Brussels, Belgium –July 8, 2025 – 7:00AM CET–

比利时布鲁塞尔——2025年7月8日——欧洲中部时间早上7:00——

UCB, a global biopharmaceutical company, today announced it will present 15 abstracts from its targeted neurology portfolio at the European Pediatric Neurology Society (EPNS) Congress, Munich, Germany, July 8-12, 2025. The data will focus on thymidine kinase 2 deficiency (TK2D) and epilepsies, including rare developmental and epileptic encephalopathies (DEEs) such as Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS)..

优时比（UCB），一家全球生物制药公司，今日宣布将在2025年7月8日至12日于德国慕尼黑举行的欧洲儿科神经学会（EPNS）大会上展示来自其靶向神经学产品组合的15项摘要。这些数据将聚焦于胸苷激酶2缺乏症（TK2D）和癫痫，包括罕见的发育性和癫痫性脑病（DEEs），如Dravet综合征（DS）和Lennox-Gastaut综合征（LGS）。

Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs, UCB, commented: “At UCB we are driven by our commitment to people living with severe diseases and where there is a high unmet need. Together, with a shared passion and purpose, we aim to redefine what is possible in the future of neurology - ensuring that no one facing a severe neurological condition is left behind.

优时比 (UCB) 首席医学官兼全球医学事务主管多纳泰罗·克罗切塔评论道：“在优时比，我们致力于服务患有严重疾病的人群，尤其是那些存在高度未满足需求的领域。怀着共同的热情与目标，我们旨在重新定义神经学的未来——确保没有任何一位面临严重神经系统疾病的患者被抛在身后。”

We look forward to the discussions at the congress and sharing our latest epilepsy and TK2d data with the medical community.”.

我们期待着在大会上进行讨论，并与医学界分享我们最新的癫痫和TK2d数据。

Highlights of data to be presented at EPNS:

将在EPNS上展示的数据亮点：

Developmental and Epileptic Encephalopathies (DEEs):

发育性和癫痫性脑病（DEEs）：

DS

数据科学

: include evaluations of preliminary real-world data on non-seizure benefits of fenfluramine treatment in pediatric and adult patients,

：包括对芬氟拉明治疗在儿科和成人患者中非癫痫发作益处的初步真实世界数据的评估，

9,10

9,10

and antiseizure medication regimen adjustments after fenfluramine initiation in adult and pediatric patients who participated in the European Early Access Program.

在参与欧洲早期访问计划的成年和儿科患者中，开始使用芬氟拉明后调整抗癫痫药物方案。

11

11

LGS

LGS

: final safety and effectiveness of fenfluramine data from the open-label extension (OLE) study,

：芬氟拉明的最终安全性和有效性数据来自开放标签扩展（OLE）研究，

12

12

as well as two post-hoc analyses looking at the onset and duration of a

以及两项事后分析，观察发作的起始和持续时间

erse events following fenfluramine treatment initiation,

开始使用芬氟拉明治疗后出现的不良事件，

13

13

and the efficacy trajectory

以及疗效轨迹

14

14

of fenfluramine based on data from patients who transitioned from placebo during randomized controlled trials to fenfluramine in the OLE study.

基于患者在随机对照试验中从安慰剂过渡到芬氟拉明的OLE研究数据。

DS and LGS

DS 和 LGS

: data include pharmacokinetics and clinical outcomes of fenfluramine in combination with cannabidiol based on results from a Phase 1 study.

：数据包括基于 1 期研究结果的芬氟拉明与大麻二酚联合使用的药代动力学和临床结果。

15

15

Data from a retrospective claims analysis that describes persistence of fenfluramine (FFA) and cannabidiol (CBD) in LGS and DS patients in Germany and their use based on age, gender, prior anti-seizure medication use, and dosage.

一项回顾性索赔分析的数据，描述了芬氟拉明 (FFA) 和大麻二酚 (CBD) 在德国 LGS 和 DS 患者中的持久性，以及它们基于年龄、性别、既往抗癫痫药物使用和剂量的使用情况。

16

16

Epilepsy

癫痫发作

:

：

Focal-onset seizures with/without focal to bilateral tonic-clonic seizures

局灶性发作伴/不伴局灶至双侧强直-阵挛性发作

: real-world prospective, non-interventional study evaluated 12-month effectiveness and tolerability of adjunctive brivaracetam (BRV) pediatric and adult patients with focal-onset seizures with no previous BRV treatment experience across mid-European countries, focusing on retention rates, responder rates, and drug-related treatment-emergent adverse events of patients in routine clinical practice..

真实世界前瞻性、非干预性研究评估了辅助使用布立西坦（BRV）在中欧国家的12个月疗效和耐受性，研究对象为既往无BRV治疗经历的儿童和成人局灶性癫痫发作患者，重点关注常规临床实践中患者的保留率、应答率以及药物相关的治疗中出现的不良事件。

17

17

TK2D

TK2D

:

：

Disease course

病程

: findings from the largest international TK2d dataset evaluating the disease course in untreated people living with TK2d, who were aged ≤ 12 years at TK2d symptom onset.

来自最大的国际TK2d数据集的发现，评估了在TK2d症状发作时年龄≤12岁的未经治疗的TK2d患者的病程。

18,19

18，19

Survival analysis and functional outcomes

生存分析与功能结局

: data demonstrates improvement in survival and functional outcomes with respect to regain of lost developmental motor milestones and decrease need of ventilatory support associated with treatment with doxecitine and doxribtimine* - an investigational pyrimidine nucleos(t)ide therapy - in patients with an age of TK2d symptom onset ≤12 years..

数据显示，对于TK2d症状发作年龄≤12岁的患者，使用多西西汀和多西替米星（一种在研的嘧啶核苷疗法）治疗后，在恢复失去的发育性运动里程碑和减少对呼吸支持的需求方面，生存率和功能结果均有改善。

20,21

20，21

Genomics

基因组学

: The Genomics England National Genomic Research Library (NGRL) and UK Biobank were used to investigate the genetic, phenotypic and clinical landscape of TK2d.

：基因组学英格兰国家基因组研究图书馆（NGRL）和英国生物银行被用于调查TK2d的遗传、表型和临床情况。

22

22

Quality of life:

生活质量：

An analysis of a TK2d patient perspectives study captured patients’ experiences of TK2d and highlights the debilitating physical impacts and severe psychological strain associated with living with TK2d.

一项针对TK2d患者视角的研究分析了患者对TK2d的体验，强调了与TK2d生活相关的严重身体影响和心理压力。

23

23

Symposium

研讨会

EPNS will feature one UCB-supported symposium:

EPNS 将举办一场由 UCB 支持的研讨会：

Title

标题

: The Clinician and Family Unified Efforts: Joint Approach on Optimising Outcomes in Lennox-Gastaut Syndrome

临床医生与家庭的共同努力：优化Lennox-Gastaut综合征结果的联合方法

Date

日期

: Wednesday, 9th July 2025, 13:00–14:00 (CEST)

日期：2025年7月9日星期三，13:00–14:00（欧洲中部夏令时间）

Overview

概览

: The upcoming symposium will spotlight the latest advances and ongoing challenges in managing LGS, with experts sharing practical insights on improving diagnosis, optimizing treatment strategies, and enhancing daily living for patients and their families.

即将到来的研讨会将重点关注管理LGS的最新进展和持续挑战，专家们将分享关于改善诊断、优化治疗策略以及提高患者及其家人日常生活质量的实用见解。

UCB presentations during the European Pediatric Neurology Society (EPNS) Congress Annual Meeting

欧洲儿科神经病学学会 (EPNS) 年会期间的UCB演讲

*Doxecitine and doxribtimine is currently under regulatory review by US and EU regulatory authorities. The safety and efficacy have not been established, and doxecitine and doxribtimine has not been approved by the US Food and Drug Administration (FDA) nor the European Medicines Agency (EMA) and by any regulatory authority worldwide..

