Jazz Pharmaceuticals将在美国神经病学学会年会上展示证明 Xywav®（钙、镁、钾和钠羟酸盐）口服溶液和 Epidiolex®（大麻二酚）治疗益处的研究成果-动脉网

Jazz Pharmaceuticals to Showcase Research Demonstrating Treatment Benefits of Xywav® (calcium, magnesium, potassium, and sodium oxybates) Oral Solution and Epidiolex® (cannabidiol) at American Academy of Neurology Annual Meeting

CISION 等信源发布 2025-03-19 19:30



可切换为仅中文







Updated top-line results demonstrate improved outcomes in adults with narcolepsy or idiopathic hypersomnia treated with Xywav as observed in the Phase 4 DUET (Developing Understanding of Hypersomnia by Evaluating Low-Sodium Oxybate Treatment) study

更新的初步结果表明，接受Xywav治疗的嗜睡症或特发性嗜睡症成人患者在第4阶段DUET（通过评估低钠氧酸盐治疗来加深对嗜睡症的理解）研究中观察到的结果有所改善。

Novel analysis of real-world Epidiolex treatment patterns underscore importance of dose optimization for improved patient persistence

对现实世界中Epidiolex治疗模式的新分析强调了剂量优化对提高患者持续性的重要性

For U.S. media and investors only

仅限美国媒体和投资者

DUBLIN

都柏林

，

March 19, 2025

2025年3月19日

/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq:

/PRNewswire/ -- Jazz制药公司（纳斯达克：

JAZZ

爵士乐

) today announced that seven abstracts from across its neuroscience portfolio will be featured at the 77

）今天宣布其神经科学领域的七篇摘要将在第77届会议上展示。

Annual American Academy of Neurology Meeting (AAN) being held

美国神经病学学会年会（AAN）正在举行。

April 5-9, 2025

2025年4月5日至9日

, in

，在

San Diego

圣地亚哥

。

Data presented at the meeting includes an updated presentation of top-line results of the open-label, single-arm, Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial, evaluating the effectiveness and safety of low-sodium oxybate, Xywav

会议上展示的数据包括更新的DUET（通过评估低钠羟丁酸治疗来发展对过度嗜睡症的理解）试验的初步结果，该试验为开放标签、单臂、第四阶段试验，评估低钠羟丁酸（Xywav）的有效性和安全性。

(calcium, magnesium, potassium, and sodium oxybates) oral solution, on key sleep outcomes and daytime symptoms, including excessive daytime sleepiness (EDS), in adults with narcolepsy or idiopathic hypersomnia (IH). Notably, the results from DUET demonstrated statistically significant improvements from baseline to end of treatment in Epworth Sleepiness Scale (ESS) scores, reduced sleep stage shifts, increased deep sleep and reduced number of awakenings among adults with narcolepsy treated with .

（钙、镁、钾和钠羟酸盐）口服溶液，对关键睡眠结果和日间症状（包括白天过度嗜睡（EDS））的影响，适用于患有嗜睡症或特发性嗜睡症（IH）的成人。值得注意的是，DUET的研究结果表明，在接受治疗的嗜睡症成人患者中，从基线到治疗结束，Epworth嗜睡量表（ESS）评分有统计学上的显著改善，同时减少了睡眠阶段转换，增加了深度睡眠，并减少了觉醒次数。

Xywav

. In adults with IH,

成年人 IH，

Xywav

treatment also showed improvements in ESS and Idiopathic Hypersomnia Severity Scale scores. Further, new patient-reported data from DUET demonstrated the association of

治疗还显示出在ESS和特发性嗜睡严重程度量表评分上的改善。此外，来自DUET的新患者报告显示了关联性。

Xywav

treatment with improvements in daytime symptoms and functional impacts, including cognitive complaints, among adults with narcolepsy or IH.

白天症状和功能影响（包括认知问题）在成人嗜睡症或特发性睡眠过度患者中有改善的治疗。

Xywav

is indicated for the treatment of EDS or cataplexy in patients 7 years of age and older with narcolepsy and for adults with idiopathic hypersomnia.

适用于治疗7岁及以上嗜睡症患者的EDS或猝倒症，以及成人特发性嗜睡症。

'This year's presentations at the AAN Annual Meeting reinforce our ongoing commitment to addressing debilitating neurological disorders, with limited or no treatment options including narcolepsy, idiopathic hypersomnia and epilepsy,' said

“今年在AAN年会上的报告再次印证了我们持续致力于解决那些治疗选择有限或无治疗方案的严重神经系统疾病，包括嗜睡症、特发性嗜睡症和癫痫，”

Sarah Akerman

萨拉·阿克曼

, MD, head of neuroscience global medical and scientific affairs of Jazz Pharmaceuticals. 'We continually strive to expand our understanding, research and capabilities in neuroscience through ongoing data generation for

，医学博士，Jazz Pharmaceuticals神经科学全球医学与科学事务负责人。“我们通过持续的数据生成，不断努力扩展我们在神经科学领域的理解、研究和能力。

Xywav

and

和

Epidiolex

to ensure patients' lived experiences and needs are reflected holistically. By listening to our patients, their care teams and leading industry experts, we aim to better address the unmet needs of those living with these difficult-to-treat conditions and ultimately help redefine possibilities for their lives.'.

确保患者的生活经历和需求得到全面的反映。通过倾听我们的患者、他们的护理团队以及行业领先专家的意见，我们旨在更好地满足那些难以治疗的疾病患者未被满足的需求，并最终帮助重新定义他们生活的可能性。

Highlights at the 2025 AAN Annual Meeting include:

2025年AAN年会的亮点包括：

Two presentations showcasing updated results from the open-label, single-arm, Phase 4 DUET trial of adults with narcolepsy or IH, which evaluated the effectiveness and safety of

两场展示来自开放标签、单臂、第四阶段DUET试验的最新结果的报告，该试验针对患有嗜睡症或特发性睡眠过度（IH）的成人，评估了其有效性和安全性。

Xywav

on key sleep outcomes, daytime symptoms, and functional impacts, including cognitive complaints, work productivity, and daily activities.

