia developed in 12% of patients. Monitor complete blood counts regularly during treatment. Interrupt treatment, reduce the dose, or discontinue treatment as warranted..

用CALQUENCE治疗的血液系统恶性肿瘤患者发生3或4级血细胞减少症，包括中性粒细胞减少症（23%），贫血（8%），血小板减少症（7%）和淋巴细胞减少症（7%）。12%的患者出现4级中性粒细胞减少症。在治疗期间定期监测全血细胞计数。中断治疗，减少剂量，或根据需要停止治疗。。

Second Primary Malignancies

第二原发恶性肿瘤

Second primary malignancies, including skin cancers and other solid tumors, occurred in 12% of 1029 patients exposed to CALQUENCE in clinical trials. The most frequent second primary malignancy was skin cancer, reported in 6% of patients. Monitor patients for skin cancers and advise protection from sun exposure..

在临床试验中暴露于CALQUENCE的1029名患者中，有12%发生了第二原发性恶性肿瘤，包括皮肤癌和其他实体瘤。最常见的第二原发性恶性肿瘤是皮肤癌，据报道有6%的患者。监测患者的皮肤癌并建议避免阳光照射。。

Cardiac Arrhythmias

心律不正

Serious cardiac arrhythmias have occurred in patients treated with CALQUENCE. Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029 patients treated with CALQUENCE, with all grades of atrial fibrillation or flutter reported in 4.1% of all patients. Grade 3 or higher ventricular arrhythmia events were reported in 0.9% of patients.

用CALQUENCE治疗的患者发生了严重的心律失常。1029例接受CALQUENCE治疗的患者中有1.1%发生3级心房颤动或扑动，所有级别的心房颤动或扑动报告占所有患者的4.1%。0.9%的患者报告了3级或更高级别的室性心律失常事件。

The risk may be increased in patients with cardiac risk factors, hypertension, previous arrhythmias, and acute infection. Monitor for symptoms of arrhythmia (eg, palpitations, dizziness, syncope, dyspnea) and manage as appropriate..

。监测心律失常症状（如心悸、头晕、晕厥、呼吸困难）并酌情处理。。

Hepatotoxicity, Including Drug-Induced Liver Injury

肝毒性，包括药物引起的肝损伤

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including CALQUENCE.

用布鲁顿酪氨酸激酶抑制剂（包括CALQUENCE）治疗的患者发生了肝毒性，包括严重，危及生命和可能致命的药物性肝损伤（DILI）病例。

Evaluate bilirubin and transaminases at baseline and throughout treatment with CALQUENCE. For patients who develop abnormal liver tests after CALQUENCE, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold CALQUENCE.

在基线和整个治疗过程中用CALQUENCE评估胆红素和转氨酶。对于在计算后出现肝脏检查异常的患者，更频繁地监测肝脏检查异常以及肝毒性的临床体征和症状。如果怀疑帝力，则停止计算。

Upon confirmation of DILI, discontinue CALQUENCE..

确认DILI后，停止计算。。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (≥20%) of any grade in patients with relapsed or refractory MCL were anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). The most common Grade ≥3 non-hematological adverse reaction (reported in at least 2% of patients) was diarrhea (3.2%)..

复发或难治性MCL患者最常见的不良反应（≥20%）是贫血，*血小板减少症，*头痛（39%），中性粒细胞减少症，*腹泻（31%），疲劳（28%），肌痛（21%）和瘀伤（21%）。最常见的≥3级非血液学不良反应（至少2%的患者报告）是腹泻（3.2%）。。

*Treatment-emergent decreases (all grades) of hemoglobin (46%), platelets (44%), and neutrophils (36%) were based on laboratory measurements and adverse reactions.

*。

Dose reductions or discontinuations due to any adverse reaction were reported in 1.6% and 6.5% of patients, respectively. Increases in creatinine to 1.5 to 3 times the upper limit of normal (ULN) occurred in 4.8% of patients.

据报道，分别有1.6%和6.5%的患者因任何不良反应而减少剂量或停药。4.8%的患者肌酐升高至正常上限（ULN）的1.5至3倍。

The most common adverse reactions (≥30%) of any grade in patients with CLL were anemia,* neutropenia,* thrombocytopenia,* headache, upper respiratory tract infection, and diarrhea.

CLL患者最常见的不良反应（≥30%）是贫血，*中性粒细胞减少症，*血小板减少症，*头痛，上呼吸道感染和腹泻。

*Treatment-emergent decreases (all grades) of hemoglobin, platelets, and neutrophils were based on laboratory measurements and adverse reactions.

*血红蛋白，血小板和中性粒细胞的治疗紧急减少（所有等级）是基于实验室测量和不良反应。

In patients with previously untreated CLL exposed to CALQUENCE, fatal adverse reactions that occurred in the absence of disease progression and with onset within 30 days of the last study treatment were reported in 2% for each treatment arm, most often from infection. Serious adverse reactions were reported in 39% of patients in the CALQUENCE plus obinutuzumab arm and 32% in the CALQUENCE monotherapy arm, most often due to events of pneumonia (7% and 2.8%, respectively)..

在先前未经治疗的CLL暴露于CALQUENCE的患者中，在没有疾病进展的情况下发生的致命不良反应以及在最后一次研究治疗后30天内发作的致命不良反应报告为每个治疗组2%，最常见的是感染。CALQUENCE加obinutuzumab组39%的患者和CALQUENCE单药治疗组32%的患者报告了严重的不良反应，最常见的原因是肺炎事件（分别为7%和2.8%）。。

Adverse reactions led to CALQUENCE dose reduction in 7% and 4% of patients in the CALQUENCE plus obinutuzumab arm (N=178) and CALQUENCE monotherapy arm (N=179), respectively. Adverse events led to discontinuation in 11% and 10% of patients, respectively. Increases in creatinine to 1.5 to 3 times ULN occurred in 3.9% and 2.8% of patients in the CALQUENCE combination arm and monotherapy arm, respectively..

不良反应分别导致CALQUENCE加obinutuzumab组（N=178）和CALQUENCE单药治疗组（N=179）中7%和4%的患者的CALQUENCE剂量减少。不良事件分别导致11%和10%的患者停药。CALQUENCE联合治疗组和单药治疗组分别有3.9%和2.8%的患者肌酐增加至ULN的1.5至3倍。。

In patients with relapsed/refractory CLL exposed to CALQUENCE, serious adverse reactions occurred in 29% of patients. Serious adverse reactions in >5% of patients who received CALQUENCE included lower respiratory tract infection (6%). Fatal adverse reactions within 30 days of the last dose of CALQUENCE occurred in 2.6% of patients, including from second primary malignancies and infection..