多西西丁和多西布汀目前正由美国和欧盟的监管机构进行审查。其安全性和有效性尚未确定，且多西西丁和多西布汀尚未获得美国食品药品监督管理局（FDA）、欧洲药品管理局（EMA）或全球任何监管机构的批准。

For further information, contact UCB:

如需更多信息，请联系UCB：

Global Communications

全球通讯

Anna Clark

安娜·克拉克

T: +44 07386 686779

电话：+44 07386 686779

Anna.Clark@ucb.com

安娜.克拉克@ucb.com

Corporate Communications

企业传播

Laurent Schots

劳伦特·肖茨

T: +32.2.559.92.64

电话：+32.2.559.92.64

laurent.schots@ucb.com

laurent.schots@ucb.com

Investor Relations

投资者关系

Antje Witte

安特耶·维特

T: +32.2.559.94.14

电话：+32.2.559.94.14

antje.witte@ucb.com

antje.witte@ucb.com

About UCB

关于UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023.

优时比公司，位于比利时布鲁塞尔（www.ucb.com），是一家全球生物制药公司，专注于发现和开发创新药物及解决方案，以改变免疫系统或中枢神经系统严重疾病患者的生活。该公司在约40个国家拥有约9,000名员工，并在2023年实现了53亿欧元的收入。

UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news..

UCB在布鲁塞尔泛欧交易所上市（股票代码：UCB）。关注我们的Twitter：@UCB_news。

Forward looking statements

前瞻性声明

This press release may contain forward-looking statements including, without limitation, statements containing the words “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “continue” and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management.

本新闻稿可能包含前瞻性陈述，包括但不限于包含“相信”、“预期”、“预计”、“打算”、“计划”、“寻求”、“估计”、“可能”、“将”、“继续”等词语及类似表达的陈述。这些前瞻性陈述基于管理层当前的计划、估计和信念。

All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results.

所有声明，除历史事实声明外，均可能被视为前瞻性声明，包括收入、营业利润率、资本支出、现金、其他财务信息、预期法律、仲裁、政治、监管或临床结果或实践以及其他此类估计和结果。

By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release.

由于此类前瞻性陈述的性质，其并非未来业绩的保证，并且受已知和未知风险、不确定性及假设的影响，这些因素可能导致UCB的实际结果、财务状况、业绩或成就，或行业结果，与本新闻稿中包含的此类前瞻性陈述所表达或暗示的内容存在重大差异。

Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability .

可能导致此类差异的重要因素包括：新冠疫情的全球传播和影响、总体经济、商业和竞争环境的变化、无法获得必要的监管批准或以可接受的条件或在预期时间内获得这些批准、与研发相关的成本、UCB在研产品或开发中产品的前景变化、未来司法裁决或政府调查的影响、安全性、质量、数据完整性或生产问题；潜在或实际的数据安全和隐私泄露，或我们信息技术系统的中断、产品责任。

Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. .

鉴于这些不确定性，您不应过分依赖任何此类前瞻性声明。无法保证本新闻稿中描述的在研或已获批产品将会在任何市场提交或获批用于销售或用于任何额外的适应症或标签，或在任何特定时间提交或获批，也无法保证此类产品在未来将会或将继续取得商业成功。

UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB.

UCB仅在本新闻稿发布之日提供此信息，包括前瞻性声明，除非另有说明，否则该信息并未反映不断演变的COVID-19大流行可能带来的影响。UCB正在密切跟踪全球发展，以评估这场大流行对UCB的财务重要性。

UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. .

UCB明确表示不对更新本新闻稿中包含的任何信息承担任何责任，无论是为了确认实际结果，还是为了报告或反映与其前瞻性声明相关的任何变化，或任何此类声明所基于的事件、条件或情况的任何变化，除非根据适用的法律法规要求进行此类声明。

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction..

此外，本文件中包含的信息不构成出售或要约购买任何证券的邀请，也不得在任何此类要约、邀请或销售根据该司法管辖区的证券法规定尚未进行登记或取得资格的司法管辖区中进行证券的要约、邀请或销售。

Important Safety Information about FINTEPLA▼ (fenfluramine) in the EU

关于芬氟拉明（FINTEPLA▼）在欧盟的重要安全信息

1

1

Indications

适应症

: Treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

：作为其他抗癫痫药物的辅助治疗，用于治疗2岁及以上患者的Dravet综合征和Lennox-Gastaut综合征相关的癫痫发作。

Dosage and Administration

用法与用量

: Please refer to SmPC for full information. Should be initiated and supervised by physicians with experience in the treatment of epilepsy. Fintepla is prescribed and dispensed according to the Fintepla controlled access programme. Dravet syndrome: Patients who are

：有关完整信息，请参阅SmPC。应由有癫痫治疗经验的医生启动和监督。Fintepla根据Fintepla管控获取计划进行处方和分发。Dravet综合征：患者

not

不是

taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day). After an additional 7 days, if tolerated and further seizure reduction required, can increase dose to a maximum of 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose.

服用施替帕酮：起始剂量为每天两次0.1毫克/千克（每天0.2毫克/千克）。7天后，如果耐受良好，可将剂量增加至每天两次0.2毫克/千克（每天0.4毫克/千克）。再过7天后，如果耐受良好且需要进一步减少癫痫发作，可将剂量增加至最大剂量，即每天两次0.35毫克/千克（每天0.7毫克/千克），这是推荐的维持剂量。

Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Patients who are taking stiripentol: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, if tolerated, can increase dose to 0.2 mg/kg twice daily (0.4 mg/kg/day), which is the recommended maintenance dose.

需要更快滴定的患者可以每4天增加一次剂量。每日最大剂量不得超过26毫克（每日两次，每次13毫克）。正在服用司替戊醇的患者：起始剂量为每日两次0.1毫克/千克（每日0.2毫克/千克）。7天后，如果耐受良好，可将剂量增加至每日两次0.2毫克/千克（每日0.4毫克/千克），这是推荐的维持剂量。

Patients requiring more rapid titration may increase the dose every 4 days. Do not exceed a total dose of 17 mg (8.6 mg twice daily). Lennox-Gastaut syndrome: Starting dose is 0.1 mg/kg twice daily (0.2 mg/kg/day). After 7 days, the dose should be increased to 0.2 mg/kg twice daily (0.4 mg/kg/day), if tolerated.

需要更快速滴定的患者可以每4天增加一次剂量。总剂量不应超过17毫克（每日两次，每次8.6毫克）。Lennox-Gastaut综合征：起始剂量为每日两次0.1毫克/千克（每日0.2毫克/千克）。如果耐受良好，7天后剂量应增加至每日两次0.2毫克/千克（每日0.4毫克/千克）。

After an additional 7 days, if tolerated, dose should be increased to 0.35 mg/kg twice daily (0.7 mg/kg/day), which is the recommended maintenance dose. Do not exceed maximum daily dose of 26 mg (13 mg twice daily). Discontinuation: When discontinuing treatment, decrease the dose gradually. As with all anti-epileptic medicines, avoid abrupt discontinuation when possible to minimize the risk of increased seizure frequency and status epilepticus.

