Lyxumia

lixisenatide

  • Email
  • Help

About

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

What is Lyxumia?

Lyxumia is a diabetes medicine that contains the active substance lixisenatide. It is available as a solution for injection in a pre‑filled pen that provides either 10 micrograms or 20 micrograms of lixisenatide in each dose.

What is Lyxumia used for?

Lyxumia is used in adults who have type 2 diabetes to control their blood glucose (sugar) level. It is used together with diabetes medicines taken by mouth and/or basal insulin (long-acting insulin) in patients whose blood glucose levels are not adequately controlled by these medicines together with diet and exercise.

The medicine can only be obtained with a prescription.

How is Lyxumia used?

Lyxumia is injected once a day, in the hour before the same meal every day. It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh. Lyxumia is started at a dose of 10 micrograms once a day which is increased to 20 micrograms once a day after 14 days.

If the patient is already taking a sulphonylurea (another diabetes medicine) or basal insulin, the doctor may need to reduce the dose of the sulphonylurea or basal insulin because there is a risk of hypoglycaemia (low blood sugar levels). Adding Lyxumia to metformin is not associated with this risk. Lyxumia should not be given with a combination of both, basal insulin and a sulphonylurea.

How does Lyxumia work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Lyxumia, lixisenatide, is a ‘GLP-1 receptor agonist’. It works by attaching to glucagon-like peptide 1 (GLP-1) receptors that are found on the surface of the cells in the pancreas and that cause the production of insulin by the pancreas. When Lyxumia is injected, lixisenatide reaches the receptors in the pancreas and activates them. This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.

How has Lyxumia been studied?

Lyxumia has been studied in seven main studies involving 3,825 adults with type 2 diabetes. Six of the studies compared Lyxumia with placebo (a dummy treatment), used alone or when added to metformin, a sulphonylurea, basal insulin, or a combination of two of these medicines, in patients in whom previous treatment had failed. In one study, Lyxumia was compared with another diabetes medicine called exenatide when added to metformin in patients whose blood sugar levels were not adequately controlled by metformin.

All of the studies measured the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached. HbA1c gives an indication of how well the blood glucose is controlled. HbA1c levels were measured after 12 weeks when Lyxumia was used alone and after 24 weeks when it was used in combination with other diabetes medicines.

What benefit has Lyxumia shown during the studies?

Lyxumia was more effective than placebo at controlling blood glucose. When used on its own, Lyxumia reduced Hb1Ac levels by 0.6% more than placebo. When used in combination with other diabetes medicines, Lyxumia reduced Hb1Ac levels by 0.4 up to 0.9% more than placebo.

The study comparing Lyxumia with exenatide (added to metformin) showed reduced HbA1c levels by 0.79% after 24 weeks treatment with Lyxumia compared to 0.96% with exenatide twice daily.

What is the risk associated with Lyxumia?

The most common side effects with Lyxumia (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea and headache. These side effects were mostly mild and usually resolved over time. When used together with a sulphonylurea or basal insulin, the most common side effect (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). Allergic reactions have been reported in less than 1 in 100 patients using Lyxumia.

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

Why has Lyxumia been approved?

The CHMP concluded that Lyxumia was shown to be effective at lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines. In addition, beneficial weight loss was seen in patients treated with Lyxumia. Regarding its safety, most side effects are comparable to those of other similar diabetes medicines with side effects affecting the gut being the most common ones. The CHMP concluded that the benefits of Lyxumia outweigh its risks and recommended that it be granted marketing authorisation.

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

A risk management plan has been developed to ensure that Lyxumia 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 Lyxumia, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Lyxumia

The European Commission granted a marketing authorisation valid throughout the European Union for Lyxumia on 1 February 2013.

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

Name Language First published Last updated
Lyxumia : EPAR - Summary for the public BG = bălgarski 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public ES = español 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public CS = čeština 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public DA = dansk 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public DE = Deutsch 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public ET = eesti keel 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public EL = elliniká 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public EN = English 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public FR = français 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public IT = italiano 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public LV = latviešu valoda 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public LT = lietuvių kalba 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public HU = magyar 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public MT = Malti 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public NL = Nederlands 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public PL = polski 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public PT = português 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public RO = română 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public SK = slovenčina 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public SL = slovenščina 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public FI = suomi 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public SV = svenska 14/03/2013 15/10/2014
Lyxumia : EPAR - Summary for the public HR = Hrvatski 14/03/2013 15/10/2014

This EPAR was last updated on 04/05/2016 .

Authorisation details

Product details

Product details for Lyxumia
NameLyxumia
Agency product numberEMEA/H/C/002445
Active substance

lixisenatide

International non-proprietary name (INN) or common name

lixisenatide

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BX10
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 Lyxumia
Marketing-authorisation holder

Sanofi-Aventis Groupe

Revision6
Date of issue of marketing authorisation valid throughout the European Union01/02/2013

Contact address:

Sanofi-Aventis Groupe
54 rue La Boétie
75008 Paris
France

Product information

Product information

02/05/2016  Lyxumia -EMEA/H/C/002445 -II/0014

Name Language First published Last updated
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016
Lyxumia : EPAR - Product Information HR = Hrvatski 14/03/2013 04/05/2016

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
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  
Lyxumia : EPAR - All Authorised presentations HR = Hrvatski 14/03/2013  

Pharmacotherapeutic group

Other blood glucose lowering drugs, excl. insulins

Therapeutic indication

Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Lyxumia : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 28/11/2013 04/05/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Lyxumia : EPAR - Public assessment report HR = Hrvatski 14/03/2013  
CHMP summary of positive opinion for Lyxumia HR = Hrvatski 16/11/2012