对睡眠结果、白天症状和功能影响（包括认知抱怨、工作生产力和日常活动）的关键因素。

Novel analysis of real-world Epidiolex

对现实世界中的Epidiolex进行新颖分析

(cannabidiol) treatment patterns from U.S. specialty pharmacy data found the overall probability of persistence at one year was nearly 70% (69.9%) among new patients and underscores the importance of dose optimization. The analysis shows how healthcare providers optimize dosing over time, with half (52%) of patients taking dosages >15 mg/kg/day at 12 months and those taking an average of >20 mg/kg/day having the lowest likelihood of discontinuation.

从美国专业药房数据中获取的大麻二酚治疗模式发现，在新患者中，一年内持续使用的总体概率接近70%（69.9%），并强调了剂量优化的重要性。分析显示了医疗保健提供者如何随着时间的推移优化剂量，其中一半（52%）的患者在12个月时服用剂量大于15毫克/千克/天，而平均服用超过20毫克/千克/天的患者停药的可能性最低。

This real-world data demonstrates the importance of dose optimization for long-term persistence, which could lead to improved seizure control and tolerability..

现实世界的数据表明了剂量优化对于长期持续用药的重要性，这能够带来更好的癫痫控制和耐受性。

The 2025 AAN Annual Meeting abstracts are available online at

2025年AAN年会摘要可在线获取，网址为

index.mirasmart.com/AAN2025

。

A full list of Jazz Pharmaceuticals' presentations follows below:

以下是Jazz Pharmaceuticals的演讲完整列表：

Presentation Title

演示标题

Lead

铅

Author

作者

Poster Number / Session Title /

海报编号 / 会议标题 /

Date & Time (PT)

日期和时间（PT）

Xywav Data

Xywav 数据

Self-Reported Cognitive Complaints and Work

自我报告的认知抱怨与工作

Productivity in Participants With Narcolepsy

嗜睡症患者的生产力

After Low-Sodium Oxybate treatment: Results

低钠氧酸酯治疗后：结果

From the Phase 4 DUET Study

源自第4阶段DUET研究

低密度（Low Density）

Schneider

施耐德

Poster #: 002

海报编号：002

Session: P8 Sleep 2

阶段：P8 睡眠 2

Session Date/Time: Tuesday, April 8,

会议日期/时间：4月8日，星期二，

8:00 AM – 9:00 AM

上午8:00 – 上午9:00

Effectiveness and Safety of Low-Sodium

低钠的有效性和安全性

Oxybate in Participants With Narcolepsy:

羟丁酸盐在嗜睡症患者中的应用：

Top-line Results From the Phase 4 DUET

第4阶段DUET的初步结果

Study

学习

低密度（Low Density）

Schneider

施耐德

Poster #: 008

海报编号：008

Session: P10: General Neurology: New,

会议：P10：普通神经学：新，

Potential, and Innovative Treatments 2

潜力与创新治疗 2

Session Date/Time: Tuesday, April 8,

会议日期/时间：4月8日，星期二，

5:00 PM – 6:00 PM

下午5:00 – 下午6:00

Efficacy and Safety of Low-Sodium Oxybate in

低钠羟丁酸盐的有效性和安全性

Narcolepsy Patients With/Without

有/无嗜睡症的患者

Psychiatric/Neurologic Comorbidities

精神科/神经科共病

C Chepke

Poster #: 004

海报编号：004

Session: P12 General Neurology Posters 5

会议：P12 普通神经学海报 5

Session Date/Time: Wednesday, April 9, 11:45 AM – 12:45 PM

会议日期/时间：星期三，4月9日，上午11点45分 – 下午12点45分

Epidiolex Data

Epidiolex 数据

Dosing Patterns and Persistence on

给药模式和持续性

Cannabidiol (CBD) – Insights From US

大麻二酚 (CBD) – 来自美国的见解

Specialty Pharmacy Data

专业药房数据

G Pohl

G 波尔

Poster #: 005

海报编号：005

Session: P12: Epilepsy/Clinical

会议：P12：癫痫/临床

Neurophysiology (EEG): Retrospective

神经生理学（EEG）：回顾性研究

Studies, Reviews, and Meta-analyses in

研究、评论和荟萃分析在

Epilepsy

癫痫

Session Date/Time: Wednesday, April 9, 11:45 AM – 12:45 PM

会议日期/时间：星期三，4月9日，上午11点45分 – 下午12点45分

Tuberous Sclerosis Complex (TSC)–

结节性硬化症 (TSC)–

Associated Neuropsychiatric Disorder (TAND)

相关神经精神障碍 (TAND)