在额外的7天后，如果耐受良好，剂量应增加至每日两次0.35 mg/kg（每日总量0.7 mg/kg），这是推荐的维持剂量。每日最大剂量不应超过26 mg（每次13 mg，每日两次）。停药：停药时应逐渐减少剂量。与所有抗癫痫药物一样，尽可能避免突然停药，以减少癫痫发作频率增加和癫痫持续状态的风险。

A final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. Renal impairment: Generally, no dose adjustment is recommended when administered to patients with mild to severe renal impairment, however, a slower titration may be considered. If adverse reactions are rep.

应在使用芬氟拉明治疗的最后一剂后3-6个月进行最终的超声心动图检查。肾功能损害：通常，对于轻度至重度肾功能损害的患者，无需调整剂量，但可以考虑较慢的滴定速度。如果出现不良反应，请及时报告。

Contraindications

禁忌症

: Hypersensitivity to active substance or any excipients. Aortic or mitral valvular heart disease and pulmonary arterial hypertension. Within 14 days of the administration of monoamine oxidase inhibitors due to an increased risk of serotonin syndrome.

对活性物质或任何辅料过敏者禁用。主动脉或二尖瓣心脏病和肺动脉高压患者禁用。在使用单胺氧化酶抑制剂的14天内，由于血清素综合征风险增加，应禁用。

Warnings and Precautions

警告和注意事项

: Aortic or mitral valvular heart disease and pulmonary arterial hypertension: Prior to starting treatment, patients must undergo an echocardiogram to establish a baseline and exclude any pre-existing valvular heart disease or pulmonary hypertension. Conduct echocardiogram monitoring every 6 months for the first 2 years and annually thereafter.

主动脉或二尖瓣瓣膜性心脏病及肺动脉高压：在开始治疗前，患者必须接受超声心动图检查，以建立基线并排除任何已存在的瓣膜性心脏病或肺动脉高压。在治疗的前2年每6个月进行一次超声心动图监测，此后每年一次。

If an echocardiogram indicates pathological valvular changes, consider follow-up earlier to evaluate whether the abnormality is persistent. If pathological abnormalities seen on echocardiogram, evaluate the benefit versus risk of continuing fenfluramine treatment with the prescriber, caregiver and cardiologist.

如果超声心动图显示病理性瓣膜改变，应考虑提前进行随访，以评估异常情况是否持续存在。如果超声心动图显示病理性异常，应与处方医生、护理人员和心脏病专家评估继续使用芬氟拉明治疗的益处与风险。

Once treatment is discontinued for any reasons, a final echocardiogram should be conducted 3-6 months after the last dose of treatment with fenfluramine. If echocardiogram findings suggestive of pulmonary arterial hypertension, perform a repeat echocardiogram as soon as possible and within 3 months to confirm these findings.

一旦因任何原因停止治疗，应在最后一次服用芬氟拉明后3-6个月内进行最终的超声心动图检查。如果超声心动图结果显示可能存在肺动脉高压，请尽快并在3个月内重复进行超声心动图以确认这些发现。

If echocardiogram finding is confirmed suggestive of an increased probability of pulmonary arterial hypertension defined as intermediate probability, conduct a benefit-risk evaluation of continuation of Fintepla by the prescriber, carer and cardiologist. If echocardiogram suggests a high probability, it is recommended fenfluramine treatment should be stopped.

如果超声心动图检查结果确认提示肺动脉高压的中间概率增加，则处方医生、护理人员和心脏病专家应进行芬特卡尼（Fintepla）继续使用的风险效益评估。如果超声心动图提示高概率，建议停止芬氟拉明（fenfluramine）治疗。

Decreased appetite and weight loss: Fenfluramine can cause decreased appetite and weight loss - an additive effect can occur in combination with other anti-epileptic medicines such as stiripentol. Monitor the patient’s weight. Undertake risk-benefit evaluation before starting treatment if history of anorexia nervosa or bulimia nervosa.

食欲减退和体重减轻：芬氟拉明可导致食欲减退和体重减轻——与其它抗癫痫药物（如司替戊醇）合用时可能会产生叠加效应。监测患者的体重。如果患者有神经性厌食症或神经性贪食症病史，在开始治疗前进行风险收益评估。

Fintepla controlled access programme: A controlled access programme has been created to 1) prevent off-label use .

Fintepla管控访问计划：已创建一个管控访问计划以1）防止标签外使用。

efficacy may be reduced. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Discontinue therapy in patients with acute decreases in visual acuity. Consider discontinuation if ocular pain of unknown origin. Effect of CYP1A2 or CYP2B6 inducers: Co-administration with strong CYP1A2 inducers or CYP2B6 inducers will decrease fenfluramine plasma concentrations, which may lower the efficacy of fenfluramine.

疗效可能会降低。青光眼：芬氟拉明可引起瞳孔散大，并可能诱发闭角型青光眼。如果患者视力急性下降，应停止治疗。若出现不明原因的眼痛，考虑停药。CYP1A2 或 CYP2B6 诱导剂的影响：与强效 CYP1A2 或 CYP2B6 诱导剂联合使用会降低芬氟拉明的血浆浓度，这可能会减弱芬氟拉明的疗效。

If co-administration is considered necessary, the patient should be monitored for reduced efficacy and a dose increase of fenfluramine could be considered provided that it does not exceed twice the.

如果认为共同给药是必要的，应监测患者是否出现疗效降低，并且在不超过两倍的情况下，可以考虑增加芬氟拉明的剂量。

maximum daily dose (52 mg/day). If a strong CYP1A2 or CYP2B6 inducer is discontinued during maintenance treatment with fenfluramine, consider gradual reduction of the fenfluramine dosage to the dose administered prior to initiating the inducer. Effect of CYP1A2 or CYP2D6 inhibitors: Initiation of concomitant treatment with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure and, therefore, adverse events should be monitored, and a dose reduction may be needed in some patients.

最大日剂量（52毫克/天）。如果在使用芬氟拉明维持治疗期间停用强效CYP1A2或CYP2B6诱导剂，应考虑逐步减少芬氟拉明的剂量至诱导剂开始前的剂量。CYP1A2或CYP2D6抑制剂的影响：与强效CYP1A2或CYP2D6抑制剂同时开始治疗可能导致更高的暴露量，因此应监测不良事件，并且部分患者可能需要减少剂量。

Excipients: Contains sodium ethyl para-hydroxybenzoate (E 215) and sodium methyl para-hydroxybenzoate (E 219) - may cause allergic reactions.

辅料：含乙基对羟基苯甲酸钠（E 215）和甲基对羟基苯甲酸钠（E 219）- 可能引起过敏反应。

(possibly delayed). It also contains sulfur dioxide (E 220) which may rarely cause severe hypersensitivity reactions and bronchospasm. Patients with rare glucose-galactose malabsorption should not take this medicine. The product contains less than 1 mmol sodium (23 mg) per the maximum daily dose of 12 mL; essentially ‘sodium-free’.

（可能有延迟）。它还含有二氧化硫 (E 220)，这种成分可能会极少数情况下引起严重的过敏反应和支气管痉挛。患有罕见的葡萄糖-半乳糖吸收不良的患者不应服用此药。该产品在每日最大剂量12毫升中含钠量少于1毫摩尔（23毫克），基本上属于“无钠”产品。

Contains glucose - may be harmful to teeth. Interactions: Pharmacodynamic interactions with other CNS depressants increase the risk of aggravated central nervous system depression. An.

含有葡萄糖 - 可能对牙齿有害。相互作用：与其他中枢神经系统抑制剂的药效学相互作用会增加中枢神经系统抑制加重的风险。

increase in dose may be necessary when coadministered with rifampicin or a strong CYP1A2 or CYP2B6 inducer. In in vitro studies coadministration with a strong CYP1A2 or CYP2D6 inhibitor may result in higher exposure (see section 4.4 of the SmPC). Coadministration with CYP2D6 substrates or MATE1 substrates may increase their plasma concentrations.