在复发/难治性CLL暴露于CALQUENCE的患者中，29%的患者发生严重不良反应。接受CALQUENCE治疗的患者中>5%的严重不良反应包括下呼吸道感染（6%）。2.6%的患者在最后一剂CALQUENCE后30天内发生致命的不良反应，包括第二原发性恶性肿瘤和感染。。

Adverse reactions led to CALQUENCE dose reduction in 3.9% of patients (N=154), dose interruptions in 34% of patients, most often due to respiratory tract infections followed by neutropenia, and discontinuation in 10% of patients, most frequently due to second primary malignancies followed by infection.

不良反应导致3.9%的患者（N=154）的剂量减少，34%的患者剂量中断，最常见的是由于呼吸道感染，其次是中性粒细胞减少，10%的患者停药，最常见的是由于第二原发性恶性肿瘤，其次是感染。

Increases in creatinine to 1.5 to 3 times ULN occurred in 1.3% of patients who received CALQUENCE..

1.3%接受CALQUENCE治疗的患者肌酐增加至ULN的1.5至3倍。。

DRUG INTERACTIONS

药物相互作用

Strong CYP3A Inhibitors: Avoid co-administration of CALQUENCE with a strong CYP3A inhibitor. If these inhibitors will be used short-term, interrupt CALQUENCE. After discontinuation of strong CYP3A inhibitor for at least 24 hours, resume previous dosage of CALQUENCE.

强CYP3A抑制剂：避免将CALQUENCE与强CYP3A抑制剂共同给药。如果这些抑制剂将短期使用，请中断计算。停用强CYP3A抑制剂至少24小时后，恢复先前剂量的CALQUENCE。

Moderate CYP3A Inhibitors: Reduce the dosage of CALQUENCE to 100 mg once daily when co-administered with a moderate CYP3A inhibitor.

中度CYP3A抑制剂：与中度CYP3A抑制剂共同给药时，每天一次将CALQUENCE的剂量减少至100 mg。

Strong CYP3A Inducers: Avoid co-administration of CALQUENCE with a strong CYP3A inducer. If co-administration is unavoidable, increase the dosage of CALQUENCE to 200 mg approximately every 12 hours.

强CYP3A诱导剂：避免将CALQUENCE与强CYP3A诱导剂共同给药。如果无法避免共同给药，则大约每12小时将CALQUENCE的剂量增加至200 mg。

SPECIFIC POPULATIONS

特定人群

Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women of the potential risk to a fetus.

。孕妇中没有可用的数据来告知与药物相关的风险。告知孕妇对胎儿的潜在风险。

Pregnancy testing is recommended for females of reproductive potential prior to initiating CALQUENCE therapy. Advise female patients of reproductive potential to use effective contraception during treatment with CALQUENCE and for 1 week following the last dose of CALQUENCE.

在开始CALQUENCE治疗之前，建议对具有生殖潜力的女性进行妊娠测试。建议有生殖潜力的女性患者在使用CALQUENCE治疗期间和最后一剂CALQUENCE后1周内使用有效的避孕措施。

It is not known if CALQUENCE is present in human milk. Advise lactating women not to breastfeed while taking CALQUENCE and for 2 weeks after the last dose.

目前尚不清楚母乳中是否存在CALQUENCE。建议哺乳期妇女在服用CALQUENCE时和最后一剂后2周内不要母乳喂养。

Avoid use of CALQUENCE in patients with severe hepatic impairment (Child-Pugh class C). No dosage adjustment of CALQUENCE is recommended in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment.

避免在严重肝功能损害（Child-Pugh C级）患者中使用CALQUENCE。轻度（Child-Pugh A级）或中度（Child-Pugh B级）肝损伤患者不建议调整剂量。

Please see full Prescribing Information, including Patient Information.

请参阅完整的处方信息，包括患者信息。

INDICATION & IMPORTANT SAFETY INFORMATION FOR VOYDEYATM (danicopan)

VOYDEYATM（danicopan）的指示和重要安全信息

INDICATION

指示

What is VOYDEYA?

VOYDEYA是什么？

VOYDEYA is a prescription medicine used along with ravulizumab or eculizumab to treat breakdown of red blood cells that takes place outside of blood vessels (extravascular hemolysis), in adults with paroxysmal nocturnal hemoglobinuria (PNH).

VOYDEYA是一种处方药，与ravulizumab或依库利珠单抗一起用于治疗成人阵发性夜间血红蛋白尿（PNH）患者血管外发生的红细胞分解（血管外溶血）。

It is not known if VOYDEYA is safe and effective in children.

目前尚不清楚VOYDEYA对儿童是否安全有效。

IMPORTANT SAFETY INFORMATION

重要安全信息

What is the most important information I should know about VOYDEYA?

关于VOYDEYA，我应该知道的最重要的信息是什么？

VOYDEYA is a medicine that affects your immune system. VOYDEYA may lower the ability of your immune system to fight infections.

VOYDEYA是一种影响免疫系统的药物。VOYDEYA可能会降低你的免疫系统抵抗感染的能力。

VOYDEYA increases your chance of getting serious infections caused by encapsulated bacteria. These serious infections may quickly become life-threatening and cause death if not recognized and treated early.

VOYDEYA增加了由包裹细菌引起的严重感染的机会。如果不及早发现和治疗，这些严重感染可能会迅速危及生命并导致死亡。

You must complete or update meningococcal vaccine(s) and streptococcus vaccine(s) at least 2 weeks before your first dose of VOYDEYA.

您必须在第一剂VOYDEYA之前至少2周完成或更新脑膜炎球菌疫苗和链球菌疫苗。

If you have not completed your vaccinations and VOYDEYA must be started right away, you should receive the required vaccinations as soon as possible.

如果您尚未完成疫苗接种，VOYDEYA必须立即开始，您应该尽快接种所需的疫苗。

If you have not been vaccinated at least 2 weeks before your first VOYDEYA dose and VOYDEYA must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.

如果您在第一次接种VOYDEYA之前至少2周没有接种疫苗，并且必须立即开始接种VOYDEYA，您还应该接受抗生素治疗，只要您的医疗保健提供者告诉您。

If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting VOYDEYA. Your healthcare provider will decide if you need additional vaccinations.

