当前位置：药品说明书与价格首页 >> 上市新药 >> Akynzeo(Netupitant and Palonosetron Capsules) 奈妥吡坦和帕洛诺司琼复合胶囊

Akynzeo(Netupitant and Palonosetron Capsules) 奈妥吡坦和帕洛诺司琼复合胶囊

2014-12-08 04:42:18 作者：新特药房来源：互联网浏览次数：659 文字大小：【大】【中】【小】

简介： AKYNZEO奈妥吡坦和帕洛诺司琼胶囊(palonosetron+Netupitant)2014年10月10日，美国FDA批准Akynzeo（奈妥吡坦和帕洛诺司琼）用于治疗实施癌症化疗患者的恶心及呕吐。Akynzeo是一种由两款药物组成的固定剂 ...

关键字：奈妥吡坦和帕洛诺司琼复合胶囊 Netupitant and Palonosetron 商品名akynzeo 预防治疗化疗恶心呕吐物质p/神经激肽1拮抗5-ht3受体拮抗剂

AKYNZEO奈妥吡坦和帕洛诺司琼胶囊(palonosetron+Netupitant)—新型复方止吐药物
2014年10月10日，美国FDA批准Akynzeo（奈妥吡坦和帕洛诺司琼）用于治疗实施癌症化疗患者的恶心及呕吐。
Akynzeo是一种由两款药物组成的固定剂量胶囊复方药物。口服帕洛诺司琼于2008年获得批准，这款药物用于预防癌症化疗开始之后急性期（24小时内）产生的恶心和呕吐。奈妥吡坦（Netupitant）是一种新药，用于预防癌症化疗开始后急性期与延迟期（从化疗后25小时到120小时）产生的恶心和呕吐。
“维持治疗产品如Akynzeo，可帮助缓解患者可能经历的作为一种癌症化疗副作用的恶心及呕吐，”FDA药物评价与研究中心药物评价III办公室主任、医学博士Beitz表示。
Akynzeo的有效性基于两项由1720名接受癌症化疗受试者参与的临床试验。受试者被随机配给Akynzeo或口服帕洛诺司琼。该两项试验旨在检测研究药物是否可预防癌症化疗开始后急性期、延迟期及化疗整体阶段的呕吐发作。
第一项试验结果显示，急性期、延迟期及化疗整体阶段分别有98.5%、90.4%和89.6%的Akynzeo治疗受试者未发生呕吐或需急救药物的恶心。相比之下，口服帕洛诺司琼治疗受试者在急性期、延迟期及化疗整体阶段分别有89.7%、80.1%和76.5%的受试者未发生呕吐或需急救药物的恶心。第二项试验显示有类似的结果。
在临床试验中，Akynzeo的常见副作用有头痛、虚弱(无力)、疲劳、消化不良（食滞）和便秘。Akynzeo由新泽西州Woodcliff Lake的Eisai公司配送和销售，这款药物是从瑞士卢加诺的Helsinn Healthcare S.A公司获许可。
批准日期： 2014年10月10日；公司： Helsinn组和Eisai Inc.
适应证和用途
AKYNZEO是netupitant和帕诺斯琼固定组合，前者是一种物质P/神经激肽1(NK1)受体拮抗剂，后者一种5-羟色胺-3(5-HT3)受体拮抗剂适用为预防伴随癌症化疗的初始和重复疗程的急性和延迟恶心和呕吐，包括，但不限于，高度致吐化疗。口服帕诺斯琼预防癌症化疗后急性相期间恶心和呕吐和netupitant预防急性和延迟相二者期间恶心和呕吐。
剂量和给药方法
化疗开始前约1小时给予一粒AKYNZEO胶囊。
AKYNZEO可有或无食物服用。
剂型和规格
胶囊：300mg netupitant/0.5mg帕诺斯琼。
禁忌证
无
警告和注意事项
⑴ 在接受帕诺斯琼对其他5-HT3受体拮抗剂有或无已知超敏性患者中曾报道超敏性反应，包括过敏反应。
⑵用单独5-HT3受体拮抗剂曾报道5-羟色胺综合征但特别是同时使用5-羟色胺激活药物。
不良反应
最常见不良反应(发生率≥3%和大于帕诺斯琼)是头痛，无力，消化不良，疲乏，便秘和红斑
药物相互作用
⑴ CYP3A4底物：CYP3A4被netupitant的抑制作用可能导致同时药物血浆浓度增高，可能持续至少4天和可能持续较长于单次剂量给予AKYNZEO；谨慎使用。
⑵ CYP3A4诱导剂(如，利福平[rifampin])：netupitant血浆浓度减低；避免使用。
特殊人群中使用
⑴ 肝受损：在有严重肝受损患者中避免使用。
⑵ 肾受损：在有严重肾受损或肾病终末期患者中避免使用。

