Latuda（盐酸鲁拉西酮 lurasidone hydrochloride）获FDA批准上市 近日，美国食品药品管理局(FDA)核准Latuda（盐酸鲁拉西酮）的两个新适应证，一是作为单药治疗、二是作为锂盐或丙戊酸的辅助治疗，用于成人患者中双相I型障碍（双相抑郁）相关的重性抑郁发作。 批准日期：2013年7月2日，公司：Sunovion制药 LATUDA（盐酸鲁拉西酮 lurasidone hydrochloride）片，用于口服使用 美国初步批准：2010年 警告： 在老年患者中与精神病相关的心肌病增加的死亡率;以及自杀的行为和行为请参阅完整的处方信息以了解完整的警告。 使用抗精神病药物治疗的老年痴呆相关精神病患者的死亡风险增加。 LATUDA不被批准用于治疗痴呆相关精神病患者。 增加儿童，青少年和年轻成年人服用抗抑郁药的自杀思维和行为的风险 监测自杀念头和行为的恶化和出现 近期主要变化 拳击警告，自杀的想法和行：  6/2013 适应症和用法，双相抑郁：  6/2013 剂量和给药，双相抑郁：  6/2013 剂型和强度：  7/2013 警告和注意事项：  6/2013 作用机制 LATUDA在治疗精神分裂症和双相抑郁症中的作用机制是未知的。 然而，其在精神分裂症和双相抑郁症中的功效可以通过中枢多巴胺2型（D2）和血清素2型（5HT2A）受体拮抗作用的组合来介导。 适应症和用法 LATUDA是一种非典型抗精神病药，用于治疗： 精神分裂症 与双相I型障碍（双相抑郁）相关的抑郁发作，作为单一疗法和作为与锂或丙戊酸盐的辅助治疗。 剂量和给药 LATUDA应与食物一起服用（至少350卡路里）。给予食物基本上增加了LATUDA的吸收。 指示开始剂量推荐剂量 精神分裂症40mg/天40mg至160mg/天 双相抑郁20mg每天20mg至120mg每天 中度和严重肾损伤：推荐的起始剂量为每天20mg，最大推荐剂量为每天80mg。 中度和严重肝损害：推荐的起始剂量为每天20mg。最大推荐剂量在中度肝损伤中为每天80mg，在严重肝损伤中为每天40mg。 中度CYP3A4抑制剂（例如地尔硫卓）的伴随使用：LATUDA剂量应减少至原始剂量水平的一半。推荐的起始剂量为每天20mg。最大推荐剂量为每天80mg 伴随使用中度CYP3A4诱导剂： 可能需要增加LATUDA的剂量。 剂量形式和强度 片剂：20mg，40mg，60mg，80mg和120mg 禁忌症 已知对LATUDA或制剂中的任何组分的超敏反应。 伴随强CYP3A4抑制剂（例如，酮康唑）的使用。 伴随强CYP3A4诱导物（例如利福平）的使用。 警告和注意事项 老年痴呆相关精神病患者的脑血管不良反应：脑血管不良事件（例如中风，短暂性脑缺血发作）的发病率增加。 神经系统恶性综合征：立即停止治疗和密切监测。 迟发性运动障碍：如果临床适当，停止。 代谢变化：非典型抗精神病药物与可能增加心血管/脑血管风险的代谢变化有关。这些代谢变化包括高血糖症，血脂异常和体重增加。 - 高血糖和糖尿病：监测患者的高血糖症状，包括多饮，多尿，多食和虚弱。在糖尿病患者或糖尿病患者中定期监测血糖。 - 血脂异常：在用非典型抗精神病药治疗的患者中观察到不希望的改变。 - 体重增加：观察到体重增加。显示器重量。 高催乳素血症：可能发生催乳素升高。 白细胞减少，中性粒细胞减少和粒细胞缺乏症：在具有预先存在的低白细胞计数（WBC）或白细胞减少或中性粒细胞减少的历史的患者中进行全血细胞计数（CBC）。如果在没有其他致病因素的情况下出现临床上显着的WBC下降，请考虑停止LATUDA。 直立性低血压和晕厥：头晕，心动过速或心动过缓和晕厥可能发生，尤其是在治疗的早期。在已知心血管或脑血管疾病的患者中，以及在抗精神病患者中，考虑较低的起始剂量和较慢的滴定。 不良反应 常见的不良反应（发生率≥5％，至少是安慰剂的两倍）为： 精神分裂症：嗜睡，静坐不能，锥体外系症状和恶心 双相抑郁：静坐不动，锥体束外症状和嗜睡 在特定人群中使用 怀孕：怀孕期间使用LATUDA只有潜在的好处证明潜在风险。 哺乳母亲：停止服用药物或护理，考虑停药的风险给母亲。 完整使用资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=afad3051-9df2-4c54-9684-e8262a133af8 Latuda(lurasidone HCl) WARNINGS AND PRECAUTIONS Cerebrovascular Adverse Reactions, Including Stroke: In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks) including fatalities compared to placebo-treated subjects. LATUDA is not approved for the treatment of patients with dementia-related psychosis. Neuroleptic Malignant Syndrome (NMS): NMS, a potentially fatal symptom complex, has been reported with administration of antipsychotic drugs, including LATUDA. NMS can cause hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment and medical monitoring, and treatment of any concomitant serious medical problems. Tardive Dyskinesia (TD): TD is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients with antipsychotic drugs. There is no known treatment for established cases of TD, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Given these considerations, LATUDA should be prescribed in a manner that is most likely to minimize the occurrence of TD. If signs and symptoms appear in a patient on LATUDA, drug discontinuation should be considered. Metabolic Changes Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing.  In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug. Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. Hyperprolactinemia: As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels.  Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Adult patients with bipolar depression: In the short-term, placebo-controlled monotherapy study, the median change from baseline to endpoint in prolactin levels for LATUDA-treated females was 3.1 ng/mL and was 1.5 ng/mL for males.  