如果您过去已经接种过这些细菌的疫苗，那么在开始VOYDEYA之前可能需要额外的疫苗接种。您的医疗保健提供者将决定您是否需要额外接种疫苗。

Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you have any of these signs and symptoms of a serious infection: fever with or without chills, fever and a rash, fever with chest pain and cough, fever with breathlessness/fast breathing, fever with high heart rate, headache with nausea or vomiting, headache and a fever, headache with a stiff neck or stiff back, confusion, body aches with flu-like symptoms, clammy skin, eyes sensitive to light..

疫苗并不能预防所有由包囊细菌引起的感染。如果你有任何严重感染的迹象和症状，请立即致电你的医疗保健提供者或获得紧急医疗护理：发烧伴或不伴寒战、发烧和皮疹、发烧伴胸痛和咳嗽、发烧伴呼吸困难/呼吸急促、发烧伴心率加快、头痛伴恶心或呕吐、头痛伴发烧、头痛伴颈部僵硬或背部僵硬、精神错乱、身体疼痛伴流感样症状、皮肤湿漉漉、眼睛对光敏感。。

Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 1 week after your last VOYDEYA dose. Your risk of serious infections may continue for a few days after your last dose of VOYDEYA. It is important to show this card to any healthcare provider who treats you.

你的医疗保健提供者会给你一张关于严重感染风险的患者安全卡。在治疗期间以及最后一次服用VOYDEYA后的1周内，始终随身携带。在服用最后一剂VOYDEYA后，您的严重感染风险可能会持续几天。向任何治疗您的医疗保健提供者出示此卡非常重要。

This will help them diagnose and treat you quickly..

这将帮助他们快速诊断和治疗您。。

VOYDEYA is only available through a program called the VOYDEYA Risk Evaluation and Mitigation Strategy (REMS). Before you can take VOYDEYA, your healthcare provider must: enroll in the VOYDEYA REMS; counsel you about the risk of serious infections caused by certain bacteria; give you information about the symptoms of serious infections; make sure that you are vaccinated against serious infections caused by encapsulated bacteria and that you receive antibiotics if you need to start VOYDEYA right away and you are not up to date on your vaccinations; give you a Patient Safety Card about your risk of serious infections, as discussed above..

VOYDEYA只能通过一项名为VOYDEYA风险评估和缓解策略（REMS）的计划获得。在服用VOYDEYA之前，您的医疗保健提供者必须：注册VOYDEYA REMS；建议您注意某些细菌引起严重感染的风险；给你关于严重感染症状的信息；确保您接种了由包裹细菌引起的严重感染的疫苗，如果您需要立即开始VOYDEYA，并且您尚未接种最新疫苗，请接受抗生素治疗；如上所述，给你一张关于严重感染风险的患者安全卡。。

Who should not receive VOYDEYA?

谁不应该接待VOYDEYA？

Do not take VOYDEYA if you have a serious infection caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae type B infection.

如果您有由包裹细菌引起的严重感染，请不要服用VOYDEYA，包括脑膜炎奈瑟菌，肺炎链球菌或B型流感嗜血杆菌感染。

Before taking VOYDEYA, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, have liver problems, are pregnant or plan to become pregnant, or are breastfeeding. It is not known if VOYDEYA will harm your unborn baby or if it passes into your breast milk.

服用VOYDEYA之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否感染或发烧、肝病、怀孕或计划怀孕或正在母乳喂养。目前尚不清楚VOYDEYA是否会伤害您未出生的婴儿，或者它是否会进入您的母乳。

Do not breastfeed during treatment with VOYDEYA and for 3 days after the last dose..

。。

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. VOYDEYA may affect the way other medicines work.

告诉你的医疗保健提供者你接种的所有疫苗和服用的药物，包括处方药和非处方药、维生素和草药补充剂，这些都可能影响你的治疗。VOYDEYA可能会影响其他药物的工作方式。

If you stop taking VOYDEYA, your healthcare provider will need to monitor you closely for at least 2 weeks after your last dose. Stopping treatment with VOYDEYA may cause a breakdown of red blood cells due to PNH. Symptoms or problems that can happen due to breakdown of red blood cells include: decreased hemoglobin level in your blood and tiredness.

如果您停止服用VOYDEYA，您的医疗保健提供者将需要在您最后一次服用后至少2周内密切监测您。停止使用VOYDEYA治疗可能会导致PNH导致红细胞分解。红细胞分解可能产生的症状或问题包括：血液中血红蛋白水平降低和疲劳。

What are the possible side effects of VOYDEYA?

VOYDEYA可能有哪些副作用？

VOYDEYA can cause serious side effects, including increased liver enzyme levels and increased cholesterol. Your healthcare provider will do blood tests to check your liver enzyme levels and cholesterol before and during treatment with VOYDEYA. Your healthcare provider may temporarily or permanently stop treatment with VOYDEYA if you develop increased liver enzyme levels..

VOYDEYA会引起严重的副作用，包括肝酶水平升高和胆固醇升高。您的医疗保健提供者将在使用VOYDEYA治疗之前和期间进行血液检查，以检查您的肝酶水平和胆固醇。如果您的肝酶水平升高，您的医疗保健提供者可能会暂时或永久停止使用VOYDEYA进行治疗。。

The most common side effect of VOYDEYA is headache.

VOYDEYA最常见的副作用是头痛。

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of VOYDEYA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088..

告诉你的医疗保健提供者任何困扰你或不会消失的副作用。这些并不是VOYDEYA可能产生的所有副作用。有关更多信息，请咨询您的医疗保健提供者或药剂师。请致电您的医疗保健提供者，获取有关副作用的医疗建议。您可以通过1-800-FDA-1088向FDA报告副作用。。

Please see the accompanying full Prescribing Information and Medication Guide for VOYDEYA (danicopan), including Boxed WARNING regarding serious infections caused by encapsulated bacteria.

请参阅随附的VOYDEYA（danicopan）的完整处方信息和药物指南，包括关于由包裹细菌引起的严重感染的盒装警告。

INDICATION(S) & IMPORTANT SAFETY INFORMATION FOR ULTOMIRIS ® (ravulizumab-cwvz)

ULTOMIRIS®（ravulizumab cwvz）的适应症和重要安全信息

INDICATION(S)

What is ULTOMIRIS?

？

ULTOMIRIS is a prescription medicine used to treat:

ULTOMIRIS是一种处方药，用于治疗：

adults and children 1 month of age and older with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).