当与利福平或强效CYP1A2或CYP2B6诱导剂联合给药时，可能需要增加剂量。在体外研究中，与强效CYP1A2或CYP2D6抑制剂联合给药可能导致更高的暴露量（见SmPC第4.4节）。与CYP2D6底物或MATE1底物联合给药可能会增加其血浆浓度。

Co-administration with CYP2B6 or CYP3A4 substrates may decrease their plasma concentrations. Pregnancy and lactation: Limited data in pregnant women. As a precaution, avoid use of Fintepla in pregnancy. It is unknown whether fenfluramine/metabolites are excreted in human milk. Animal.

与CYP2B6或CYP3A4底物共同给药可能会降低其血浆浓度。妊娠和哺乳：孕妇中的数据有限。作为预防措施，避免在妊娠期间使用Fintepla。目前尚不清楚芬氟拉明/代谢物是否排泄到人乳中。动物。

data have shown excretion of fenfluramine/metabolites in milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fintepla taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Drive and use machines.: Fintepla has moderate influence on the ability to drive/ use machines as it may cause somnolence and fatigue.

数据显示芬氟拉明/代谢物会排泄到乳汁中。必须权衡母乳喂养对婴儿的益处和该药物治疗对妇女的益处，以决定是否停止母乳喂养或停止/避免使用Fintepla。驾驶和操作机器：Fintepla对驾驶/操作机器的能力有中度影响，因为它可能引起嗜睡和疲劳。

Advise patients not to drive or operate machinery until they have sufficient experience to gauge whether it adversely.

建议患者在他们有足够的经验来判断是否会产生不良影响之前，不要驾驶或操作机器。

affects their abilities.

影响他们的能力。

Adverse effects

不良反应

: Dravet syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, pyrexia, fatigue, blood glucose decreased, echocardiogram abnormal (Consisted of trace and mild mitral regurgitation, and trace aortic regurgitation, which are considered physiologic).

Dravet综合征：很常见（≥1/10）：上呼吸道感染、食欲减退、嗜睡、腹泻、发热、疲劳、血糖降低、超声心动图异常（包括微量和轻度二尖瓣反流及微量主动脉瓣反流，这些被认为是生理性的）。

Common (≥1/100 to <1/10): Bronchitis, abnormal behaviour, aggression, agitation, insomnia, mood swings, ataxia, hypotonia, lethargy, seizure, status epilepticus, tremor, constipation, salivary hypersecretion, weight decreased and blood prolactin increased. Lennox-Gastaut syndrome: Very common (≥1/10): Upper respiratory tract infection, decreased appetite, somnolence, diarrhoea, vomiting, fatigue.

常见（≥1/100 至 <1/10）：支气管炎、异常行为、攻击性、躁动、失眠、情绪波动、共济失调、肌张力减退、嗜睡、癫痫发作、癫痫持续状态、震颤、便秘、唾液分泌过多、体重减轻和血液催乳素升高。Lennox-Gastaut 综合征：很常见（≥1/10）：上呼吸道感染、食欲下降、嗜睡、腹泻、呕吐、疲劳。

Common (≥1/100 to <1/10): Bronchitis, influenza, pneumonia, seizure, status epilepticus, lethargy, tremor, constipation, salivary hypersecretion, blood prolactin increased, weight decreased, fall. Refer to SmPC for other adverse reactions. .

常见（≥1/100 至 <1/10）：支气管炎、流感、肺炎、癫痫发作、癫痫持续状态、嗜睡、震颤、便秘、唾液分泌过多、血液催乳素升高、体重减轻、跌倒。其他不良反应请参阅 SmPC。

▼

▼

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

该药品受到额外的监控。这将有助于快速识别新的安全信息。医疗专业人员被要求报告任何可疑的不良反应。

Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information.

请参阅欧洲产品特性总结中的其他不良反应和完整的处方信息。

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

.

。

FINTEPLA

芬特普拉

®

®

is a registered trademark of the UCB Group of Companies.

是UCB集团公司群的注册商标。

Important Safety Information about BRIVIACT® (brivaracetam) in the EU

关于BRIVIACT®（布立西坦）在欧盟的重要安全信息

2

2

Therapeutic indications

治疗适应症

: BRIVIACT is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.

BRIVIACT作为辅助治疗，用于治疗2岁及以上患有癫痫的成人、青少年和儿童的部分性发作，伴或不伴继发性全身性发作。

Posology and method of administration

用法和用量

: The physician should prescribe the most appropriate formulation and strength according to weight and dose. It is recommended to parent and care giver to administer BRIVIACT oral solution with the measuring device (10 ml or 5 ml oral dosing syringe) provided in the carton box. BRIVIACT solution for injection/infusion is an alternative route of administration for patients when oral administration is temporarily not feasible.

医生应根据体重和剂量开具最合适的剂型和强度。建议父母和护理人员使用包装盒内提供的测量装置（10毫升或5毫升口服注射器）给予BRIVIACT口服溶液。当暂时无法口服时，BRIVIACT注射/输注溶液是患者的另一种给药途径。

There is no experience with twice daily intravenous administration of.

没有每天两次静脉注射的经验。

brivaracetam for a period longer than 4 days. Adults: The recommended starting dose is 50 or 100 mg/day based on physician’s assessment of required for seizure reduction versus potential side effects. Brivaracetam can be taken with or without food. Based on individual patient response and tolerability, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.

超过4天的布立西坦用药。成人：推荐的起始剂量为每天50或100毫克，具体取决于医生对减少癫痫发作的需求与潜在副作用的评估。布立西坦可以随餐或空腹服用。根据患者的个体反应和耐受性，剂量可以在有效剂量范围50毫克/天至200毫克/天内进行调整。

Children and adolescents weighing 50 kg or more: The recommended starting dose is 50 mg/day. Brivaracetam may also be initiated at 100 mg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 100 mg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 50 mg/day to 200 mg/day.

体重在 50 公斤或以上的儿童和青少年：推荐的起始剂量为每天 50 毫克。根据医生对癫痫控制需求的评估，布立西坦也可从每天 100 毫克开始服用。推荐的维持剂量为每天 100 毫克。根据个别患者的反应，可在每天 50 至 200 毫克的有效剂量范围内调整剂量。

Children and adolescents weighing from 20 kg to less than 50 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2 mg/kg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 2 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 4 mg/kg/day.

体重在20公斤至不足50公斤的儿童和青少年：推荐的起始剂量为1毫克/公斤/天。根据医生对癫痫控制需求的评估，布立西坦也可从高达2毫克/公斤/天的剂量开始使用。推荐的维持剂量为2毫克/公斤/天。根据个体患者的反应，剂量可在1毫克/公斤/天至4毫克/公斤/天的有效剂量范围内进行调整。

Children weighing from 10 kg to less than 20 kg: The recommended starting dose is 1 mg/kg/day. Brivaracetam may also be initiated at doses up to 2.5 mg/kg/day based on physician’s assessment of need for seizure control. The recommended maintenance dose is 2.5 mg/kg/day. Based on individual patient response, the dose may be adjusted in the effective dose range of 1 mg/kg/day to 5 mg/kg/day.

体重在10公斤至不足20公斤的儿童：推荐的起始剂量为每天1毫克/公斤。根据医生对癫痫控制需求的评估，布立西坦也可以以每天2.5毫克/公斤的剂量开始使用。推荐的维持剂量为每天2.5毫克/公斤。根据个别患者的反应，剂量可以在每天1毫克/公斤至5毫克/公斤的有效剂量范围内进行调整。

For adults, adolescents and children from 2 years of age, the dose should be administered in two equally divided doses,.

