近日，美国FDA批准了用于治疗“舞蹈病症状”（与亨廷顿舞蹈症相关）的药物AUSTEDO™（deutetrabenazine；SD-809），AUSTEDO™是FDA批准的首个氘代产品，也是第二个获得FDA批准的针对亨廷顿舞蹈症（Huntington’s disease ，简称HD）的药物，该药物先前FDA已授予孤儿药资格。 AUSTEDO™是一种单胺囊泡转运体2（VMAT2）的口服小分子抑制剂，FDA的批准是基于随机、双盲、安慰剂对照的多中心第三期临床试验的研究结果，减轻HD患者“舞蹈病”的疗效明显。  批准日期：2017年4月3日；公司：Teva Pharmaceutical Industries Ltd. AUSTEDO™(deutetrabenazine)片，为口服使用 美国初次批准：2017 作用机制 不知道AUSTEDO(deutetrabenazine)发挥其抗-舞蹈症作用的精准机制，但被相信是与它的作用为一种来自神经神经终端器[nerve terminals]单胺(例如多巴胺，5羟色胺，去甲肾上腺素，和组胺)可逆性耗竭剂[depletory]相关。Deutetrabenazine的主要的循环代谢物(α-双氢tetrabenazine[HTBZ]和β-HTBZ)，是VMAT2的可逆性抑制剂，导致单胺的摄取入突触囊泡减低和单胺贮存的耗竭。. 适应证和用途 AUSTEDO是一种血管单按转运蛋白2(VMAT2)抑制剂适用为伴随亨丁顿病[Huntington’s disease]舞蹈症的治疗 剂量和给药方法 ● 开始剂量是6 mg每天1次。在每周间隔向上滴定调整by 6 mg每天至一个减低舞蹈症的耐受剂量，至一个最大每天推荐剂量48mg(24mg每天2次) ● 在两个分次剂量中给予每天总剂量12mg或以上。 ● 与食物给予 ● 吞咽整片；不要咀嚼，粉碎或破碎片 ● 如患者从四苯嗪[tetrabenazine]转换，终止四苯嗪和在后面天开始AUSTEDO。对推荐的转换片见完整处方资料 ● AUSTEDO在CYP2D6差代谢者中最大推荐剂量为36mg每天(即，18mg每天2次) 剂型和规格 片：6mg，9mg，和12mg 禁忌证 ● 有自杀倾向的，或未治疗的/不佳地治疗抑郁 ● 肝受损 ● 用MAOIs，利血平[reserpine]，或四苯嗪(XENAZINE®) 警告和注意事项 ● 抗精神病药物恶性症候群[Neuroleptic Malignant Syndrome](NMS)：如这发生终止 ● 静坐不能，激动，不安，和帕金森症：如这发生减低剂量或终止。 ● 镇静/嗜睡：可能损害患者驾驶或操作复杂机械的能力 不良反应 最常见不良反应(>8%的AUSTEDO-治疗患者和大于安慰剂)为：嗜睡，腹泻，口干，和疲乏 药物相互作用 ●强CYP2D6抑制剂的同时使用：AUSTEDO的最大推荐剂量是36mg每天(18mg每天2次) ● 酒精或其他镇静药物：可能有相加镇静和嗜睡 在特殊人群中使用 妊娠：根据动物数据，可能致胎儿危害 包装供应/贮存和处置 供应 AUSTEDO片可得到以下的规格和包装： 6mg：圆形，紫色-涂层片，在一侧黑墨水打印有“SD”上面“6”。 60片瓶：NDC 68546-170-60. 9mg：圆形，蓝色-涂层片，在一侧黑墨水打印有“SD”上面“9”. 60片瓶：NDC 68546-171-60. 12mg：圆形，米色-涂层片，在一侧黑墨水打印有“SD”上面“12”. 60片瓶：NDC 68546-172-60. 贮存 贮存在25º C(77ºF)；外出允许至15°C至30ºC(59°F至86ºF)[见USP控制室温]。避光和潮湿保护。 完整说明书附件： 1）：http://druginformation.com/RxDrugs/D/Deutetrabenazine%20Tablets.html 2）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7ea3c60a-45c7-44cc-afc2-d87fa53993c0 Austedo(Deutetrabenazine Tablets) AUSTEDO® can cause serious side effects in people with Huntington’s disease, including: depression, suicidal thoughts, or suicidal actions. Do not start taking AUSTEDO® if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is especially important when AUSTEDO® is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of suicide. Do not take AUSTEDO® if you: have Huntington’s disease and are depressed or have thoughts of suicide. have liver problems. are taking a monoamine oxidase inhibitor (MAOI) medicine. Do not take an MAOI within 14 days after you stop taking AUSTEDO®. Do not start AUSTEDO® if you stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure. are taking reserpine. Do not take medicines that contain reserpine (such as Serpalan® and Renese®-R) with AUSTEDO®. If your healthcare provider plans to switch you from taking reserpine to AUSTEDO®, you must wait at least 20 days after your last dose of reserpine before you start taking AUSTEDO®. are taking tetrabenazine (Xenazine®). If your healthcare provider plans to switch you from tetrabenazine (Xenazine®) to AUSTEDO®, take your first dose of AUSTEDO® on the day after your last dose of tetrabenazine (Xenazine®). are taking valbenazine (Ingrezza®). Other possible serious side effects include: Irregular heartbeat (QT prolongation). AUSTEDO® increases your chance of having certain changes in the electrical activity in your heart. These changes can lead to a dangerous abnormal heartbeat. Taking AUSTEDO® with certain medicines may increase this chance. If you are at risk of QT prolongation, your healthcare provider should check your heart before and after increasing your AUSTEDO® dose above 24 mg a day. Neuroleptic Malignant Syndrome. Call your healthcare provider right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: high fever, stiff muscles, problems thinking, very fast or uneven heartbeat, or increased sweating. Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia. Parkinsonism in people with Huntington’s disease. Symptoms include: slight shaking, body stiffness, trouble moving, or keeping your balance. Sleepiness (sedation) is a common side effect of AUSTEDO®. While taking AUSTEDO®, do not drive a car or operate dangerous machinery until you know how AUSTEDO® affects you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking AUSTEDO® may increase any sleepiness caused by AUSTEDO®. The most common side effects of AUSTEDO® in people with Huntington’s disease include sleepiness (sedation), diarrhea, tiredness, and dry mouth. The most common side effects of AUSTEDO® in people with tardive dyskinesia include inflammation of the nose and throat (nasopharyngitis) and problems sleeping (insomnia). AUSTEDO Rx Generic Name and Formulations: Deutetrabenazine 6mg, 9mg, 12mg; tabs. Company: Teva Pharmaceuticals Select therapeutic use: Miscellaneous neurodegenerative disorders Indications for AUSTEDO: Huntington's chorea. Tardive dyskinesia. Adult: Swallow whole. Take with food. Individualize. Chorea: initially 6mg once daily. Dyskinesia: initially 6mg twice daily. Both: may titrate at weekly intervals by 6mg/day increments; max 48mg/day. Total daily dose ≥12mg: give in 2 divided doses. Switching from tetrabenazine: see full labeling. Concomitant strong CYP2D6 inhibitors or poor CYP2D6 metabolizers: max 36mg/day (max 18mg/dose). Children: Not established. Contraindications: Suicidal, untreated or inadequately treated depression in patients with Huntington's disease. Hepatic impairment. During or within 14 days of discontinuing an MAOI. During or within 20 days of discontinuing reserpine. Concomitant tetrabenazine or valbenazine. Warnings/Precautions: Increased risk of depression and suicidality in Huntington's patients; monitor for emergence or worsening of depression, suicidality, or unusual changes in behavior; consider discontinuing if not resolved. Avoid in congenital long QT syndrome or history of cardiac arrhythmias. Assess QT interval before and after dose increases of Austedo ≥24mg/day or other QT-prolonging drugs. Bradycardia. Hypokalemia. Hypomagnesemia. Monitor for neuroleptic malignant syndrome (NMS); discontinue and treat if develops. Reduce dose or discontinue if akathisia or parkinsonism develops. History of breast cancer. Consider discontinuing if symptomatic hyperprolactinemia develops. Reevaluate periodically. Poor CYP2D6 metabolizers. Pregnancy. Nursing mothers. Interactions: See Contraindications. Avoid concomitant other drugs that can cause QT prolongation (eg, chlorpromazine, haloperidol, thioridazine, ziprasidone, moxifloxacin, quinidine, procainamide, amiodarone, sotalol). Potentiated by strong CYP2D6 inhibitors (eg, quinidine, paroxetine, fluoxetine, bupropion); see Adult. Increased risk of parkinsonism, NMS, akathisia with dopamine antagonists or antipsychotics. Additive CNS effects with alcohol or other sedatives. Pharmacological Class: Vesicular monoamine transporter 2 (VMAT2) inhibitor. Adverse Reactions: Somnolence, diarrhea, dry mouth, fatigue, UTI, nasopharyngitis, insomnia; NMS, QTc prolongation, akathisia, agitation, restlessness, parkinsonism, possible ophthalmic effects. Generic Availability: NO How Supplied: Tabs—60