患有阵发性夜间血红蛋白尿（PNH）疾病的1个月及以上的成年人和儿童。

adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

患有非典型溶血性尿毒症综合征（aHUS）的成人和1个月及以上的儿童。ULTOMIRIS不用于治疗志贺毒素大肠杆菌相关溶血性尿毒症综合征（STEC-HUS）患者。

adults with a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

。

adults with a disease called Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody positive.

。

It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age.

目前尚不清楚ULTOMIRIS对1个月以下的儿童是否安全有效。

It is not known if ULTOMIRIS is safe and effective for the treatment of gMG or NMOSD in children.

目前尚不清楚ULTOMIRIS是否安全有效地治疗儿童gMG或NMOSD。

IMPORTANT SAFETY INFORMATION

重要安全信息

What is the most important information I should know about ULTOMIRIS?

关于ULTOMIRIS，我应该知道的最重要的信息是什么？

ULTOMIRIS is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

ULTOMIRIS是一种影响免疫系统的药物，可能会降低免疫系统抵抗感染的能力。

ULTOMIRIS increases your chance of getting serious meningococcal infections that may quickly become life-threatening or cause death if not recognized and treated early.

ULTOMIRIS会增加你感染严重脑膜炎球菌的机会，如果不及早发现和治疗，可能会迅速危及生命或导致死亡。

You must complete or update meningococcal vaccine(s) at least 2 weeks before your first dose of ULTOMIRIS.

您必须在第一剂ULTOMIRIS之前至少2周完成或更新脑膜炎球菌疫苗。

If you have not completed your meningococcal vaccines and ULTOMIRIS must be started right away, you should receive the required vaccine(s) as soon as possible.

如果您尚未接种脑膜炎球菌疫苗，并且必须立即接种ULTOMIRIS，则应尽快接种所需疫苗。

If you have not been vaccinated and ULTOMIRIS must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.

如果你没有接种疫苗，ULTOMIRIS必须立即开始，你也应该接受抗生素治疗，只要你的医疗保健提供者告诉你。

If you had a meningococcal vaccine in the past, you might need additional vaccines before starting ULTOMIRIS. Your healthcare provider will decide if you need additional meningococcal vaccines.

如果您过去曾接种过脑膜炎球菌疫苗，那么在使用ULTOMIRIS之前可能需要额外的疫苗。您的医疗保健提供者将决定您是否需要额外的脑膜炎球菌疫苗。

Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and a rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light..

脑膜炎球菌疫苗并不能预防所有脑膜炎球菌感染。如果您出现脑膜炎球菌感染的任何体征和症状，请立即致电您的医疗保健提供者或获得紧急医疗护理：发烧，心率过高发烧，头痛发烧，精神错乱，肌肉酸痛伴流感样症状，发烧皮疹，头痛伴恶心或呕吐，头痛伴颈部僵硬或背部僵硬，或眼睛对光敏感。。

Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. Your risk of meningococcal infection may continue for several months after your last dose of ULTOMIRIS.

您的医疗保健提供者会给您一张关于严重脑膜炎球菌感染风险的患者安全卡。在治疗期间以及最后一次服用ULTOMIRIS后的8个月内，始终随身携带。在最后一剂ULTOMIRIS后，脑膜炎球菌感染的风险可能会持续数月。

It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly..

向任何治疗您的医疗保健提供者出示此卡非常重要。这将帮助他们快速诊断和治疗您。。

ULTOMIRIS is only available through a program called the ULTOMIRIS and SOLIRIS Risk Evaluation and Mitigation Strategy (REMS). Before you can receive ULTOMIRIS, your healthcare provider must: enroll in the REMS program; counsel you about the risk of serious meningococcal infections; give you information about the signs and symptoms of serious meningococcal infection; make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start ULTOMIRIS right away and are not up to date on your vaccines; give you a Patient Safety Card about your risk of meningococcal infection..

ULTOMIRIS只能通过名为ULTOMIRIS和SOLIRIS风险评估和缓解策略（REMS）的计划获得。在您接受ULTOMIRIS之前，您的医疗保健提供者必须：注册REMS计划；建议您注意严重脑膜炎球菌感染的风险；向您提供有关严重脑膜炎球菌感染的体征和症状的信息；；给你一张关于脑膜炎球菌感染风险的患者安全卡。。

ULTOMIRIS may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if treated with ULTOMIRIS. Certain people may be at risk of serious infections with gonorrhea..

ULTOMIRIS还可能增加其他类型严重感染的风险，包括肺炎链球菌，流感嗜血杆菌和淋病奈瑟菌。如果用ULTOMIRIS治疗，您的孩子应该接种肺炎链球菌和b型流感嗜血杆菌（Hib）疫苗。某些人可能有严重感染淋病的风险。。

Who should not receive ULTOMIRIS?

谁不应该接受ULTOMIRIS？

Do not receive ULTOMIRIS if you have a serious meningococcal infection when you are starting ULTOMIRIS.

如果您在使用ULTOMIRIS时患有严重的脑膜炎球菌感染，请不要使用ULTOMIRIS。

Before you receive ULTOMIRIS, tell your healthcare provider about all of your medical conditions, including if you:

在您接受ULTOMIRIS之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否：

have an infection or fever

感染或发烧

are pregnant or plan to become pregnant. It is not known if ULTOMIRIS will harm your unborn baby.

怀孕或计划怀孕。目前尚不清楚ULTOMIRIS是否会伤害您的未出生婴儿。

Pregnancy Registry: There is a registry for pregnant women who take ULTOMIRIS to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking ULTOMIRIS, talk to your healthcare provider about how you can join this registry or you may contact the registry at 1-833-793-0563 or www.UltomirisPregnancyStudy.com to enroll..

怀孕登记处：有一个登记处供服用ULTOMIRIS的孕妇检查孕妇及其婴儿的健康。如果您怀孕或在服用ULTOMIRIS时怀孕，请与您的医疗保健提供者联系，了解如何加入此注册表，或者您可以通过1-833-793-0563或www.UltomirisPregnancyStudy.com联系注册表进行注册。。

are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.

正在母乳喂养或计划母乳喂养。目前尚不清楚ULTOMIRIS是否会进入你的母乳。在治疗期间以及服用ULTOMIRIS最后一剂后的8个月内，您不应进行母乳喂养。

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.

告诉你的医疗保健提供者你接种的所有疫苗和服用的药物，包括处方药和非处方药、维生素和草药补充剂，这些都可能影响你的治疗。

If you have PNH and you stop receiving ULTOMIRIS, your healthcare provider will need to monitor you closely for at least 16 weeks after you stop ULTOMIRIS. Stopping ULTOMIRIS may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include: drop in your red blood cell count, tiredness, blood in your urine, stomach-area (abdomen) pain, shortness of breath, blood clots, trouble swallowing, and erectile dysfunction (ED) in males..

