FDA 批准了首个用于治疗亨廷顿舞蹈症的药物

美国食品与药品管理局 (FDA) 最近批准了Xenazine (丁苯那嗪) 用于治疗亨廷顿病 (Huntington’s disease) 的舞蹈症。舞蹈症是发生在患有这种疾病的人身上的不自主的抽动症状。
Xenazine 是美国 FDA 批准的可用于治疗亨廷顿病的首个药物。目前尚没有其它药物获得 FDA 批准用于治疗舞蹈症。服用 Xenazine 可能带来的严重副作用包括抑郁症和自杀倾向。因此 Xenazine 不能用于有自杀倾向的人或者没有得到治疗的抑郁症病人。
Xenazine 能够减少脑部多巴胺的量。多巴胺是一种用于神经细胞间进行信息传递的化学物质。在亨廷顿病人身上，这种信息传递过度活跃并导致身体异常运动，称为舞蹈症。Xenazine 通过减少多巴胺的量来达到减少身体不自主运动的疗效。
这种药物可以在短期内改善舞蹈症，但研究人员在临床试验中也发现，它可能会引起病人在情绪、认知、稳定性以及个体能力的恶化。因此病人在服用该药物时，医生以及病人家属需要留心病人在各个方面的表现和可能出现的副作用。

通用名称为XENAZINE
丁苯那嗪12.5mg; 25毫克+（刻痕）;标签。

法律分类：
RX

药理类为XENAZINE
单胺depletor。

对XENAZINE制造商

Lundbeck公司公司

主治为XENAZINE
亨廷顿氏舞蹈病。

成人剂量为XENAZINE
个性化。最初12.5mg每日一次，然后在AM 12.5mg每日两次一个星期后。滴定每周一班，慢慢12.5mg。应在3次/天疗程，最大25mg/dose 37.5-50mg/day剂量。应患者要求≥50mg/day CYP2D6的基因。代谢不佳（CYP2D6的）：最大25mg/dose和50mg/day广泛和中间代谢：最大37.5mg/dose和100mg/day。伴随强CYP2D6抑制剂（如帕罗西汀，氟西汀，奎尼丁）：减少半丁苯剂量;中度弱CYP2D6抑制剂：没有评估。返滴定，如果超过5天的治疗中断。

儿童剂量为XENAZINE
不推荐使用。

禁忌的XENAZINE
抑郁症。自杀意念。肝功能损害。伴随单胺氧化酶抑制剂（MAOIs）。期间或在20天内停止利血平。

为XENAZINE警告/注意事项
避免在先天性长QT综合征或心律失常的历史。心动过缓。低血钾。低镁血症。最近的MI。不稳定的心脏疾病。心血管疾病。历史上的抑郁症，自杀意念，或乳腺癌。抑郁症，情绪不稳，静坐不能监控。 （CYP2D6）代谢不佳。重新评估定期。怀孕（Cat.C）。哺乳母亲：不推荐。

为XENAZINE的相互作用
见禁忌。避免其他可导致QT间期延长的药物（如氯丙嗪，甲硫达嗪，齐拉西酮，莫西沙星，奎尼丁，普鲁卡因胺，胺碘酮，索他洛尔）。 Potentiated CYP2D6抑制剂（如帕罗西汀，氟西汀）。抗精神病药物恶性症候群的风险增加，抗精神病药锥体外系综合征，多巴胺拮抗剂。添加剂中枢神经系统抑郁症与酒精，镇静剂等中枢神经系统。

为XENAZINE不良反应
镇静，疲劳，失眠，抑郁症，吞咽困难，静坐不能，恶心，帕金森氏症，QT间期延长，体位性低血压，血清催乳素升高，很少：抗精神病药恶性综合征，迟发性运动障碍，锥体外系反应。

XENAZINE如何提供？
标签-112

相关疾病：
亨廷顿氏病

Xenazine（丁苯那嗪）药理作用及作用机制：

丁苯那嗪，是一种具有高度选择性和可逆作用消耗多巴胺的药物，通过耗竭大脑神经末梢内的多巴胺来发挥作用，主要用于控制运动功能障碍。

美批准Xenazine 用于亨廷顿舞蹈病

近日美国FDA批准了Prestwick公司的Xenazine (tetrabenazine) 用于治疗亨廷顿舞蹈病（Huntington’ chorea，一种遗传性疾病）。Xenazine成为美国批准的用于治疗该症的首种药物。该药报道的严重副作用包括抑郁与自杀想法与行为。该药不能用于有活跃自杀想法与未接受过治疗的抑郁症患者。

