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 详细处方信息以本药内容附件PDF文件（2018112900173527.pdf）的“原文Priscribing Information”为准
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部分中文布瓦西坦处方资料（仅供参考）

新一代抗癫痫药物Briviact（Brivaracetam，中文药名：布瓦西坦）被美国FDA批准上市 2016年2月19日，美国FDA批准Briviact(brivaracetam) 作为其他药物的附加药物治疗部分性发作性癫痫，患者年龄为16岁以上。

FDA 的药物评价和研究中心精神科主任Billy Dunn, M.D.说:'患者接受不同的治疗就会有不同反应。Briviact的批准，我高兴为癫痫患者有提供一种新的治疗选择。

BRIVIACT®(布瓦西坦)的安全和有效使用，请参阅完整处方资料

批准日期：2016年2月19日；公司：UCB, Inc.

BRIVIACT®(布瓦西坦)注射液，为静脉使用 美国初次批准：2016

适应证和用途

BRIVIACT是适用为作为辅助治疗在16岁和以上有癫痫患者部分发作性癫痫的治疗。(1)

剂量和给药方法

⑴ 推荐起始剂量是50mg每天2次。根据个体患者耐受性和治疗反应，剂量可能被向下调整至25 mg每天2次(50 mg每天)或至100 mg每天2次(200 mg每天)。(2.1)

⑵ 当口服给药是短暂不可行可能使用BRIVIACT注射液。

⑶ 肝受损：对肝受损的所有期，推荐起始剂量是25 mg每天2次；最大剂量是75 mg每天2次(2.5，8.7，12.3)。

剂型和规格

注射液：50 mg/5 mL单剂量小瓶(3)

禁忌证

对布瓦西坦或在BRIVIACT中无活性成分的任何超敏性。(4)

警告和注意事项

⑴ 自杀行为和意念：对患者监视自杀行为和意念。(5.1)

⑴ 神经学不良反应：对睡意和疲乏监视，和忠告患者不要驾驶或操作机械直至他们对BRIVIACT已得到充分经验。(5.2)

⑵ 精神学不良反应：行为反应包括精神症状，易怒，抑郁，攻击性行为，和焦虑；对患者监视症状。(5.3)

⑶ 超敏性：支气管痉挛和血管水肿：告知患者寻求立即医学护理。如发生超敏性终止和不要再开始BRIVIACT。(5.4)

⑷ 抗癫痫药撤药：BRIVIACT应被逐步地撤去。(5.5)

不良反应

最常见不良反应(对BRIVIACT至少5%和至少比安慰剂更频2%)是睡意/镇静，眩晕，疲乏，和恶心/呕吐。(6.1)

报告怀疑不良反应，联系UCB，Inc.电话1-844-599-2273或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。

药物相互作用

⑴ 利福平[Rifampin]：因为减低的BRIVIACT浓度，建议同时用利福平患者中增加BRIVIACT 剂量。(2.6，7.1)

⑵ 卡马西平[Carbamazepine]：因为对卡马西平代谢物增加的暴露，如出现耐受性问题，同时用BRIVIACT患者中考虑减低卡马西平剂量。(7.2)

⑶ 苯妥英[Phenytoin]：因为苯妥英浓度可能增加，同时用BRIVIACT患者中应监视苯妥英水平。(7.3)

⑷ 左乙拉西坦[Levetiracetam]：当与左乙拉西坦共同给药BRIVIACT不增加治疗获益。(7.4) 在特殊人群中使用

妊娠：根据动物数据，可能致胎儿危害。(8.1)

A new generation of anti-epileptic drug Briviact (Brivaracetam, Chinese drug name: bovistam) was approved by the US FDA On February 19, 2016, the US FDA approved Briviact (brivaracetam) as an additional drug for the treatment of partial episodic seizures with other patients over the age of 16.

Billy Dunn, M.D., director of psychiatry at the FDA's Center for Drug Evaluation and Research, said: 'Patients will respond differently to different treatments. With the approval of Briviact, I am pleased to offer a new treatment option for patients with epilepsy.

For safe and effective use of BRIVIACT®, please refer to the complete prescription information

Approval date: February 19, 2016; Company: UCB, Inc.

BRIVIACT® (Bevastatin) injection for intravenous use Initial US approval: 2016

Indications and Uses

BRIVIACT is indicated as a treatment for partial epileptic seizures in patients with epilepsy at age 16 and older. (1)

Dose and method of administration

(1) The recommended starting dose is 50 mg twice daily. Depending on individual patient tolerance and treatment response, the dose may be adjusted down to 25 mg twice daily (50 mg daily) or to 100 mg twice daily (200 mg daily). (2.1)

(2) BRIVIACT injection may be used when oral administration is short-lived.

(3) Hepatic impairment: For all stages of liver damage, the recommended starting dose is 25 mg twice daily; the maximum dose is 75 mg twice daily (2.5, 8.7, 12.3).

Formulations and specifications

Injection: 50 mg/5 mL single dose vial (3)

Contraindications

Any hypersensitivity to bovisamine or inactive ingredients in BRIVIACT. (4)

Warnings and Precautions

(1) Suicidal behaviors and ideas: Monitor suicidal behaviors and thoughts on patients. (5.1)

(1) Neurological side effects: Monitor sleepiness and fatigue, and advise patients not to drive or operate the machine until they have sufficient experience with BRIVIACT. (5.2)

(2) Psychosociatic adverse reactions: Behavioral responses include psychiatric symptoms, irritability, depression, aggressive behavior, and anxiety; monitoring symptoms for patients. (5.3)

(3) Hypersensitivity: bronchospasm and angioedema: Inform patients to seek immediate medical attention. If hypersensitivity is terminated and do not start BRIVIACT again. (5.4)

(4) Antiepileptic drug withdrawal: BRIVIACT should be removed step by step. (5.5)

Adverse reactions

The most common adverse reactions (at least 5% for BRIVIACT and at least 2% for placebo) are drowsiness/sedation, dizziness, fatigue, and nausea/vomiting. (6.1)

Report suspected adverse reactions, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug interaction

(1) Rifampin: Because of the reduced BRIVIACT concentration, it is recommended to increase the BRIVIACT dose in patients with rifampicin. (2.6, 7.1)

(2) Carbamazepine: Due to increased exposure to carbamazepine metabolites, if there is a problem with tolerance, consider reducing the dose of carbamazepine in patients with BRIVIACT. (7.2)

(3) Phenytoin: Because phenytoin may increase in concentration, phenytoin levels should be monitored in patients with BRIVIACT. (7.3)

(4) Levetiracetam: When BRIVIACT is administered with levetiracetam, it does not increase the benefit of treatment. (7.4) Use

in special people

Pregnant: According to animal data, it may cause fetal harm. (8.1)

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 详细处方信息以本药内容附件PDF文件（2018112900173527.pdf）的“原文Priscribing Information”为准
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