Outcomes Following Add-on Cannabidiol

附加大麻二酚后的结果

(CBD) Treatment: 3-Month Analysis of Open-

(CBD) 治疗：3个月开放性分析

Label Phase 3b/4 Trial EpiCom

标签 3b/4 期试验 EpiCom

A van Eeghen

范·埃格恩

Poster #: 005

海报编号：005

Session: P8: Epilepsy/Clinical

会议：P8：癫痫/临床

Neurophysiology (EEG): Anti-seizure

神经生理学（脑电图）：抗癫痫

Medications: Clinical Trials

药物：临床试验

Session Date/Time: Tuesday, April 8,

会议日期/时间：4月8日，星期二，

8:00 AM – 9:00 AM

上午8:00 – 上午9:00

Caregiver-Reported Real-World Use of

照料者报告的真实世界使用情况

Cannabidiol (CBD) and Effects on Seizures

大麻二酚（CBD）对癫痫发作的影响

and Caregiver Burden: Results From the

与照料者负担：来自

CARE-EpiC Survey

CARE-EpiC 调查

S Thomas

S 托马斯

Poster #: 003

海报编号：003

Session: P1: Epilepsy/Clinical

会议：P1：癫痫/临床

Neurophysiology (EEG): Special

神经生理学（EEG）：特殊

Populations: Women with Epilepsy,

人群：癫痫女性，

Caregivers, Adolescents, and Elderly

照料者、青少年和老年人

Session Date/Time: Saturday, April 5, 11:45 AM – 12:45 PM

会议日期/时间：4月5日，星期六，上午11点45分 – 下午12点45分

Nurse-Reported Outcomes of Cannabidiol

护士报告的大麻二酚结果

(CBD) Treatment in the Long-Term Care

长期护理中的（CBD）治疗

(LTC) Setting: Results From the BECOME-

(LTC) 设置：BECOME-的结果

LTC Survey

LTC 调查

N Wrobel

N 罗布尓

Poster #: 016

海报编号：016

Session: P2: Epilepsy/Clinical

会议：P2：癫痫/临床

Neurophysiology (EEG): Clinical Outcomes

神经生理学（EEG）：临床结果

in Epilepsy

在癫痫中

Session Date/Time: Sunday, April 6,

会议日期/时间：星期日，四月六日，

8:00 AM – 9:00 AM PT

上午8:00 - 上午9:00（太平洋时间）

About Xywav

关于Xywav

(calcium, magnesium, potassium, and sodium oxybates) oral solution

（钙、镁、钾和钠羟酸盐）口服溶液

Xywav

is the only low-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for

是美国食品药品监督管理局（FDA）批准的唯一低钠羟丁酸盐，用于治疗7岁及以上嗜睡症患者的猝倒或过度日间嗜睡（EDS）。FDA认可了其七年的孤儿药独占权。

Xywav

for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for

用于治疗7岁及以上患有嗜睡症的患者的猝倒症或EDS。FDA的孤儿产品开发办公室（OOPD）还发布了其关于临床优势发现的总结。

Xywav

for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem

用于治疗7岁及以上发作性睡病患者的猝倒症或日间过度嗜睡（EDS），相比Xyrem具有更高的心血管安全性。

(sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that

（羟丁酸钠）口服溶液。孤儿药产品开发办公室（OOPD）的决定基于FDA的调查结果，

Xywav

provides a greatly reduced chronic sodium burden compared to

与...相比，大大减少了慢性钠负荷

Xyrem

佐米瑞林

。

Xywav

has 131 mg of sodium at the maximum recommended nightly dose whereas other high sodium oxybates have 1640 mg at the equivalent dose.

在最高推荐的夜间剂量下含有131毫克钠，而其他高钠羟丁酸盐在同等剂量下含有1640毫克钠。

Xywav

is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night at the recommended dose range of 6 g to 9 g/night.

由独特的阳离子组成，钠含量减少92%，或在推荐剂量范围为每晚6克至9克的情况下，每晚减少约1000至1500毫克。

Xywav

is the only oxybate therapy that does not carry a warning in the label related to use in patients sensitive to high sodium intake.

是唯一一种在标签上没有针对高钠摄入敏感患者使用的警告的羟丁酸盐疗法。

Xywav

is also the first and only U.S. FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for

也是首个且唯一一个获得美国FDA批准的治疗成人特发性嗜睡症的药物。FDA授予其七年孤儿药独占权。

Xywav

for the treatment of idiopathic hypersomnia in adults.

用于治疗成人特发性嗜睡症。

Xywav

is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as EDS, sleep inertia (severe grogginess or confusion when waking up), long sleep duration and cognitive impairment.

是唯一经FDA批准的、针对特发性嗜睡症多种症状（如白天过度嗜睡、睡眠惯性（醒来时严重昏沉或混乱）、长睡眠时间及认知障碍）进行研究的治疗方法。

Xywav

can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.

可以作为每晚两次或一次的治疗方案，用于治疗成人特发性嗜睡症。

The exact mechanism of action of

确切的作用机制

Xywav

in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of

在治疗成人特发性嗜睡症以及发作性睡病中的猝倒和日间过度嗜睡（EDS）方面的效果尚不清楚。假设其治疗效果是基于

Xywav

are mediated through GABA

通过GABA介导

actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.

在去甲肾上腺素能和多巴胺能神经元以及丘脑皮层神经元的睡眠期间活动。

The U.S. Drug Enforcement Agency (DEA) has designated

美国缉毒局 (DEA) 已指定

Xywav

as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.

作为第三类药物。美国缉毒署（DEA）将第三类药物、物质或化学物质定义为具有中低程度的生理和心理依赖潜力的药物。

1,2

Because of the risks of central nervous system (CNS) depression and abuse and misuse,

由于中枢神经系统（CNS）抑制、滥用和误用的风险，

Xywav

is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.

仅可通过风险评估和缓解策略 (REMS) 下的受限计划获得，该计划名为 XYWAV 和 XYREM REMS。

Important Safety Information for Xywav

Xywav的重要安全信息

WARNING: CENTRAL NERVOUS SYSTEM DEPRESSION and ABUSE AND MISUSE.

警告：中枢神经系统抑制、滥用和误用。

Central Nervous System Depression

中枢神经系统抑制

XYWAV is a CNS depressant. Clinically significant respiratory depression and

XYWAV是一种中枢神经系统抑制剂。临床上显著的呼吸抑制和

obtundation may occur in patients treated with XYWAV at recommended doses. Many

在推荐剂量下使用XYWAV治疗的患者可能会出现意识模糊。许多

patients who received XYWAV during clinical trials in narcolepsy and idiopathic

在嗜睡症和特发性临床试验中接受XYWAV治疗的患者

hypersomnia were receiving CNS stimulants.