The proportion of female patients with prolactin elevations ≥5x ULN was 0.6% for LATUDA-treated patients versus 0% for placebo-treated female patients. The proportion of male patients with prolactin elevations ≥5x ULN was 0% for LATUDA-treated patients versus 0% for placebo-treated male patients.In the short-term, placebo-controlled adjunctive therapy with lithium or valproate study, the median change from baseline to endpoint in prolactin levels for LATUDA-treated females was 3.2 ng/mL and was 2.4 ng/mL for males. The proportion of female patients with prolactin elevations ≥5x ULN was 0% for LATUDA-treated patients versus 0% for placebo-treated female patients. The proportion of male patients with prolactin elevations ≥5x ULN was 0% for LATUDA-treated patients versus 0% for placebo-treated male patients. Adult patients with schizophrenia: In the short-term, placebo-controlled studies, the median change from baseline to endpoint in prolactin levels for LATUDA-treated females was -0.2 ng/mL and was 0.5 ng/mL for males. The proportion of female patients with prolactin elevations ≥5x ULN was 5.7% for LATUDA-treated patients versus 2.0% for placebo-treated female patients. The proportion of male patients with prolactin elevations ≥5x ULN was 1.6% for LATUDA-treated patients versus 0.6% for placebo-treated male patients. Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia/neutropenia has been reported during treatment with antipsychotic agents. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Patients with a preexisting low white blood cell count (WBC) or a history of drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy, and LATUDA should be discontinued at the first sign of a decline in WBC in the absence of other causative factors. Orthostatic Hypotension and Syncope: LATUDA may cause orthostatic hypotension. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension, in patients with known cardiovascular disease or history of cerebrovascular disease and in patients who are antipsychotic-naїve. Seizures: LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold (e.g., Alzheimer’s dementia). Potential for Cognitive and Motor Impairment: Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with LATUDA does not affect them adversely. Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents.  Appropriate care is advised when prescribing LATUDA for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration. Suicide: The possibility of suicide attempt is inherent in psychotic illness and close supervision of high-risk patients should accompany drug therapy. Prescriptions for LATUDA should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose. Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer’s dementia. LATUDA and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. ADVERSE REACTIONS Commonly observed adverse reactions (≥5% incidence and at least twice the rate of placebo) for LATUDA: •Adult patients with bipolar depression: akathisia, extrapyramidal symptoms, and somnolence •Adult patients with schizophrenia: somnolence, akathisia, extrapyramidal symptoms, and nausea Indications LATUDA is indicated for: •Treatment of major depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate in adults •Treatment of schizophrenia in adults ------------------------------------------------------ 注：本品美国包装，不同规格和不同价格，采购在线咨询为准 ------------------------------------------------------ LATUDA TAB 120MG 30  LURASIDONE HCL     63402-0312-30 LATUDA TAB 20MG 30  LURASIDONE HCL     63402-0302-30 LATUDA TAB 40MG 30  LURASIDONE HCL     63402-0304-30 LATUDA TAB 40MG U/D 100  LURASIDONE HCL     63402-0304-10  LATUDA TAB 60MG 30  LURASIDONE HCL     63402-0306-30 LATUDA TAB 60MG U/D 100  LURASIDONE HCL     63402-0306-10  LATUDA TAB 80MG 30  LURASIDONE HCL     63402-0308-30 LATUDA TAB 80MG U/D 100  LURASIDONE HCL     63402-0308-10