Revestive

teduglutide

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This is a summary of the European public assessment report (EPAR) for Revestive. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Revestive.

What is Revestive?

Revestive is a medicine that contains the active substance teduglutide. It is available as a powder and a solvent to be made up into a solution for injection.

What is Revestive used for?

Revestive is used to treat adults and children from the age of 1 year with short bowel syndrome. Short bowel syndrome is a condition in which nutrients and fluids are not properly absorbed by the gut, usually following the surgical removal of a large portion of the small intestine. Revestive is used after ‘intestinal adaptation’ has occurred (changes in the function of the bowel to compensate for its reduced size following surgery).

Because the number of patients with short bowel disease is low, the disease is considered ‘rare’, and Revestive was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 11 December 2001.

The medicine can only be obtained with a prescription.

How is Revestive used?

Treatment should be started under the supervision of a doctor with experience in treating short bowel syndrome. At the time of starting treatment with Revestive and regularly during treatment, a specialist should perform a colonoscopy (an examination of the bowel) to find out whether there are polyps (growths) in the large intestine. A colonoscopy should also be performed in children under 12 years of age if blood is detected in their stool. Any polyps detected before treatment will have to be removed.

Revestive is given as an injection under the skin of the abdomen. The recommended dose is 0.05 mg per kilogram body weight once a day. The daily dose may be lowered if needed to reduce side effects. The daily dose should be reduced by half in patients with moderate or severely reduced kidney function. If a benefit is not observed, treatment should be stopped.

How does Revestive work?

The active substance in Revestive, teduglutide, is similar to human glucagon-like peptide 2 (GLP‑2), a hormone made in the gut that increases absorption of nutrients from the intestine.

Teduglutide works in a similar way to GLP-2 and increases intestinal absorption by: increasing blood flow to and from the gut, reducing the speed at which food passes through and reducing acid secretions in the stomach which can interfere with absorption in the intestine. Teduglutide has the advantage of lasting longer than GLP-2 in the body.

How has Revestive been studied?

Revestive was studied in two main studies. The first study involved 86 adults with short bowel syndrome due to removal of a large section of the small intestine and who needed parenteral nutrition (nutrients and fluids given directly into a vein) at least three times a week.

In this study, patients received Revestive or placebo (a dummy treatment) every day for 24 weeks. The main measure of effectiveness was the percentage of patients who responded to treatment. Response to treatment was defined as reaching at least a 20% reduction in the volume of parenteral nutrition at week 20, and maintaining at least a 20% reduction of weekly volume of parenteral nutrition at week 24.

The second study involved 42 children with short bowel syndrome who needed parenteral nutrition. Patients received different doses of Revestive or standard treatment for 12 weeks. The main measure of effectiveness was the percentage of patients who responded to treatment, defined as those who reached at least a 10% reduction in the volume of parenteral nutrition at week 12.

What benefit has Revestive shown during the studies?

In the study in adults, 62.8% (27 out of 43) of patients who received Revestive responded to treatment, compared with 30.2% (13 out of 43) who received placebo.

In the second study, 53% (8 out of 15) of children who received Revestive responded to treatment, while none responded to the standard treatment (0 out of 5).

What is the risk associated with Revestive?

The most commonly reported side effects with Revestive were abdominal pain and distension (aching and swollen stomach, 49%), respiratory tract infections (infections of the throat, sinuses, airways or lungs, 28%), nausea (feeling sick, 27%), reddening, pain or swelling at the site of the injection (21%), headache (17%), vomiting (14%) and peripheral oedema (swelling of hands and/or feet, 10%). Approximately 38% of the treated patients with a stoma (an artificial opening at the front of the abdomen to collect faeces or urine from the body) experienced stoma complications such as swelling of the stoma. The majority of these reactions were mild or moderate. For the full list of all side effects reported with Revestive, see the package leaflet.

Revestive must not be used in patients who have, or are suspected to have, a cancer. It must not be used in patients who have had a gastrointestinal cancer (cancer of the stomach, gut or liver) in the last five years. For the full list of restrictions, see the package leaflet.

Why has Revestive been approved?

The CHMP considered that Revestive was beneficial for adults with short bowel syndrome as it significantly reduced the amount of parenteral nutrition needed, an effect which was maintained after a year of treatment. Patients who need high volumes of parenteral nutrition may benefit from a significant reduction, whereas patients in need of low amounts may have the chance to be weaned off completely. The Committee also noted that short bowel syndrome is a serious and disabling condition for which only limited symptomatic treatment exists. Furthermore, Revestive showed an acceptable safety profile for up to one year of treatment in adults. Similar efficacy results and safety profile were seen in children, supporting the use of Revestive in these patients.

Therefore, the CHMP decided that Revestive’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of Revestive?

Revestive was shown to stimulate the growth of cells in the lining of the gut in experimental models. Although Revestive was not shown to have an effect on initiating tumours, the company will closely monitor the medicine’s safety and effectiveness by setting up a registry of patients. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revestive have also been included in the summary of product characteristics and the package leaflet.

Other information about Revestive

The European Commission granted a marketing authorisation valid throughout the European Union for Revestive on 30 August 2012.

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

Name Language First published Last updated
Revestive : EPAR - Summary for the public BG = bălgarski 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public ES = español 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public CS = čeština 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public DA = dansk 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public DE = Deutsch 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public ET = eesti keel 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public EL = elliniká 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public EN = English 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public FR = français 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public IT = italiano 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public LV = latviešu valoda 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public LT = lietuvių kalba 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public HU = magyar 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public MT = Malti 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public NL = Nederlands 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public PL = polski 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public PT = português 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public RO = română 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public SK = slovenčina 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public SL = slovenščina 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public FI = suomi 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public SV = svenska 24/09/2012 30/08/2016
Revestive : EPAR - Summary for the public HR = Hrvatski 24/09/2012 30/08/2016

This EPAR was last updated on 30/08/2016 .

Authorisation details

Product details

Product details for Revestive
NameRevestive
Agency product numberEMEA/H/C/002345
Active substance

teduglutide

International non-proprietary name (INN) or common name

teduglutide

Therapeutic area Malabsorption Syndromes
Anatomical therapeutic chemical (ATC) code A16AX08
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.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Revestive
Marketing-authorisation holder

Shire Pharmaceuticals Ireland Ltd

Revision6
Date of issue of marketing authorisation valid throughout the European Union30/08/2012

Contact address:

Shire Pharmaceuticals Ireland Ltd

Citywest Business Campus
5 Riverwalk
Dublin 24
Dublin
IRELAND

Product information

Product information

29/06/2016  Revestive -EMEA/H/C/002345 - II/0020

Name Language First published Last updated
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016
Revestive : EPAR - Product Information HR = Hrvatski 24/09/2012 20/09/2016

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
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  
Revestive : EPAR - All Authorised presentations HR = Hrvatski 24/09/2012  

Pharmacotherapeutic group

Other alimentary tract and metabolism products

Therapeutic indication

Revestive is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome. Patients should be stable following a period of intestinal adaptation after surgery.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Revestive : EPAR - Public assessment report HR = Hrvatski 24/09/2012  
CHMP summary of positive opinion for Revestive HR = Hrvatski 22/06/2012