嗜睡症患者正在接受中枢神经系统兴奋剂治疗。

Abuse and Misuse

滥用和误用

The active moiety of XYWAV is oxybate or gamma-hydroxybutyrate (GHB). Abuse or

XYWAV 的活性部分是羟丁酸盐或 γ-羟基丁酸 (GHB)。滥用或

misuse of illicit GHB, either alone or in combination with other CNS depressants, is

滥用非法的GHB，无论是单独使用还是与其他中枢神经系统抑制剂结合使用，都会

associated with CNS adverse reactions, including seizure, respiratory depression,

与中枢神经系统不良反应相关，包括癫痫发作、呼吸抑制，

decreases in the level of consciousness, coma, and death.

意识水平下降、昏迷和死亡。

Because of the risks of CNS depression and abuse and misuse, XYWAV is available only

由于中枢神经系统抑制和滥用及误用的风险，XYWAV仅在以下情况下可用

through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the

通过风险评估和缓解策略 (REMS) 下的一个受限程序，称为

XYWAV and XYREM REMS.

XYWAV 和 XYREM 风险评估与缓解策略 (REMS)。

Contraindications

禁忌症

XYWAV is contraindicated

XYWAV 是禁忌的

in combination with sedative hypnotics or alcohol and

与镇静催眠药或酒精结合使用时

in patients with succinic semialdehyde dehydrogenase deficiency.

在琥珀酸半醛脱氢酶缺乏症患者中。

Warnings and Precautions

警告和注意事项

Central Nervous System Depression

中枢神经系统抑制

The concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death.

同时使用XYWAV与其他中枢神经系统（CNS）抑制剂，包括但不限于阿片类镇痛药、苯二氮卓类药物、镇静抗抑郁药或抗精神病药、镇静抗癫痫药、全身麻醉剂、肌肉松弛剂和/或非法CNS抑制剂，可能会增加呼吸抑制、低血压、深度镇静、晕厥和死亡的风险。

If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYWAV should be considered..

如果需要将这些中枢神经系统抑制剂与XYWAV联合使用，应考虑减少一种或多种中枢神经系统抑制剂（包括XYWAV）的剂量或停药。此外，如果需要短期使用阿片类药物（例如，术后或围手术期），应考虑中断XYWAV的治疗。

After first initiating treatment and until certain that XYWAV does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes.

在初次开始治疗后，并且在确保XYWAV不会对他们产生不良影响（例如，损害判断力、思维能力或运动技能）之前，应警告患者避免从事需要完全精神警觉性或运动协调性的危险活动，例如操作危险机械，包括汽车或飞机。

Also caution patients against these hazardous activities for at least 6 hours after taking XYWAV. Patients should be queried about CNS depression-related events upon initiation of XYWAV therapy and periodically thereafter..

此外，在服用XYWAV后至少6小时内，应告诫患者避免这些危险活动。在开始XYWAV治疗时及之后定期应询问患者有关中枢神经系统抑制相关事件的情况。

Abuse and Misuse

滥用和误用

XYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.

XYWAV 是一种第三类管制物质。XYWAV 的活性部分是氧代巴比酯，也称为 γ-羟基丁酸 (GHB)，是一种第一类管制物质。滥用非法的 GHB，无论是单独使用还是与其他中枢神经系统抑制剂联合使用，都与中枢神经系统的不良反应相关，包括癫痫发作、呼吸抑制、意识水平下降、昏迷和死亡。

The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely..

GHB的快速镇静作用，特别是与酒精结合使用时，其导致记忆丧失的特性已被证明对自愿和非自愿使用者（例如，性侵受害者）来说都是危险的。医生应仔细评估患者是否有药物滥用史，并密切跟踪此类患者。

XYWAV

and

和

XYREM

REMS

风险评估与缓解策略 (REMS)

Because of the risks of central nervous system depression and abuse and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS.

由于中枢神经系统抑制和滥用及误用的风险，XYWAV 只能通过名为 XYWAV 和 XYREM REMS 的受限分销计划获取。

Notable requirements of the XYWAV and XYREM REMS include the following:

XYWAV 和 XYREM REMS 的显著要求包括以下内容：

Healthcare Providers who prescribe XYWAV are specially certified

开具XYWAV处方的医疗保健提供者均经过特别认证。

XYWAV will be dispensed only by the central pharmacy that is specially certified

XYWAV 将仅由特别认证的中央药房配发。

XYWAV will be dispensed and shipped only to patients who are enrolled in the XYWAV and XYREM REMS with documentation of safe use

XYWAV 将仅配发和运送至已注册 XYWAV 和 XYREM REMS 的患者，并需提供安全使用的证明文件。

Further information is available at

更多信息可在此处获取：

www.XYWAVXYREMREMS.com

or 1-866-997-3688.

或 1-866-997-3688。

Respiratory Depression and Sleep-Disordered Breathing

呼吸抑制和睡眠呼吸障碍

XYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate and with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and pediatric patients.

XYWAV可能会削弱呼吸驱动力，尤其是在呼吸功能受损的患者中。在羟丁酸盐过量使用以及非法使用GHB的情况下，已有报告称会出现危及生命的呼吸抑制。在成人和儿童患者中，使用XYWAV可能会增加呼吸暂停并降低氧合水平。

A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy..

使用XYWAV治疗的阻塞性睡眠呼吸暂停患者可能会出现中枢性呼吸暂停次数显著增加以及临床上显著的氧饱和度下降。处方医生应注意，与睡眠相关的呼吸障碍在肥胖患者、男性、未接受激素替代疗法的绝经后女性以及发作性睡病患者中更为普遍。

Depression and Suicidality

抑郁和自杀倾向

In Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depression and depressed mood were reported in 3% and 4%, respectively, of patients treated with XYWAV. Two patients (1%) discontinued XYWAV because of depression. In most cases, no change in XYWAV treatment was required. .