对于2岁及以上的成人、青少年和儿童，剂量应分为两等分给药。

approximately 12 hours apart.

大约相隔12小时。

If patients miss one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. Brivaracetam oral solution can be diluted in water or juice shortly before swallowing; a nasogastric tube or a gastrostomy tube may also be used.

如果患者漏服一次或多次剂量，建议他们一旦记起就立即服用单次剂量，并在通常的早晨或晚上时间服用下一剂。布立西坦口服液可在吞咽前短时间用水或果汁稀释；也可以使用鼻胃管或胃造口管给药。

Brivaracetam may be initiated with either intravenous or oral administration. When converting from oral to intravenous administration or vice versa, the total daily dose and frequency of administration should be maintained. Brivaracetam may be administered as an intravenous bolus without dilution or diluted in a compatible diluent and administered as a 15-minute intravenous infusion.

布立西坦可以通过静脉或口服给药开始治疗。当从口服转换为静脉给药或反之亦然时，应保持每日总剂量和给药频率不变。布立西坦可以不经稀释直接作为静脉推注给药，或者在相容的稀释剂中稀释后作为15分钟的静脉输注给药。

This medicinal product must not be mixed with other medicinal products. Brivaracetam bolus injection or intravenous infusion has not been studied in acute conditions, e.g. status epilepticus, and is therefore not recommended for such conditions. For patients from 16 years of age, if brivaracetam has to be discontinued, it is recommended that the dose is reduced gradually by 50 mg/day on a weekly basis.

本药品不得与其他药品混合使用。布瓦西坦推注注射或静脉输注尚未在急性病症（如癫痫持续状态）中进行研究，因此不建议用于此类情况。对于16岁及以上的患者，如果必须停用布瓦西坦，建议每周将剂量逐步减少50毫克/天。

For patients below the age of 16 years, if brivaracetam has to be discontinued, it is recommended that the dose is reduced by a maximum of half the dose every week until a dose of 1 mg/kg/day (for patients with a body weight less than 50 kg) or 50 mg/day (for patients with body weight of 50 kg or more) is reached.

对于16岁以下的患者，如果必须停用布瓦西坦，建议每周最多减少一半的剂量，直到达到每日1毫克/公斤体重（体重小于50公斤的患者）或每日50毫克（体重50公斤或以上的患者）。

After 1 week of treatment at 50 mg/day, a final week of treatment at 20 mg/day is recommended. No dose adjustment is needed for elderly patients (≥65 years of age) or for those with renal impairment. Based on data in adults, no dose adjustment is necessary in paediatric patients with impaired renal function.

在以每天50毫克的剂量治疗1周后，建议再以每天20毫克的剂量进行最后一周的治疗。老年患者（≥65岁）或肾功能受损者无需调整剂量。根据成人数据，肾功能受损的儿科患者也无需调整剂量。

No clinical data are available on paediatric patients with ren.

没有关于肾病儿科患者的临床数据。

Contraindications

禁忌症

: Hypersensitivity to the active substance, other pyrrolidone derivatives or any of the excipients.

对活性物质、其他吡咯烷酮衍生物或任何辅料过敏。

Special warnings and precautions for use

特别警告和使用注意事项

: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic drugs (AEDs) in several indications, including brivaracetam. Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers) should be advised to seek medical advice should any signs of suicidal ideation or behaviour emerge.

在接受抗癫痫药物（AEDs）治疗的患者中，包括使用布立西坦，已报告出现自杀意念和行为。应监测患者是否出现自杀意念和行为的迹象，并考虑适当的治疗措施。应告知患者（及护理人员），一旦出现任何自杀意念或行为的迹象，需寻求医疗建议。

Clinical data on the use of brivaracetam in patients with pre-existing hepatic impairment are limited. Dose adjustments are recommended for patients with hepatic impairment. Brivaracetam film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take brivaracetam..

关于在已有肝功能损害患者中使用布立西坦的临床数据有限。建议对肝功能损害患者进行剂量调整。布立西坦薄膜衣片含有乳糖。患有罕见的半乳糖不耐受、完全乳糖酶缺乏或葡萄糖-半乳糖吸收不良的患者不应服用布立西坦。

Brivaracetam film-coated tablets, solution for injection/infusion and oral solution contain less than 1 mmol sodium (23mg) per tablet/vial/ml respectively, that is to say essentially ‘sodium free’. Brivaracetam oral solution contains 168 mg sorbitol (E420) in each ml. Patients with hereditary fructose intolerance (HFI) should not take this medicinal product.

布立西坦薄膜衣片、注射/输注溶液和口服溶液每片/瓶/毫升分别含有少于1毫摩尔钠（23毫克），即基本上“无钠”。布立西坦口服溶液每毫升含168毫克山梨醇（E420）。患有遗传性果糖不耐症（HFI）的患者不应使用该药物。

The oral solution contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed). Brivaracetam oral solution contains propylene glycol (E1520). .

口服液含有对羟基苯甲酸甲酯 (E218)，可能会引起过敏反应（可能是迟发性的）。布立西坦口服液含有丙二醇 (E1520)。

Interaction with other medicinal products and other forms of interaction

与其他药物的相互作用及其他形式的相互作用

: In clinical studies, although patient numbers were limited, brivaracetam had no observed benefit over placebo among patients taking concomitant levetiracetam. No additional safety or tolerability concern was observed. In an interaction study between brivaracetam 200 mg single dose and ethanol 0.6 g/L continuous infusion in healthy volunteers, there was no pharmacokinetic interaction, but the effect of alcohol on psychomotor function, attention and memory was approximately doubled with the intake of brivaracetam.

在临床研究中，尽管患者人数有限，但在同时服用左乙拉西坦的患者中，布立西坦与安慰剂相比没有观察到益处。未观察到额外的安全性或耐受性问题。在一项健康志愿者中进行的布立西坦200毫克单剂量与乙醇0.6克/升连续输注的相互作用研究中，没有发现药代动力学相互作用，但酒精对精神运动功能、注意力和记忆的影响在服用布立西坦后大约增加了一倍。

Intake of brivaracetam with alcohol is not recommended. In vitro data suggest that brivaracetam has a low interaction potential. The main disposition pathway of brivaracetam® is by CYPindependent hydrolysis; a second pathway involves hydroxylation mediated by CYP2C19. Brivaracetam plasma concentrations may increase when co-administered with CYP2C19 strong inhibitors (e.g.

不建议将布立西坦与酒精一起摄入。体外数据显示布立西坦的相互作用潜力较低。布立西坦的主要代谢途径是通过非CYP依赖性的水解；另一条途径涉及由CYP2C19介导的羟基化。当与CYP2C19强抑制剂（例如

fluconazole, fluvoxamine), but the risk of a clinically relevant CYP2C19 mediated interaction is considered to be low. Limited clinical data are available implying that coadministration of cannabidiol may increase the plasma exposure of brivaracetam, possibly through CYP2C19 inhibition, but the clinical relevance is uncertain.

氟康唑、氟伏沙明），但临床上有关CYP2C19介导的相互作用的风险被认为较低。有限的临床数据表明，同时使用大麻二酚可能会增加布瓦西坦的血浆暴露量，可能通过CYP2C19抑制作用，但其临床意义尚不确定。

In healthy subjects, co-administration with the strong enzyme inducer rifampicin (600 mg/day for 5 days), decreased brivaracetam area under the plasma concentration curve (AUC) by 45%. Prescribers should consider adjusting the dose of brivaracetam in patients starting or ending treatment with rifampicin.