如果您患有PNH并且停止服用ULTOMIRIS，您的医疗保健提供者将需要在您停止ULTOMIRIS后至少16周内密切监测您。停止ULTOMIRIS可能会导致PNH导致您的红细胞分解。红细胞分解可能产生的症状或问题包括：男性红细胞计数下降、疲劳、尿液中有血、腹部（腹部）疼痛、呼吸急促、血块、吞咽困难和勃起功能障碍（ED）。。

If you have aHUS, your healthcare provider will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke..

如果您患有aHUS，在停止治疗aHUS恶化的迹象或与一种异常凝血和红细胞分解（称为血栓性微血管病（TMA））相关的问题后，您的医疗保健提供者将需要对您进行至少12个月的密切监测。。。

What are the possible side effects of ULTOMIRIS?

ULTOMIRIS可能有哪些副作用？

ULTOMIRIS can cause serious side effects including infusion-related reactions. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, stomach (abdominal) pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, or bad taste.

ULTOMIRIS可引起严重的副作用，包括输液相关反应。ULTOMIRIS输液相关反应的症状可能包括腰痛、胃痛（腹痛）、肌肉痉挛、血压变化、疲倦、头晕、发冷（僵硬）、手臂或腿部不适或味道不好。

Stop treatment of ULTOMIRIS and tell your healthcare provider right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion-related reaction, including: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out..

停止ULTOMIRIS的治疗，如果您在ULTOMIRIS输注过程中出现这些症状或任何其他症状，可能意味着您有严重的输注相关反应，包括：胸痛、呼吸困难或呼吸急促、面部、舌头或喉咙肿胀，感觉昏厥或昏厥，请立即告诉您的医疗保健提供者。。

The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory tract infection and headache.

ULTOMIRIS在PNH患者中最常见的副作用是上呼吸道感染和头痛。

The most common side effects of ULTOMIRIS in people treated for aHUS are upper respiratory tract infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever.

在接受aHUS治疗的人群中，ULTOMIRIS最常见的副作用是上呼吸道感染，腹泻，恶心，呕吐，头痛，高血压和发烧。

The most common side effects of ULTOMIRIS in people with gMG are diarrhea and upper respiratory tract infections.

ULTOMIRIS在gMG患者中最常见的副作用是腹泻和上呼吸道感染。

The most common side effects of ULTOMIRIS in people with NMOSD are COVID-19 infection, headache, back pain, urinary tract infection, and joint pain (arthralgia).

ULTOMIRIS在NMOSD患者中最常见的副作用是COVID-19感染，头痛，背痛，尿路感染和关节痛（关节痛）。

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of ULTOMIRIS. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider right away if you miss an ULTOMIRIS infusion or for medical advice about side effects.

告诉你的医疗保健提供者任何困扰你或不会消失的副作用。这些都不是ULTOMIRIS可能产生的副作用。有关更多信息，请咨询您的医疗保健提供者或药剂师。如果您错过了ULTOMIRIS输液或有关副作用的医疗建议，请立即致电您的医疗保健提供者。

You may report side effects to FDA at 1-800-FDA-1088..

您可以通过1-800-FDA-1088向FDA报告副作用。。

Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious meningococcal infections.

请参阅随附的ULTOMIRIS的完整处方信息和药物指南，包括关于严重脑膜炎球菌感染的盒装警告。

INDICATION(S) & IMPORTANT SAFETY INFORMATION FOR SOLIRIS® (eculizumab)

SOLIRIS®（依库利珠单抗）的适应症和重要安全信息

INDICATION(S)

指示

What is SOLIRIS?

什么是SOLIRIS？

SOLIRIS is a prescription medicine used to treat:

SOLIRIS是一种处方药，用于治疗：

people with paroxysmal nocturnal hemoglobinuria (PNH).

阵发性夜间血红蛋白尿（PNH）患者。

people with atypical hemolytic uremic syndrome (aHUS).

非典型溶血性尿毒症综合征（aHUS）患者。

SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

。

adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

抗乙酰胆碱受体（AChR）抗体阳性的全身性重症肌无力（gMG）成人。

adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

患有抗水通道蛋白4（AQP4）抗体阳性的视神经脊髓炎谱系障碍（NMOSD）疾病的成年人。

It is not known if SOLIRIS is safe and effective in children with PNH, gMG, or NMOSD

目前尚不清楚SOLIRIS对PNH，gMG或NMOSD儿童是否安全有效

IMPORTANT SAFETY INFORMATION

重要安全信息

What is the most important information I should know about SOLIRIS?

关于SOLIRIS，我应该知道的最重要的信息是什么？

SOLIRIS is a medicine that affects your immune system and may lower the ability of your immune system to fight infections.

SOLIRIS是一种影响免疫系统的药物，可能会降低免疫系统抵抗感染的能力。

SOLIRIS increases your chance of getting serious meningococcal infections that may quickly become life-threatening or cause death if not recognized and treated early.

如果不及早发现和治疗，SOLIRIS会增加你感染严重脑膜炎球菌的机会，这些脑膜炎球菌感染可能会迅速危及生命或导致死亡。

You must complete or update your meningococcal vaccine(s)at least 2 weeks before your first dose of SOLIRIS.

您必须在第一剂SOLIRIS之前至少2周完成或更新脑膜炎球菌疫苗。

If you have not been vaccinated and SOLIRIS must be started right away, you should receive the required vaccine(s) as soon as possible.

如果您尚未接种疫苗，必须立即开始SOLIRIS，您应尽快接种所需疫苗。

If you have not been vaccinated and SOLIRIS must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.

如果您尚未接种疫苗，并且必须立即开始SOLIRIS，那么您也应该接受抗生素治疗，只要您的医疗保健提供者告诉您。

If you had a meningococcal vaccine in the past, you might need additional vaccines before starting SOLIRIS. Your healthcare provider will decide if you need additional meningococcal vaccines.

如果您过去曾接种过脑膜炎球菌疫苗，那么在开始SOLIRIS之前可能需要额外的疫苗。您的医疗保健提供者将决定您是否需要额外的脑膜炎球菌疫苗。

Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light..