在研究1中，针对成年嗜睡症患者（n=201）的随机撤药临床试验中，分别有3%和4%的使用XYWAV治疗的患者报告了抑郁和情绪低落。两名患者（1%）因抑郁而停止使用XYWAV。在大多数情况下，无需调整XYWAV的治疗。

In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment.

在研究2中，针对成人特发性嗜睡症患者（n=154）的随机撤药临床试验中，分别有1%和3%的接受XYWAV治疗的患者报告了抑郁和情绪低落。所有患者继续接受XYWAV治疗。

Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders.

在使用氧丁酸（与XYWAV相同的活性部分）的成人临床试验中，发生了两起自杀和两起自杀未遂事件。在一例儿童氧丁酸临床试验中，一名患者出现自杀意念，两名患者报告抑郁。这些事件发生在有或无既往抑郁症病史的患者身上。

The emergence of depression in patients treated with XYWAV requires careful and immediate evaluation. Monitor patients for the emergence of increased depressive symptoms and/or suicidality while taking XYWAV..

使用XYWAV治疗的患者出现抑郁需要仔细且立即的评估。在服用XYWAV期间，监测患者是否出现加重的抑郁症状和/或自杀倾向。

Other Behavioral or Psychiatric Adverse Reactions

其他行为或精神不良反应

In Study 1, confusion and anxiety occurred in 1% and 5% of patients with narcolepsy treated with XYWAV, respectively. One patient experienced visual hallucinations and confusion after ingesting approximately 9 grams of XYWAV.

在研究1中，分别有1%和5%的嗜睡症患者在使用XYWAV后出现了困惑和焦虑的症状。一名患者在摄入约9克XYWAV后经历了视觉幻觉和困惑。

In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively. One patient experienced visual hallucinations, which led to discontinuation of XYWAV.

在研究2中，特发性嗜睡症患者中有3%和16%分别出现了困惑和焦虑。一名患者出现了视觉幻觉，导致停止使用XYWAV。

Other neuropsychiatric reactions reported with oxybate (same active moiety as XYWAV) in adult or pediatric clinical trials and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should be carefully monitored..

在成人或儿科临床试验以及上市后环境中，报道的与羟丁酸（与XYWAV相同的活性部分）相关的其他神经精神反应包括幻觉、妄想、精神病、攻击性、躁动、困惑和焦虑。对于服用XYWAV的患者，应仔细监测行为或精神事件的出现或发生频率的增加。

Parasomnias

异睡症

Parasomnias can occur in patients taking XYWAV.

服用XYWAV的患者可能会出现异态睡眠。

In Study 1 and Study 2, parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated with XYWAV, respectively.

在研究1和研究2中，分别有6%和5%的接受XYWAV治疗的成年患者报告了包括梦游在内的寄生性睡眠障碍。

In a clinical trial of XYREM (same active moiety as XYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate (same active moiety as XYWAV) and in postmarketing experience with sodium oxybate..

在一项针对成年嗜睡症患者的XYREM（与XYWAV活性部分相同）的临床试验中，报告了五例梦游事件，并存在潜在或显著的受伤风险。在一项关于羟丁酸钠（与XYWAV活性部分相同）的儿科临床试验以及羟丁酸钠的上市后使用经验中，也有包括梦游在内的异态睡眠的报告。

Episodes of sleepwalking should be fully evaluated and appropriate interventions considered.

应充分评估梦游发作的情况，并考虑采取适当的干预措施。

Most Common Adverse Reactions

最常见的不良反应

The most common adverse reactions (occurring in ≥5% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor.

在成人临床试验中，XYWAV治疗的嗜睡症或特发性嗜睡患者中，最常见的不良反应（发生率≥5%）包括恶心、头痛、头晕、焦虑、失眠、食欲减退、多汗、呕吐、腹泻、口干、异态睡眠、嗜睡、疲劳和震颤。

In the pediatric clinical trial with XYREM (same active moiety as XYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (≥5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%).

在使用XYREM（与XYWAV具有相同活性部分）进行的儿科临床试验中，纳入了7至17岁患有嗜睡症的儿科患者，最常见的不良反应（≥5%）为恶心（20%）、遗尿（19%）、呕吐（18%）、头痛（17%）、体重减轻（13%）、食欲减退（9%）、头晕（8%）和梦游（6%）。

The overall adverse reaction profile of XYREM in the pediatric clinical trial was similar to that seen in the adult clinical trial program. The safety profile in pediatric patients with XYWAV is expected to be similar to that of adult patients treated with XYWAV and to that of pediatric patients treated with XYREM..

在儿童临床试验中，XYREM 的总体不良反应特征与成人临床试验中的相似。预计使用 XYWAV 的儿童患者的安全性特征将与使用 XYWAV 治疗的成年患者以及使用 XYREM 治疗的儿童患者的安全性特征相似。

Additional Adverse Reactions

其他不良反应

Adverse reactions that occurred in 2-<5% of adult patients treated with XYWAV in the Open Label Titration and Stable Dose Periods of the randomized-withdrawal study in adult patients with narcolepsy with cataplexy (Study 1) were fatigue, dry mouth, depressed mood, enuresis, irritability, paresthesia, depression, tremor, somnolence, and muscle spasms.

在成年患者中进行的随机撤药研究（伴有猝倒的嗜睡症患者的研究1）中，接受XYWAV治疗的患者在开放标签滴定期和稳定剂量期间发生的不良反应（发生率为2%-<5%）包括疲劳、口干、情绪低落、遗尿、易怒、感觉异常、抑郁、震颤、嗜睡和肌肉痉挛。

Adverse reactions occurring in 2-<5% of patients treated with XYWAV in the IH study include balance disorder, muscle spasms, fall, paresthesia, snoring, weight decreased, bruxism, confusional state, depressed mood, feeling drunk, and irritability..