在健康受试者中，与强效酶诱导剂利福平（每天600毫克，持续5天）共同给药时，布瓦西坦的血浆浓度曲线下面积（AUC）降低了45%。开处方者应考虑调整正在开始或结束利福平治疗的患者的布瓦西坦剂量。

Brivaracetam plasma concentrations are decreased when co-administered with strong enzyme-inducing AEDs (carbamazepine, phenobarbital, phenytoin) but no dose adjustment is required. Other strong enzyme inducers such as St John’s wort (Hypericum perforatum) may decrease t.

当与强酶诱导抗癫痫药物（卡马西平、苯巴比妥、苯妥英）联合使用时，布立西坦的血浆浓度会降低，但无需调整剂量。其他强酶诱导剂如圣约翰草（贯叶连翘）也可能降低其浓度。

clinically relevant CYP3A4 interactions is considered low. In vitro studies have shown that brivaracetam exhibits little or no inhibition of CYP450 isoforms except for CYP2C19 and may therefore increase plasma concentrations of medicinal products metabolised by CYP2C19 (e.g. lansoprazole, omeprazole, diazepam).

临床上相关的CYP3A4相互作用被认为较低。体外研究表明，布立西坦对CYP450亚型几乎没有或完全没有抑制作用，但CYP2C19除外，因此可能会增加经CYP2C19代谢的药物（如兰索拉唑、奥美拉唑、地西泮）的血浆浓度。

Brivaracetam did not induce CYP1A1/2 but induced CYP3A4 and CYP2B6 in vitro. No CYP3A4 induction was found in vivo. CYP2B6 induction has not been investigated in vivo and brivaracetam may decrease plasma concentrations of medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro interaction studies to determine the potential inhibitory effects on transporters concluded that there were no clinically relevant effects, except for OAT3.

Brivaracetam 未诱导 CYP1A1/2，但在体外诱导了 CYP3A4 和 CYP2B6。在体内未发现 CYP3A4 的诱导作用。CYP2B6 的诱导作用尚未在体内进行研究，brivaracetam 可能会降低由 CYP2B6 代谢的药物（如 efavirenz）的血浆浓度。用于确定对转运蛋白潜在抑制作用的体外相互作用研究表明，除了 OAT3 外，没有临床上显著的影响。

In vitro, brivaracetam inhibits OAT3 with a half maximal inhibitory concentration 42-fold higher than the Cmax at the highest clinical dose. Brivaracetam 200 mg/day may increase plasma concentrations of medicinal products transported by OAT3. Brivaracetam is a moderate reversible inhibitor of epoxide hydrolase, resulting in an increased concentration of carbamazepine epoxide, an active metabolite of carbamazepine.

在体外，布瓦西坦抑制OAT3的半数最大抑制浓度比最高临床剂量下的Cmax高出42倍。布瓦西坦200毫克/天可能会增加由OAT3转运的药物的血浆浓度。布瓦西坦是环氧水解酶的中度可逆抑制剂，导致卡马西平环氧化物（卡马西平的活性代谢物）浓度升高。

In controlled clinical studies, carbamazepine epoxide plasma concentration increased by a mean of 37%, 62% and 98% with little variability at Brivaracetam doses of 50 mg/day, 100 mg/day and 200 mg/day, respectively. No safety risks were observed. There was no additive effect of brivaracetam and valproate on the AUC of carbamazepine epoxide.

在对照临床研究中，卡马西平环氧化物的血浆浓度在每日50毫克、100毫克和200毫克的布立西坦剂量下分别平均增加了37%、62%和98%，且变异较小。未观察到安全性风险。布立西坦和丙戊酸对卡马西平环氧化物的AUC没有叠加效应。

No dose adjustment is needed when brivaracetam is co-administered with carbamazepine, phenobarbital or phenytoin. Brivaracetam had no clinically relevant effect on the plasma concentrations of clobazam, clonazepam, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, phenobarb.

当布立西坦与卡马西平、苯巴比妥或苯妥英联合使用时，无需调整剂量。布立西坦对氯巴占、氯硝西泮、拉科酰胺、拉莫三嗪、左乙拉西坦、奥卡西平、苯巴比妥的血浆浓度没有临床相关影响。

plasma concentrations. Co-administration of brivaracetam (100 mg/day) with an oral contraceptive containing ethinylestradiol (0.03 mg) and levonorgestrel (0.15 mg) did not influence the pharmacokinetics of either substance. However, when brivaracetam was coadministered at a dose of 400 mg/day (twice the recommended maximum daily dose), a reduction in estrogen and progestin AUCs of 27% and 23%, respectively, was observed without impact on suppression of ovulation.

血浆浓度。布立西坦（100毫克/天）与含乙炔雌二醇（0.03毫克）和左炔诺孕酮（0.15毫克）的口服避孕药联合使用时，不影响任何一种物质的药代动力学。然而，当布立西坦以400毫克/天的剂量（推荐最大日剂量的两倍）联合使用时，观察到雌激素和孕激素的AUC分别减少了27%和23%，但对排卵抑制没有影响。

.

。

Pregnancy

怀孕

: Data on the use of brivaracetam in pregnant women are limited. There are no data on placental transfer in humans, but brivaracetam was shown to readily cross the placenta in rats. The potential risk for humans is unknown. Animal studies did not detect any teratogenic potential of brivaracetam. In clinical studies, adjunctive brivaracetam used concomitantly with carbamazepine induced a dose-related increase in the concentration of.

：关于布里瓦拉西坦在孕妇中的使用数据有限。尚无关于其在人体中胎盘转移的数据，但已证明布里瓦拉西坦可轻易穿过大鼠的胎盘。其对人类的潜在风险尚不清楚。动物研究未发现布里瓦拉西坦有任何致畸潜力。在临床研究中，与卡马西平同时使用的辅助性布里瓦拉西坦导致浓度呈剂量相关性增加。

the active metabolite, carbamazepine-epoxide. There are insufficient data to determine the clinical significance of this effect in pregnancy. Brivaracetam should not be used during pregnancy unless clinically necessary.

活性代谢物卡马西平环氧化物。目前尚无足够的数据来确定这种影响在妊娠期的临床意义。除非临床上必要，否则不应在怀孕期间使用布立西坦。

Breast-feeding

母乳喂养

: Brivaracetam is excreted in human breast milk. The decision to discontinue either breastfeeding or brivaracetam should be made based on the benefit of the medicinal product to the mother. In case of co-administration of brivaracetam and carbamazepine, the amount of carbamazepine-epoxide excreted in breast milk could increase.

：布立西坦会排泄到人乳中。是否停止哺乳或停用布立西坦应根据该药物对母亲的益处来决定。如果同时使用布立西坦和卡马西平，可能会增加卡马西平环氧化物在母乳中的排泄量。

The clinical significance remains unknown. .

临床意义尚不清楚。

Fertility

生育能力

: No human data on the effect of brivaracetam on fertility are available. There was no effect on fertility in rats.

：关于布立西坦对生育能力影响的人类数据尚不可用。在大鼠中未发现对生育能力的影响。

Effects on ability to drive and use machines

对驾驶和使用机器能力的影响

: Brivaracetam has minor or moderate influence on the ability to drive and use machines. Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities.

布瓦西坦对驾驶和操作机器的能力有轻微或中度影响。应告知患者，在熟悉布瓦西坦对其从事此类活动的能力的影响之前，不要驾驶汽车或操作其他潜在危险的机器。

Undesirable effects

不良反应

: The most frequently reported adverse reactions with brivaracetam were somnolence (14.3%) and dizziness (11.0%); they were usually mild-to-moderate in intensity. Somnolence and fatigue were reported at a higher incidence with increasing dose. Very common adverse reactions (≥1%-<10%) were influenza, decreased appetite, depression, anxiety, insomnia, irritability, convulsion, vertigo, upper respiratory tract infections, cough, nausea, vomiting, constipation and fatigue.

