Qtern

saxagliptin / dapagliflozin

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

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

What is Qtern and what is it used for?

Qtern is used to treat adults with type 2 diabetes to improve control of their blood glucose (sugar) levels. It contains the active substances saxagliptin and dapagliflozin.

Qtern is used in patients whose blood glucose levels are not satisfactorily controlled with:

  • metformin and one of the components of Qtern;
  • a sulphonylurea and one of the components of Qtern;
  • metformin, a sulphonylurea and one of the components of Qtern.

Qtern can also be used to replace saxagliptin and dapagliflozin taken as separate tablets.

How is Qtern used?

Qtern is available as tablets (5 mg saxagliptin and 10 mg dapagliflozin) and can only be obtained with a prescription. The recommended dose is one tablet taken once a day. For further information, see the package leaflet.

How does Qtern work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the levels of glucose in the blood or when the body is unable to respond to insulin effectively. This leads to high levels of glucose in the blood.

Qtern contains two different active substances, which work in different ways:

  • dapagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2). As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine. By blocking the action of SGLT2, dapagliflozin causes more glucose to be removed via the kidney, through the urine, thereby reducing the levels of glucose in the blood. Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
  • saxagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor. It works by blocking the breakdown of incretin hormones in the body. These hormones are released after a meal and stimulate the pancreas to produce insulin. By increasing levels of incretin hormones in the blood, saxagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high. Saxagliptin does not work when the blood glucose is low. Saxagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Saxagliptin has been authorised in the EU as Onglyza since 2009.

As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.

What benefits of Qtern have been shown in studies?

Dapagliflozin in combination with saxagliptin (the same combination as in Qtern) was evaluated in 3 main studies involving 1,169 adults with type 2 diabetes. The main measure of effectiveness was the change after 24 weeks of treatment in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.

The first study included patients whose blood glucose levels were not satisfactorily controlled with metformin alone. Results showed that when saxagliptin and dapagliflozin were taken together with metformin, they decreased HbA1c levels by 1.5 percentage points after 24 weeks, compared with a reduction of 0.9 percentage points with saxagliptin and metformin and 1.2 percentage points with dapagliflozin and metformin. HbA1c levels were on average around 9% at the start of the study.

The second study included patients whose blood glucose levels were not satisfactorily controlled with metformin and dapagliflozin. Results showed that adding saxagliptin to treatment with dapagliflozin and metformin for 24 weeks reduced HbA1c levels by 0.5 percentage points, compared with a reduction of 0.2 percentage points when placebo (a dummy treatment) was added to treatment with dapagliflozin and metformin. HbA1c levels were around 8% at the start of the study.

A further study, which included patients not controlled with metformin and saxagliptin, showed that adding dapagliflozin to treatment with saxagliptin and metformin for 24 weeks reduced HbA1c levels by 0.8 percentage points, compared with a reduction of 0.1 percentage points when placebo was added to saxagliptin and metformin.

The company also provided studies that were used in the authorisation of Forxiga and Onglyza where saxagliptin or dapagliflozin were used together with a sulphonylurea.

What are the risks associated with Qtern?

The most common side effects with Qtern (which may affect more than 1 in 10 people) are upper respiratory tract infection (such as nose and throat infections) and, when used with a sulphonylurea, hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with Qtern, see the package leaflet.

Qtern must not be used in people who are hypersensitive (allergic) to saxagliptin, dapagliflozin, any of the other ingredients or who have ever had a serious allergic reaction to any DPP-4 or SGLT2 inhibitor.

Why is Qtern approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Qtern’s benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP concluded that Qtern is effective when using it to replace saxagliptin and dapagliflozin taken as separate tablets. The CHMP also considered Qtern to be effective at controlling blood glucose levels when used in patients who were not satisfactorily controlled with metformin plus either saxagliptin or dapagliflozin. Although both components of Qtern contribute to lowering blood glucose levels, the effects of each may vary in different patients. The CHMP therefore considered that Qtern should only be used in patients already receiving at least one component to avoid over-treatment and so that the value of each component can be judged individually.