在IH研究中，使用XYWAV治疗的患者中有2-<5%发生了不良反应，包括平衡障碍、肌肉痉挛、跌倒、感觉异常、打鼾、体重减轻、磨牙、意识模糊、情绪低落、醉酒感和易怒。

Adverse reactions that occurred in ≥2% of patients in clinical studies with oxybate (but not in Study 1) and which may be relevant for XYWAV, were pain, feeling drunk, pain in extremity, cataplexy, disturbance in attention, sleep paralysis, and disorientation.

在临床研究中，使用氧酸盐（但不包括研究1）的患者中发生率≥2%的不良反应，且可能与XYWAV相关，包括疼痛、醉酒感、四肢疼痛、猝倒、注意力障碍、睡眠瘫痪和迷失方向。

Discontinuation: In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%).

退出研究：在研究1中，201名患者中有9名（4%）报告了导致退出研究的不良反应（焦虑、食欲减退、情绪低落、抑郁、疲劳、头痛、易怒、恶心、四肢疼痛、睡眠障碍、嗜睡和呕吐）。导致退出的最常见不良反应是恶心（1.5%）。

In Study 2, 17 of 154 (11%) patients across all study periods (excluding placebo during the DB RWP) (up to 42 weeks) reported adverse reactions that led to withdrawal from the study (anxiety, nausea, insomnia, vomiting, fatigue, feeling abnormal, fall, decreased appetite, dizziness, paresthesia, tremor, parasomnia, confusional state, hallucination visual, and irritability).

在研究2中，154名患者（排除双盲相对剂量期的安慰剂组）中，共有17名（11%）患者在所有研究阶段（最长42周）报告了导致退出研究的不良反应（焦虑、恶心、失眠、呕吐、疲劳、感觉异常、跌倒、食欲减退、头晕、感觉异常、震颤、异睡症、意识模糊、视觉幻觉和易怒）。

The most common adverse reaction leading to discontinuation was anxiety (3.2%). In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment..

导致停药的最常见不良反应是焦虑（3.2%）。在研究1和研究2中，大多数导致停药的不良反应发生在治疗的前几周内。

In the pediatric clinical trial with XYREM (same active moiety as XYWAV), 7 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache)..

在使用XYREM（与XYWAV相同的活性部分）的儿科临床试验中，104名患者中有7名报告了导致退出研究的不良反应（触觉幻觉；自杀意念；体重减轻；睡眠呼吸暂停综合征；情绪不稳定；愤怒、焦虑、抑郁；和头痛）。

Drug Interactions

药物相互作用

XYWAV is contraindicated in combination with alcohol or sedative hypnotics. Use of other CNS depressants may potentiate the CNS-depressant effects of XYWAV.

XYWAV与酒精或镇静催眠药合用时禁用。其他中枢神经系统抑制剂的使用可能会增强XYWAV的中枢神经系统抑制作用。

Concomitant use of sodium oxybate with divalproex sodium results in an increase in systemic exposure to GHB, which was shown to cause a greater impairment on some tests of attention and working memory in a clinical study. A similar increase in exposure is expected with concomitant use of XYWAV and divalproex sodium; therefore, an initial dose reduction of XYWAV is recommended when used concomitantly with divalproex sodium.

同时使用羟丁酸钠和丙戊酸钠会导致GHB的全身暴露增加，临床研究显示这会对某些注意力和工作记忆测试造成更大的损害。预计同时使用XYWAV和丙戊酸钠时也会出现类似的暴露增加；因此，建议在与丙戊酸钠同时使用时，初始剂量应减少XYWAV。

Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of XYWAV and divalproex sodium is warranted..

如果需要同时使用XYWAV和双丙戊酸钠，建议处方医生密切监测患者反应并相应调整剂量。

Pregnancy and Lactation

怀孕和哺乳期

There are no adequate data on the developmental risk associated with the use of XYWAV or sodium oxybate in pregnant women. XYWAV should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. GHB is excreted in human milk after oral administration of sodium oxybate. There is insufficient information on the risk to a breastfed infant, and there is insufficient information on milk production in nursing mothers. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XYWAV and any potential adverse effects on the breastfed infant from XYWAV or from the underlying maternal condition..

目前尚无关于孕妇使用XYWAV或羟丁酸钠对发育风险的充分数据。仅在潜在益处大于对胎儿的潜在风险时，才应在怀孕期间使用XYWAV。口服羟丁酸钠后，GHB会分泌到母乳中。关于哺乳婴儿的风险以及哺乳母亲乳汁生成的信息不足。应综合考虑母乳喂养对发育和健康的益处、母亲对XYWAV的临床需求，以及XYWAV或母亲的基础健康状况可能对哺乳婴儿造成的任何潜在不良影响。

Pediatric Use

儿科使用

The safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial for narcolepsy or IH. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and wellcontrolled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers..

XYWAV 对于治疗 7 岁及以上患有嗜睡症的儿童患者的猝倒或白天过度嗜睡的安全性和有效性已经确立。XYWAV 尚未在嗜睡症或特发性嗜睡症的儿童临床试验中进行研究。支持 XYWAV 在 7 岁及以上患有嗜睡症的儿童患者中的使用依据包括：一项针对 7 至 17 岁儿童患者进行的充分且良好对照的羟丁酸钠研究、一项显示 XYWAV 治疗效果与羟丁酸钠相似的成人研究、来自成人和儿童患者的羟丁酸钠药代动力学数据，以及来自健康成年志愿者的 XYWAV 药代动力学数据。

Safety and effectiveness of XYWAV in pediatric patients below the age of 7 years with narcolepsy have not been established.

7岁以下患有嗜睡症的儿童患者使用XYWAV的安全性和有效性尚未确定。

Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established.

XYWAV治疗儿童特发性嗜睡症的安全性和有效性尚未确定。

Geriatric Use

老年使用

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

一般来说，老年患者用药剂量的选择应谨慎，通常从剂量范围的低端开始，这反映了肝、肾或心脏功能下降的频率较高，并发疾病或其他药物治疗的情况也较多。

Hepatic Impairment

肝功能损害

The starting dose of XYWAV should be reduced in patients with liver impairment.

