Akynzeo

netupitant / palonosetron

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Akynzeo. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Akynzeo.

For practical information about using Akynzeo, patients should read the package leaflet or contact their doctor or pharmacist.

What is Akynzeo and what is it used for?

Akynzeo is a medicine used to prevent nausea (feeling sick) and vomiting in adult patients with cancer who are receiving chemotherapy (medicines to treat cancer).

Some chemotherapy is known to induce severe nausea and vomiting, and Akynzeo is used in patients receiving either highly emetogenic (vomit-inducing) chemotherapy based on the cancer medicine cisplatin, or other chemotherapies that are moderately emetogenic.

Akynzeo contains the active substances netupitant and palonosetron.

How is Akynzeo used?

Akynzeo is available as capsules containing 300 mg of netupitant and 0.5 mg of palonosetron. The patient takes one capsule one hour before starting each chemotherapy cycle.

The medicine can only be obtained with a prescription.

How does Akynzeo work?

The two active substances in Akynzeo work by blocking two different mechanisms involved in inducing nausea and vomiting during chemotherapy. Netupitant works by blocking neurokinin-1 (NK1)-receptors, which are found in the nervous system and are responsible for the delayed phase of nausea and vomiting (that occurs after the first 24 hours); palonosetron, on the other hand, blocks 5HT3 receptors in the gut, which are responsible for the immediate phase (that occurs within the first 24 hours).

By having both active substances together, Akynzeo helps provide control for both the immediate and delayed phases of nausea and vomiting than occur following chemotherapy.

One of the active substances, palonosetron, has been authorised on its own in the EU since 2005.

What benefits of Akynzeo have been shown in studies?

In a main study comparing Akynzeo with palonosetron alone, 90% of patients taking Akynzeo (121 out of 135) experienced no vomiting within 5 days of starting highly emetogenic chemotherapy compared with 77% of patients taking palonosetron alone (104 out of 136).

A second main study looked at the benefits of Akynzeo in patients undergoing moderately emetogenic chemotherapy. Around 88% of patients taking Akynzeo experienced no vomiting on day 1 following the first chemotherapy cycle, compared with 85% of patients taking palonosetron. The figures for day 2 to day 5 were 77% for patients in the Akynzeo group and 70% for those in the palonosetron group. This study involved 1,455 patients and the patients took dexamethasone, another medicine used to prevent vomiting, as an additional treatment.

What are the risks associated with Akynzeo?

The most common side effects reported with Akynzeo are headache (seen in 3.6% of patients), constipation (3.0%) and fatigue (1.2%). For the full list of all side effects and restrictions, see the package leaflet.

Why is Akynzeo approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) noted that Akynzeo was effective at preventing both the immediate and delayed phases of nausea and vomiting following chemotherapy, and that the medicine has a favourable safety profile. The Committee therefore concluded that the medicine’s benefits are greater than its risk and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Akynzeo?

A risk management plan has been developed to ensure that Akynzeo is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Akynzeo, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Akynzeo

The European Commission granted a marketing authorisation valid throughout the European Union for Akynzeo on 27 May 2015.

For more information about treatment with Akynzeo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Akynzeo : EPAR - Summary for the public BG = bălgarski 23/06/2015  
Akynzeo : EPAR - Summary for the public ES = español 23/06/2015  
Akynzeo : EPAR - Summary for the public CS = čeština 23/06/2015  
Akynzeo : EPAR - Summary for the public DA = dansk 23/06/2015  
Akynzeo : EPAR - Summary for the public DE = Deutsch 23/06/2015  
Akynzeo : EPAR - Summary for the public ET = eesti keel 23/06/2015  
Akynzeo : EPAR - Summary for the public EL = elliniká 23/06/2015  
Akynzeo : EPAR - Summary for the public EN = English 23/06/2015  
Akynzeo : EPAR - Summary for the public FR = français 23/06/2015  
Akynzeo : EPAR - Summary for the public IT = italiano 23/06/2015  
Akynzeo : EPAR - Summary for the public LV = latviešu valoda 23/06/2015  
Akynzeo : EPAR - Summary for the public LT = lietuvių kalba 23/06/2015  
Akynzeo : EPAR - Summary for the public HU = magyar 23/06/2015  
Akynzeo : EPAR - Summary for the public MT = Malti 23/06/2015  
Akynzeo : EPAR - Summary for the public NL = Nederlands 23/06/2015  
Akynzeo : EPAR - Summary for the public PL = polski 23/06/2015  
Akynzeo : EPAR - Summary for the public PT = português 23/06/2015  
Akynzeo : EPAR - Summary for the public RO = română 23/06/2015  
Akynzeo : EPAR - Summary for the public SK = slovenčina 23/06/2015  
Akynzeo : EPAR - Summary for the public SL = slovenščina 23/06/2015  
Akynzeo : EPAR - Summary for the public FI = suomi 23/06/2015  
Akynzeo : EPAR - Summary for the public SV = svenska 23/06/2015  
Akynzeo : EPAR - Summary for the public HR = Hrvatski 23/06/2015  
Name Language First published Last updated
Akynzeo : EPAR - Risk-management-plan summary (English only) 23/06/2015  

This EPAR was last updated on 11/08/2016 .

Authorisation details

Product details

Product details for Akynzeo
NameAkynzeo
Agency product numberEMEA/H/C/003728
Active substance

netupitant / palonosetron hydrochloride

International non-proprietary name (INN) or common name

netupitant / palonosetron

Therapeutic area NauseaVomitingCancer
Anatomical therapeutic chemical (ATC) code A04AA
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Akynzeo
Marketing-authorisation holder

Helsinn Birex Pharmaceuticals Ltd

Revision1
Date of issue of marketing authorisation valid throughout the European Union27/05/2015

Contact address:

Helsinn Birex Pharmaceuticals Ltd
Damastown 
Mulhuddart 
15 Dublin
Ireland

Product information

Product information

16/06/2016  Akynzeo -EMEA/H/C/003728 -IB/0006

Name Language First published Last updated
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016
Akynzeo : EPAR - Product Information EN = English 23/06/2015 11/08/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  
Akynzeo : EPAR - All Authorised presentations EN = English 23/06/2015  

Pharmacotherapeutic group

Antiemetics and antinauseants

Therapeutic indication

Akynzeo is indicated in adults for the:

  • Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy.
  • Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Akynzeo : EPAR - Procedural steps taken and scientific information after authorisation EN = English 11/08/2016  
CHMP summary of positive opinion for Akynzeo EN = English 27/03/2015  

Initial marketing-authorisation documents

Name Language First published Last updated
Akynzeo : EPAR - Public assessment report EN = English 23/06/2015  

Authorised

This medicine is approved for use in the European Union