FDA官员表示该药的批准将给该症患者及其家庭带来希望。亨廷顿症为一种罕见的遗传性神经疾病，在美国发病率为万分之一。在美国有3万亨廷顿症患者，有20 人有发展成此症的风险，症状通常出现在30-50岁。患者在症状出现后可存活15-20年。

Xenazine降低了脑中多巴胺的含量，亨廷顿症患者脑中多巴胺引起的神经活动过度从而引起肢体不正常的运动。

XENAZINE®: 25 mg, scored tablets
(INN: tetrabenazine)
Xenazine® is indicated for the treatment of Huntington’s chorea.
GENERIC NAME: Tetrabenazine
BRAND NAME: Xenazine
How does it work?
Xenazine (Tetrabenazine) works by depleting the stores of certain chemicals called neurotransmitters within nerve cells in the brain. These neurotransmitters include dopamine, serotonin and noradrenaline and are normally involved with the passage of messages between nerve cells in the brain and the normal functioning of the brain and nervous system.
Depleting the brain of these neurotransmitters can help control movement disorders caused by diseases of the brain and nervous system, although the exact mechanism of action is not fully understood.
Xenazine (Tetrabenazine) is mainly used to control movement disorders associated with diseases of the brain and nervous system, such as Huntington's chorea, but can also be used to control movement disorders caused by antipsychotic medicines.
The older antipsychotic medicines such as chlorpromazine, haloperidol and flupentixol can cause side effects involving involuntary movement of the tongue, face, mouth and jaw, which may sometimes be accompanied by involuntary movements of the arms and legs (tardive dyskinesia). If this is disabling or socially embarrasing, and persists despite stopping or reducing the dose of the antipsychotic, the symptoms can be treated using tetrabenazine. Xenazine (Tetrabenazine) can also be used if it is not possible to stop or change the antipsychotic.
What is it used for?
Movement disorders associated with disease of the brain and spinal cord
Nerve cell breakdown resulting in irregular involuntary movements and brain disease (Huntington's chorea)
Rhythmical involuntary movement of the tongue, face, mouth and jaw, which may sometimes be accompanied by involuntary movements of the arms and legs (tardive dyskinesia)
Warning!
Do not drink alcohol whilst taking this medicine.
This medicine may cause drowsiness. If affected do not drive or operate machinery.
Not to be used in: No known conditions
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding: Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
There is no information about the safety of this medicine during pregnancy, but it has been widely used for many years without apparent ill consequence.
As there is no safety information available, the manufacturer does not recommend the use of this medicine when breastfeeding. Alternatively, if this medicine must be used, the mother should not breastfeed. Seek medical advice from your doctor.
Label warnings: This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
Side effects: Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
Low blood pressure (hypotension)
High temperature combined with falling levels of consciousness, paleness, sweating and a fast heart beat (neuroleptic malignant syndrome). Requires stopping the medicine and immediate medical treatment.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
Xenazine (Tetrabenazine) should not be taken at the same time as, or for 14 days following a course of monoamine oxidase inhibitor (MAOI) antidepressants, as this can cause restlessness, disorientation and confusion.
Xenazine (Tetrabenazine) opposes the effects of levodopa.
Xenazine (Tetrabenazine) should not be taken with alcohol as this may increase the drowsiness experienced.

注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
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原产地英文商品名:
Xenazine 25mg/tab 112tabs/bottle
原产地英文药品名:
tetrabenazine
中文参考商品译名:
Xenazine 25毫克/片 112片/瓶
中文参考药品译名:
丁苯那嗪
生产厂家中文参考译名:
Cambridge Laboratories
生产厂家英文名:
Cambridge Laboratories

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原产地英文商品名:
Generic Xenazine 25mg/tab 100tabs/bottle
原产地英文药品名:
tetrabenazine
中文参考商品译名:
Xenazine仿制药 25毫克/片 100片/瓶
中文参考药品译名:
丁苯那嗪