最常见的不良反应为嗜睡（14.3%）和头晕（11.0%），通常为轻至中度。随着剂量增加，嗜睡和疲劳的报告频率更高。非常常见的不良反应（≥1%-<10%）包括流感、食欲减退、抑郁、焦虑、失眠、易怒、惊厥、眩晕、上呼吸道感染、咳嗽、恶心、呕吐、便秘和疲劳。

Neutropenia was reported in 6/1099 (0.5%) of brivaracetam and none (0/459) of the placebo-treated patients. Four of these subjects had decreased neutrophil counts at baseline. None of the neutropenia cases were severe, required any specific treatment or led to discontinuation of brivaracetam and none had associated infections.

在1099名服用布立西坦的患者中有6名（0.5%）报告了中性粒细胞减少症，而459名服用安慰剂的患者中则没有（0/459）。其中四名患者在基线时中性粒细胞计数已减少。这些中性粒细胞减少症病例均不严重，无需特殊治疗，也未导致布立西坦停药，且均未伴随感染。

Suicidal ideation was reported in 0.3% (3/1099) of brivaracetam and 0.7% (3/459) of placebo-treated patients. In short-term clinical studies of brivaracetam in patients with epilepsy, there were no cases of completed suicide and suicide.

在接受布瓦西坦治疗的患者中，有0.3%（3/1099）报告有自杀意念，而接受安慰剂治疗的患者中有0.7%（3/459）。在癫痫患者中进行的布瓦西坦短期临床研究中，没有发生完成自杀和自杀的案例。

attempt; however, both were reported in open-label extension studies. The safety profile of brivaracetam observed in children from 1 month of age was consistent with the safety profile observed in adults. In the open label, uncontrolled, long-term studies suicidal ideation was reported in 4.7 % of paediatric patients (assessed from 6 years onwards, more common in adolescents) compared with 2.4 % of adults and behavioural disorders were reported in 24.8 % of paediatric patients compared with 15.1 % of adults.

尝试；然而，这两者都在开放标签扩展研究中被报告。布立西坦在一个月大的儿童中的安全性与在成人中观察到的安全性一致。在开放标签、非对照的长期研究中，自杀意念在儿科患者中占4.7％（从6岁开始评估，青少年更常见），而成人中占2.4％，行为障碍在儿科患者中占24.8％，而成人中占15.1％。

The majority of events were mild or moderate in intensity, were non-serious, and did not lead to discontinuation of study drug. An additional adverse reaction reported in children was psychomotor hyperactivity (4.7 %). No specific pattern of adverse event (AE) was identified in children from 1 month to < 4 years of age when compared to older paediatric age groups.

大多数不良事件的强度为轻度或中度，不严重，且并未导致研究药物的停用。在儿童中报告的另一不良反应是精神运动过度活跃（4.7%）。在1个月至不到4岁的儿童中，与年龄较大的儿科组相比，未发现特定的不良事件（AE）模式。

No significant safety information was identified indicating the.

未发现任何重大的安全信息表明。

increasing incidence of a particular AE in this age group. As data available in children younger than 2 years of age are limited, brivaracetam is not indicated in this age range. Limited clinical data are available in neonates. Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.

在这一年龄段中，某种特定不良事件（AE）的发生率正在增加。由于2岁以下儿童的数据有限，不建议在此年龄段使用布立西坦。新生儿中的临床数据也很有限。在临床开发期间，有少量布立西坦患者（9/3022）报告了提示即时（I型）超敏反应的症状。

.

。

Overdose

过量服用

: There is limited clinical experience with brivaracetam overdose in humans. Somnolence and dizziness have been reported in a healthy

：人类对布立西坦过量的临床经验有限。有报道称在健康人中出现嗜睡和头晕。

subject taking a single dose of 1,400 mg of brivaracetam. The following adverse reactions were reported with brivaracetam overdose: nausea, vertigo, balance disorder, anxiety, fatigue, irritability, aggression, insomnia, depression, and suicidal ideation in the postmarketing experience. In general, the adverse reactions associated with brivaracetam overdose were consistent with the known adverse reactions.

受试者单次服用1400毫克布立西坦。在过量服用布立西坦的情况下，报告了以下不良反应：恶心、眩晕、平衡障碍、焦虑、疲劳、易怒、攻击性、失眠、抑郁以及自杀意念发生在上市后经验中。总体而言，与布立西坦过量相关的不良反应与其已知的不良反应一致。

There is no specific antidote for overdose with brivaracetam. Treatment of an overdose should include general supportive measures. Since <10% of brivaracetam is excreted in urine, haemodialysis is not expected to significantly enhance brivaracetam clearance..

对于布立西坦过量，目前尚无特定的解毒剂。过量治疗应包括一般的支持性措施。由于布立西坦在尿液中的排泄量不到10%，因此血液透析预计不会显著提高布立西坦的清除率。

Refer to the European Summary of Product Characteristics for other adverse reactions and full Prescribing Information.

请参阅欧洲产品特性总结中的其他不良反应和完整的处方信息。

https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf

BRIVIACT

布立伐克

®

®

is a registered trademark of the UCB Group of Companies.

是UCB集团公司注册商标。

References:

参考文献：

Fintepla

芬特普利

®

®

EU SmPC. Available at:

欧盟药品特性摘要。可于以下网址获取：

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/fintepla-epar-product-information_en.pdf

. Accessed: May 2025.

访问日期：2025年5月。

Briviact

布里瓦克特

®

®

EU SmPC.

欧盟药品特性摘要。

https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf

https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf

. Accessed: May 2025.

访问日期：2025年5月。

Berardo A, Domínguez-González C, Engelstad K, et al. Advances in Thymidine Kinase 2 Deficiency: Clinical Aspects, Translational Progress, and Emerging Therapies. J Neuromuscul Dis. 2022;9(2):225-35.

Berardo A, Domínguez-González C, Engelstad K, 等。胸苷激酶2缺乏症的进展：临床方面、转化研究进展及新兴疗法。《神经肌肉疾病杂志》。2022年；第9卷(第2期)：225-35页。

Wang J, El-Hattab AW, and Wong LJC. TK2-Related Mitochondrial DNA Maintenance Defect, Myopathic Form. 2018. In: Adam MP, Feldman J, Mirzaa GM, et al. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993–2025.

王杰、El-Hattab AW 和 Wong LJC。TK2 相关线粒体 DNA 维持缺陷，肌病形式。2018。In: Adam MP、Feldman J、Mirzaa GM 等。GeneReviews® [互联网]。西雅图（华盛顿州）：华盛顿大学，西雅图；1993–2025。

Garone C, Taylor RW, Nascimento A, et al. Retrospective natural history of thymidine kinase 2 deficiency. J Med Genet. 2018;55(8):515-21.

加罗内 C，泰勒 RW，纳西门托 A，等。胸苷激酶2缺乏的回顾性自然史。医学遗传学杂志。2018；55（8）：515-21。

Domínguez-González C, Hernández-Laín A, Rivas E, et al. Late-onset Thymidine Kinase 2 Deficiency: A Review of 18 cases. Orphanet J Rare Dis. 2019;14(1):100.

多明格斯-冈萨雷斯 C，埃尔南德斯-拉因 A，里瓦斯 E，等。迟发性胸苷激酶2缺乏症：18例病例回顾。《孤儿药杂志：罕见病》2019；14(1):100。

National Institutes of Health. TK2-related mitochondrial DNA depletion syndrome, myopathic form. Available at:

美国国立卫生研究院。TK2相关的线粒体DNA耗竭综合征，肌病形式。可用资源：

https://medlineplus.gov/genetics/condition/tk2-related-mitochondrial-dna-depletion-syndrome-myopathic-form/#genes

https://medlineplus.gov/genetics/condition/tk2-related-mitochondrial-dna-depletion-syndrome-myopathic-form/#genes

.  Accessed: May 2025.

