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精神分裂症长效针剂新药ARISTADA又获FDA批准上市

2016-08-22 09:42:08 作者：新特药房来源：互联网浏览次数：13 文字大小：【大】【中】【小】

简介： 精神分裂症新药ARISTADA(ARIPIPRAZOLE LAUROXIL)阿立哌唑长效针剂又获FDA批准上市日前，美国食品及药物管理局（FDA）批准Alkermes公司的一种阿立哌唑长效注射剂型，即月桂酰阿立哌唑（Aripiprazole lau ...

关键字：阿立哌唑长效针剂ARIPIPRAZOLE LAUROXIL 商品名ARISTADA 精神分裂症新药

精神分裂症新药ARISTADA(ARIPIPRAZOLE LAUROXIL)阿立哌唑长效针剂又获FDA批准上市
日前，美国食品及药物管理局（FDA）批准Alkermes公司的一种阿立哌唑长效注射剂型，即月桂酰阿立哌唑（Aripiprazole lauroxil，商品名Aristada）上市，用于治疗成人精神分裂症。该药每4-6周注射一次，注射部位为上臂或臀部。
FDA之所以批准该药上市，是基于一项随机双盲安慰剂对照3期研究的结果。该研究共纳入了超过600名精神分裂症患者。数据显示，经多种剂量的月桂酰阿立哌唑治疗12周后，患者的PANSS量表总分出现了具有统计学及临床意义的显著降低，达到了研究主要终点。此外，研究同时达到了预设的次要转归终点，即临床总体印象-改善量表得分的改善。
月桂酰阿立哌唑总体耐受性良好，安全性数据与阿立哌唑口服剂型相当。研究中报告率最高的不良反应为失眠、静坐不能及头痛。
与其他非典型抗精神病药一样，月桂酰阿立哌唑也带有黑框警告，提示该药超适应征治疗老年痴呆相关精神病时或升高死亡风险。“目前，尚无一种非典型抗精神病药被批准治疗痴呆相关精神病。”FDA指出。
“随着医师逐渐认识到给药频率较低的优势，并考虑在疾病的更早阶段即启用长效针剂，此类药物已成为精神分裂症治疗的优选之一。”麻省总医院精神病学副教授David Henderson博士称。
2013年2月，FDA批准大冢及灵北的阿立哌唑长效针剂（商品名Abilify Maintena）上市，该药也是获FDA批准上市的首个阿立哌唑长效针剂。当时Aristada尚处于3期临床研究中。
Aristada™ (aripiprazole lauroxil) for the Treatment of Schizophrenia, United States of America
Aristada™ (aripiprazole lauroxil), discovered and developed by Alkermes, is an antipsychotic drug indicated for the treatment of schizophrenia in adults.
Alkermes submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of Aristada for the treatment of schizophrenia in August 2014. The FDA approved Aristada in October 2015 making it the first and only atypical antipsychotic drug approved in the US for the treatment of schizophrenia.
ARISTADA Rx
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Generic Name and Formulations:
Aripiprazole lauroxil extended-release injectable suspension 441mg/1.6mL, 662mg/2.4mL, 882mg/3.2mL; for IM inj.
Company:
Alkermes

Select therapeutic use: Psychosis
Indications for ARISTADA:
Schizophrenia.

Adult:
Treatment-naive: establish tolerability with oral aripiprazole first. Give by IM inj into the deltoid (441mg dose only) or gluteal muscle (all doses). Initial and maintenance: 441mg, 662mg, or 882mg once monthly (no sooner than 14 days after the previous inj) or 882mg once every 6 weeks. In conjunction with first injection, administer oral aripiprazole for 21 consecutive days. Dose adjustments for missed dose, CYP2D6 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling.

Children:
<18yrs: not established.

Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Reevaluate periodically. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

Interactions:
Potentiate antihypertensives; monitor BP and adjust dose. Concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or strong CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine); reduce Aristada dose if concomitant use >14 days. Concomitant strong CYP3A4 inducers (eg, carbamazepine, rifampin); consider increasing Aristada dose if concomitant use >14 days. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

Pharmacological Class:
Atypical antipsychotic.

Adverse Reactions:
Akathisia, headache, anxiety, insomnia, inj site pain, restlessness, orthostatic hypotension, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others.

Note:
For women exposed to Aristada during pregnancy, contact the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

Generic Availability:
NO

How Supplied:
Kit—1 (prefilled syringe + safety needles)