Moventig

naloxegol

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This is a summary of the European public assessment report (EPAR) for Moventig. 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 Moventig.

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

What is Moventig and what is it used for?

Moventig is a medicine used in adults to treat constipation caused by pain relief medicines called opioids. It is used in patients in whom treatment with laxatives has failed.

Moventig contains the active substance naloxegol.

How is Moventig used?

Moventig is available as tablets (12.5 and 25 mg). The recommended dose is one 25 mg tablet a day. A lower starting dose of 12.5 mg may be prescribed in patients with moderately or severely reduced kidney function or who are taking certain other medicines that increase the effects of Moventig. Before starting treatment with Moventig, treatment with laxatives should be stopped.

The medicine can only be obtained with a prescription.

How does Moventig work?

Opioids relieve pain by attaching to ‘opioid receptors’ in the brain and spinal cord. However, these receptors are also found in the gut and when opioids attach to the gut receptors, they reduce the movement of the gut and can cause constipation.

The active substance in Moventig, naloxegol, is a peripheral mu-opioid-receptor antagonist. This means that it attaches to a specific type of opioid receptor called the ‘mu-opioid receptor’ and blocks opioids from binding to these receptors. Naloxegol is derived from naloxone, a well-known substance that is used to block the action of opioids. Naloxegol is less able to enter the brain than naloxone, meaning that it can block the mu-opioid receptors in the gut but less in the brain. By blocking receptors in the gut, Moventig reduces the constipation due to opioids, but does not interfere with their pain relief effects.

What benefits of Moventig have been shown in studies?

Moventig has been shown to be effective at treating constipation in adults who had an inadequate response to laxatives in two main studies. The studies involved 1,352 adults with constipation caused by opioids that were being used to treat non-cancer pain, half of whom had an inadequate response to laxatives (720). People either received Moventig (at 12.5 and 25 mg) or placebo (a dummy treatment) for 12 weeks. The response to treatment was based on an improvement of the number of spontaneous bowel movements per week which had to be maintained for most of the duration of the study. When looking at the results of both main studies together, 48% (115 out of 241) of adults who previously had an inadequate response to laxatives and who took 25 mg Moventig responded to treatment compared with 30% (72 out of 239) of adults on placebo. For adults who took 12.5 mg Moventig and who previously had an inadequate response to laxatives, 43% (102 out of 240) responded to treatment.

What are the risks associated with Moventig?

The most common side effects with Moventig (which may affect more than 5 in 100 people) are abdominal pain (stomach ache), diarrhoea, nausea (feeling sick), headache and flatulence (passing wind). The majority of side effects affecting the gut were mild to moderate, occurred early in treatment and got better during continued treatment.

Moventig must not be used in patients who have or who are at high risk of bowel obstruction (blockage in the gut) or in patients with cancer who are at a high risk of gastro-intestinal perforation (a hole that develops in the wall of the gut). It must also not be used with certain medicines that affect the way Moventig is broken down in the body.

For the full list of all side effects and restrictions reported with Moventig, see the package leaflet.

Why is Moventig approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Moventig’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that Moventig had shown a clinically relevant benefit when used in adults who have not responded adequately to previous treatment with laxatives. Although studies in patients with cancer-related pain had not been conducted, based on the mechanism of action of the medicine, the benefit for these patients was not expected to be different but the safety should be closely monitored. In terms of safety, the side effects were considered acceptable or manageable.

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

A risk management plan has been developed to ensure that Moventig 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 Moventig, 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 Moventig

The European Commission granted a marketing authorisation valid throughout the European Union for Moventig on 8 December 2014.

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

Name Language First published Last updated
Moventig : EPAR - Summary for the public BG = bălgarski 2014-12-17  
Moventig : EPAR - Summary for the public ES = español 2014-12-17  
Moventig : EPAR - Summary for the public CS = čeština 2014-12-17  
Moventig : EPAR - Summary for the public DA = dansk 2014-12-17  
Moventig : EPAR - Summary for the public DE = Deutsch 2014-12-17  
Moventig : EPAR - Summary for the public ET = eesti keel 2014-12-17  
Moventig : EPAR - Summary for the public EL = elliniká 2014-12-17  
Moventig : EPAR - Summary for the public EN = English 2014-12-17  
Moventig : EPAR - Summary for the public FR = français 2014-12-17  
Moventig : EPAR - Summary for the public IT = italiano 2014-12-17  
Moventig : EPAR - Summary for the public LV = latviešu valoda 2014-12-17  
Moventig : EPAR - Summary for the public LT = lietuvių kalba 2014-12-17  
Moventig : EPAR - Summary for the public HU = magyar 2014-12-17  
Moventig : EPAR - Summary for the public MT = Malti 2014-12-17  
Moventig : EPAR - Summary for the public NL = Nederlands 2014-12-17  
Moventig : EPAR - Summary for the public PL = polski 2014-12-17  
Moventig : EPAR - Summary for the public PT = português 2014-12-17  
Moventig : EPAR - Summary for the public RO = română 2014-12-17  
Moventig : EPAR - Summary for the public SK = slovenčina 2014-12-17  
Moventig : EPAR - Summary for the public SL = slovenščina 2014-12-17  
Moventig : EPAR - Summary for the public FI = suomi 2014-12-17  
Moventig : EPAR - Summary for the public SV = svenska 2014-12-17  
Moventig : EPAR - Summary for the public HR = Hrvatski 2014-12-17  
Name Language First published Last updated
Moventig : EPAR - Risk-management-plan summary (English only) 2014-12-17  

This EPAR was last updated on 10/05/2017 .

Authorisation details

Product details

Product details for Moventig
NameMoventig
Agency product numberEMEA/H/C/002810
Active substance

naloxegol oxalate

International non-proprietary name (INN) or common name

naloxegol

Therapeutic area ConstipationOpioid-Related Disorders
Anatomical therapeutic chemical (ATC) code A06AH03
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 Moventig
Marketing-authorisation holder

Kyowa Kirin Limited

Revision3
Date of issue of marketing authorisation valid throughout the European Union08/12/2014

Contact address:

Kyowa Kirin Limited
Galabank Business Park
Galashiels
TD1 1QH
United Kingdom
 

Product information

Product information

21/04/2017  Moventig -EMEA/H/C/002810 -N/0013

Name Language First published Last updated
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10
Moventig : EPAR - Product Information EN = English 2014-12-17 2017-05-10

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
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  
Moventig : EPAR - All Authorised presentations EN = English 2014-12-17  

Pharmacotherapeutic group

Film-coated tablet

Therapeutic indication

Treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Moventig : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-05-30 2017-05-10

Initial marketing-authorisation documents

Name Language First published Last updated
Moventig : EPAR - Public assessment report EN = English 2014-12-17  
CHMP summary of positive opinion for Moventig EN = English 2014-09-26  

Authorised

This medicine is approved for use in the European Union