访问时间：2025年5月。

U.S. FDA TK2d Patient Listening Session. Available at:

美国食品药品监督管理局（FDA）TK2d患者倾听会议。可用地址：

https://www.umdf.org/tk2d-patient-listening-session-january-2022

https://www.umdf.org/tk2d-患者倾听会议-2022年1月

. Accessed: May 2025.

访问日期：2025年5月。

Jakobsen AV, et al. Non-Seizure Benefits of Long-Term Fenfluramine Treatment in Pediatric Patients With Dravet Syndrome. EPNS. 2025. Abstract number: 421.

Jakobsen AV, 等。长期使用芬氟拉明治疗Dravet综合征儿科患者的非癫痫发作益处。EPNS。2025。摘要编号：421。

Jakobsen AV, et al. Prospective Evaluation of Non-Seizure Benefits of Treatment With Fenfluramine in Pediatric and Adult Patients With Dravet Syndrome. EPNS. 2025. Abstract number: 423.

雅各布森 AV 等。对芬氟拉明治疗 Dravet 综合征儿童和成人患者的非癫痫发作益处的前瞻性评估。欧洲儿科神经病学会（EPNS)。2025年。摘要编号：423。

Pringsheim M, et al. Antiseizure Medication Regimen Adjustment After Fenfluramine Initiation: Lessons Learned From European Early Access Program in Pediatric and Adult Patients With Dravet Syndrome – Encore. EPNS. 2025. Abstract number: 55.

Pringsheim M, 等。芬氟拉明启动后抗癫痫药物方案调整：从欧洲早期获取项目中在Dravet综合征儿童和成人患者身上学到的经验 – 再度呈现。EPNS。2025。摘要编号：55。

Schoonjans A, et al. Safety and Effectiveness of Fenfluramine for the Treatment of Seizures in Lennox-Gastaut Syndrome: Results From the Final Analysis of an Open-Label Extension Study. EPNS. 2025. Abstract number: 545.

Schoonjans A 等。芬氟拉明治疗Lennox-Gastaut综合征癫痫发作的安全性和有效性：一项开放标签扩展研究的最终分析结果。EPNS。2025。摘要编号：545。

Lagae L, et al. Onset and Duration of Adverse Events in Patients Treated With Fenfluramine in the Lennox-Gastaut Syndrome Clinical Trials. EPNS. 2025. Abstract number: 467.

Lagae L, 等。在Lennox-Gastaut综合征临床试验中使用芬氟拉明治疗的患者不良事件的起始与持续时间。EPNS。2025。摘要编号：467。

Lagae L, et al. Fenfluramine Efficacy Trajectories in Placebo or Treatment Groups From Randomized Controlled Trial to Open-Label Extension in Patients With Lennox-Gastaut Syndrome. EPNS. 2025. Abstract number: 525.

Lagae L, 等。芬氟拉明在伦诺克斯-加斯特综合征患者中从随机对照试验到开放标签延长期的安慰剂或治疗组中的疗效轨迹。欧洲儿科神经病学会（EPNS）。2025年。摘要编号：525。

Roper RZ, et al. Safety, Tolerability, Pharmacokinetics, and Efficacy of Fenfluramine in Combination With Cannabidiol: Results From a Phase 1 Study. EPNS. 2025. Abstract number: 524.

Roper RZ 等。芬氟拉明与大麻二酚联合使用的安全性、耐受性、药代动力学和疗效：一项1期研究的结果。EPNS。2025。摘要编号：524。

Pringsheim M, et al. Use of Fenfluramine and Cannabidiol in Daily Practice: A Retrospective Analysis of German Prescription Claims. EPNS. 2025. Abstract number: 431.

普林斯海姆 M 等。芬氟拉明和大麻二酚在日常实践中的使用：德国处方索赔的回顾性分析。欧洲儿科神经科学学会（EPNS）。2025年。摘要编号：431。

Zafeiriou D, et al. Brivaracetam Adjunctive Therapy in Paediatric and Adult Patients With Focal-Onset Seizures in Mid-European Countries: 12-Month, Real-World Outcomes from the BRIVA-REG Study. EPNS. 2025. Abstract number: 343.

Zafeiriou D, 等。布里瓦拉西坦辅助治疗中欧国家儿童及成人局灶性癫痫发作：来自BRIVA-REG研究的12个月真实世界结果。EPNS。2025。摘要编号：343。

Dominguez-Gonzalez C, et al. Functional Outcomes in Untreated Patients with Thymidine Kinase 2 Deficiency (TK2d) Aged ≤12 Years at TK2d Symptom Onset: Findings from the Largest International TK2d Dataset. EPNS. 2025. Abstract number: 365.

Dominguez-Gonzalez C 等。症状发作时年龄 ≤12 岁的未治疗胸苷激酶 2 缺乏症（TK2d）患者的机能结局：来自最大国际 TK2d 数据集的结果。EPNS。2025。摘要编号：365。

Dominguez-Gonzalez C, et al. Survival Analysis in Untreated Patients with Thymidine Kinase 2 Deficiency (TK2d) Aged ≤12 Years at TK2d Symptom Onset: Findings from the Largest International TK2d Dataset. EPNS. 2025. Abstract number: 196.

Dominguez-Gonzalez C 等。未接受治疗的胸苷激酶2缺乏症（TK2d）患者在12岁及以下出现TK2d症状时的生存分析：来自最大国际TK2d数据集的结果。EPNS。2025。摘要编号：196。

Garone C, et al. Survival Analyses in Patients With Thymidine Kinase 2 Deficiency (TK2d) Aged ≤12 Years at Symptom Onset who Received Pyrimidine Nucleos(t)ide Therapy. EPNS. 2025. Abstract number: 365.

Garone C, 等。发病年龄≤12岁的胸苷激酶2缺乏症（TK2d）患者接受嘧啶核苷（t）治疗的生存分析。EPNS。2025。摘要编号：365。

Garone C, et al. Functional Outcomes in Patients with Thymidine Kinase 2 Deficiency (TK2d) Aged ≤12 Years at Symptom Onset Who Received Pyrimidine Nucleos(t)ide Therapy. EPNS. 2025. Abstract number: 368.

Garone C, 等。症状发作年龄 ≤12 岁的胸苷激酶 2 缺乏症（TK2d）患者接受嘧啶核苷（酸）治疗的功能结局。EPNS。2025。摘要编号：368。

McFarland R, et al. Using the Genomics England National Genomic Research Library (NGRL) and UK Biobank to Investigate the Genetic, Phenotypic and Clinical Landscape of Thymidine Kinase 2 Deficiency (TK2d). EPNS. 2025. Abstract number: 322.

麦克法兰 R 等。利用英格兰基因组学国家基因组研究图书馆（NGRL）和英国生物银行研究胸苷激酶2缺乏症（TK2d）的遗传、表型和临床情况。EPNS。2025。摘要编号：322。

Waller K, et al. Patients’ Lived Experience of Thymidine Kinase 2 Deficiency (TK2d): Results From the Assessment of TK2d Patient Perspectives (ATP) Study. EPNS. 2025. Abstract number: 318.

沃勒 K 等。胸苷激酶2缺乏症（TK2d）患者的生存体验：来自TK2d患者视角评估（ATP）研究的结果。EPNS。2025。摘要编号：318。