肝功能不全患者的 XYWAV 起始剂量应减少。

Dosage Modification in Patients with Hepatic Impairment:

肝功能不全患者的剂量调整：

The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses.

肝功能不全患者的建议起始剂量为每晚原剂量的一半，口服给药，分为两次服用。

Dependence and Tolerance

依赖与耐受性

There have been case reports of withdrawal, ranging from mild to severe, following discontinuation of illicit use of GHB at frequent repeated doses (18 g to 250 g per day) in excess of the recommended dosage range. Signs and symptoms of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium.

已有案例报告显示，在频繁重复使用超推荐剂量范围（每天18克至250克）的GHB非法使用后，突然停药会出现从轻度到重度的戒断反应。GHB戒断的体征和症状包括失眠、不安、焦虑、精神病、嗜睡、恶心、震颤、出汗、肌肉痉挛、心动过速、头痛、头晕、反弹性疲劳和嗜睡、困惑，尤其是严重戒断的情况下，还会出现视觉幻觉、躁动和谵妄。

These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required..

这些症状通常在3到14天内消退。在严重戒断的情况下，可能需要住院治疗。

In the clinical trial experience with XYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time.

在推荐剂量下使用XYREM治疗嗜睡症/猝倒症患者的临床试验中，两名患者在试验结束时突然停药后报告出现焦虑，一名患者报告出现失眠；在两名焦虑患者中，猝倒症的频率同时明显增加。

In the XYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses, one patient reported insomnia following abrupt discontinuation of XYWAV. In the XYWAV clinical trial in adult idiopathic hypersomnia patients at recommended doses, six patients reported insomnia, two patients reported early insomnia, and one patient reported visual and auditory hallucinations following abrupt discontinuation of XYWAV.

在推荐剂量下进行的成人嗜睡症/猝倒症患者的XYWAV临床试验中，一名患者在突然停用XYWAV后报告了失眠。在推荐剂量下进行的成人特发性嗜睡症患者的XYWAV临床试验中，六名患者报告了失眠，两名患者报告了早期失眠，一名患者在突然停用XYWAV后报告了视觉和听觉幻觉。

。

Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen.

在对照临床试验中，尚未系统研究对XYWAV的耐受性。有一些病例报告显示，在远超推荐的XYWAV剂量方案的非法使用后，出现了耐受症状。

About Epidiolex

关于Epidiolex

/Epidyolex

(cannabidiol)

（大麻二酚）

Epidiolex/Epidyolex

is a prescription, plant-derived cannabis-based medicine administered as an oral solution which contains highly purified cannabidiol (CBD). Cannabidiol, the active ingredient in

是一种处方药，来源于植物的基于大麻的药物，以口服溶液形式给药，含有高纯度的大麻二酚 (CBD)。大麻二酚是

Epidiolex

, is a cannabinoid that naturally occurs in the

，是一种天然存在于其中的大麻素，

Cannabis sativa

大麻

L. plant. The precise mechanisms by which

植物。其确切的机制是通过哪些方式

Epidiolex

exerts its anticonvulsant effect in humans are unknown

在人类中发挥其抗惊厥作用的机制尚不清楚。

. Epidiolex

Epidiolex

was approved by the U.S. Food and Drug Administration (FDA) for use in the U.S., the European Commission (EC) for use in

获得了美国食品药品监督管理局（FDA）的批准，可以在美国使用，也获得了欧盟委员会（EC）的批准，可以在

Europe

欧洲

, the Medicines and Healthcare products Regulatory Agency (MHRA) for use in

，药品和健康产品监管局（MHRA）用于

Great Britain

英国

, the Therapeutic Goods Administration for use in

，治疗用品管理局用于

Australia

澳大利亚

, Swissmedic for use in

，瑞士医药局用于

Switzerland

瑞士

, the Food & Nutrition Services of the Israel Ministry of Health for use in

，以色列卫生部食品与营养服务部门用于

Israel

以色列

, and the New Zealand Medicines and Medical Devices Safety Authority for use in

，以及新西兰药品和医疗器械安全管理局用于

New Zealand

新西兰

, is an oral solution which contains highly purified cannabidiol (CBD). In the U.S.,

，是一种含有高纯度大麻二酚（CBD）的口服溶液。在美国，

Epidiolex

is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older.

适用于治疗一岁及以上患者的Lennox-Gastaut综合征（LGS）、Dravet综合征（DS）或结节性硬化症（TSC）相关的癫痫发作。

Epidiolex

has received approval in the European Union under the tradename

已在欧盟获得批准，商品名为

Epidyolex

for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and DS in patients two years and older, and for adjunctive use to treat seizures associated with TSC, in patients two years of age and older.

用于辅助治疗与LGS和DS相关的癫痫发作，适用于两岁及以上的患者；以及用于辅助治疗与TSC相关的癫痫发作，适用于两岁及以上的患者。

Epidiolex

has received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of seizures associated with LGS, DS, and TSC. Similarly,

已获得美国FDA授予的用于治疗与LGS、DS和TSC相关的癫痫发作的孤儿药资格（ODD）。同样，

Epidyolex

received ODD from the European Medicines Agency (EMA) for the same indications.

收到欧洲药品管理局 (EMA) 针对相同适应症的ODD。

Important Safety Information & Indications

重要的安全信息和适应症

CONTRAINDICATION: HYPERSENSITIVITY

禁忌症：过敏反应

EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product.

EPIDIOLEX（大麻二酚）口服溶液禁用于对大麻二酚或产品中任何成分有过敏史的患者。

WARNINGS & PRECAUTIONS

警告与注意事项

Hepatic Injury:

肝损伤：

EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Obtain transaminase and bilirubin levels prior to starting treatment, at 1, 3, and 6 months after initiation of treatment, and periodically thereafter, or as clinically indicated.