脑膜炎球菌疫苗并不能预防所有脑膜炎球菌感染。如果您出现严重脑膜炎球菌感染的任何体征和症状，请立即致电您的医疗保健提供者或获得紧急医疗护理：发烧、心率过高发烧、头痛发烧、精神错乱、肌肉酸痛伴流感样症状、发烧皮疹、头痛伴恶心或呕吐、头痛伴颈部僵硬或背部僵硬或眼睛对光敏感。。

Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of SOLIRIS. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS.

您的医疗保健提供者会给您一张关于严重脑膜炎球菌感染风险的患者安全卡。在治疗期间以及服用最后一剂SOLIRIS后的3个月内，请随身携带。服用最后一剂SOLIRIS后，脑膜炎球菌感染的风险可能会持续数周。

It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly..

向任何治疗您的医疗保健提供者出示此卡非常重要。这将帮助他们快速诊断和治疗您。。

SOLIRIS is only available through a program called the ULTOMIRIS and SOLIRIS Risk Evaluation and Mitigation Strategy (REMS). Before you can receive SOLIRIS, your healthcare provider must: enroll in the REMS program; counsel you about the risk of serious meningococcal infections; give you information about the signs and symptoms of serious meningococcal infection; make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start SOLIRIS right away and you are not up to date on your vaccines; give you a Patient Safety Card about your risk of meningococcal infection..

SOLIRIS只能通过名为ULTOMIRIS和SOLIRIS风险评估和缓解策略（REMS）的计划获得。在您接受SOLIRIS之前，您的医疗保健提供者必须：注册REMS计划；建议您注意严重脑膜炎球菌感染的风险；向您提供有关严重脑膜炎球菌感染的体征和症状的信息；确保您接种了由脑膜炎球菌引起的严重感染的疫苗，如果您需要立即开始SOLIRIS并且您没有接种最新疫苗，请接受抗生素治疗；给你一张关于脑膜炎球菌感染风险的患者安全卡。。

SOLIRIS may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) if treated with SOLIRIS. Certain people may be at risk of serious infections with gonorrhea.

SOLIRIS还可能增加其他类型严重感染的风险，包括肺炎链球菌，流感嗜血杆菌和淋病奈瑟菌。如果用SOLIRIS治疗，您的孩子应该接种肺炎链球菌和b型流感嗜血杆菌（Hib）疫苗。某些人可能有严重感染淋病的风险。

Certain fungal infections (Aspergillus) may occur if you take SOLIRIS and have a weak immune system or a low white blood cell count..

如果服用SOLIRIS且免疫系统较弱或白细胞计数低，可能会发生某些真菌感染（曲霉）。。

Who should not receive SOLIRIS?

谁不应该接受SOLIRIS？

Do not receive SOLIRIS if you have a serious meningococcal infection when you are starting SOLIRIS.

如果您在开始使用SOLIRIS时患有严重的脑膜炎球菌感染，请不要使用SOLIRIS。

Before you receive SOLIRIS, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if SOLIRIS will harm your unborn baby or if it passes into your breast milk..

在您接受SOLIRIS之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否感染或发烧，是否怀孕或计划怀孕，是否正在母乳喂养或计划母乳喂养。目前尚不清楚SOLIRIS是否会伤害您未出生的婴儿或是否会进入您的母乳。。

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.

告诉你的医疗保健提供者你接种的所有疫苗和服用的药物，包括处方药和非处方药、维生素和草药补充剂，这些都可能影响你的治疗。

If you have PNH, your healthcare provider will need to monitor you closely for at least 8 weeks after stopping SOLIRIS. Stopping treatment with SOLIRIS may cause breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include: drop in the number of your red blood cell count, drop in your platelet count, confusion, kidney problems, blood clots, difficulty breathing, and chest pain..

如果您患有PNH，您的医疗保健提供者需要在停止SOLIRIS治疗后至少8周对您进行密切监测。停止SOLIRIS治疗可能会导致PNH导致您的红细胞分解。红细胞分解可能产生的症状或问题包括：红细胞计数下降、血小板计数下降、精神错乱、肾脏问题、血块、呼吸困难和胸痛。。

If you have aHUS, your healthcare provider will need to monitor you closely during and for at least 12 weeks after stopping SOLIRIS for signs of worsening aHUS symptoms or problems related to abnormal clotting (thrombotic microangiopathy). Symptoms or problems that can happen with abnormal clotting may include: stroke, confusion, seizure, chest pain (angina), difficulty breathing, kidney problems, swelling in arms or legs, and a drop in your platelet count..

如果您患有aHUS，您的医疗保健提供者将需要在停止SOLIRIS后至少12周内密切监测您aHUS症状恶化的迹象或与异常凝血（血栓性微血管病）相关的问题。异常凝血可能出现的症状或问题可能包括：中风、精神错乱、癫痫发作、胸痛（心绞痛）、呼吸困难、肾脏问题、手臂或腿部肿胀以及血小板计数下降。。

What are the possible side effects of SOLIRIS?

SOLIRIS可能有哪些副作用？

SOLIRIS can cause serious side effects including serious infusion-related reactions. Tell your healthcare provider or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out.

SOLIRIS会引起严重的副作用，包括严重的输液相关反应。如果您在输注SOLIRIS期间出现以下任何症状，请立即告诉您的医疗保健提供者或护士：胸痛，呼吸困难或呼吸急促，面部，舌头或喉咙肿胀，感觉昏厥或昏厥。

If you have an infusion-related reaction to SOLIRIS, your healthcare provider may need to infuse SOLIRIS more slowly, or stop SOLIRIS..

如果您对SOLIRIS有输注相关反应，您的医疗保健提供者可能需要更缓慢地输注SOLIRIS，或停止SOLIRIS。。

The most common side effects in people with PNH treated with SOLIRIS include: headache, pain or swelling of your nose or throat (nasopharyngitis), back pain, and nausea.

用SOLIRIS治疗的PNH患者最常见的副作用包括：头痛，鼻子或喉咙疼痛或肿胀（鼻咽炎），背痛和恶心。

The most common side effects in people with aHUS treated with SOLIRIS include: headache, diarrhea, high blood pressure (hypertension), common cold (upper respiratory infection), stomach-area (abdominal) pain, vomiting, pain or swelling of your nose or throat (nasopharyngitis), low red blood cell count (anemia), cough, swelling of legs or feet (peripheral edema), nausea, urinary tract infections, and fever..

