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Akynzeo(Netupitant and Palonosetron Capsules) 奈妥吡坦和帕洛诺司琼复合胶囊
2014-12-08 23:22:03 来源: 作者: 【 】 浏览:617次 评论:0
AKYNZEO奈妥吡坦和帕洛诺司琼胶囊  (palonosetron+Netupitant) 
Drug Name(s) AKYNZEO
FDA Application No. (NDA) 205718
Active Ingredient(s) NETUPITANT; PALONOSETRON HYDROCHLORIDE
Company HELSINN HLTHCARE
Action
Date

Supplement
Number

Approval
Type
Letters,
Reviews,
Labels,
Patient Package Insert  
Note
10/10/2014  000  Approval   Letter (PDF)11 Label is not available
on this site.  

本品是两种药物的复方制剂:帕洛诺司琼(palonosetron),2008年批准的第一个用于防止化疗后24小时内呕吐的药品;奈妥匹坦(netupitant),一种用于治疗化疗后120小时内发生的最初的反胃及恶心。

Akynzeo临床试验中的不良反应包括头疼,乏力,消化不良及便秘。

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: -  
Akynzeo (netupitant and palonosetron)
AKYNZEO(netupitant/palonosetron)
 

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