On the basis of previous studies with the individual components of Qtern used together with a sulphonylurea, the CHMP also approved the combination of Qtern with a sulphonylurea.

Regarding its safety profile, Qtern was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.

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

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Qtern have been included in the summary of product characteristics and the package leaflet.

Other information about Qtern

The European Commission granted a marketing authorisation valid throughout the European Union for Qtern on 15 July 2016.

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

Name Language First published Last updated
Qtern : EPAR - Summary for the public BG = bălgarski 2016-07-27  
Qtern : EPAR - Summary for the public ES = español 2016-07-27  
Qtern : EPAR - Summary for the public CS = čeština 2016-07-27  
Qtern : EPAR - Summary for the public DA = dansk 2016-07-27  
Qtern : EPAR - Summary for the public DE = Deutsch 2016-07-27  
Qtern : EPAR - Summary for the public ET = eesti keel 2016-07-27  
Qtern : EPAR - Summary for the public EL = elliniká 2016-07-27  
Qtern : EPAR - Summary for the public EN = English 2016-07-27  
Qtern : EPAR - Summary for the public FR = français 2016-07-27  
Qtern : EPAR - Summary for the public IT = italiano 2016-07-27  
Qtern : EPAR - Summary for the public LV = latviešu valoda 2016-07-27  
Qtern : EPAR - Summary for the public LT = lietuvių kalba 2016-07-27  
Qtern : EPAR - Summary for the public HU = magyar 2016-07-27  
Qtern : EPAR - Summary for the public MT = Malti 2016-07-27  
Qtern : EPAR - Summary for the public NL = Nederlands 2016-07-27  
Qtern : EPAR - Summary for the public PL = polski 2016-07-27  
Qtern : EPAR - Summary for the public PT = português 2016-07-27  
Qtern : EPAR - Summary for the public RO = română 2016-07-27  
Qtern : EPAR - Summary for the public SK = slovenčina 2016-07-27  
Qtern : EPAR - Summary for the public SL = slovenščina 2016-07-27  
Qtern : EPAR - Summary for the public FI = suomi 2016-07-27  
Qtern : EPAR - Summary for the public SV = svenska 2016-07-27  
Qtern : EPAR - Summary for the public HR = Hrvatski 2016-07-27  

This EPAR was last updated on 13/06/2017 .

Authorisation details

Product details

Product details for Qtern
NameQtern
Agency product numberEMEA/H/C/004057
Active substance

saxagliptin / dapagliflozin propanediol monohydrate

International non-proprietary name (INN) or common name

saxagliptin / dapagliflozin

Therapeutic area Diabetes Mellitus, Type 2
Anatomical therapeutic chemical (ATC) code A10BD21
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 Qtern
Marketing-authorisation holder

Astra Zeneca AB

Revision1
Date of issue of marketing authorisation valid throughout the European Union15/07/2016

Contact address:

Astra Zeneca AB
51 85 Södertälje
Sweden

Product information

Product information

21/04/2017  Qtern -EMEA/H/C/004057 -WS/1055

Name Language First published Last updated
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13
Qtern : EPAR - Product Information HR = Hrvatski 2016-07-27 2017-06-13

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
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  
Qtern : EPAR - All Authorised presentations HR = Hrvatski 2016-07-27  

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:

  • to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control,
  • when already being treated with the free combination of dapagliflozin and saxagliptin.
  • (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)

    Assessment History

    Changes since initial authorisation of medicine

    Name Language First published Last updated
    Qtern : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-06-13  

    Initial marketing-authorisation documents

    Name Language First published Last updated
    Qtern : EPAR - Public assessment report HR = Hrvatski 2016-07-27  
    CHMP summary of opinion for Qtern HR = Hrvatski 2016-05-27  

    Authorised

    This medicine is approved for use in the European Union