EPIDIOLEX 可能导致与剂量相关的转氨酶升高。同时使用丙戊酸和基线时转氨酶水平升高会增加这种风险。在开始治疗前、治疗开始后 1、3 和 6 个月，以及之后定期或根据临床需要获取转氨酶和胆红素水平。

Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam).

转氨酶升高在停用EPIDIOLEX、减少EPIDIOLEX剂量和/或同时使用的丙戊酸，或无需减量的情况下得到解决。对于转氨酶水平升高的患者，应考虑减少EPIDIOLEX剂量或停用EPIDIOLEX，或同时使用的影响肝脏的药物（如丙戊酸或氯巴占）。

Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury. There have been postmarketing reports of cholestatic or mixed patterns of liver injury. Elevated ammonia levels were reported in some patients with transaminase elevations; most taking concomitant valproate, clobazam, or both.

对于中度或重度肝功能不全的患者，建议调整剂量并减缓剂量滴定速度。对于有明显肝损伤证据的患者，考虑不启动EPIDIOLEX治疗。已有上市后报告称出现胆汁淤积型或混合型肝损伤。部分转氨酶升高的患者报告了血氨水平升高；其中大多数同时服用丙戊酸、氯巴占或两者兼用。

Consider discontinuation or dose adjustment of valproate or clobazam if ammonia is elevated..

如果氨水平升高，应考虑停用或调整丙戊酸或氯巴占的剂量。

Somnolence and Sedation:

嗜睡和镇静：

EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants.

EPIDIOLEX可能导致嗜睡和镇静，这些症状通常在治疗早期出现，并可能随时间减弱；使用氯巴占的患者更常出现这些症状，并可能因其他中枢神经系统抑制剂而增强。

Suicidal Behavior and Ideation:

自杀行为和意念：

Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise them to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness..

抗癫痫药物（AEDs），包括EPIDIOLEX，会增加自杀念头或行为的风险。告知患者、护理人员和家属该风险，并建议他们监测和报告任何抑郁、自杀念头或行为或情绪或行为异常变化的迹象。如果出现这些症状，考虑它们是否与AED或基础疾病有关。

Withdrawal of Antiepileptic Drugs:

撤回抗癫痫药物：

As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.

与大多数AED一样，由于癫痫发作频率和癫痫持续状态的风险增加，通常应逐渐停用EPIDIOLEX。

ADVERSE REACTIONS:

不良反应：

The most common adverse reactions in patients receiving EPIDIOLEX (≥10% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed..

接受EPIDIOLEX治疗的患者中最常见的不良反应（≥10%且高于安慰剂组）包括转氨酶升高；嗜睡；食欲减退；腹泻；发热；呕吐；疲劳、不适和乏力；皮疹；失眠、睡眠障碍和睡眠质量差；以及感染。还观察到血液学异常。

PREGNANCY:

怀孕：

EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the EPIDIOLEX Pregnancy Surveillance Program and the North American Antiepileptic Drug (NAAED) Pregnancy Registry..

只有在潜在益处大于对胎儿的潜在风险时，才应在怀孕期间使用EPIDIOLEX。鼓励在怀孕期间服用EPIDIOLEX的女性注册EPIDIOLEX妊娠监测计划和北美抗癫痫药物（NAAED）妊娠登记。

DRUG INTERACTIONS:

药物相互作用：

Strong inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates (see full Prescribing Information). Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX.

强诱导剂CYP3A4和CYP2C19可能影响EPIDIOLEX的暴露量。EPIDIOLEX可能影响CYP2C19底物（如氯巴占、地西泮、司替戊醇）、口服P-gp底物或其他底物的暴露量（详情请参阅完整的处方信息）。当依维莫司与EPIDIOLEX联合使用时，考虑减少口服依维莫司的剂量，并进行适当的治疗药物监测。

A lower starting dose of everolimus is recommended when added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary..

当依维莫司加入EPIDIOLEX治疗时，建议降低起始剂量。EPIDIOLEX与丙戊酸联合使用会增加肝酶升高的发生率。EPIDIOLEX与氯巴占联合使用时更常观察到肺炎。可能需要调整EPIDIOLEX或其他合并用药的剂量。

INDICATIONS:

适应症：

EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

EPIDIOLEX（大麻二酚）口服溶液适用于治疗与Lennox-Gastaut综合征（LGS）、Dravet综合征（DS）或结节性硬化症（TSC）相关的癫痫发作，适用于1岁及以上的患者。

Please read the EPIDIOLEX full Prescribing Information for additional important information

请阅读EPIDIOLEX完整的处方信息以获取更多重要信息。

here

这里

。

About Jazz Pharmaceuticals

关于Jazz制药公司

Jazz Pharmaceuticals plc (Nasdaq:

Jazz Pharmaceuticals plc（纳斯达克：

JAZZ

爵士乐

) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

）是一家全球生物制药公司，其宗旨是通过创新来改变患者及其家人的生活。我们致力于为患有严重疾病的人群开发可能改变生命的药物——这些疾病通常缺乏或没有任何治疗选择。我们拥有多种已上市的药品组合，包括针对睡眠障碍和癫痫的领先疗法，并且我们的癌症治疗产品组合也在不断增长。

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.

我们以患者为中心、以科学为驱动的方法，推动了我们在肿瘤学和神经科学领域强大创新治疗管道中的开创性研发进展。Jazz 总部位于爱尔兰都柏林，在多个国家设有研发实验室、制造设施和员工，致力于为全球患者服务。

Please visit .

请访问。

www.jazzpharmaceuticals.com

for more information.

更多信息，请参阅。

Contacts:

联系人：

Media:

媒体：

Kristin Bhavnani

克里斯汀·巴夫纳尼