使用SOLIRIS治疗的aHUS患者最常见的副作用包括：头痛，腹泻，高血压（高血压），普通感冒（上呼吸道感染），胃区（腹部）疼痛，呕吐，鼻子或喉咙疼痛或肿胀（鼻咽炎），红细胞计数低（贫血），咳嗽，腿或脚肿胀（外周水肿），恶心，尿路感染和发烧。。

The most common side effects in people with gMG treated with SOLIRIS include: muscle and joint (musculoskeletal) pain.

用SOLIRIS治疗的gMG患者最常见的副作用包括：肌肉和关节（肌肉骨骼）疼痛。

The most common side effects in people with NMOSD treated with SOLIRIS include: common cold (upper respiratory infection), pain or swelling of your nose or throat (nasopharyngitis), diarrhea, back pain, dizziness, flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches, joint pain (arthralgia), throat irritation (pharyngitis), and bruising (contusion)..

使用SOLIRIS治疗的NMOSD患者最常见的副作用包括：普通感冒（上呼吸道感染），鼻子或喉咙疼痛或肿胀（鼻咽炎），腹泻，背痛，头晕，流感样症状（流感），包括发烧，头痛，疲倦，咳嗽，喉咙痛和身体疼痛，关节痛（关节痛），喉咙刺激（咽炎）和瘀伤（挫伤）。。

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of SOLIRIS. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088..

告诉你的医疗保健提供者任何困扰你或不会消失的副作用。这些并不是SOLIRIS所有可能的副作用。有关更多信息，请咨询您的医疗保健提供者或药剂师。请致电您的医疗保健提供者，获取有关副作用的医疗建议。您可以通过1-800-FDA-1088向FDA报告副作用。。

Please see the accompanying full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections

请参阅随附的SOLIRIS完整处方信息和药物指南，包括关于严重脑膜炎球菌感染的盒装警告

Notes

注意事项

CALQUENCE® (acalabrutinib)

calsequence® （阿卡拉布替尼）

CALQUENCE® (acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). CALQUENCE binds covalently to BTK, thereby inhibiting its activity.15 In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion..

CALQUENCE®（acalabrutinib）是布鲁顿酪氨酸激酶（BTK）的第二代选择性抑制剂。。。

CALQUENCE has been used to treat more than 85,000 patients worldwide16 and is approved for the treatment of CLL and small lymphocytic lymphoma (SLL) in the US and Japan, approved for CLL in the EU and many other countries worldwide and approved in China for relapsed or refractory CLL and SLL. CALQUENCE is also approved in the US, China and several other countries for the treatment of adult patients with MCL who have received at least one prior therapy.

CALQUENCE已被用于治疗全球超过85000名患者16，并在美国和日本被批准用于治疗CLL和小淋巴细胞淋巴瘤（SLL），在欧盟和全球许多其他国家被批准用于CLL，并在中国被批准用于复发或难治性CLL和SLL。CALQUENCE在美国，中国和其他几个国家也被批准用于治疗至少接受过一次治疗的成年MCL患者。

CALQUENCE is not currently approved for the treatment of MCL in Japan or the EU..

CALQUENCE目前尚未在日本或欧盟批准用于治疗MCL。。

As part of an extensive clinical development program, CALQUENCE is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.

作为广泛临床开发计划的一部分，CALQUENCE目前正在作为单一治疗方法进行评估，并与多种B细胞血癌（包括CLL，MCL和弥漫性大B细胞淋巴瘤）患者的标准护理化学免疫疗法相结合。

VOYDEYA™ (danicopan)

旅行者™ （丹麦）

VOYDEYA™ (danicopan) is a first-in-class oral Factor D inhibitor. The medication works by selectively inhibiting Factor D, a complement system protein that plays a key role in the amplification of the complement system response. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells.

VOYDEYA™（danicopan）是一流的口服D因子抑制剂。该药物通过选择性抑制因子D发挥作用，因子D是一种补体系统蛋白，在补体系统反应的扩增中起关键作用。当以不受控制的方式激活时，补体级联反应过度，导致身体攻击自己的健康细胞。

VOYDEYA has been granted Breakthrough Therapy designation by the US Food and Drug Administration and PRIority MEdicines (PRIME) status by the European Medicines Agency. VOYDEYA has also been granted Orphan Drug Designation in the US, EU and Japan for the treatment of PNH..

VOYDEYA已被美国食品和药物管理局授予突破性治疗称号，并被欧洲药品管理局授予优先药物（PRIME）地位。VOYDEYA还被美国、欧盟和日本授予孤儿药称号，用于治疗PNH。。

VOYDEYA is approved in the US, EU, Japan and other countries as add-on therapy to ravulizumab or eculizumab for the treatment of certain adults with PNH.

VOYDEYA在美国，欧盟，日本和其他国家被批准作为ravulizumab或eculizumab的附加疗法，用于治疗某些成人PNH。

Alexion is also evaluating VOYDEYA as a potential monotherapy for geographic atrophy in a Phase II clinical trial.

Alexion还在II期临床试验中评估VOYDEYA作为地理萎缩的潜在单一疗法。

ULTOMIRIS® (ravulizumab-cwvz)

到期® （拉武利珠单抗cwvz）

ULTOMIRIS® (ravulizumab-cwvz), the longest-acting C5 complement inhibitor, provides immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. When activated in an uncontrolled manner, the complement cascade over-responds, leading the body to attack its own healthy cells.

ULTOMIRIS®（ravulizumab cwvz）是作用最长的C5补体抑制剂，可立即，完全和持续地抑制补体。该药物通过抑制末端补体级联（人体免疫系统的一部分）中的C5蛋白起作用。当以不受控制的方式激活时，补体级联反应过度，导致身体攻击自己的健康细胞。

Following a loading dose, ULTOMIRIS is administered intravenously every eight weeks in adults, or every four or eight weeks in pediatric patients (based on body weight)..

负荷剂量后，成人每八周静脉注射一次ULTOMIRIS，儿科患者每四周或八周静脉注射一次ULTOMIRIS（基于体重）。。

ULTOMIRIS is approved in the US, EU, Japan and other countries for the treatment of certain adults with paroxysmal nocturnal hemoglobinuria (PNH) and for certain children with PNH in the US and EU.

ULTOMIRIS在美国，欧盟，日本和其他国家被批准用于治疗某些成人阵发性夜间血红蛋白尿（PNH）以及美国和欧盟的某些PNH儿童。

ULTOMIRIS is also approved in the US, EU, Japan and other countries for the treatment of certain adults and children with atypical hemolytic uremic syndrome (aHUS).

