Toujeo (previously Optisulin)

insulin glargine

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This is a summary of the European Public Assessment Report (EPAR) for Toujeo. 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 Toujeo.

What is Toujeo?

Toujeo is a solution for injection that contains the active substance insulin glargine. Toujeo 300 units/ml is available in prefilled SoloStar pens. The 100 units/ml strength is approved in vials, cartridges, prefilled OptiSet pens and prefilled SoloStar pens.

What is Toujeo used for?

Toujeo 300 units/ml is used to treat diabetes in adult patients. The 100 units/ml strength is used to treat diabetes in patients aged two years or older.

The medicine can only be obtained with a prescription.

How is Toujeo used?

Toujeo is given by injection under the skin in the abdominal wall (tummy), the thigh, or the deltoid region (shoulder). The site of injection should be changed with each injection to avoid changes to the skin (such as thickening) that can make the insulin work less well than expected. The patient’s blood glucose (sugar) should be regularly tested to find the lowest effective dose.

Toujeo is given once a day. In adults (aged 18 years or over) it can be given at any time, provided that it is at the same time each day. The 100 units/ml strength should be given in the evening in patients aged less than 18 years. Toujeo can also be given together with diabetes medicines taken by mouth in patients who have type-2 diabetes.

Patients can inject themselves with Toujeo if they have been trained appropriately.

Toujeo 300 units/ml and insulin glargine 100 units/ml must not be used interchangeably. This is because a given dose of Toujeo 300 units/ml does not result in the same amount of insulin in the body at the same dose of the insulin glargine 100 units/ml. The volume to be injected of Toujeo 300 units/ml is smaller in comparison with insulin glargine 100 units/ml.

When switching from insulin glargine 100 units/ml to Toujeo 300 units/ml or vice versa the dose of insulin may need to be adjusted. Care should also be taken when switching from other basal insulins to Toujeo or vice versa as the dose of insulin may need to be adjusted. Further information can be found in the summary of product characteristics (also part of the EPAR).

How does Toujeo work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Toujeo is a replacement insulin that is very similar to the insulin made by the body.

The active substance in Toujeo, insulin glargine, is slightly different from human insulin. The change means that it is absorbed more slowly and regularly by the body after an injection, and that it has a long duration of action. The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has Toujeo been studied?

Insulin glargine 100 units/ml was originally studied in 10 studies, in both type-1 diabetes (when the pancreas cannot produce insulin) and type-2 diabetes (when the body is unable to use insulin effectively). A total of 2,106 patients received insulin glargine 100 units/ml in all trials combined. The main studies compared insulin glargine 100 units/ml given once a day at bedtime with human insulin NPH (an intermediate-acting insulin) given once or twice a day. Injections of fast-acting insulin were also used at mealtimes. In one study, patients with type-2 diabetes also received antidiabetes medicines by mouth.

Further studies have also been carried out to compare insulin glargine 100 units/ml and human insulin NPH in patients with type-1 diabetes aged between five and 18 years, 200 of whom received insulin glargine 100 units/ml, and in children aged two to six years, 61 of whom received insulin glargine 100 units/ml.

Studies have also been carried out in nearly 1,400 adults with type 1 or type 2 diabetes to measure the effectiveness of insulin glargine 100 units/ml injected at any time during the day, compared with an injection given in the evening.

All of the studies measured the level of ‘fasting’ blood glucose (measured when the patient had not eaten for at least eight hours) or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.

In four more studies, the effects on the blood sugar levels of the higher strength of Toujeo (300 units/ml) were compared with those of insulin glargine 100 units/ml in 3,045 patients with either type-1 or type-2 diabetes. Additional studies (known as pharmacokinetic studies) compared the levels of insulin glargine in the blood obtained after administering the two strengths.

What benefit has Toujeo shown during the studies?

Toujeo 100 units/ml led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with human insulin. Insulin glargine 100 units/ml was effective in managing diabetes in adults and children aged two years and above. The effectiveness of insulin glargine 100 units/ml was seen regardless of the time of the injection.

In the studies comparing the two strengths of insulin glargine, Toujeo 300 units/ml strength was comparable to insulin glargine (100 units/ml) at controlling sugar levels.

What is the risk associated with Toujeo?

The most common side effect with Toujeo (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). Reactions at the site of the injection (redness, pain, itching and swelling) and skin reactions (rash) have been seen more often in children than in adults.

In type-2 diabetes patients, the incidence of confirmed hypoglycaemia was lower with Toujeo 300 units/ml, in particular at night, as compared to insulin glargine 100 units/ml.

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

Why has Toujeo been approved?

The CHMP decided that Toujeo’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

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

Other information about Toujeo

The European Commission granted a marketing authorisation valid throughout the European Union for Optisulin on 27 June 2000. The name of the medicine was changed to Toujeo on 24 April 2015.

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

Name Language First published Last updated
Toujeo : EPAR - Summary for the public BG = bălgarski 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public ES = español 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public CS = čeština 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public DA = dansk 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public DE = Deutsch 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public ET = eesti keel 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public EL = elliniká 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public EN = English 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public FR = français 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public IT = italiano 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public LV = latviešu valoda 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public LT = lietuvių kalba 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public HU = magyar 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public MT = Malti 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public NL = Nederlands 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public PL = polski 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public PT = português 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public RO = română 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public SK = slovenčina 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public SL = slovenščina 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public FI = suomi 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public SV = svenska 11/05/2009 07/05/2015
Toujeo : EPAR - Summary for the public HR = Hrvatski 11/05/2009 07/05/2015

This EPAR was last updated on 25/01/2016 .

Authorisation details

Product details

Product details for Toujeo (previously Optisulin)
NameToujeo (previously Optisulin)
Agency product numberEMEA/H/C/000309
Active substance

insulin glargine

International non-proprietary name (INN) or common name

insulin glargine

Therapeutic area Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code A10AE04

Publication details

Publication details for Toujeo (previously Optisulin)
Marketing-authorisation holder

sanofi-aventis Deutschland GmbH

Revision22
Date of issue of marketing authorisation valid throughout the European Union27/06/2000

Contact address:

sanofi-aventis Deutschland GmbH
D-65926 Frankfurt am Main
Germany

Product information

Product information

04/12/2015  Toujeo (previously Optisulin) -EMEA/H/C/000309 -IB/0093/G

Name Language First published Last updated
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016
Toujeo : EPAR - Product Information HR = Hrvatski 11/05/2009 25/01/2016

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
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015
Toujeo : EPAR - All Authorised presentations HR = Hrvatski 11/05/2009 09/07/2015

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Optisulin : EPAR - Procedural steps taken before authorisation HR = Hrvatski 21/10/2005  
Optisulin : EPAR - Scientific Discussion HR = Hrvatski 21/10/2005  

Authorised

This medicine is approved for use in the European Union

Preventing medication errors