包装规格
AKYNZEO 300MG/0.5MG CAP 1/EA NETUPITANT/PALONOSETRON EISAI INC. 62856-0796-01
AKYNZEO CAP 300MG/0.5 MG 1 NETUPITANT/PALONOSETRON HCL EISAI INC 62856-0796-01
AKYNZEO 300MG/0.5MG CAP 1/EA NETUPITANT/PALONOSETRON HELSINN THERAPEUTICS 69639-0101-01
AKYNZEO CAP 300MG/0.5MG 1 NETUPITANT/PALONOSETRON HCL HELSINN THERAPEUTICS INC 69639-0101-01
AKYNZEO CAP 235mg/0.25MG 1 NETUPITANT/PALONOSETRON HCL HELSINN THERAPEUTICS INC 69639-102-01

Chemotherapy-Induced Nausea & Vomiting
Indicated for prevention of acute and delayed nausea and vomiting (N/V) associated with cancer chemotherapy
Highly emetogenic chemotherapy
Includes cisplatin-based chemotherapy
1 capsule (300mg/0.5mg) PO ~1 hr before starting chemotherapy PLUS
Dexamethasone 12 mg PO 30 minutes prior to chemotherapy on day 1 and 8mg PO qDay on days 2-4
Chemotherapy not considered highly emetogenic
Includes anthracyclines and cyclophosphamide-based chemotherapy
1 capsule (300 mg/0.5 mg) PO ~1 hr before starting chemotherapy PLUS
Dexamethasone 12mg PO 30minutes prior to chemotherapy on day 1
Administration of dexamethasone on days 2-4 is not necessary
Dosage Modifications
Renal impairment
Mild or moderate: No dosage adjustment required
Severe or ESRD: Avoid use
Hepatic impairment
Mild or moderate (Child-Pugh 5-8): No dosage adjustment required
Severe (Child-Pugh ≥9): Avoid use
Dosing Considerations
Indication includes, but is not limited to, highly emetogenic chemotherapy
Palonosetron prevents N/V during acute phase
Netupitant prevents N/V during both acute and delayed phase
Administration
May take with or without food

New Drugs Online Report for netupitant + palonosetron
Information
Generic Name: netupitant + palonosetron
Trade Name: Akynzeo
Entry Type: New formulation
Developmental Status
UK: Pre-registration (Filed)
EU: Pre-registration (Filed)
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Oct 14: Approved in the US [7].
13/10/2014 11:22:43
Feb 14: Filed in the EU [5].
22/02/2014 19:03:39
Dec 13: Filed in the US for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly and moderately emetogenic chemotherapy [4].
13/12/2013 13:36:30
May 13: Both PIII studies have completed (NCT01339260 + NCT01376297); no results have been published - a request to delay results was accepted 16 Jan 2013 [3]
22/05/2013 09:38:48
Apr 12: Two on-going PIII studies (NCT01339260 + NCT01376297) are expected to complete H2 2012 [2]
20/04/2012 13:44:23
Trial or other data
May 13: PII study results reported at ASCO. In a study involving 1,455 patients having a first course of moderately emetogenic chemotherapy (MEC), complete response rates (no emesis or rescue medicines) over 120 hours were 74% with oral single-dose NEPA and 67% with single-dose palonosetron (P=0.001), both with dexamethasone [6].
20/03/2014 11:01:32
A multi-centered Phase III clinical study program investigating the Netupitant/Palonosetron (300mg/0.50mg) oral fixed-dose combination for the prevention of chemotherapy-induced nausea and vomiting (CINV) has commenced. The program consists of three studies which are expected to enroll 2,600 oncology patients receiving highly or moderately emetogenic chemotherapy in approximately 250 study sites in 18 countries [1].
27/09/2011 09:37:36
References
Available only to registered users
Category
BNF Category: Drugs used in nausea and vertigo (04.06)
Pharmacology: Netupitant (a neurokinin-1 receptor antagonist) + palonosetron (a serotonin-3 receptor antagonist) [2]
Epidemiology: Nausea and vomiting cause considerable distress to many patients who receive chemotherapy and to a lesser extent abdominal radiotherapy, and may lead to refusal of further treatment; prophylaxis of nausea and vomiting is therefore extremely important. Symptoms may be acute (occurring within 24 hours of treatment), delayed (first occurring more than 24 hours after treatment), or anticipatory (occurring prior to subsequent doses).
Indication: Chemotherapy-induced nausea & vomiting
Method(s) of Administration
Oral
Company Information
Name: Not Known
US Name: Eisai
NICE Information
Anticipated Commissioning route (England) -
In timetable: -