ULTOMIRIS在美国、欧盟、日本和其他国家也被批准用于治疗某些患有非典型溶血性尿毒症综合征（aHUS）的成人和儿童。

Additionally, ULTOMIRIS is approved in the US, EU, Japan and other countries for the treatment of certain adults with generalized myasthenia gravis (gMG).

此外，ULTOMIRIS在美国，欧盟，日本和其他国家被批准用于治疗某些患有全身性重症肌无力（gMG）的成年人。

Further, ULTOMIRIS is approved in the US, EU, Japan and other countries for the treatment of certain adults with neuromyelitis optica spectrum disorder (NMOSD).

此外，ULTOMIRIS在美国，欧盟，日本和其他国家被批准用于治疗某些患有视神经脊髓炎谱系障碍（NMOSD）的成年人。

ULTOMIRIS is being assessed as a treatment for additional indications as part of a broad development program.

ULTOMIRIS正在被评估为一种治疗其他适应症的方法，作为广泛发展计划的一部分。

SOLIRIS® (eculizumab)

索利斯® （艾库珠单抗）

SOLIRIS® (eculizumab) is a first-in-class C5 complement inhibitor. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system. When activated in an uncontrolled manner, the terminal complement cascade over-responds, leading the body to attack its own healthy cells.

SOLIRIS®（依库丽单抗）是一流的C5补体抑制剂。该药物通过抑制末端补体级联（人体免疫系统的一部分）中的C5蛋白起作用。当以不受控制的方式激活时，末端补体级联反应过度，导致身体攻击自己的健康细胞。

SOLIRIS is administered intravenously every two weeks, following an introductory dosing period..

在开始给药后，每两周静脉注射一次SOLIRIS。。

SOLIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain children and adults with paroxysmal nocturnal hemoglobinuria (PNH).

SOLIRIS在美国、欧盟、日本、中国和其他国家被批准用于治疗某些患有阵发性夜间血红蛋白尿（PNH）的儿童和成人。

SOLIRIS is also approved in the US, EU, Japan, China and other countries for the treatment of certain children and adults with atypical hemolytic uremic syndrome (aHUS).

SOLIRIS在美国、欧盟、日本、中国和其他国家也被批准用于治疗某些患有非典型溶血性尿毒症综合征（aHUS）的儿童和成人。

Additionally, SOLIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with generalized myasthenia gravis (gMG), and for certain pediatric patients with gMG in the EU, Japan and other countries.

此外，SOLIRIS在美国，欧盟，日本，中国和其他国家被批准用于治疗某些成人全身性重症肌无力（gMG），以及欧盟，日本和其他国家的某些小儿gMG患者。

Further, SOLIRIS is approved in the US, EU, Japan, China and other countries for the treatment of certain adults with neuromyelitis optica spectrum disorder (NMOSD).

此外，SOLIRIS在美国，欧盟，日本，中国和其他国家被批准用于治疗某些患有视神经脊髓炎谱系障碍（NMOSD）的成年人。

SOLIRIS is not indicated for the treatment of patients with Shiga-toxin E. coli-related hemolytic uremic syndrome.

SOLIRIS不适用于治疗志贺毒素大肠杆菌相关溶血性尿毒症综合征患者。

AstraZeneca in hematology

阿斯利康血液学

AstraZeneca is pushing the boundaries of science to redefine care in hematology. Our goal is to help transform the lives of patients living with malignant, rare and other related hematologic diseases through innovative medicines and approaches that are shaped by insights from patients, caregivers and physicians..

阿斯利康正在推动科学界重新定义血液学护理。我们的目标是通过患者、护理人员和医生的见解形成的创新药物和方法，帮助改变恶性、罕见和其他相关血液病患者的生活。。

In addition to our marketed products, we are spearheading the development of novel therapies designed to target underlying drivers of disease across multiple scientific platforms. Our acquisitions of Alexion, with expertise in rare, non-malignant blood disorders, and Gracell Biotechnologies Inc., pioneers of autologous cell therapies, expand our hematology pipeline and enable us to reach more patients with high unmet needs through the end-to-end discovery, development and delivery of novel therapies..

除了我们销售的产品外，我们还率先开发新疗法，旨在跨多个科学平台针对疾病的潜在驱动因素。我们收购了具有罕见非恶性血液疾病专业知识的Alexion和自体细胞疗法先驱Gracell Biotechnologies Inc.，扩大了我们的血液学渠道，使我们能够通过端到端的发现，开发和提供新疗法来接触更多需求未得到满足的患者。。

AstraZeneca in oncology

阿斯利康肿瘤学

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

阿斯利康（AstraZeneca）正在领导一场肿瘤学革命，致力于为各种形式的癌症提供治疗，遵循科学理解癌症及其复杂性，发现、开发并向患者提供改变生命的药物。

The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

。正是通过不断的创新，阿斯利康建立了行业内最多样化的投资组合和渠道之一，有可能催化医学实践的变化并改变患者的体验。

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

阿斯利康的愿景是重新定义癌症护理，并有一天消除癌症作为死亡原因。

Alexion

亚历克西斯

Alexion, AstraZeneca Rare Disease is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and delivery of life-changing medicines. A pioneering leader in rare disease for more than three decades, Alexion was the first to translate the complex biology of the complement system into transformative medicines, and today it continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities.

阿斯利康罕见病公司Alexion专注于通过发现、开发和提供改变生命的药物，为受罕见疾病和破坏性疾病影响的患者和家庭提供服务。三十多年来，亚力兄一直是罕见疾病领域的先驱，是第一个将补体系统的复杂生物学转化为转化药物的人，今天，它继续使用一系列创新模式，在需求严重未满足的疾病领域建立多样化的管道。

As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US..

作为阿斯利康（AstraZeneca）的一部分，亚力兄（Alexion）正在不断扩大其全球地理足迹，为全球更多罕见病患者提供服务。总部位于美国波士顿。。

AstraZeneca

阿斯利康

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide.

阿斯利康是一家以科学为主导的全球生物制药公司，专注于肿瘤学、罕见病和生物制药（包括心血管、肾脏和代谢以及呼吸和免疫学）处方药的发现、开发和商业化。阿斯利康的创新药物总部位于英国剑桥，在125多个国家销售，全球数百万患者使用。

Please visit www.astrazeneca-us.com and follow the Company on social media @AstraZeneca..

请访问www.astrazeneca-us.com并在社交媒体@astrazeneca上关注公司。。

References

参考文献

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2024..

2024..

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Data on File, REF-236261. AstraZeneca Pharmaceuticals LP.

。阿斯利康制药有限公司。